DUOTRAV

Israel - English - Ministry of Health

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Active ingredient:
TIMOLOL AS MALEATE; TRAVOPROST
Available from:
NOVARTIS ISRAEL LTD
ATC code:
S01ED51
Pharmaceutical form:
OPHTHALMIC SOLUTION
Composition:
TRAVOPROST 40 MCG/ML; TIMOLOL AS MALEATE 5 MG/ML
Administration route:
OCULAR
Prescription type:
Required
Manufactured by:
ALCON COUVREUR, BELGIUM
Therapeutic group:
TIMOLOL, COMBINATIONS
Therapeutic area:
TIMOLOL, COMBINATIONS
Therapeutic indications:
Decrease of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Authorization number:
144 33 31764 00
Authorization date:
2015-09-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

10-06-2018

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

This medicine is dispensed with a doctor’s prescription only

DuoTrav

Eye Drops (Solution)

Composition:

Active ingredients:

Travoprost 40 mcg/mL

Timolol as maleate 5 mg/mL

For the list of inactive ingredients in the preparation see section 6 - “Further Information” and

section 2 – “Important information regarding some of the ingredients of the medicine”.

Read this leaflet carefully in its entirety before using the medicine. This leaflet

contains concise information about the medicine. If you have further questions, refer to

the doctor or pharmacist.

Keep this leaflet; you may need to read it again.

This medicine has been prescribed for the treatment of your ailment. Do not pass it on to

others. It may harm them even if it seems to you that their medical condition is similar.

1. WHAT IS THE MEDICINE INTENDED FOR?

To reduce intraocular pressure in cases of open-angle glaucoma or intraocular hypertension

that are insufficiently responsive to topical beta blockers or prostaglandin analogs.

Therapeutic group:

Travoprost – prostaglandin analog, which works by increasing the outflow of aqueous fluid

from the eye, thereby lowering ocular pressure.

Timolol (as maleate) – beta blocker, which works by reducing the production of fluid within

the eye.

The two substances work together to reduce pressure within the eye.

2. BEFORE USING THE MEDICINE

X

Do not use this medicine if:

∙ You are sensitive (allergic) to travoprost, prostaglandins, timolol, beta blockers or to any

of the other ingredients of the medicine (as detailed in section 6).

∙ You are breastfeeding.

∙ You are suffering, or have suffered in the past, from breathing problems, such as asthma

or severe chronic bronchitis (a severe lung disease that may cause wheezing, breathing

difficulties and/or persistent cough) or other breathing problems.

∙ You suffer from severe hay fever.

∙ You have a slow heart rate, heart failure or arrhythmia (irregular heart rate).

∙ You suffer from cloudiness of the surface of the eye.

If any of these conditions apply to you, consult the doctor.

Special warnings regarding the use of the medicine

!

Before treatment with DuoTrav, tell the doctor if you are suffering, or have

suffered in the past, from -

Coronary heart disease (symptoms may include tightness or pain in the chest, shortness

of breath or choking), heart failure, low blood pressure.

Heart rhythm disorder, such as a slow heart rate.

Breathing problems, asthma or chronic obstructive pulmonary disease.

Impaired blood flow (such as Raynaud’s disease or Raynaud’s syndrome).

Diabetes (as timolol may mask signs and symptoms of low blood sugar).

Overactive thyroid (as timolol may mask signs and symptoms of thyroid disease).

Myasthenia gravis (chronic neuromuscular weakness).

Cataract surgery.

Eye inflammation.

If you are due to undergo any surgery, inform the doctor that you are using DuoTrav,

since timolol may change the effect of certain medicines used during anesthesia.

If you experience any severe allergic reaction (skin rash, redness and itchiness in the

eye) when using DuoTrav, regardless of the cause, treatment with adrenalin may be less

effective. Therefore, when receiving any other treatment, it is important that you tell the

doctor that you are using DuoTrav.

DuoTrav may change the color of the iris (the colored part of the eye). This change may

be irreversible.

DuoTrav may increase the length, thickness, color and/or number of eye lashes, and can

cause unusual hair growth on the eyelids.

Travoprost may be absorbed through the skin and therefore should not be used by women

who are pregnant or are trying to become pregnant. If the medicine comes into contact with

the skin, it should be rinsed off immediately.

!

Children and adolescents:

DuoTrav is not intended for use in children and adolescents under 18 years of age.

!

Drug interactions

DuoTrav can affect or be affected by other medicines you use (including other eye drops

for glaucoma treatment).

If you are taking, or have recently taken, other medicines, including non-prescription

medicines and nutritional supplements, tell the doctor or pharmacist. In particular,

if you are taking or planning to take:

∙ Medicines to lower blood pressure

∙ Medicines for the heart including quinidine (used to treat heart problems and certain types

of malaria)

∙ Preparations to treat diabetes

∙ Antidepressants: fluoxetine or paroxetine

!

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you are pregnant or are planning a pregnancy,

consult the doctor before using this medicine.

Do not use DuoTrav during pregnancy, unless the doctor thinks it is necessary.

If you are of child-bearing age, use adequate contraceptives during use of DuoTrav.

Do not use DuoTrav if you are breastfeeding. DuoTrav may pass into breast milk.

!

Driving and using machines

Use of DuoTrav may cause blurred vision for some time after use. Do not drive or operate

dangerous machinery until this effect passes.

!

Important information regarding some of the ingredients of the medicine

DuoTrav contains hydrogenated castor oil and 7.5 mg/ml propylene glycol, which may cause

reaction and irritation of the skin.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the doctor's instructions. Check with the doctor

or pharmacist if you are uncertain about the dosage and treatment regimen of the

preparation.

The dosage and the treatment regimen will be determined by the doctor only.

The usual dosage is generally: One drop in the treated eye, once a day (in the morning or

evening).

Make sure to use at the same time every day.

Only use DuoTrav in both eyes if the doctor has instructed you to do so. Use DuoTrav as

eye drops only.

Do not exceed the recommended dose.

Do not swallow! This medicine is intended for external use only.

Direction for use:

∙ Immediately before using the bottle for the first time, tear off the over-wrap to open (Figure

1), remove the bottle and record the opening date on the label.

∙ Make sure that you have a mirror close by.

∙ To prevent contamination, do not allow the tip of the bottle to come into contact with any

surface (including the eye itself). Keep the bottle tightly closed.

∙ The bottle of drops may not be full; this is meant to allow better control over the drip

rate.

∙ How to use the drops: First, wash your hands. Hold the bottle, pointing downwards, between

your thumb and index finger (Figure 3). Tilt your head back. Using your index finger, pull

your lower lid downward to create a kind of “pocket” (Figure 2). Bring the bottle close to

the eye; use a mirror if it helps. Drip the medicine gently, to allow for release of one drop

of DuoTrav, into the “pocket” that has been formed (Figure 2). Close your eyes gently.

Do not blink. Leave your eyes closed for 2 minutes.

∙ In addition to the instructions above – immediately after instilling the drops into the eye,

press on the inner corner of the eye using your middle finger (Figure 4). Continue applying

pressure for 2 minutes after instilling into the eye. This action helps avoid the absorption

of the medicine into the body thus helping to prevent side effects.

∙ If you didn’t succeed in instilling into the eye – try again.

∙ If you have to use DuoTrav in both eyes, repeat the above steps for the other eye.

∙ Close the bottle tightly immediately after use.

∙ After using the medicine, wash your hands thoroughly in order to wash off remnants of

the medicine.

∙ In order to avoid spread of infection, do not use the same bottle of medicine for more than

one person. Do not open the over-wrap until you need to use the bottle.

Use DuoTrav for the amount of time your doctor has instructed you to.

If you accidentally used a higher dosage, rinse the eye with lukewarm water. Do not

instill more drops into the eye until time for the next dose.

If you accidentally swallow the medicine, refer immediately to a doctor or proceed to a

hospital emergency room and bring the package of the medicine with you.

If you forgot to take this medicine at the required time, take the next dose at the usual

time and consult the doctor. Do not take a double dose to compensate for the forgotten

dose. Do not exceed the dosage of one drop daily per treated eye(s).

Adhere to the treatment regimen recommended by the doctor. Even if there is an improvement

in your condition, do not stop taking the medicine without consulting the doctor.

Discontinuing use of the medicine without consulting the doctor, may lead to

uncontrolled intraocular pressure, which may lead to loss of vision.

If you are using other eye drops in addition to DuoTrav, wait at least 5 minutes between

the application of DuoTrav and other eye drops.

If you are wearing soft contact lenses, do not use the drops while wearing the lenses. Wait

15 minutes after using the drops before putting back the lenses.

Do not take medicines in the dark! Check the label and the dose each time you

take the medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine, consult the doctor

or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of DuoTrav may cause side effects in some users. Do not be

alarmed by the list of side effects. You may not suffer from any of them.

You will usually be able to continue using the medicine, unless the effects are severe. If you

are concerned, refer to the doctor or pharmacist. Do not stop using the medicine without

consulting the doctor.

Very common side effects – side effects that occur in more than one user in ten:

Effects in the eye

Eye redness.

Common side effects – effects that occur in 1-10 users in 100:

Effects in the eye

Inflammation with damage to the surface of the eye, eye pain, blurred vision, visual

disturbances, dry eyes, eye itching, eye discomfort, signs and symptoms of eye irritation

(such as tingling and burning sensations in the eye).

Uncommon side effects – effects that occur in 1-10 users in 1,000:

Effects in the eye

Inflammation of the surface of the eye, inflammation of the eyelid, swelling of the conjunctiva,

increased growth of eyelashes, inflammation of the iris, eye inflammation, sensitivity to light,

vision impairment, tired eyes, eye allergy, eye swelling, increased tear production, eyelid

redness, eyelid discoloration, skin darkening (around the eye).

General effects

Allergic reactions to the active ingredient, dizziness, headaches, increased or lowered blood

pressure, shortness of breath, excessive hair growth, postnasal drip, skin inflammation and

itching, decreased heart rate.

Rare side effects – effects that occur in 1-10 users in 10,000:

Effects in the eye

Thinning of the surface of the eye, inflammation of the eyelid glands, rupture of blood

vessels in the eye, crusty layer on the eyelid, irregular position of the eyelashes, irregular

growth of eyelashes.

General effects

Nervousness, irregular heart rate, hair loss, voice disorders, breathing difficulty, cough, throat

irritation, urticaria, abnormal liver function test results, skin discoloration, thirst, tiredness,

discomfort in the inner part of the nose, dark urine, pains in hands and legs.

Side effects of unknown frequency (effects whose frequency has not been

determined yet):

Effects in the eye

Drooping eyelids (causes the eyes to be partially shut), sunken eyes (the eyes look more

sunken), change in the color of the iris (the colored part of the eye).

General effects

Rash, heart failure, chest pains, stroke, fainting, depression, asthma, increased heart rate,

numbness or tingling sensation, palpitations, swelling in lower limbs, bad taste in the

mouth.

In addition;

DuoTrav contains a combination of two active ingredients, travoprost and timolol. Like other

eye medicines, travoprost and timolol (beta blocker) are absorbed into the blood. This can

cause side effects similar to those can be seen with oral or intravenous administration of

beta blocker medicines. The frequency of these side effects is lower following use in eyes

as compared with oral or intravenous administration.

The side effects listed below include reactions observed upon treatment with beta blocker

medicines when administered for the treatment of eye effects, or reactions observed upon

administration of travoprost alone:

Effects in the eye

Eyelid inflammation, keratitis, detachment of the layer under the retina containing blood

vessels following filtration surgery, which might result in visual disturbances, reduced corneal

sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, discharge

from the eye, swelling around the eye, eyelid itching, outward turning of the eyelid with

redness, irritation and excess tearing, blurred vision (signs of cloudiness on the lenses of

the eye), inflammation of part of the eye (uvea), eyelid eczema, halo vision, decreased eye

sensation, pigmentation inside the eye, dilated pupils, change in eyelash color, change in

eyelash texture, abnormal field of vision.

General effects

Ear and labyrinth (inner ear) disorders: dizziness with spinning sensation, ringing in the

ears.

Heart and blood vessels: slow heart rate, palpitations, edema (fluid retention), change

in heartbeat rhythm or speed, heart failure (a heart disease accompanied by shortness

of breath and swelling of the feet and legs due to fluid retention), a certain type of heart

rhythm disturbance, heart attack, low blood pressure, Raynaud’s effect, cold hands and legs,

reduced blood supply to the brain.

Airways: narrowing of the airways in the lungs (mostly in patients with pre-existing disease,

runny nose or nasal congestion, sneezing (due to allergy), difficulty breathing, nose bleed,

dry nose.

Nervous system and general effects: difficulty sleeping (insomnia), nightmares, memory

loss, reduced strength and energy, anxiety (excessive emotional stress).

Gastrointestinal system: taste disorders, nausea, indigestion, diarrhea, dry mouth, abdominal

pain, vomiting and constipation.

Allergy: increase in allergy symptoms, general allergic reactions including swelling under

the skin, which can occur in areas such as the face and limbs and cause obstruction of the

airways, which can cause difficulty in swallowing or breathing, generalized or local rash,

itching, acute life-threatening allergic reaction.

Skin: skin rash with a white-silvery appearance (psoriasiform rash) or aggravated psoriasis,

skin peeling, unusual hair texture, skin inflammation accompanied by a red, itchy rash, hair

discoloration, eyelash loss, itching, unusual hair growth, skin redness.

Muscles: increased signs and symptoms of myasthenia gravis (a muscle disorder), abnormal

sensations such as prickling, muscles weakness/tiredness, muscle pain not due to physical

exercise, joint pain.

Kidney and urinary system disturbances: difficulty and pain upon passing urine, urinary

incontinence.

Reproductive system: impotence, decreased libido.

Metabolism: low blood sugar levels, increased prostate cancer markers.

If a side effect occurs, if one of the side effects worsens or if you suffer from a

side effect not mentioned in this leaflet, consult with the doctor.

Reporting side effects

Side effects can be reported to the Ministry of Health by clicking on the link "Report Side

Effects of Drug Treatment" found on the Ministry of Health homepage (www.health.gov.il),

that directs you to the online form for reporting side effects, or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMed

ic@moh.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine and any other medicine should be kept in a safe place out

of the reach of children and/or infants in order to avoid poisoning. Do not induce vomiting

unless explicitly instructed to do so by the doctor.

∙ Do not use the medicine after the expiry date (exp. date) that appears on the package/

label. The expiry date refers to the last day of that month.

∙ Do not store above 25°C.

∙ Can be used for up to 4 weeks after first opening, in order to prevent risk of infections.

Each time you start using a new bottle, record the opening date on the label and carton.

∙ To help protect the environment, consult the pharmacist regarding how to dispose of

medicines that are no longer in use.

6. FURTHER INFORMATION

In addition to the active ingredients, the medicine also contains:

Propylene glycol, boric acid, mannitol, sodium chloride, polyoxyethylene hydrogenated, Castor

oil 40 (HCO-40), Polyquanterium-1 solution (equivalent to Polyquanterium-1), hydrochloric

acid and/or sodium hydroxide (for pH adjustment), purified water.

What the medicine looks like and the contents of the package

DuoTrav is a clear, colorless solution provided in a plastic 2.5 mL bottle with a screw cap.

The bottle is packaged in an aluminum wrapper.

Manufacturer and address: Alcon Couvreur, Puurs, Belgium.

ALCON COUVREUR, RIJKSWEG 14, 2870 PUURS, BELGIUM

Registration holder: Novartis Israel Ltd., 36 Shacham St., Petach-Tikva.

This leaflet was checked and approved by the Ministry of Health in: January 2016 and was

updated in April 2018, in accordance with the Ministry of Health guidelines.

Registration number of the medicine in the National Drug Registry of the Ministry

of Health: 144 33 31764

SH DUO APL NOT APR18 CL V2

SH DUO APL NOT APR18 CL V2

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ﺎﺿﺍﺮﻋﺃ ﺐﺒﺴﻳ ﺪﻗ ڤﺍﺮﺗﻮﺋﻭﺩ ﻝﺎﻤﻌﺘﺳﺇ ﻥﺇ ،ﺀﺍﻭﺩ ﻞﻜﺑ ﺎﻤﻛ .ﺎﻬﻨﻣ

ﺎﻳﺃ ﻲﻧﺎﻌﺗ ﻻﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ .ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﻊﺟﺍﺭ ،

ﺎﻘﻠﻗ ﺖﻨﻛ ﺍﺫﺇ .ﺓﺪﻳﺪﺷ ﺽﺍﺮﻋﻷﺍ ﺖﻧﺎﻛ ﺍﺫﺇ ﻻﺇ ،ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺔﻠﺻﺍﻮﻣ ﺓﺩﺎﻋ ﻚﻨﻜﻤﻳ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﻥﻭﺪﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻋ ﻒﻗﻮﺘﺗ ﻻ ﺪﺣﺍﻭ ﻞﻤﻌﺘﺴﻣ ﻦﻣ ﺮﺜﻛﺃ ﻯﺪﻟ ﺮﻬﻈﺗ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ـ (

very common

)

ﺍﺪﺟ ﺔﻌﺋﺎﺷ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :ﺓﺮﺸﻋ ﻦﻴﺑ ﻦﻣ ﻦﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ .ﻦﻴﻌﻟﺍ ﻲﻓ ﺭﺍﺮﻤﺣﺇ :١٠٠ ﻦﻴﺑ ﻦﻣ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ ـ (

common

) ﺔﻌﺋﺎﺷ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﻲﻓ ﺔﻜﺣ ،ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﻑﺎﻔﺟ ،ﺔﻳﺅﺮﻟﺍ ﻲﻓ ﺏﺍﺮﻄﺿﺇ ،ﺔﻳﺅﺮﻟﺍ ﺵﻮﺸﺗ ،ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﻡﻻﺁ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﻲﻓ ﺭﺮﻀﺗ ﻊﻣ ﺏﺎﻬﺘﻟﺇ .(ﻦﻴﻌﻟﺍ ﻲﻓ ﺔﻗﺮﺣﻭ ﺰﺧﻮﺑ ﺭﻮﻌﺸﻟﺍ ،

ﻼﺜﻣ) ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺞﻴﻬﺘﻟ ﺽﺍﺮﻋﺃﻭ ﺕﺎﻣﻼﻋ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺝﺎﻋﺰﻧﺇ ،ﻦﻴﻌﻟﺍ :١٠٠٠ ﻦﻴﺑ ﻦﻣ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ ـ (

uncommon

) ﺔﻌﺋﺎﺷ ﺮﻴﻏ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺏﺎﻬﺘﻟﺇ ،ﺔﻴﺣﺰﻘﻟﺍ ﺏﺎﻬﺘﻟﺇ ،ﺵﻮﻣﺮﻠﻟ ﺪﺋﺍﺯ ﻮﻤﻧ ،ﺔﻤﺤﺘﻠﻤﻟﺍ ﺥﺎﻔﺘﻧﺇ ،ﻦﻔﺠﻟﺍ ﻲﻓ ﺏﺎﻬﺘﻟﺇ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﺏﺎﻬﺘﻟﺇ ﺭﺍﺮﻤﺣﺇ ،ﻉﻮﻣﺪﻟﺍ ﺝﺎﺘﻧﺇ ﺓﺩﺎﻳﺯ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺥﺎﻔﺘﻧﺇ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺔﻴﺳﺎﺴﺣ ،ﻦﻴﻨﻴﻌﻟﺍ ﺐﻌﺗ ،ﺔﻳﺅﺮﻟﺍ ﻲﻓ ﺭﺮﻀﺗ ،ﺀﻮﻀﻠﻟ ﺔﻴﺳﺎﺴﺣ .(ﻦﻴﻌﻟﺍ ﻝﻮﺣ ﻦﻣ) ﺪﻠﺠﻟﺍ ﺔﻧﺎﻛﺩ ،ﻦﻔﺠﻟﺍ ﻥﻮﻟ ﻲﻓ ﺮﻴﻐﺗ ،ﻦﻔﺠﻟﺍ ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ ﻂﻴﻘﻨﺗ ،ﺮﻌﺸﻠﻟ ﺪﺋﺍﺯ ﻮﻤﻧ ،ﺲﻔﻨﺗ ﻖﻴﺿ ،ﻡﺪﻟﺍ ﻂﻐﺿ ﺽﺎﻔﺨﻧﺇ ﻭﺃ ﻉﺎﻔﺗﺭﺇ ،ﻉﺍﺪﺻ ،ﺭﺍﻭﺩ ،ﺔﻟﺎﻌﻔﻟﺍ ﺓﺩﺎﻤﻠﻟ ﺔﻴﺴﺴﺤﺗ ﻞﻌﻓ ﺩﻭﺩﺭ .ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻲﻓ ﺺﻗﺎﻨﺗ ،ﺪﻠﺠﻟﺍ ﻲﻓ ﺔﻜﺣﻭ ﺏﺎﻬﺘﻟﺇ ،ﻖﻠﺤﻠﻟ ﻲﻔﻠﺨﻟﺍ ﻢﺴﻘﻟﺍ ﻲﻓ :١٠٠٠٠ ﻦﻴﺑ ﻦﻣ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠-١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ ـ (

rare

) ﺓﺭﺩﺎﻧ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﻱﺩﺎﻋ ﺮﻴﻏ ﻊ

ﺿﻮﺗ ،ﻦﻔﺠﻟﺍ ﻰﻠﻋ ﺓﺮﺸﻗ ﺔﻘﺒﻃ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺔﻳﻮﻣﺩ ﺔﻴﻋﻭﺃ ﻕ

ﺰﻤﺗ ،ﻦﻔﺠﻟﺍ ﺩﺪﻏ ﺏﺎﻬﺘﻟﺇ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﻖﻗﺮﺗ .ﺵﻮﻣﺮﻠﻟ ﻱﺩﺎﻋ ﺮﻴﻏ ﻮﻤﻧ ،ﺵﻮﻣﺮﻠﻟ ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ ﻲﻓ ﺞﻴﻬﺗ ،ﻝﺎﻌﺳ ،ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﺔﺑﻮﻌﺻ ،ﺕﻮﺼﻟﺍ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺇ ،ﺮﻌﺸﻟﺍ ﻂﻗﺎﺴﺗ ،ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻡﺎﻈﺘﻧﺇ ﻡﺪﻋ ،ﺔﻴﺒﺼﻋ ﻲﻠﺧﺍﺪﻟﺍ ﻢﺴﻘﻟﺍ ﻲﻓ ﺝﺎﻋﺰﻧﺇ ،ﻕﺎﻫﺭﺇ ،ﺶﻄﻋ ،ﺪﻠﺠﻟﺍ ﻥﻮﻟ ﺮﻴﻐﺗ ،ﺪﺒﻜﻟﺍ ﻒﺋﺎﻇﻭ ﺺﺤﻔﻟ ﺔﻤﻴﻠﺳ ﺮﻴﻏ ﺞﺋﺎﺘﻧ ،ﻯﺮﺷ ،ﺓﺮﺠﻨﺤﻟﺍ .ﻦﻴﻠﺟﺮﻟﺍﻭ ﻦﻳﺪﻴﻟﺍ ﻲﻓ ﻡﻻﺁ ،ﻦﻛﺍﺩ ﻝﻮﺑ ،ﻒﻧﻷﺍ ﻦﻣ :(ﺎﻬﻋﻮﻴﺷ ﺪﻌﺑ ﺩ

ﺪﺤ

ﻳ ﻢﻟ ﺽﺍﺮﻋﺃ ) ﻑﻭﺮﻌﻣ ﺮﻴﻏ ﻉﻮﻴﺷ ﺕﺍﺫ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﻲﻓ ﺕﺍﺮﻴﻐﺗ ،(ﺮﺜﻛﺃ ﻞﻜﺸﺑ ﻦﻴﺗﺮﺋﺎﻏ ﻦﻴﻨﻴﻌﻟﺍ ﻭﺪﺒﺗ) ﺓﺮﺋﺎﻏ ﻥﻮﻴﻋ ،(ﻒﺼﻨﻟﺍ ﻰﻟﺇ ﻦﻴﻨﻴﻌﻟﺍ ﻕﻼﻐﻧﻹ ﻱﺩﺆﻳ) ﻦﻴﻨﻔﺠﻟﺍ ﻲﻟﺪﺗ .(ﻦﻴﻌﻟﺍ ﻦﻣ ﻥﻮﻠﻤﻟﺍ ﻢﺴﻘﻟﺍ) ﺔﻴﺣﺰﻘﻟﺍ ﻥﻮﻟ ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ ﺕﺎﺑﺮﺿ ،ﺰﺧﻮﺑ ﺭﻮﻌﺸﻟﺍ ﻭﺃ ﺭﺪﺧ ،ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻲﻓ ﺓﺩﺎﻳﺯ ،ﻮﺑﺭ ،ﺏﺎﺌﺘﻛﺇ ،ﺀﺎﻤﻏﺇ ،ﺔﺘﻜﺳ ،ﺭﺪﺼﻟﺍ ﻲﻓ ﻡﻻﺁ ،ﺐﻠﻘﻟﺍ ﺭﻮﺼﻗ ،ﺢﻔﻃ .ﻢﻔﻟﺍ ﻲﻓ ﺀﻲﺳ ﻢﻌﻃ ،ﺔﻴﻠﻔﺴﻟﺍ ﻑﺍﺮﻃﻷﺍ ﻲﻓ ﺥﺎﻔﺘﻧﺇ ،ﺐﻠﻗ ؛ﻚﻟﺬﻟ ﺔﻓﺎﺿﻹﺎﺑ ﻢﺘﻳ ،ﻯﺮﺧﻷﺍ ﻦﻴﻨﻴﻌﻟﺍ ﺔﻳﻭﺩﻷ ﻪﺑﺎﺸﻤﻟﺎﺑ .ﻝﻮﻟﻮﻤﻴﺗﻭ ﺖﺳﻭﺮﭘﻮﭬﺍﺮﺗ ،ﻦﻴﺘﻟﺎﻌﻓ ﻦﻴﺗﺩﺎﻣ ﻦﻣ ﺞﻳﺰﻣ ﻰﻠﻋ ڤﺍﺮﺗﻮﺋﻭﺩ ﻱﻮﺘﺤﻳ ﻲﺘﻟﺍ ﻚﻠﺗ ﻪﺒﺸﺗ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﺐﺒﺴﻳ ﻥﺃ ﻦﻜﻤﻳ ﺮﻣﻷﺍ ﺍﺬﻫ .ﻡﺪﻟﺍ ﻰﻟﺇ (ﺎﺘﻴﺑ ﺐﺟﺎﺣ) ﻝﻮﻟﻮﻤﻴﺗﻭ ﺖﺳﻭﺮﭘﻮﭬﺍﺮﺗ ﺹﺎﺼﺘﻣﺇ ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻌﺑ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻉﻮﻴﺷ ﻥﺇ .ﻦﻘﺤﻟﺎﺑ ﻭﺃ ﻢﻔﻟﺍ ﻖﻳﺮﻃ ﻦﻋ ﺎﺘﻴﺑ ﺕﺎﺒﺟﺎﺣ ﻉﻮﻧ ﻦﻣ ﺔﻳﻭﺩﺃ ﺀﺎﻄﻋﺇ ﺪﻨﻋ ﺮﻬﻈﺗ .ﻦﻘﺤﻟﺎﺑ ﻭﺃ ﻢﻔﻟﺍ ﻖﻳﺮﻃ ﻦﻋ ﺀﺎﻄﻋﻺﻟ ﺔﻧﺭﺎﻘﻤﻟﺎﺑ ﺾﻔﺨﻨﻣ ﻮﻫ ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺎﻣﺪﻨﻋ ﺎﺘﻴﺑ ﺕﺎﺒﺟﺎﺣ ﻉﻮﻧ ﻦﻣ ﺔﻳﻭﺩﺄﺑ ﺝﻼﻌﻟﺍ ﻲﻓ ﺖﻈﺣﻮﻟ ﻲﺘﻟﺍ ﻞﻌﻔﻟﺍ ﺩﻭﺩﺭ ﻞﻤﺸﺗ

ﺎﻘﺣﻻ ﺔﻧﻭﺪﻤﻟﺍ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻥﺇ :ﻩﺪﺣﻮﻟ ﺖﺳﻭﺮﭘﻮﭬﺍﺮﺗ ﺀﺎﻄﻋﺈﺑ ﺖﻈﺣﻮﻟ ﻲﺘﻟﺍ ﻞﻌﻔﻟﺍ ﺩﻭﺩﺭ ﻭﺃ ﺔﻴﻨﻴﻌﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﺠﻟﺎﻌﻤﻟ ﻰﻄﻌ

ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﺔﻴﻠﻤﻋ ﺏﺎﻘﻋﺃ ﻲﻓ ﺔﻳﻮﻣﺩ ﺔﻴﻋﻭﺃ ﻰﻠﻋ ﺔﻳﻭﺎﺤﻟﺍ ﺔﻴﻜﺒﺸﻟﺍ ﺖﺤﺗ ﺔﻘﺒﻄﻟﺍ ﻝﺎﺼﻔﻧﺇ ،ﺔﻴﻧﺮﻘﻟﺍ ﻲﻓ ﺏﺎﻬﺘﻟﺇ ،ﻦﻔﺠﻟﺍ ﻲﻓ ﺏﺎﻬﺘﻟﺇ ﺭﺮﻀﺗ) ﺔﻴﻧﺮﻘﻟﺍ ﻞﻛﺂﺗ ،ﺔﻴﻧﺮﻘﻟﺍ ﺔﻴﺳﺎﺴﺣ ﻲﻓ ﺺﻗﺎﻨﺗ ،ﺔﻳﺅﺮﻟﺍ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺇ ﺙﻭﺪﺤﻟ ﻱﺩﺆﺗ ﺪﻗ ﻲﺘﻟﺍ ﺔﻴﺣﺍﺮﺠﻟﺍ ﺢﻴﺷﺮﺘﻟﺍ ﻦﻴﻨﻔﺠﻟﺍ ﻝ

ﻮﺤﺗ ،ﻦﻔﺠﻟﺍ ﻲﻓ ﺔﻜﺣ ،ﻦﻴﻌﻟﺍ ﻝﻮﺣ ﺥﺎﻔﺘﻧﺇ ،ﻦﻴﻌﻟﺍ ﻦﻣ ﺕﺍﺯﺍﺮﻓﺇ ،ﺔﻳﺅﺮﻟﺍ ﺝﺍﻭﺩﺯﺇ ،(ﻦﻴﻌﻟﺍ ﺔﻠﻘﻤﻟ ﺔﻴﻣﺎﻣﻷﺍ ﺔﻘﺒﻄﻟﺍ ﻢﺴﻗ ﺥﺎﻔﺘﻧﺇ ،(ﻦﻴﻌﻟﺍ ﺕﺎﺳﺪﻋ ﻲﻓ ﺔﻴﺑﺎﺒﺿ ﺕﺎﻣﻼﻋ) ﺔﻳﺅﺮﻟﺍ ﻲﻓ ﺵﻮﺸﺗ ،ﻉﻮﻣﺪﻟﺍ ﺓﺩﺎﻳﺯﻭ ﺞﻴﻬﺗ ،ﺭﺍﺮﻤﺣﺇ ﻊﻣ ﺔﻳﻮﺳ ﺝﺭﺎﺨﻟﺍ ﻮﺤﻧ ﻍﺎﺒﺻ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺲﺤﻟﺍ ﺺﻗﺎﻨﺗ ،(

halo vision

) ﺔﻟﺎﻫ ﺔﻳﺅﺭ ،ﻦﻴﻨﻔﺠﻟﺍ ﻲﻓ ﺎﻤﻳﺰﻛﺇ ،(

uvea

ـ ﺔ

ﻴﺒﻨﻌﻟﺍ) ﻦﻴﻌﻟﺍ ﻦﻣ .ﺔﻳﺅﺮﻟﺍ ﻞﻘﺣ ﺔﻣﻼﺳ ﻡﺪﻋ ،ﺵﻮﻣﺮﻟﺍ ﻡﺍﻮﻗ ﻲﻓ ﺕﺍﺮﻴﻐﺗ ،ﺵﻮﻣﺮﻟﺍ ﻥﻮﻟ ﻲﻓ ﺕﺍﺮﻴﻐﺗ ،ﻦﻴﺘﻗﺪﺤﻟﺍ ﻊﺳﻮﺗ ،ﻦﻴﻌﻟﺍ ﻞﺧﺍﺩ ﻲﻓ ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ .ﻦﻴﻧﺫﻷﺍ ﻲﻓ ﻦﻴﻨﻃ ،ﻥﺍﺭﻭﺪﺑ ﺭﻮﻌﺸﻟﺎﺑ ﻖﻓﺍﺮﺘﻳ ﺭﺍﻭﺩ :(ﺔﻴﻠﺧﺍﺪﻟﺍ ﻥﺫﻷﺍ) ﻥﺫﻷﺍ ﺥﺎﻤ

ﺻ ﻲﻓﻭ ﻦﻴﻧﺫﻷﺍ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺇ ﺕﺎﻀﺒﻧ ﺔﻋﺮﺳ ﻭﺃ ﻢﻈﻧ ﻲﻓ ﺮﻴﻐﺗ ،(ﻞﺋﺍﻮﺴﻟﺍ ﺱﺎﺒﺘﺣﺇ) ﺔﻣﺫﻭ ،ﺐﻠﻗ ﺕﺎﺑﺮﺿ ،ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﺆﻃﺎﺒﺗ :ﺔﻳﻮﻣﺪﻟﺍ ﺔﻴﻋﻭﻷﺍﻭ ﺐﻠﻘﻟﺍ ،(ﻞﺋﺍﻮﺴﻟﺍ ﺱﺎﺒﺘﺣﺇ ﺀﺍﺮﺟ ﻦﻴﻠﺟﺮﻟﺍﻭ ﻦﻴﻣﺪﻘﻟﺍ ﻲﺘﺣﺍﺭ ﺥﺎﻔﺘﻧﺇﻭ ﺲﻔﻨﺗ ﻖﻴﻀﺑ ﻖﻓﺍﺮﺘﻳ ﻲﺒﻠﻗ ﺽﺮﻣ) ﺐﻠﻘﻟﺍ ﺭﻮﺼﻗ ،ﺐﻠﻘﻟﺍ ﺺﻗﺎﻨﺗ ،ﻦﻴﻠﺟﺮﻟﺍﻭ ﻦﻳﺪﻴﻟﺍ ﺓﺩﻭﺮﺑ ،ﻮﻨﻳﺭ ﺓﺮﻫﺎﻇ ،ﻡﺪﻟﺍ ﻂﻐﺿ ﺽﺎﻔﺨﻧﺇ ،ﺔﻴﺒﻠﻗ ﺔﺑﻮﻧ ،ﺐﻠﻘﻟﺍ ﻢﻈﻧ ﻲﻓ ﺏﺍﺮﻄﺿﺇ ﻦﻣ ﻦﻴﻌﻣ ﻉﻮﻧ .ﻍﺎﻣﺪﻠﻟ ﻡﺪﻟﺍ ﺪﻳﻭﺰﺗ ﻲﻓ ﻭﺃ ﺢﺷﺭ ،ﻲﻟﺎﺣ ﺽﺮﻣ ﻦﻣ ﻥﻮﻧﺎﻌﻳ ﻦﻴﺠﻟﺎﻌﺘﻣ ﻯﺪﻟ ﺐﻠﻏﻷﺍ ﻰﻠﻋ) ﻦﻴﺘﺋﺮﻟﺍ ﻲﻓ ﺔﻴﺴﻔﻨﺘﻟﺍ ﻕﺮﻄﻟﺍ ﻖﻴﻀﺗ :ﺔﻴﺴﻔﻨﺘﻟﺍ ﻕﺮﻄﻟﺍ .ﻒﻧﻷﺍ ﻲﻓ ﻑﺎﻔﺟ ،ﻑﺎﻋﺭ ،ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﺔﺑﻮﻌﺻ ،(ﺔﻴﺳﺎﺴﺤﻟﺍ ﺐﺒﺴﺑ) ﺱﺎﻄﻋ ،ﻒﻧﻷﺍ ﻲﻓ ﻥﺎﻘﺘﺣﺇ ﻖﻠﻗ ،ﺔﻗﺎﻄﻟﺍﻭ ﺓﻮﻘﻟﺍ ﺺﻗﺎﻨﺗ ،ﺓﺮﻛﺍﺬﻟﺍ ﻥﺍﺪﻘﻓ ،ﺔﻴﻠﻴﻟ ﺲﻴﺑﺍﻮﻛ ،(ﻕﺭﺃ) ﻡﻮﻨﻟﺍ ﻲﻓ ﺔﺑﻮﻌﺻ :ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃﻭ ﻲﺒﺼﻌﻟﺍ ﺯﺎﻬﺠﻟﺍ .(ﻲﻟﺎﻌﻔﻧﻹﺍ ﻂﻐﻀﻟﺍ ﺓﺩﺎﻳﺯ) ﺆﻴﻘﺗ ،ﻦﻄﺒﻟﺍ ﻲﻓ ﻡﻻﺁ ،ﻢﻔﻟﺍ ﻲﻓ ﻑﺎﻔﺟ ،ﻝﺎﻬﺳﺇ ،ﺔﻴﻤﻀﻫ ﺕﺎﺑﺍﺮﻄﺿﺇ ،ﻥﺎﻴﺜﻏ ،ﻕﺍﺬﻤﻟﺍ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺇ :ﻢﻀﻬﻟﺍ ﺯﺎﻬﺟ .ﻙﺎﺴﻣﺇﻭ ﻰﻠﻋ ﺃﺮﻄﻳ ﻥﺃ ﻦﻜﻤﻳ ﻱﺬﻟﺍ ﺪﻠﺠﻟﺍ ﺖﺤﺗ ﻦﻣ ﺥﺎﻔﺘﻧﺇ ﻞﻤﺸﺗ ﺔﻣﺎﻋ ﺔﻴﺴﺴﺤﺗ ﻞﻌﻓ ﺩﻭﺩﺭ ،ﺲﺴﺤﺘﻟﺍ ﺽﺍﺮﻋﺃ ﺓﺩﺎﻳﺯ :ﺔﻴﺳﺎﺴﺣ ﻲﻓ ﻭﺃ ﻊﻠﺒﻟﺍ ﻲﻓ ﺕﺎﺑﻮﻌﺼﻟ ﻱﺩﺆﻳ ﻥﺃ ﻦﻜﻤﻳ ﻱﺬﻟﺍ ﺮﻣﻷﺍ ﺔﻴﺴﻔﻨﺘﻟﺍ ﻕﺮﻄﻟﺍ ﺩﺍﺪﺴﻧﻹ ﻱﺩﺆﻳ ﻥﺃﻭ ،ﻑﺍﺮﻃﻷﺍﻭ ﻪﺟﻮﻟﺍ ﻞﺜﻣ ﻖﻃﺎﻨﻣ .ﺓﺎﻴﺤﻟﺍ ﻰﻠﻋ

ﺍﺮﻄﺧ ﻞﻜﺸﻳ ﺪﻳﺪﺷ ﻲﺴﺴﺤﺗ ﻞﻌﻓ ﺩﺭ ،ﺔﻜﺣ ،ﻲﻌﺿﻮﻣ ﻭﺃ ﻞﻣﺎﺷ ﺢﻔﻃ ،ﺲﻔﻨﺘﻟﺍ ،ﺪﻠﺠﻟﺍ ﺮﺸﻘﺗ ،ﺔﻴﻓﺪﺼﻟﺍ ﻢﻗﺎﻔﺗ ﻭﺃ (ﻞﻜﺸﻟﺍ ﻲﻓﺪﺻ ﻉﻮﻨﻟﺍ ﻦﻣ ﺢﻔﻃ) ﻲﻀﻓ ـ ﺾﻴﺑﺃ ﺮﻬﻈﻣ ﻭﺫ ﻱﺪﻠﺟ ﺢﻔﻃ :ﺪﻠﺠﻟﺍ ﻮﻤﻧ ،ﺔﻜﺣ ،ﺵﻮﻣﺮﻟﺍ ﻂﻗﺎﺴﺗ ،ﺮﻌﺸﻟﺍ ﻥﻮﻟ ﻲﻓ ﺕﺍﺮﻴﻐﺗ ،ﻙﺎﺣ ﺮﻤﺣﺃ ﺢﻔﻄﺑ ﻖﻓﺍﺮﺘﻳ ﻱﺪﻠﺟ ﺏﺎﻬﺘﻟﺇ ،ﺮﻌﺸﻠﻟ ﻱﺩﺎﻋ ﺮﻴﻏ ﻡﺍﻮﻗ .ﺪﻠﺠﻟﺍ ﻲﻓ ﺭﺍﺮﻤﺣﺇ ،ﺮﻌﺸﻠﻟ ﻱﺩﺎﻋ ﺮﻴﻏ ،ﺰﺧﻭ ﻞﺜﻣ ﻱﺩﺎﻋ ﺮﻴﻏ ﺭﻮﻌﺷ ،(ﺕﻼﻀﻌﻟﺍ ﻲﻓ ﺏﺍﺮﻄﺿﺇ) ﻞﻴﺑﻮﻟﺍ ﻲﻠﻀﻌﻟﺍ ﻦﻫﻮﻟﺍ ﺽﺍﺮﻋﺃﻭ ﺕﺎﻣﻼﻋ ﺓﺩﺎﻳﺯ :ﺕﻼﻀﻌﻟﺍ .ﻞﺻﺎﻔﻤﻟﺍ ﻲﻓ ﻡﻻﺁ ،ﻲﻧﺪﺑ ﺪﻬﺟ ﻦﻋ ﻢﺟﺎﻧ ﺮﻴﻏ ﺕﻼﻀﻌﻟﺍ ﻲﻓ ﻢﻟﺃ ،ﻲﻠﻀﻋ ﻕﺎﻫﺭﺇ/ﻡﺎﻋ ﻒﻌﺿ .ﻱﺩﺍﺭﺇ ﻻ ﻲﻟﻮﺑ ﺲﻠﺳ ،ﻝﻮﺒﺘﻟﺍ ﺀﺎﻨﺛﺃ ﻢﻟﺃﻭ ﺔﺑﻮﻌﺻ :ﺔﻴﻟﻮﺒﻟﺍ ﻚﻟﺎﺴﻤﻟﺍﻭ ﻰﻠﻜﻟﺍ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺇ .ﺔﻴﺴﻨﺠﻟﺍ ﺔﺒﻏﺮﻟﺍ ﻲﻓ ﺺﻗﺎﻨﺗ ،ﻲﺴﻨﺟ ﺰﺠﻋ :ﺮﺛﺎﻜﺘﻟﺍ ﺯﺎﻬﺟ .ﺕﺎﺘﺳﻭﺮﭙﻟﺍ ﺓﺪﻏ ﻥﺎﻃﺮﺳ ﺕﺍﺮﺷﺆﻣ ﻉﺎﻔﺗﺭﺇ ،ﻡﺪﻟﺍ ﻲﻓ ﺮﻜﺴﻟﺍ ﺐﺴﻧ ﺽﺎﻔﺨﻧﺇ :ﺏﻼﻘﺘﺳﻹﺍ ﻩﺬﻫ ﻲﻓ ﺮﻛﺬﻳ ﻢﻟ ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﻦﻣ ﻲﻧﺎﻌﺗ ﺎﻣﺪﻨﻋ ﻭﺃ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻯﺪﺣﺇ ﺖﻤﻗﺎﻔﺗ ﺍﺫﺇ ،ﻲﺒﻧﺎﺟ ﺽﺮﻋ ﺮﻬﻇ ﺍﺫﺇ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﻚﻴﻠﻋ ،ﺓﺮﺸﻨﻟﺍ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﺐﻘﻋ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺗ» ﻂﺑﺍﺮﻟﺍ ﻰﻠﻋ ﻂﻐﻀﻟﺍ ﺔﻄﺳﺍﻮﺑ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻮﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻥﺎﻜﻣﻹﺎﺑ ﻰﻟﺇ ﻚﻬﺟﻮﻳ ﻱﺬﻟﺍ (

www.health.gov.il

) ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻊﻗﻮﻤﻟ ﺔﻴﺴﻴﺋﺮﻟﺍ ﺔﺤﻔﺼﻟﺍ ﻰﻠﻋ ﺩﻮﺟﻮﻤﻟﺍ «ﻲﺋﺍﻭﺩ ﺝﻼﻋ :ﻂﺑﺍﺮﻟﺍ ﺢﻔﺼﺗ ﻖﻳﺮﻃ ﻦﻋ ﻭﺃ ،ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻠﻟ ﺮﺷﺎﺒﻤﻟﺍ ﺝﺫﻮﻤﻨﻟﺍ ؟ﺀﺍﻭﺪﻟﺍ ﻦﻳﺰﺨﺗ ﺔﻴﻔﻴﻛ (٥ ﻭﺃ/ﻭ ﻝﺎﻔﻃﻷﺍ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ ﻦﻋ

ﺍﺪﻴﻌﺑ ﻖﻠﻐﻣ ﻥﺎﻜﻣ ﻲﻓ ﺮﺧﺁ ﺀﺍﻭﺩ ﻞﻛﻭ ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻆﻔﺣ ﺐﺠﻳ !ﻢﻤﺴﺘﻟﺍ ﺐﻨﺠﺗ ∙ .ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺔﺤﻳﺮﺻ ﺕﺎﻤﻴﻠﻌﺗ ﻥﻭﺪﺑ ﺆﻴﻘﺘﻟﺍ ﺐﺒﺴﺗ ﻻ .ﻢﻤﺴﺘﻟﺎﺑ ﻢﻬﺘﺑﺎﺻﺇ ﻱﺩﺎﻔﺘﻟ ﻚﻟﺫﻭ ،ﻊﺿﺮﻟﺍ .ﺔﻘﺼﻠﻤﻟﺍ/ﺔﺒﻠﻌﻟﺍ ﺮﻬﻇ ﻰﻠﻋ ﺮﻬﻈﻳ ﻱﺬﻟﺍ (

exp. date

) ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺀﺎﻀﻘﻧﺇ ﺪﻌﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺯﻮﺠﻳ ﻻ ∙ .ﺮﻬﺸﻟﺍ ﺲﻔﻧ ﻦﻣ ﺮﻴﺧﻷﺍ ﻡﻮﻴﻟﺍ ﻰﻟﺇ ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺮﻴﺸﻳ .ﺔﻳﻮﺌﻣ ﺔﺟﺭﺩ ٢٥ ﻦﻋ ﺪﻳﺰﺗ ﺓﺭﺍﺮﺣ ﺔﺟﺭﺪﺑ ﻦﻳﺰﺨﺘﻟﺍ ﺯﻮﺠﻳ ﻻ ∙ ﺦﻳﺭﺎﺗ ﻦﻳﻭﺪﺘﺑ ﻢﻗ .ﺙﻮﻠﺗ ﺙﻭﺪﺣ ﺓﺭﻮﻄﺧ ﺐﻨﺠﺘﻟ ﻚﻟﺫﻭ ﻊﻴﺑﺎﺳﺃ ٤ ﺓﺪﻤﻟ ﻝﺎﻤﻌﺘﺳﻹﺍ ﻥﺎﻜﻣﻹﺎﺑ ﻲﻟﻭﻷﺍ ﺢﺘﻔﻟﺍ ﺪﻌﺑ ∙ .ﺓﺪﻳﺪﺟ ﺔﻨﻴﻨﻗ ﻝﺎﻤﻌﺘﺳﺈﺑ ﺎﻬﻴﻓ ﺃﺪﺒﺗ ﺓﺮﻣ ﻞﻛ ﻲﻓ ﻚﻟﺫﻭ ،ﺔﻧﻮﺗﺮﻜﻟﺍ ﻰﻠﻋﻭ ﺔﻘﺼﻠﻤﻟﺍ ﻰﻠﻋ ﺓﻮﺒﻌﻟﺍ ﺢﺘﻓ ﺔﻳﺎﻤﺣ ﻰﻠﻋ ﺓﺪﻋﺎﺴﻤﻠﻟ ﻚﻟﺫﻭ ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻴﻗ ﺪﻌﺗ ﻢﻟ ﻲﺘﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻲﻣﺭ ﺔﻴﻔﻴﻛ ﻦﻋ ﻲﻟﺪﻴﺼﻟﺍ ﺮﺸﺘﺳﺇ ∙ .ﺔﺌﻴﺒﻟﺍ ﺔﻴﻓﺎﺿﺇ ﺕﺎﻣﻮﻠﻌﻣ (٦

ﺎﻀﻳﺃ ﺔﻟﺎﻌﻔﻟﺍ ﺩﺍﻮﻤﻠﻟ ﺔﻓﺎﺿﻹﺎﺑ ﺀﺍﻭﺪﻟﺍ ﻱﻮﺘﺤﻳ ﺔﺒﻠﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ﺀﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ .ﻲﺒﻟﻮﻟ ﺀﺎﻄﻏ ﺕﺍﺫ ﻞﻠﻣ ٢٫٥ ﻩﺭﺪﻗ ﻢﺠﺤﺑ ﻚﻴﺘﺳﻼﭙﻟﺍ ﻦﻣ ﺔﻨﻴﻨﻗ ﻦﻤﺿ ﺮﻓﻮﺘﻣ ﻥﻮﻠﻟﺍ ﻢﻳﺪﻋ ،ﻖﺋﺍﺭ ﻝﻮﻠﺤﻣ ﻮﻫ ڤﺍﺮﺗﻮﺋﻭﺩ .ﻡﻮﻴﻨﻣﻮﻟﻷﺍ ﻦﻣ ﻑﻼﻏ ﻦﻤﺿ ﺓﺄﺒﻌ

ﻣ ﺔﻨﻴﻨﻘﻟﺍ .ﺎﻜﻴﺠﻠﺑ ،ﺱﺭﻮﭘ ،ﺭﻭﺮﭬﻮﻛ ﻥﻮﻜﻟﺃ :ﻪﻧﺍﻮﻨﻋﻭ ﺞﺘﻨﻤﻟﺍ ﻢﺳﺇ

ALCON COUVREUR, RIJKSWEG 14, 2870 PUURS, BELGIUM

.ﺎﭭﻜﺗ ـ ﺢﺘﻴﭘ ،٣٦ ﻡﺎﺣﺎﺷ ﻉﺭﺎﺷ ،.ﺽ.ﻡ ﻞﻴﺋﺍﺮﺳﺇ ﺲﻴﺗﺭﺎﭬﻮﻧ :ﺯﺎﻴﺘﻣﻹﺍ ﺐﺣﺎﺻ ﺐﺟﻮﻤﺑ ﺎﻬﺜﻳﺪﺤﺗ ﻢﺗﻭ ٢٠١٦ ﻲﻧﺎﺜﻟﺍ ﻥﻮﻧﺎﻛ ﺦﻳﺭﺎﺗ ﻲﻓ ﺺﺧ

ﺭﻭ ﺺﺤ

ﻓ ﺎﻫﺍﻮﺘﺤﻣﻭ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻐﻴﺻ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﺕﺮﻗﺃ ٢٠١٨ ﻥﺎﺴﻴﻧ ﺦﻳﺭﺎﺘﺑ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﺕﺎﻤﻴﻠﻌﺗ ١٤٤ ٣٣ ٣١٧٦٤ :ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻲﻓ ﻲﻣﻮﻜﺤﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻞﺠﺳ ﻲﻓ ﺀﺍﻭﺪﻟﺍ ﻞﺠﺳ ﻢﻗﺭ ﺺﺼﺨﻣ ﺀﺍﻭﺪﻟﺍ ﻥﺈﻓ ،ﻚﻟﺫ ﻦﻣ ﻢﻏﺮﻟﺍ ﻰﻠﻋ .ﺮﻛﺬﻤﻟﺍ ﺔﻐﻴﺼﺑ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻏﺎﻴﺻ ﺖﻤﺗ ،ﺓﺀﺍﺮﻘﻟﺍ ﻦﻳﻮﻬﺗﻭ ﺔﻟﻮﻬﺳ ﻞﺟﺃ ﻦﻣ .ﻦﻴﺴﻨﺠﻟﺍ ﻼﻜﻟ

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM

edic@moh.gov.il

Propylene glycol, boric acid, mannitol, sodium chloride, polyoxyethylene hydrogenated,

Castor oil 40 (HCO-40), Polyquanterium-1 solution (equivalent to Polyquanterium-1),

hydrochloric acid and/or sodium hydroxide (for pH adjustment), purified water.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 1

1.

NAME OF THE MEDICINAL PRODUCT

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).

Excipient(s) with known effect:

Each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5

mg, polyoxyethylene hydrogenated castor oil 40 1.0 mg (see section 4.4).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ophthalmic solution (eye drops).

Clear, colourless solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section-

5.1).

4.2 Posology and method of administration

Posology

Use in adults, including the elderly

The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the

morning or evening. It should be administered at the same time each day.

If a dose is missed, treatment should be continued with the next dose as planned. The dose should

not exceed one drop in the affected eye(s) daily.

Special populations

Hepatic and renal impairment

No studies have been conducted with DuoTrav or with timolol 5 mg/ml eye drops in patients with

hepatic or renal impairment.

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with

mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was

necessary in these patients.

Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see

section 5.2).

Paediatric population

The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not

been established. No data are available.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 2

Method of administration

For ocular use.

The patient should remove the protective overwrap immediately prior to initial use. To

prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids,

surrounding areas or other surfaces with the dropper tip of the bottle.

When nasolacrimal occlusion is used or the eyelids are closed for 2 minutes, systemic absorption is

reduced. This may result in a decrease in systemic side effects and an increase in local activity (see

section 4.4).

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be

administered at least 5 minutes apart (see section 4.5).

When substituting another ophthalmic antiglaucoma medicinal product with DuoTrav, the other

medicinal product should be discontinued and DuoTrav should be started the following day.

Patients must be instructed to remove soft contact lenses prior to application of DuoTrav and wait

15 minutes after instillation of the dose before reinsertion (see section 4.4).

4.3 Contraindications

Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1.

Hypersensitivity to other beta blockers.

Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe

chronic obstructive pulmonary disease.

Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second or third-degree

atrioventricular block not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.

Severe allergic rhinitis and corneal dystrophies.

4.4 Special warnings and precautions for use

Systemic effects

Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically. Due

to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other

adverse reactions seen with systemic beta- adrenergic blocking medicinal products may occur. The

incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic

administration. For information on how to reduce systemic absorption, see section 4.2.

Cardiac disorders

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and

cardiac failure) and hypotension, therapy with beta blockers should be critically assessed and

therapy with other active substances should be considered. Patients with cardiovascular diseases

should be watched for signs of deterioration of these diseases and of adverse reactions.

Due to their negative effect on conduction time, betablockers should only be given with caution to

patients with first degree heart block.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 3

Vascular disorders

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's

disease or Raynaud's syndrome) should be treated with caution.

Respiratory disorders

Respiratory reactions, including death due to bronchospasm in patients with asthma, have been

reported following administration of some ophthalmic beta blockers.

DuoTrav should be used with caution, in patients with mild/moderate chronic obstructive pulmonary

disease (COPD) and only if the potential benefit outweighs the potential risk.

Hypoglycaemia/diabetes

Beta blockers should be administered with caution in patients subject to spontaneous

hypoglycaemia or in patients with labile diabetes, as beta blockers may mask the signs and

symptoms of acute hypoglycaemia.

Muscle weakness

Beta- adrenergic blocking medicinal products have been reported to potentiate muscle weakness

consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).

Corneal diseases

Ophthalmic beta blockers may induce dryness of eyes. Patients with corneal diseases should be

treated with caution.

Choroidal detachment

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g.

timolol, acetazolamide) after filtration procedures.

Other beta-blocking agents

The effect on intra ocular pressure or the known effects of systemic beta blockade may be

potentiated when timolol is given to patients already receiving a systemic beta- blocking medicinal

product. The response of these patients should be closely observed. The use of two topical beta-

adrenergic blocking agents is not recommended (see section 4.5).

Surgical anaesthesia

Beta-blocking ophthalmological preparations may block systemic beta-agonist effects, e.g. of

adrenaline. The anaesthetist should be informed when the patient is receiving timolol.

Hyperthyroidism

Beta blockers may mask the signs of hyperthyroidism.

Skin contact

Prostaglandins and prostaglandin analogues are biologically active substances that may be absorbed

through the skin. Women who are pregnant or attempting to become pregnant should exercise

appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of

coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 4

exposed area immediately.

Anaphylactic reactions

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic

reaction to a variety of allergens may be more reactive to repeated challenge with such allergens

and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Concomitant therapy

Timolol may interact with other medicinal products (see section 4.5).

The use of two local prostaglandins is not recommended.

Ocular effects

Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment

granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of

a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The

long term effects on the melanocytes and any consequences thereof are currently unknown. The

change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye

colour has predominantly been seen in patients with mixed coloured irides, i.e. blue- brown, grey-

brown, yellow- brown and green- brown; however, it has also been observed in patients with brown

eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery

in affected eyes, but the entire iris or parts of it may become more brownish. After discontinuation of

therapy, no further increase in brown iris pigment has been observed.

In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of

travoprost has been reported.

Periorbital and lid changes, including deepening of the eyelid sulcus have been observed with

prostaglandin analogues.

Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in

about half of the patients in clinical trials and include: increased length, thickness, pigmentation,

and/or number of lashes. The mechanism of eyelash changes and their long-term consequences are

currently unknown.

Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the

monkey. However, this effect was not observed during the clinical trials and is considered to be

species specific.

There is no experience of DuoTrav in inflammatory ocular conditions, nor in neovascular, angle-

closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in

open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.

Macular oedema has been reported during treatment with prostaglandin F

analogues. Caution is

recommended when using DuoTrav in aphakic patients, pseudophakic patients with a torn posterior

lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular

oedema.

In patients with known predisposing risk factors for iritis/uveitis, and in patients with active

intraocular inflammation, DuoTrav can be used with caution.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 5

Excipients

DuoTrav contains propylene glycol which may cause skin irritation.

DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin

reactions.

Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 15

minutes after instillation of the dose before reinsertion (see section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

No specific drug interaction studies have been performed with travoprost or timolol.

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when

ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers,

beta adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides,

parasympathomimetics or guanethidine.

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-

blockers.

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported

during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and

timolol

Mydriasis resulting from concomitant use of ophthalmic beta blockers and adrenaline (epinephrine)

has been reported occasionally.

Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products. Beta

blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential/contraception

DuoTrav must not be used in women of child-bearing age/potential unless adequate

contraceptive measures are in place (see section 5.3).

Pregnancy

Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/newborn child.

There are no or limited amount of data from the use of DuoTrav or the individual components in

pregnant women. Timolol should not be used during pregnancy unless clearly necessary.

Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth

retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of

beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been

observed in the neonate when beta-blockers have been administered until delivery. If DuoTrav is

administered until delivery, the neonate should be carefully monitored during the first days of life.

DuoTrav should not be used during pregnancy unless clearly necessary. For information on how to

reduce systemic absorption, see section 4.2.

Breast-feeding

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 6

It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies

have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk

and has the potential to cause serious adverse reactions in the breast- fed infant. However, at

therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in

breast milk to produce clinical symptoms of beta-blockade in the infant. For information on how to

reduce systemic absorption, see section 4.2.

The use of DuoTrav by breast-feeding women is not recommended.

Fertility

There are no data on the effects of DuoTrav on human fertility. Animal studies showed no effect of

travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas

no relevant effect of timolol was noted at this dose level.

4.7 Effects on ability to drive and use machines

DuoTrav has no or negligible influence on the ability to drive and use machines.

As with any eye drops, temporary blurred vision or other visual disturbances may occur. If blurred

vision occurs at instillation, the patient must wait until the vision clears before driving or using

machines.

4.8 Undesirable effects

Summary of the safety profile

In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported

treatment-related adverse reaction was ocular hyperaemia (12.0%).

Tabulated summary of adverse reactions

The adverse reactions listed in the table below were observed in clinical studies or with post-marketing

experience. They are ranked according to system organ class and classified according to the following

convention: very common (

>

1/10), common (

>

1/100 to <1/10), uncommon (

>

1/1,000 to <1/100), rare

>

1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available

data). Within each frequency grouping, adverse reactions are presented in decreasing order of

seriousness.

System Organ Class

Frequency

Adverse reactions

Immune system disorders

Uncommon

Hypersensitivity

Psychiatric disorders

Rare

Nervousness

Not known

Depression

Nervous system disorders

Uncommon

Dizziness, headache

Not known

Cerebrovascular accident, syncope,

paraesthesia

Eye disorders

Very

common

Ocular hyperaemia

Common

Punctate keratitis, eye pain, visual

disturbance, vision blurred, dry eye, eye

pruritus, ocular discomfort, eye irritation

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 7

Uncommon

Keratitis, iritis, conjunctivitis, anterior

chamber inflammation, blepharitis,

photophobia, visual acuity reduced,

asthenopia, eye swelling, lacrimation

increased, erythema of eyelid, growth of

eyelashes, eye allergy, conjunctival

oedema, eyelid oedema.

Rare

Corneal erosion, meibomianitis,

conjunctival haemorrhage, eyelid margin

crusting, trichiasis, distichiasis.

Not known

Macular oedema, eyelid ptosis, lid sulcus

deepened, iris hyperpigmentation, corneal

disorder.

Cardiac disorders

Uncommon

Bradycardia.

Rare

Arrhythmia, heart rate irregular.

Not known

Cardiac failure, tachycardia, chest pain,

palpitations.

Vascular disorders

Uncommon

Hypertension, hypotension.

Not known

Oedema peripheral

Respiratory, thoracic and

mediastinal disorders

Uncommon

Dyspnoea, postnasal drip.

Rare

Dysphonia, bronchospasm, cough,

throat irritation, oropharyngeal pain,

nasal discomfort.

Not known

Asthma.

Gastrointestinal disorders

Not known

Dysgeusia.

Hepatobiliary disorders

Rare

Alanine aminotransferase increased,

aspartate aminotransferase increased.

Skin and subcutaneous

tissue disorders

Uncommon

Dermatitis contact, hypertrichosis, skin

hyperpigmentation (periocular).

Rare

Urticaria, skin discolouration, alopecia.

Not known

Rash.

Musculoskeletal and

connective tissue disorders

Rare

Pain in extremity.

Renal and urinary disorders

Rare

Chromaturia.

General disorders and

administration site

conditions

Rare

Thirst, fatigue.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 8

Additional adverse reactions that have been seen with one of the active substances and may

potentially occur with DuoTrav:

Travoprost

System organ class

MedDRA preferred term

Immune system disorders

Seasonal allergy

Psychiatric disorders

Anxiety, insomnia

Eye disorders

Uveitis, conjunctival follicles, eye discharge,

periorbital oedema, eyelids pruritus, ectropion,

cataract, iridocyclitis, ophthalmic herpes simplex,

eye inflammation, photopsia, eczema eyelids,

halo vision, hypoaesthesia eye, anterior chamber

pigmentation, mydriasis, eyelash

hyperpigmentation, eyelash thickening, visual

field defect

Ear and labyrinth disorders

Vertigo, tinnitus

Vascular disorders

Blood pressure diastolic decreased, blood

pressure systolic increased

Respiratory, thoracic and mediastinal disorders

Asthma aggravated, rhinitis allergic, epistaxis,

respiratory disorder, nasal congestion, nasal

dryness

Gastrointestinal disorders

Peptic ulcer reactivated, gastrointestinal disorder,

diarrhoea, constipation, dry mouth, abdominal

pain, nausea, vomiting

Skin and subcutaneous tissue disorders

Skin exfoliation, hair texture abnormal, dermatitis

allergic, hair colour changes, madarosis, pruritus,

hair growth abnormal, erythema

Musculoskeletal and connective tissue disorders

Musculoskeletal pain, arthralgia

Renal and urinary disorders

Dysuria, urinary incontinence

General disorders and administration site

conditions

Asthenia

Investigations

Prostatic specific antigen increased

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EU SmPC TDOC-0016604 v.2.0 9

Timolol

Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic

circulation. This may cause undesirable effects similar to those seen with systemic beta-blocking

agents. Additional listed adverse reactions include reactions seen within the class of ophthalmic

beta-blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower

than for systemic administration. For information on how to reduce systemic absorption, see

section 4.2.

System organ class

MedDRA preferred term

Immune system disorders

Systemic allergic reactions including

angioedema, urticaria, localized and generalized

rash, pruritus, anaphylaxis.

Metabolism and nutrition disorders

Hypoglycaemia.

Psychiatric disorders

Insomnia, nightmares, memory loss.

Nervous system disorders

Cerebral ischaemia, increases in signs

and symptoms of myasthenia gravis.

Eye disorders

Signs and symptoms of ocular irritation (e.g.

burning, stinging, itching, tearing, redness),

choroidal detachment following filtration surgery

(see section 4.4), decreased corneal sensitivity,

diplopia.

Cardiac disorders

Oedema, congestive heart failure,

atrioventricular block, cardiac arrest.

Vascular disorders

Raynaud's phenomenon, cold hands and feet.

Gastrointestinal disorders

Nausea, dyspepsia, diarrhea, dry mouth,

abdominal pain, vomiting.

Skin and subcutaneous tissue disorders

Psoriasiform rash or exacerbation of psoriasis.

Musculoskeletal and connective tissue disorders

Myalgia.

Reproductive system and breast disorders

Sexual dysfunction, decreased libido.

General disorders and administration site

conditions

Asthenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.

gov.il

4.9 Overdose

A topical overdose with DuoTrav is not likely to occur or to be associated with toxicity.

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EU SmPC TDOC-0016604 v.2.0 10

In case of accidental ingestion, symptoms of overdose from systemic beta blockade may

include bradycardia, hypotension, bronchospasm and heart failure.

If overdose with DuoTrav occurs, treatment should be symptomatic and supportive.

Timolol does not dialyse readily.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma

preparations and miotics. ATC code: S01ED51.

Mechanism of action

DuoTrav contains two active substances: travoprost and timolol maleate. These two

components lower intraocular pressure by complementary mechanisms of action and the

combined effect results in additional IOP reduction compared to either compound alone.

Travoprost, a prostaglandin F

analogue, is a full agonist which is highly selective and has a

high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by

increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral

pathways. Reduction of IOP in man starts within approximately 2 hours after administration

and maximum effect is reached after 12 hours. Significant lowering of intraocular pressure

can be maintained for periods exceeding 24 hours with a single dose.

Timolol is a non-selective adrenergic blocking agent that has no intrinsic sympathomimetic,

direct myocardial depressant or membrane-stabilising activity. Tonography and

fluorophotometry studies in man suggest that its predominant action is related to reduced

aqueous humour formation and a slight increase in outflow facility.

Secondary pharmacology

Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of

topical ocular administration (1.4 micrograms, once-daily).

Pharmacodynamic effects

Clinical effects

In a twelve-month, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of

DuoTrav dosed once-daily in the morning was 8 to 10 mmHg. The non-inferiority of

DuoTrav as compared to latanoprost 50 micrograms/ml + timolol 5 mg/ml in the mean IOP

reduction was demonstrated across all time-points at all visits.

In a three-month, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 27 to 30 mmHg, the mean IOP-lowering effect of

DuoTrav dosed once-daily in the morning was 9 to 12 mmHg, and was up to 2 mmHg

greater than that of travoprost 40 micrograms/ml dosed once-daily in the evening and 2 to 3

mmHg greater than that of timolol 5 mg/ml dosed twice daily. A statistically superior

reduction in morning mean IOP (8:00, 24 hours after the last dose of DuoTrav) was

observed compared to travoprost at all visits throughout the study.

In two three-month, controlled clinical studies in patients with open-angle glaucoma or

ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering

effect of DuoTrav dosed once-daily in the morning was 7 to 9 mmHg. Mean IOP reductions

were non-inferior, although numerically lower, to those achieved by concomitant therapy

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 11

with travoprost 40 micrograms/ml dosed once-daily in the evening and timolol 5 mg/ml

dosed once-daily in the morning.

In a 6-week, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of

DuoTrav (polyquaternium-1-preserved) dosed once-daily in the morning was 8 mmHg and

equivalent to that of DuoTrav (benzalkonium chloride-preserved).

Inclusion criteria were common across the studies, with the exception of the IOP entry

criteria and response to previous IOP therapy. The clinical development of DuoTrav

included both patients naive and on therapy. Insufficient responsiveness to monotherapy

was not an inclusion criterion.

Existing data suggest that evening dosing might have some advantages as regards mean

IOP reduction. Consideration should be given to patient convenience and their likely

compliance when recommending morning vs. evening dosing.

5.2 Pharmacokinetic properties

Absorption

Travoprost and timolol are absorbed through the cornea. Travoprost is a prodrug

that undergoes rapid ester hydrolysis in the cornea to the active free acid. Following

once daily administration of DuoTrav PQ in healthy subjects (N= 22) for 5 days,

travoprost free acid was not quantifiable in plasma samples from the majority of

subjects (94.4%) and generally was not detectable one hour after dosing. When

measurable (>0.01 ng/ml, the assay limit of quantitation), concentrations ranged

from 0.01 to 0.03 ng/ml. The mean timolol steady-state C

was 1.34 ng/ml and T

was approximately 0.69 hours after once-daily administration of DuoTrav.

Distribution

Travoprost free acid can be measured in the aqueous humour during the first few hours in

animals and in human plasma only during the first hour after ocular administration of

DuoTrav. Timolol can be measured in human aqueous humour after ocular administration

of timolol and in plasma for up to 12 hours after ocular administration of DuoTrav.

Biotransformation

Metabolism is the major route of elimination of both travoprost and the active free acid.

The systemic metabolic pathways parallel those of endogenous prostaglandin F

which

are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and

β-oxidative cleavages of the upper side chain.

Timolol is metabolised by two pathways. One route yields an ethanolamine side chain on the

thiadiazole ring and the other gives an ethanolic side chain on the morpholine nitrogen and a

second similar side chain with a carbonyl group adjacent to the nitrogen. The plasma t

timolol is 4 hours after ocular administration of DuoTrav.

Elimination

Travoprost free acid and its metabolites are mainly excreted by the kidneys. Less than

2% of an ocular dose of travoprost was recovered in urine as free acid. Timolol and its

metabolites are primarily excreted by the kidneys. Approximately 20% of a timolol dose

is excreted in the urine unchanged and the remainder excreted in urine as metabolites.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 12

5.3 Preclinical safety data

In monkeys, administration of DuoTrav twice–daily was shown to induce increased palpebral

fissure and to increase iris pigmentation similar to that observed with ocular administration of

prostanoids.

DuoTrav preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared

to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and

following topical ocular administration in rabbits.

Travoprost

Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to

the right eye, twice daily for one year resulted in no systemic toxicity.

Reproduction toxicity studies with travoprost have been undertaken in rats, mice and rabbits

using the systemic route. Findings are related to FP receptor agonist activity in uterus with

early embryolethality, post-implantation loss and foetotoxicity. In pregnant rats, systemic

administration of travoprost at doses more than 200 times the clinical dose during the period

of organogenesis resulted in an increased incidence of malformations. Low levels of

radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered

H-travoprost. Reproduction and development studies have demonstrated a potent effect on

foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma,

respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).

Timolol

Non-clinical data revealed no special hazard for humans with timolol based on conventional

studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.

Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no

adverse effects on postnatal development (7000 times the clinical dose) and increased

foetal resorptions in rabbits (14000 times the clinical dose).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol

Boric acid

Mannitol

Sodium chloride

Polyoxyethylene hydrogenated Castor oil 40

(HCO-40)

Polyquaternium-1

Sodium hydroxide and/ or hydrochloric acid (for pH adjustment)

Purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.

DUO API NOT APR18 CL V2

EU SmPC TDOC-0016604 v.2.0 13

Discard 4 weeks after first opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

2.5 mL oval syndiotactic polypropylene (sPP) bottle with a PP dispensing plug with PP

closure, presented in an overwrap.

Pack size of 1 bottle.

6.6 Special precautions for disposal

No special requirements.

7. DRUG REGISTRATION NUMBER

144 33 31764

8. MANUFACTURER

Alcon CouvreurN.V,

RIJKSWEG 14, 2870,

PUURS,BELGIUM

9. LICENSE HOLDER

NOVARTIS ISRAEL LTD

36 SHACHAM ST.,

KIRYAT MATALON,

PETACH TIKVA 4951729, ISRAEL

This leaflet format has been determined by the Ministry of Health and the content has

been checked and approved in JAN 2016 and updated according to the guidelines of the

Minestry of Health in Apr 2018.

.מ"עב לארשי סיטרבונ םחש 'חר

חתפ ןולטמ תיירק

הוקת

.ד.ת

7759

חתפ

הוקת

4951729

:ןופלט

03-9201111

:סקפ

03-9229230

Novartis Israel Ltd.

36 Shaham St., Kiryat Matalon, Petach-Tikva

P.O.B 7759, Petach Tikva 4951729, Israel

Tel: 972-3-9201111 Fax: 972-3-9229230

ינוי

2018

ה/דבכנ ת/חקור ,ה/דבכנ ה/אפור

,

ןודנה

:

DUOTRAV

ברטואוד

לע םכעידוהל וננוצרב םינוכדע

ולעב םינ

רל אפו

ןכרצל

.

האבה היוותהל לארשיב םושר רישכתה

:

Decrease of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension

who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

ביכרמה םי

ליעפה םי

:

TRAVOPROST 40 MCG/ML

TIMOLOL ( AS MALEATE ) 5 MG/ML

.ןודנב םירישכתה לש ןכרצל ןולעהו אפורל ןולעב םינוכדע לע םכעידוהל וננוצרב

עה ינולע לע םיססבתמ םינול

EU

הרמחה םיווהמ רשא םייוניש ןומיס םע םכנויעל םיאלמה םינולעה תא םיפרצמ ונא , עקר םע םינמוסמ( בוהצ נולעב םינמוסמ אל םירחא םייוניש .) .םיפרוצמה םי

םינולעה ןכרצלו אפורל האלמה םתסרגב םלבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל וחלשנ לע םיספדומ

.םושירה לעבל הינפ ידי

,הכרבב

מ יבד ילאכי

הנוממ תחקור

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 1

1.

NAME OF THE MEDICINAL PRODUCT

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).

Excipient(s) with known effect:

Each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5

mg, polyoxyethylene hydrogenated castor oil 40 1.0 mg (see section 4.4).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ophthalmic solution (eye drops).

Clear, colourless solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section-

5.1).

4.2 Posology and method of administration

Posology

Use in adults, including the elderly

The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the

morning or evening. It should be administered at the same time each day.

If a dose is missed, treatment should be continued with the next dose as planned. The dose should

not exceed one drop in the affected eye(s) daily.

Special populations

Hepatic and renal impairment

No studies have been conducted with DuoTrav or with timolol 5 mg/ml eye drops in patients with

hepatic or renal impairment.

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with

mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was

necessary in these patients.

Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see

section 5.2).

Paediatric population

The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not

been established. No data are available.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 2

Method of administration

For ocular use.

The patient should remove the protective overwrap immediately prior to initial use. To

prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids,

surrounding areas or other surfaces with the dropper tip of the bottle.

When nasolacrimal occlusion is used or the eyelids are closed for 2 minutes, systemic absorption is

reduced. This may result in a decrease in systemic side effects and an increase in local activity (see

section 4.4).

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be

administered at least 5 minutes apart (see section 4.5).

When substituting another ophthalmic antiglaucoma medicinal product with DuoTrav, the other

medicinal product should be discontinued and DuoTrav should be started the following day.

Patients must be instructed to remove soft contact lenses prior to application of DuoTrav and wait

15 minutes after instillation of the dose before reinsertion (see section 4.4).

4.3 Contraindications

Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1.

Hypersensitivity to other beta blockers.

Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe

chronic obstructive pulmonary disease.

Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second or third-degree

atrioventricular block not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.

Severe allergic rhinitis and corneal dystrophies.

4.4 Special warnings and precautions for use

Systemic effects

Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically. Due

to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other

adverse reactions seen with systemic beta- adrenergic blocking medicinal products may occur. The

incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic

administration. For information on how to reduce systemic absorption, see section 4.2.

Cardiac disorders

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and

cardiac failure) and hypotension, therapy with beta blockers should be critically assessed and

therapy with other active substances should be considered. Patients with cardiovascular diseases

should be watched for signs of deterioration of these diseases and of adverse reactions.

Due to their negative effect on conduction time, betablockers should only be given with caution to

patients with first degree heart block.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 3

Vascular disorders

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's

disease or Raynaud's syndrome) should be treated with caution.

Respiratory disorders

Respiratory reactions, including death due to bronchospasm in patients with asthma, have been

reported following administration of some ophthalmic beta blockers.

DuoTrav should be used with caution, in patients with mild/moderate chronic obstructive pulmonary

disease (COPD) and only if the potential benefit outweighs the potential risk.

Hypoglycaemia/diabetes

Beta blockers should be administered with caution in patients subject to spontaneous

hypoglycaemia or in patients with labile diabetes, as beta blockers may mask the signs and

symptoms of acute hypoglycaemia.

Muscle weakness

Beta- adrenergic blocking medicinal products have been reported to potentiate muscle weakness

consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).

Corneal diseases

Ophthalmic beta blockers may induce dryness of eyes. Patients with corneal diseases should be

treated with caution.

Choroidal detachment

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g.

timolol, acetazolamide) after filtration procedures.

Other beta-blocking agents

The effect on intra ocular pressure or the known effects of systemic beta blockade may be

potentiated when timolol is given to patients already receiving a systemic beta- blocking medicinal

product. The response of these patients should be closely observed. The use of two topical beta-

adrenergic blocking agents is not recommended (see section 4.5).

Surgical anaesthesia

Beta-blocking ophthalmological preparations may block systemic beta-agonist effects, e.g. of

adrenaline. The anaesthetist should be informed when the patient is receiving timolol.

Hyperthyroidism

Beta blockers may mask the signs of hyperthyroidism.

Skin contact

Prostaglandins and prostaglandin analogues are biologically active substances that may be absorbed

through the skin. Women who are pregnant or attempting to become pregnant should exercise

appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of

coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 4

exposed area immediately.

Anaphylactic reactions

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic

reaction to a variety of allergens may be more reactive to repeated challenge with such allergens

and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Concomitant therapy

Timolol may interact with other medicinal products (see section 4.5).

The use of two local prostaglandins is not recommended.

Ocular effects

Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment

granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of

a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The

long term effects on the melanocytes and any consequences thereof are currently unknown. The

change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye

colour has predominantly been seen in patients with mixed coloured irides, i.e. blue- brown, grey-

brown, yellow- brown and green- brown; however, it has also been observed in patients with brown

eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery

in affected eyes, but the entire iris or parts of it may become more brownish. After discontinuation of

therapy, no further increase in brown iris pigment has been observed.

In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of

travoprost has been reported.

Periorbital and lid changes, including deepening of the eyelid sulcus have been observed with

prostaglandin analogues.

Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in

about half of the patients in clinical trials and include: increased length, thickness, pigmentation,

and/or number of lashes. The mechanism of eyelash changes and their long-term consequences are

currently unknown.

Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the

monkey. However, this effect was not observed during the clinical trials and is considered to be

species specific.

There is no experience of DuoTrav in inflammatory ocular conditions, nor in neovascular, angle-

closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in

open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.

Macular oedema has been reported during treatment with prostaglandin F

analogues. Caution is

recommended when using DuoTrav in aphakic patients, pseudophakic patients with a torn posterior

lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular

oedema.

In patients with known predisposing risk factors for iritis/uveitis, and in patients with active

intraocular inflammation, DuoTrav can be used with caution.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 5

Excipients

DuoTrav contains propylene glycol which may cause skin irritation.

DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin

reactions.

Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 15

minutes after instillation of the dose before reinsertion (see section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

No specific drug interaction studies have been performed with travoprost or timolol.

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when

ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers,

beta adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides,

parasympathomimetics or guanethidine.

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-

blockers.

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported

during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and

timolol

Mydriasis resulting from concomitant use of ophthalmic beta blockers and adrenaline (epinephrine)

has been reported occasionally.

Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products. Beta

blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential/contraception

DuoTrav must not be used in women of child-bearing age/potential unless adequate

contraceptive measures are in place (see section 5.3).

Pregnancy

Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/newborn child.

There are no or limited amount of data from the use of DuoTrav or the individual components in

pregnant women. Timolol should not be used during pregnancy unless clearly necessary.

Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth

retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of

beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been

observed in the neonate when beta-blockers have been administered until delivery. If DuoTrav is

administered until delivery, the neonate should be carefully monitored during the first days of life.

DuoTrav should not be used during pregnancy unless clearly necessary. For information on how to

reduce systemic absorption, see section 4.2.

Breast-feeding

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 6

It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies

have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk

and has the potential to cause serious adverse reactions in the breast- fed infant. However, at

therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in

breast milk to produce clinical symptoms of beta-blockade in the infant. For information on how to

reduce systemic absorption, see section 4.2.

The use of DuoTrav by breast-feeding women is not recommended.

Fertility

There are no data on the effects of DuoTrav on human fertility. Animal studies showed no effect of

travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas

no relevant effect of timolol was noted at this dose level.

4.7 Effects on ability to drive and use machines

DuoTrav has no or negligible influence on the ability to drive and use machines.

As with any eye drops, temporary blurred vision or other visual disturbances may occur. If blurred

vision occurs at instillation, the patient must wait until the vision clears before driving or using

machines.

4.8 Undesirable effects

Summary of the safety profile

In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported

treatment-related adverse reaction was ocular hyperaemia (12.0%).

Tabulated summary of adverse reactions

The adverse reactions listed in the table below were observed in clinical studies or with post-marketing

experience. They are ranked according to system organ class and classified according to the following

convention: very common (

>

1/10), common (

>

1/100 to <1/10), uncommon (

>

1/1,000 to <1/100), rare

>

1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available

data). Within each frequency grouping, adverse reactions are presented in decreasing order of

seriousness.

System Organ Class

Frequency

Adverse reactions

Immune system disorders

Uncommon

Hypersensitivity

Psychiatric disorders

Rare

Nervousness

Not known

Depression

Nervous system disorders

Uncommon

Dizziness, headache

Not known

Cerebrovascular accident, syncope,

paraesthesia

Eye disorders

Very

common

Ocular hyperaemia

Common

Punctate keratitis, eye pain, visual

disturbance, vision blurred, dry eye, eye

pruritus, ocular discomfort, eye irritation

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 7

Uncommon

Keratitis, iritis, conjunctivitis, anterior

chamber inflammation, blepharitis,

photophobia, visual acuity reduced,

asthenopia, eye swelling, lacrimation

increased, erythema of eyelid, growth of

eyelashes, eye allergy, conjunctival

oedema, eyelid oedema.

Rare

Corneal erosion, meibomianitis,

conjunctival haemorrhage, eyelid margin

crusting, trichiasis, distichiasis.

Not known

Macular oedema, eyelid ptosis, lid sulcus

deepened, iris hyperpigmentation, corneal

disorder.

Cardiac disorders

Uncommon

Bradycardia.

Rare

Arrhythmia, heart rate irregular.

Not known

Cardiac failure, tachycardia, chest pain,

palpitations.

Vascular disorders

Uncommon

Hypertension, hypotension.

Not known

Oedema peripheral

Respiratory, thoracic and

mediastinal disorders

Uncommon

Dyspnoea, postnasal drip.

Rare

Dysphonia, bronchospasm, cough,

throat irritation, oropharyngeal pain,

nasal discomfort.

Not known

Asthma.

Gastrointestinal disorders

Not known

Dysgeusia.

Hepatobiliary disorders

Rare

Alanine aminotransferase increased,

aspartate aminotransferase increased.

Skin and subcutaneous

tissue disorders

Uncommon

Dermatitis contact, hypertrichosis, skin

hyperpigmentation (periocular).

Rare

Urticaria, skin discolouration, alopecia.

Not known

Rash.

Musculoskeletal and

connective tissue disorders

Rare

Pain in extremity.

Renal and urinary disorders

Rare

Chromaturia.

General disorders and

administration site

conditions

Rare

Thirst, fatigue.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 8

Additional adverse reactions that have been seen with one of the active substances and may

potentially occur with DuoTrav:

Travoprost

System organ class

MedDRA preferred term

Immune system disorders

Seasonal allergy

Psychiatric disorders

Anxiety, insomnia

Eye disorders

Uveitis, conjunctival follicles, eye discharge,

periorbital oedema, eyelids pruritus, ectropion,

cataract, iridocyclitis, ophthalmic herpes simplex,

eye inflammation, photopsia, eczema eyelids,

halo vision, hypoaesthesia eye, anterior chamber

pigmentation, mydriasis, eyelash

hyperpigmentation, eyelash thickening, visual

field defect

Ear and labyrinth disorders

Vertigo, tinnitus

Vascular disorders

Blood pressure diastolic decreased, blood

pressure systolic increased

Respiratory, thoracic and mediastinal disorders

Asthma aggravated, rhinitis allergic, epistaxis,

respiratory disorder, nasal congestion, nasal

dryness

Gastrointestinal disorders

Peptic ulcer reactivated, gastrointestinal disorder,

diarrhoea, constipation, dry mouth, abdominal

pain, nausea, vomiting

Skin and subcutaneous tissue disorders

Skin exfoliation, hair texture abnormal, dermatitis

allergic, hair colour changes, madarosis, pruritus,

hair growth abnormal, erythema

Musculoskeletal and connective tissue disorders

Musculoskeletal pain, arthralgia

Renal and urinary disorders

Dysuria, urinary incontinence

General disorders and administration site

conditions

Asthenia

Investigations

Prostatic specific antigen increased

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 9

Timolol

Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic

circulation. This may cause undesirable effects similar to those seen with systemic beta-blocking

agents. Additional listed adverse reactions include reactions seen within the class of ophthalmic

beta-blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower

than for systemic administration. For information on how to reduce systemic absorption, see

section 4.2.

System organ class

MedDRA preferred term

Immune system disorders

Systemic allergic reactions including

angioedema, urticaria, localized and generalized

rash, pruritus, anaphylaxis.

Metabolism and nutrition disorders

Hypoglycaemia.

Psychiatric disorders

Insomnia, nightmares, memory loss.

Nervous system disorders

Cerebral ischaemia, increases in signs

and symptoms of myasthenia gravis.

Eye disorders

Signs and symptoms of ocular irritation (e.g.

burning, stinging, itching, tearing, redness),

choroidal detachment following filtration surgery

(see section 4.4), decreased corneal sensitivity,

diplopia.

Cardiac disorders

Oedema, congestive heart failure,

atrioventricular block, cardiac arrest.

Vascular disorders

Raynaud's phenomenon, cold hands and feet.

Gastrointestinal disorders

Nausea, dyspepsia, diarrhea, dry mouth,

abdominal pain, vomiting.

Skin and subcutaneous tissue disorders

Psoriasiform rash or exacerbation of psoriasis.

Musculoskeletal and connective tissue disorders

Myalgia.

Reproductive system and breast disorders

Sexual dysfunction, decreased libido.

General disorders and administration site

conditions

Asthenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.

gov.il

4.9 Overdose

A topical overdose with DuoTrav is not likely to occur or to be associated with toxicity.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 10

In case of accidental ingestion, symptoms of overdose from systemic beta blockade may

include bradycardia, hypotension, bronchospasm and heart failure.

If overdose with DuoTrav occurs, treatment should be symptomatic and supportive.

Timolol does not dialyse readily.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma

preparations and miotics. ATC code: S01ED51.

Mechanism of action

DuoTrav contains two active substances: travoprost and timolol maleate. These two

components lower intraocular pressure by complementary mechanisms of action and the

combined effect results in additional IOP reduction compared to either compound alone.

Travoprost, a prostaglandin F

analogue, is a full agonist which is highly selective and has a

high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by

increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral

pathways. Reduction of IOP in man starts within approximately 2 hours after administration

and maximum effect is reached after 12 hours. Significant lowering of intraocular pressure

can be maintained for periods exceeding 24 hours with a single dose.

Timolol is a non-selective adrenergic blocking agent that has no intrinsic sympathomimetic,

direct myocardial depressant or membrane-stabilising activity. Tonography and

fluorophotometry studies in man suggest that its predominant action is related to reduced

aqueous humour formation and a slight increase in outflow facility.

Secondary pharmacology

Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of

topical ocular administration (1.4 micrograms, once-daily).

Pharmacodynamic effects

Clinical effects

In a twelve-month, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of

DuoTrav dosed once-daily in the morning was 8 to 10 mmHg. The non-inferiority of

DuoTrav as compared to latanoprost 50 micrograms/ml + timolol 5 mg/ml in the mean IOP

reduction was demonstrated across all time-points at all visits.

In a three-month, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 27 to 30 mmHg, the mean IOP-lowering effect of

DuoTrav dosed once-daily in the morning was 9 to 12 mmHg, and was up to 2 mmHg

greater than that of travoprost 40 micrograms/ml dosed once-daily in the evening and 2 to 3

mmHg greater than that of timolol 5 mg/ml dosed twice daily. A statistically superior

reduction in morning mean IOP (8:00, 24 hours after the last dose of DuoTrav) was

observed compared to travoprost at all visits throughout the study.

In two three-month, controlled clinical studies in patients with open-angle glaucoma or

ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering

effect of DuoTrav dosed once-daily in the morning was 7 to 9 mmHg. Mean IOP reductions

were non-inferior, although numerically lower, to those achieved by concomitant therapy

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 11

with travoprost 40 micrograms/ml dosed once-daily in the evening and timolol 5 mg/ml

dosed once-daily in the morning.

In a 6-week, controlled clinical study in patients with open-angle glaucoma or ocular

hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of

DuoTrav (polyquaternium-1-preserved) dosed once-daily in the morning was 8 mmHg and

equivalent to that of DuoTrav (benzalkonium chloride-preserved).

Inclusion criteria were common across the studies, with the exception of the IOP entry

criteria and response to previous IOP therapy. The clinical development of DuoTrav

included both patients naive and on therapy. Insufficient responsiveness to monotherapy

was not an inclusion criterion.

Existing data suggest that evening dosing might have some advantages as regards mean

IOP reduction. Consideration should be given to patient convenience and their likely

compliance when recommending morning vs. evening dosing.

5.2 Pharmacokinetic properties

Absorption

Travoprost and timolol are absorbed through the cornea. Travoprost is a prodrug

that undergoes rapid ester hydrolysis in the cornea to the active free acid. Following

once daily administration of DuoTrav PQ in healthy subjects (N= 22) for 5 days,

travoprost free acid was not quantifiable in plasma samples from the majority of

subjects (94.4%) and generally was not detectable one hour after dosing. When

measurable (>0.01 ng/ml, the assay limit of quantitation), concentrations ranged

from 0.01 to 0.03 ng/ml. The mean timolol steady-state C

was 1.34 ng/ml and T

was approximately 0.69 hours after once-daily administration of DuoTrav.

Distribution

Travoprost free acid can be measured in the aqueous humour during the first few hours in

animals and in human plasma only during the first hour after ocular administration of

DuoTrav. Timolol can be measured in human aqueous humour after ocular administration

of timolol and in plasma for up to 12 hours after ocular administration of DuoTrav.

Biotransformation

Metabolism is the major route of elimination of both travoprost and the active free acid.

The systemic metabolic pathways parallel those of endogenous prostaglandin F

which

are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and

β-oxidative cleavages of the upper side chain.

Timolol is metabolised by two pathways. One route yields an ethanolamine side chain on the

thiadiazole ring and the other gives an ethanolic side chain on the morpholine nitrogen and a

second similar side chain with a carbonyl group adjacent to the nitrogen. The plasma t

timolol is 4 hours after ocular administration of DuoTrav.

Elimination

Travoprost free acid and its metabolites are mainly excreted by the kidneys. Less than

2% of an ocular dose of travoprost was recovered in urine as free acid. Timolol and its

metabolites are primarily excreted by the kidneys. Approximately 20% of a timolol dose

is excreted in the urine unchanged and the remainder excreted in urine as metabolites.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 12

5.3 Preclinical safety data

In monkeys, administration of DuoTrav twice–daily was shown to induce increased palpebral

fissure and to increase iris pigmentation similar to that observed with ocular administration of

prostanoids.

DuoTrav preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared

to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and

following topical ocular administration in rabbits.

Travoprost

Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to

the right eye, twice daily for one year resulted in no systemic toxicity.

Reproduction toxicity studies with travoprost have been undertaken in rats, mice and rabbits

using the systemic route. Findings are related to FP receptor agonist activity in uterus with

early embryolethality, post-implantation loss and foetotoxicity. In pregnant rats, systemic

administration of travoprost at doses more than 200 times the clinical dose during the period

of organogenesis resulted in an increased incidence of malformations. Low levels of

radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered

H-travoprost. Reproduction and development studies have demonstrated a potent effect on

foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma,

respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).

Timolol

Non-clinical data revealed no special hazard for humans with timolol based on conventional

studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.

Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no

adverse effects on postnatal development (7000 times the clinical dose) and increased

foetal resorptions in rabbits (14000 times the clinical dose).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol

Boric acid

Mannitol

Sodium chloride

Polyoxyethylene hydrogenated Castor oil 40

(HCO-40)

Polyquaternium-1

Sodium hydroxide and/ or hydrochloric acid (for pH adjustment)

Purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.

DUO API NOT APR18 MOH V2

EU SmPC TDOC-0016604 v.2.0 13

Discard 4 weeks after first opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

2.5 mL oval syndiotactic polypropylene (sPP) bottle with a PP dispensing plug with PP

closure, presented in an overwrap.

Pack size of 1 bottle.

6.6 Special precautions for disposal

No special requirements.

7. DRUG REGISTRATION NUMBER

144 33 31764

8. MANUFACTURER

Alcon CouvreurN.V,

RIJKSWEG 14, 2870,

PUURS,Belgium

9. LICENSE HOLDER

NOVARTIS ISRAEL LTD

36 SHACHAM ST.,

KIRYAT MATALON,

PETACH TIKVA

4951729

, ISRAEL

This leaflet format has been determined by the Ministry of Health and the content has

been checked and approved in JAN 2016 and updated according to the guidelines of the

Minestry of Health in Apr 2018.

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

ןולע ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל

-

1986

דבלב אפור םשרמ יפ לע תקוושמ הפורתה

ברטואוד

םייניע תופיט

)הסימת(

:בכרה

רמוח םי

ליעפ םי

( טסורפוברט

Travoprost

, 40 mcg/ mL

לולומיט

טאלמ

Timolol as maleate

5 mg/mL

תמישרל

םירמוחה

יתלבה

םיליעפ

רישכתב

האר

ףיעס

"

עדימ

ףסונ

"

ףיעסו

לע בושח עדימ" "הפורתה יביכרממ קלח

ויעב ארק הפורתב שמתשת םרטב ופוס דע ןולעה תא ן

.

הפורתה לע יתיצמת עדימ ליכמ הז ןולע

חקורה לא וא אפורה לא הנפ ,תופסונ תולאש ךל שי םא

ו ןכתיי ,הז ןולע רומש .בוש וב ןייעל ךרטצת

רנ וז הפורת המש ךתלחמב לופיטל םא וליפא םהל קיזהל הלולע איה .םירחאל התוא ריבעת לא .

יאופרה םבצמ יכ ךל הארנ

.המוד

1

.

המל

תדעוימ

הפורתה

?

תתחפהל

לש םיבצמב יניע ךות ץחל תיווז תחותפ המוקואלג

ךות םד ץחל רתי וא יניע

םניא רשא ןפואב םיביגמ

אטב ימסוחל אלמ

םיימוק טסורפ לש םיגולנאל וא םינידנלג

:תיטיופרת הצובק

טסורפוברט

טסורפ ןידנלג

גולנא

דבועה

תלדגה ידי ל ךכו ןיעהמ ימימ לזונ לש הצוחה המירזה .יניע ץחל תיחפמ

)טאלמכ( לולומיט

סוח

אטב עופ רשא ,

.ןיעה ךותב לזונה לש רוצייה תתחפה ידי לע

.ןיעה ךותב ץחלה תא תיחפהל ידכ דחי םילעופ םירמוחה ינש

2

.

הפורתב שומיש ינפל

:םא הפורתב שמתשהל ןיא

סורפ ,טסורפוברטל )יגרלא( שיגר התא ,לולומיט ,םינידנלגט אטב ימסוח

וא

יביכרממ דחאל הפורתה

םירחא

ףיעסב טרופמכ (

הקינמ ךנ

לבוס ךנה רבעב תלבס וא ןוגכ המישנ תויעבמ סא

המ וא תיתמיסח תונופמס תקלד

תינורכ

הרומח

לחמ

רומח תואיר

לולעה

)ךשמתמ לועיש וא/ו המישנ יישק ,םיפוצפצל םורגל

וא מישנ תויעב תורחא ה

.הרומח תחשה תחדקמ לבוס ךנה

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

ךל שי בצק בל

יט ערפה וא בל תקיפס יא ,

בלה בצקב

)רידס אל בל בצק(

תוריכעמ לבוס ךנה

.ןיעה לש חטשה ינפ

םא אפורה םע ץעייתהל שי דחא ל"נה םיבצמהמ תמ ךילא סחיי

ונה תודחוימ תורהזא הפורתב שומישל תועג

נפל םא אפורל רפס ,ברטואודב לופיטה י מ רבעב תלבס וא לבוס ךנה

-

תילילכ בל תלחמ

םינימסת

וא המישנ רצוק ,הזחב םיבאכ וא ץחל לולכל םילוכי

)קנח

יא בל תקיפס

ךומנ םד ץחל

בלה בצקב תוערפה

בל בצק ןוגכ

יט

,המישנ תויעב סא

המ וא תלחמ

תואיר

תיתמיסח

תינורכ

תמירז םד היוקל ונייר תלחמ ןוגכ(

Raynaud's disease

ונייר םורדניס וא

Raynaud’s

syndrome

תרכוס

לולומיטש ןוויכ(

רכוס לש םינימסתו םינמיס ךסמל לולע ךומנ

)םדב

ליעפ רתי לש תו

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ש ןוויכ( לולומיט

לש םינימסתו םינמיס ךסמל לולע לחמ סירתה תטולב ת

( סיברג הינתסאימ תשלוח םירירש תיבצע

תינורכ

.טקרטק חותינ

.ןיעב תקלד

םא

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דמוע

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חותינ

והשלכ

שי

עידוהל

אפורל

שמתשמ התאש ואודב ברט

ןוויכמ

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לולע

תונשל

העפשהה תא

לש

תופורת

תומיוסמ

תושמשמה

ןמזב

המדרה

התא םא הווח דרגו תוימומדא ,תירוע החירפ( יהשלכ הרומח תיגרלא הבוגת

שומישה ןמזב )ןיע

ברטואוד ,םרוגל רשק אלל ,

יהל לולע ןילנרדאב לופיט תלבק תעב ,ןכל .ליעי תוחפ תו לכ לופיט ,רחא תש בושח ב שמתשמ ךנה יכ אפורל רפס ברטואוד

ברטואוד

לולע

תא תונשל

)ןיעה לש ינועבצה קלחה( תיתשקה עבצ

יתלב תויהל לולע הז יוניש .ךיפה

ד

ו

ברטוא

לוכי

איבהל

עבצ ,יבוע ,ךרואב היילע

רפסמ וא/ו םיסירה לש ם

לוכיו

םורגל

תחימצ לע הליגר אל רעיש עפעה םייפ

הל סנכיהל תוסנמה וא תורה םישנב וב שמתשהל ןיא ןכלו רועה ךרד גפסיהל לולע טסורפוברט

.ןויר שי ,רועה םע עגמב האב הפורתה םא טשל התוא ףו

ידיימ ןפואב

םידלי

:םירגבתמו

ברטואוד

מ הניא תחתמ םירגבתמו םידליב שומישל תדעוי ליגל

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

יב תובוגת

ן

תויתפורת

ברטואוד

לוכי

עפשומ תויהל וא עיפשהל

רחא תופורתמ שמתשמ התאש תו

םייניע תופיט ללוכ( )המוקואלגב לופיטל תורחא

םא וא ,חקול התא םא

,הנורחאל תחקל ,הנוזת יפסותו םשרמ אלל תופורת ללוכ תורחא תופורת .חקורל וא אפורל ךכ לע רפס דחוימב

חקול התא םא תחקל ןנכתמ וא ,

תופורת

םד ץחל תתחפהל

בלל תופורת

ללוכ

ןידיניכ

יגוסו בל תויעבב לופיטל שמשמה( לש םימיוסמ ם

)הירלמ

רישכת סב לופיטל םי

תרכ

:ןואכיד ידגונ םירישכת ןיטסקואולפ

fluoxetine)

וא

ןיטסקורפ

paroxetine)

ה

י

ןויר

,

הקנה תוירופו

שומישה םרט אפורה םע יצעייתה ,ןויריה תננכתמ וא ןויריהב תאש תבשוח ,הקינמ וא ןויריהב תא םא .וז הפורתב

ב שמתשהל ןיא ברטואוד

הב

ןויר

אלא םא פורה

יחרכה הזש בשוח

תא םא ה ליגב ,תוירופ

לע

העינמ יעצמאב שמתשהל ךי םיקפסמ ב שומישה ןמזב ברטואוד

ב שמתשהל ןיא ברטואוד

.הקינמ ךנה םא ברטואוד

לולע

רובעל .םא בלחל

תונוכמב שומישו הגיהנ

ב שומיש ברטואוד ל לולע םורג

שוטשטל

אר

הי

ומישה רחאל המ ןמזל

ליעפהל וא גוהנל ןיא תונוכמ .ףולחת וז העפותש דע

בושח עדימ תודוא

לש םיביכרמהמ קלח הפורתה

ברטואוד

הליכמ

hydrogenated castor oil

ל"מ/ג"מ לש

propylene glycol

םילולע רשא רועב יוריגו תובוגתל םורגל

3

?הפורתב שמתשת דציכ .

ל שי שמתשה רישכתב

דימת

םאתהב

תוארוה ךניא םא חקורה וא אפורה םע קודבל ךילע .אפורה חוטב

רישכתב לופיטה ןפואו ןונימל עגונב

.דבלב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה

אוה ללכ ךרדב לבוקמה ןונימה

.)ברעב וא רקובב( םויב םעפ תלפוטמה ןיעב תחא הפיט

התואב םוי לכ תחקל דיפקהל שי

.העש

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

םייניעה יתשב ברטואודב שמתשה קר החנה אפורה םא .ךכל ךתוא

תופיטכ ברטואודב שמתשהל שי יניע .דבלב םי

.תצלמומה הנמה לע רובעל ןיא

ןיא

!עולבל

דבלב ינוציח שומישל תדעוימ וז הפורת

שה ןפוא :שומי

הנושארה םעפב קובקבב שומישה ינפל דימ החיתפל ערק

תא תזירא

םייניבה

רויא

תא אצוה , .תיותה יבג לע החיתפה ךיראת תא םושרו קובקבה

די גשיהב הארמ ךל שיש אדו

ל קובקבה הצקל תתל ןיא ,םוהיזמ ענמיהל ידכב המצע ןיעה ללוכ( והשלכ חטשמב תעג

ל שי רומש רוגס קובקבה לע

בטיה

ףוטפטה בצק לע רתוי הבוט הטילש רשפאל דעונ רבדה ;אלמ וניא תופיטה קובקבו ןכתי

.ךידי תא ץחר ,תישאר :תופיטב שמתשהל דציכ קובקבה תא קזחה הטמ ןוויכל עבצאל לדוגאה ןיב הרומה רויא(

תא הטמ יפלכ ךושמ ,הרומה עבצאה תרזעב .רוחאל שארה תא הטה

ףעפעה ןיעמ תריציל ,ןותחתה סיכ"

"

רויא(

.רזועו הדימב הארמב רזעיהו ןיעל קובקבה תא ברק שי הפורתה תא ףטפטל לש תחא הפיט ררחשל ידכ תונידעב ברטואוד

רצונש "סיכ"ה ךות לא

רויא(

ןיא .תונידעב ךייניע םוצע .

ךשמל תומוצע םייניעב ראשה .ץמצמל

תוקד

רוהל ףסונב ליעל ונתינש תוא

לא תופיטה ףוטפט רחאל דימ

עבצאה תועצמאב ץחל ,ןיעה ןיעה לש תימינפה הניפה לע תיעצמאה

רויא(

ץחלב ךישמהל שי .

ףוטפטה רחאל תוקד

לא .ןיעה

יאוול תועפות עונמל תרזוע ךכבו ףוגה ךות לא הפורתה תגיפסמ ענמיהל תרזוע וז הלועפ

א ףטפטל תחלצה אל םא ןיעה ךות ל

.בוש הסנ

ב שמתשהל ךילע םא ברטואוד

ייניעה יתשב .היינשה ןיעה רובע הלעמלש םידעצה לכ לע רוזח ,ם

.שומישה רחאל דיימ בטיה קובקבה תא רוגס

הפורת לש תויראשמ ןתוקנל ידכב ךידי תא בטיה ףוטש ,הפורתב שומישה רחאל

ידכב

ענמיהל

תצפהמ

םוהיז

ןיא

שמתשהל

ותואב

קובקב

לש

הפורת

רתויל

םדאמ

דחא

חותפל ןיא תפיטע תא םייניבה

.קובקבב שמתשהל ךירצ התאש דע

שמתשהל שי ברטואודב

.ךתוא החנה אפורהש ןמזה ךשמל

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

םא

תלטנ

תועטב

ןונימ

הובג

רתוי

ךילע

ןיעה לא ףטפטל ןיא .םירשופ םימ תרזעב ןיעה תא ףוטשל יט האבה הנמה תליטנל ןמזה עיגיש דע תופסונ תופ

תועטב תעלבו הדימב

תזירא אבהו םילוח תיב לש ןוימ רדחל וא אפורל דימ הנפ ,הפורתה ןמ .ךתיא הפורתה

םא

תחכש

לוטיל

הפורת

וז

ןמזב

דעוימה

חק

תא

הנמה

האבה

ןמזב

ליגרה

אפורב ץעוויהו ןיא . נמה לע תוצפל תנמ לע הלופכ הנמב שמתשהל לש ןונימה תא רובעל ןיא .החכשנש ה

תחא הפיט .תולפוטמה םייניעב וא תלפוטמה ןיעב םויב

אפורה ידי לע ץלמוהש יפכ לופיטב דימתהל שי

םג

םא

לח

רופיש

בצמב

ךתואירב

ןיא

קיספהל

לופיטה

הפורתב

אלל

תוצעייתה

םע

אפורה

םא הפורתה תליטנ תא קיספמ התא אפורה םע תוצעייתה אלל הז

לע איבהל לו ש ךכל ןיעב ץחלה היהי אל

רקובמ המ ,

לולע הל ליבו יאר ןדבואל

התא םא

שמתשמ

םייניע תופיט

תורחא

ל ףסונב ברטואוד שי , ןיתמהל

תוחפל

תוקד ןיב תליטנ ברטואוד

םייניע תופיט תורחא

תא םא

תוכר עגמ תושדע ביכרמ תופיטב שמתשהל ןיא , רשאכ

תושדעה םייניעב שומישה רחאל . ןיתמהל שי ,תופיטב

תושדעה לש ןתבכרה ינפל תוקד

הרזחב

ןיא

לוטיל

תופורת

ךשוחב

!

קודב

תיוותה

הנמהו

לכב

םעפ

ךנהש

לטונ

הפורת

.

בכרה

םייפקשמ

םא

ךנה

קוקז

םהל

.

ב שומישל עגונב תופסונ תולאש ךל שי םא הפורת אפורב ץעוויה ,

.חקורב וא

4

יאוול תועפות .

לכב ומכ

,הפורת שה ב שומי ברטואוד

לולע

יאוול תועפותל םורגל .םישמתשמהמ קלחב

להבית לא .יאוולה תועפות תמישר ארקמל

.ןהמ תחא ףאמ לובסת אלו ןכתי

לכות ללכ ךרדב .תורומח ןה תועפותה םא אלא ,הפורתב שמתשהלו ךישמהל הנפ ,גאדומ התא םא צעייתה אלל הפורתב שומישה תא קיספת לא .חקורה וא אפורה לא .אפורה םע תו

דואמ תוחיכש יאוול תועפות

(very common)

דחא שמתשממ רתויב תועיפומש יאוול תועפות הרשעמ

:

ןיעב תועפות

תוימומדא

ןיעב

תוחיכש יאוול תועפות

(common)

ב תועיפומש תועפות

1-10

מ

ךותמ םישמתש

100

:

ןיעב תועפות

ןיעה חטש ינפב העיגפ םע תקלד

,םייניע יבאכ

,הייארב הערפה ,הייאר שוטש

,םייניעב שבוי דרג ,ןיעב ,ןיעב תוחונ יא

ו םינמיס םינימסת

( םייניעב יוריג לש ץוצקע תושוחת ,לשמל

הפירשו

.)ןיעב

תוחיכש ןניאש יאוול תועפות

(uncommon)

ב תועיפומש תועפות

1-10

ךותמ םישמתשמ

1,000

:

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

ות ןיעב תועפ

לש תקלד

ינפ

תקלד ,ןיעה חטש

,תימחלה תוחיפנ ,ףעפע החימצ

רבגומ

לש

,םיסיר תקלד ,תיתשקה תקלד

,רואל תושיגר ,ןיע הייארב העיגפ

,תופייע םייניע ,ןיעה תוחיפנ ,ןיעב היגרלא

רוצי עבצב יוניש ,ףעפעה תוימומדא ,רבגומ תועמד

ףעפע

)ןיעה ביבס( רועה לש תוהכתה

תויללכ תועפות

,ליעפה רמוחל תויגרלא תובוגת ,שאר יבאכ ,תרוחרחס ב הדירי וא היילע ץחל

םד ,המישנ רצוק , תחימצ לש רתי

,רעיש ב ףוטפט קלח

ירוחא ה לש ןורג

עב דרגו תקלד ,רו ב הדירי בצק

.בל

תורידנ יאוול תועפות

(rare)

ב תועיפומש תועפות

1-10

ךותמ םישמתשמ

10,000

:

ןיעב תועפות

תוקקדיה

לש ינפ ,ףעפעה תוטולב לש תקלד ,ןיעה חטש לש העירק

םד ילכ ,ןיעב דלג תבכש

,ףעפעב םוקימ םיסיר יתרגש יתלב

החימצ

לש תיתרגש יתלב

.םיסיר

תועפות

תויללכ

,תונבצע

,רידס אל בל בצק רעיש תרישנ

תוערפה

לוק ןורגב יוריג ,לועיש ,המישנב ישוק ,

,תדפרס

אל דבכ ידוקפת תקידב תואצות תוניקת

,רועה ןווג יוניש

לש ימינפה קלחב תוחונ יא ,תופייע ,ןואמיצ ןתש ,ףאה

ההכ

ו םיידיב םיבאכ

.םיילגר

תועפות

יאוול

ןתוחיכשש

הניא

העודי

(

תועפות

ןתוחיכשש

םרט

העבקנ

:)

ןיעב תועפות

ייפעפע

לופנ םי

תויהל םייניעל םרוג( תורוגס

הצחמל

)רתוי תועוקש תוארנ םייניעה( תועוקש םייניע

.)ןיעה לש ינועבצה קלחה( תיתשקה עבצב םייוניש

תויללכ תועפות

,ץבש ,הזחב םיבאכ ,בל תקיפס יא ,החירפ

ד ,ןופלע

,ןואכ סא

המ וא השוחת רסוח ,בל בצקב היילע , ער םעט ,תונותחת םייפגב תוחיפנ ,בל תוקיפד ,ץוצקע תשגרה

הפב

;ףסונב

ברטואוד

הליכמ לש בוליש ינש

םיליעפ םירמוח לולומיטו טסורפוברט , ,םייניעל תורחא תופורת ומכ . לולומיטו טסורפוברט

)אטב םס םיגפסנ

.םדל הז

תופצנה ולאל תומוד יאוול תועפותל םורגל לוכי ח גוסמ תופורת ןתמב

אטב ימס

הפה ךרד

הקירזב וא

תוחיכש לש יאוול תועפות שומיש רחאל םייניעב הכומנ הקירזב וא הפה ךרד ןתמל האוושהב

תועפות

יאוול הטמ תומושרה

ופצנ רשא תובוגת תוללוכ ב לופיטב תופורת ח גוסמ

רשאכ אטב ימס םייניעב תועפותב לופיטל תונתינ

דבל טסורפוברט ןתמב ופצנש תובוגת וא

םייניעב תועפות

מה תיתשרל תחתמ הבכשה תוקתנתה ,תינרקב תקלד ,ףעפעב תקלד חותינ תובקעב םד ילכ הליכ לולע רשא היצרטליפ

תינרקה תקיחש ,תינרקה תושיגרב הדירי ,הייארב תוערפהל ליבוהל

קזנ( לש תימדקה הבכשל לגלג )ןיעה ,הלופכ הייאר ,

יעהמ תושרפה ,ןיעה ביבס תוחיפנ ,ן ףעפעב דרג

ץוח יפלכ םייפעפעה לש היטה

ע דחי

ריג ,תוימומדא תועמד ףדועו יו ( הייארב שוטשט , ינמיס לופרע

תושדעב

)ןיעה היבנע( ןיעהמ קלח לש תוחיפנ ,

uvea

המזקא ,) ,םייפעפעה לש ( הליה תייאר

(halo

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

vision

הדירי , ב השוחתב ,ןיע היצטנמגיפ

עבצב םייוניש ,םיבחרומ םינושיא ,ןיעה ךותב םיסירה

םקרמב םייוניש םיסירה .ןיקת אל הייאר הדש ,

ות תויללכ תועפ

תוערפה

םיינז )תימינפה ןזואה( ךובמבו שוחתב הוולמה תרוחרחס : תיבוביס ה םיינזואב םילוצלצ ,

תוקצב ,בל תוקיפד ,יטיא בל בצק :םד ילכו בל

)םילזונ תריגא( ב יוניש , קפוד בצק

וא תוריהמ יא , בל תקיפס

הו םיילגרה תופכ לש תוחיפנו המישנ רצוקב הוולמה בל תלחמ( תריגא בקע םיילגר )םילזונ

לש םיוסמ גוס ערפה

בלה בצקב

,ךומנ םד ץחל ,בל ףקתה תעפות

ונייר םיילגרו םיידי , .חומל םד תקפסאב הדירי ,תורק

בורל( תואירב המישנה יכרד תורצה :המישנ יכרד םילפוטמב

םע לחמ

מייק

תלזנ

ףאב שדוג וא

תויושטעתה

א ללגב ,)היגרל ,המישנב ישוק מ םומיד

ףא ףאב שבוי ,

( הנישב ישוק :תויללכ תועפותו םיבצעה תכרעמ הניש ידודנ

יטויס

הליל א ,

ורכיז

חוכב הדירי , היגרנאבו

)ישגר ץחל ףדוע( הדרח

,תוליחב ,םעט תוערפה :לוכיעה תכרעמ לוכיע תוערפה אכ ,הפב שבוי ,לושלש , תואקה ,ןטב יב

תוריצעו

:היגרלא סתב היילע ,היגרלא ינימ

תויללכ תויגרלא תובוגת ללוכ

לוחל הלוכיש רועל תחתמ תוחיפנ ו םינפה ןוגכ םירוזאב

,םייפג

המישנה יכרד לש המיסחל םורגל ל םורגל לוכיש המ וא העילבב ישוק ת ,דרג ,תימוקמ וא תיללכ החירפ ,המישנב תיגרלא הבוג הרומח

.םייח תנכסמ

רועב החירפ :רוע תלעב

ןבל הארמ

גוסמ החירפ( ףוסכ

psoriasiform

וא ) הרמחה

פב ,סיזאירוס ה ףוליק רוע

לש ליגר אל םקרמ רעישה ב הוולמה רועב תקלד , עבצב םייוניש ,תדרגמ המודא החירפ ,דרג ,םיסיר לש הרישנ ,רעישה חימצ

,הליגר אל רעיש רועב תוימומדא

לש םינימסתו םינמיס תרבגה :םירירש הינתסאימ

סיברג

)םירירשב הערפה( ןוגכ תוליגר אל תושוחת , ,תוריקד תופייע/תשלוח םירירש תינפוג תוליעפ בקע םרגנ אלש םירירש באכ ,

םיבאכ םיקרפמב

ש לש תינוצר אל הפילד ,ןתש ןתמ תעב באכו ישוק :ןתשה תכרעמבו תוילכב תוערפה .ןת

הדירי ,תונוא ןיא :הייברה תכרעמ ינימה קשחב

םדב רכוס לש תוכומנ תומר :םזילובטמ תינומרעה תטולב ןטרס ינמסב היילע ,

םא

העיפוה

תעפות

יאוול

,

םא

תחא

תועפותמ

יאוולה

הרימחמ

וא

רשאכ

התא

לבוס

תעפותמ

יאוול

אלש

הניוצ

ןולעב

,

ךילע

ץעייתהל

םע

אפורה

.

ול תועפות לע חוויד יאו

ה לע הציחל תועצמאב תואירבה דרשמל יאוול תועפות לע חוודל ןתינ יאוול תועפות לע חוויד" רושיק "יתפורת לופיט בקע תואירבה דרשמ רתא לש תיבה ףדב אצמנש

www.health.gov.il

הנפמה יאוול תועפות לע חווידל ןווקמה ספוטל

י"ע וא

רושיקל הסינכ

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe

ctMedic@moh.gov.il

TDOC-0016604 v.2.0

DUO APL NOT APR18 MOH V2

5

כ . הפורתה תא ןסחאל דצי

?

וא/ו םידלי לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכו וז הפורת !הלערה ענמ .אפורהמ תשרופמ הארוה אלל האקהל םורגת לא .הלערה ענמת ךכ ידי לעו תוקונית

( הגופתה ךיראת ירחא הפורתב שמתשהל ןיא

exp. date

הזיראה יבג לע עיפומה ) תיות / ךיראת . ויל סחייתמ הגופתה .שדוח ותוא לש ןורחאה ם

לעמ ןסחאל ןיא

ךשמב שמתשהל ןתינ הנושארה החיתפה רחאל

תועובש

לכב .םימוהיזל ןוכיס עונמל תנמ לע םעפ

הת

ליחתמ שמתשהל

.ןוטרקהו תיוותה יבג לע החיתפה ךיראת תא םושר שדח קובקבב

ץעוויה

דכב רתוי שומישב ןניאש תופורתה תא קורזל דציכ חקור .הביבסה לע ןגהל רוזעל י

6

ףסונ עדימ .

ףסונ

לע

םירמוחה

םיליעפה

הפורתה

הליכמ

םג

Propylene Glycol, boric Acid, mannitol, sodium chloride, polyoxyethylene hydrogenated,

Castor Oil 40 (HCO-40)

Polyquanterium-1 Solution (equivalent to Polyquanterium-1),

hydrochloric acid and/or sodium hydroxide (for pH adjustment) , purified Water.

הזיראה ןכות המו הפורתה תיארנ דציכ

ברטואוד

עבצ תרסח ,הלולצ הסימ

קפוסמה

קיטסלפ קובקבב חפנב לש

לעב קקפ גרבומ

.םוינימולא תפיטעב זורא קובקבה

םש

ןרציה

ותבותכו

:

רבוק ןוקלא

היגלב ,סרופ ,ר

ALCON COUVREUR, RIJKSWEG 14, 2870 PUURS, BELGIUM

םושירה לעב

יטרבונ

'חר ,מ"עב לארשי םחש

חתפ ,

קת

ראוני :ךיראתב תואירבה דרשמ י"ע רשואו קדבנ הז ןולע

2016

דרשמ תוארוהל םאתהב ןכדועו לירפא ךיראתב תואירבה

2018

תואירבה דרשמב יתכלממה תופורתה סקנפב הפורתה םושיר רפסמ

:

144 33 31764

חסונ הז ןולע ,האירקה תלקהלו תוטשפה םשל ינש ינבל תדעוימ הפורתה ,תאז ףא לע .רכז ןושלב .םינימה

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