VIGAMOX

SH VIG APL AUG17 CL V1 COR MAT CL

The format of this leaflet was

determined by the Ministry of Health and its

content was checked and approved by it

Patient package insert in

accordance with the Pharmacists’

Regulations (Preparations) – 1986

The medicine is dispensed according

to a doctor’s prescription only

VIGAMOX

Eye Drops, Solution.

Composition: Moxifloxacin (as Hydrochloride) 0.5%

Inactive ingredients appear in section 6 - “Further

information”.

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.

This medicine has been prescribed for you. 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?

For treatment of conjunctivitis caused by bacteria

susceptible to the medicine.

Therapeutic

group:

Fourth-generation

fluoroquinolone antibiotic.

2. BEFORE USING THE MEDICINE

X

Do not use the medicine if:

∙ you have a known sensitivity to moxifloxacin

or to any of the ingredients of the medicine or

to other quinolone antibiotics.

Special warnings regarding use of the

medicine

∙ If you experience an allergic reaction to

Vigamox. Allergic reactions are uncommon

and serious allergic reactions are rare. If you

experience any allergic reaction or any side

effect, please see section 4.

∙ If you wear contact lenses – stop wearing

contact lenses if signs or symptoms of an eye

infection occur. Wear glasses instead. Do not

start wearing lenses again until the signs of the

infection have cleared and until you have stopped

using Vigamox.

∙ Tendon swelling and rupture occur in people

taking oral or intravenous fluoroquinolones,

particularly in older patients and in those treated

concurrently with corticosteroids. Stop using

Vigamox if you develop pain or swelling of the

tendons (tendinitis).

∙ Vigamox can be used in children, elderly patients

and patients with kidney or liver dysfunction.

As with any antibiotic, use of Vigamox for a

protracted period may lead to other infections.

!

If you are taking, or have recently taken, other

medicines, including non-prescription medicines

or nutritional supplements, tell the doctor or

pharmacist.

!

Pregnancy and breastfeeding

If you are pregnant, planning a pregnancy or are

breastfeeding, consult the doctor or pharmacist

before using the medicine.

!

Driving and using machines

You may experience blurry vision for a short time

after using the medicine. Do not drive or operate

machines until this effect has passed.

!

Treatment in children and infants:

Vigamox preparation is safe and effective for use in

children and infants. There is not enough information

regarding use of Vigamox in newborns, therefore its

use is not recommended for them.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are

uncertain.

The dosage and treatment regimen will be

determined by the doctor only.

The recommended dosage unless otherwise

prescribed by a doctor: 1 drop in the treated

eye, 3 times a day for 4 days.

Do not exceed the recommended dosage.

This medicine should be used at specified times as

prescribed by the attending doctor.

Do not swallow! This medicine is intended for

external use only.

∙ To avoid contamination, do not allow the tip of

the bottle to touch any surface (including the eye

itself). Keep the bottle tightly closed.

∙ The bottle of drops may not be full; this is intended

to allow better control of the drip rate.

∙ Do not squeeze the bottle; gentle pressure on the

base of the bottle is sufficient to remove the drop.

∙ How to use the drops: Using a mirror can make it

easier to use the medicine. First, wash your hands.

Tilt your head back. Using the index finger, pull down

the lower eyelid to form a “pocket” (Fig. 1). Instill the

medicine into the “pocket” that is formed (Fig. 2).

Close your eyes gently. Do not blink. Keep your

eyes closed for 1 to 2 minutes.

∙ In addition to the instructions given above -

immediately after instilling the drop into the eye,

press with the middle finger on the inner corner

of the eye (Fig. 3). Continue applying pressure

for 1 to 2 minutes after instilling into the eye. This

action helps to avoid absorption of the medicine

into the body and thus helps prevent side effects.

∙ After using the medicine, wash your hands

thoroughly to clean them of any residue of the

medicine.

∙ To avoid spreading infection, do not use the same

bottle of medicine for more than one person.

∙ If you have not been able to instill into the eye - try

again.

∙ If you need to instill a drop into the other eye, wash

your hands to avoid spreading infections

from one eye to the other and then repeat

the above instructions also for the other eye.

∙ Close the bottle tightly immediately after use.

∙ If you use more than one type of eye drops, wait

at least 5-10 minutes between instilling Vigamox

and other eye drops. Eye ointments should only be

used after you have finished using the eye drops.

If you accidentally take a higher dosage, wash

your eye with lukewarm water.

If you took an overdose, or if a child has accidentally

swallowed the medicine, proceed immediately to

a hospital emergency room and bring the package

of the medicine with you.

If you forget to take this medicine at the required

time, do not take a double dose. Take a dose as soon

as you remember. However, if it is almost time to take

the next dose, skip the forgotten dose and return to

the normal dosing regimen with the next dose.

Adhere to the treatment as recommended by the

doctor. Even if there is an improvement in your

health, do not stop treatment with this medicine

without consulting the doctor.

Do not take medicines in the dark! Check the label

and the dose each time you take your medicine.

Wear glasses if you need them.

If you have additional questions about use of the

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Vigamox may cause

side effects in some users. Do not be alarmed when

reading the list of side effects. You may not suffer

from any of them.

Stop using the medicine and refer immediately

to a doctor if you suffer from a serious

allergic reaction or from one of the following

symptoms: swelling of the hands, feet, ankles, face,

lips, mouth or throat that may cause difficulty in

swallowing or breathing, rash or urticaria (a stinging

skin rash), blisters, sores and ulcers.

Other side effects:

Common side effects - effects that

occur

in

1-10 users out of 100:

Eye effects: eye pain, eye irritation.

Uncommon side effects - effects that occur in

1-10 users out of 1,000:

Eye effects: dry eye, itchy eye, redness of the eye,

eye surface inflammation or scarring, broken blood

vessel in the eye, abnormal eye sensation, eyelid

abnormality, itching, redness or swelling.

General effects: headache and bad taste in the

mouth.

Rare side effects - effects that occur in 1-10

users out of 10,000:

Eye effects: corneal disorder, blurred or reduced

vision, inflammation or infection of the conjunctiva,

eye strain, eye swelling.

General effects: vomiting, nose discomfort, feeling

of a lump in the throat, decreased blood iron,

abnormal results of blood tests for liver enzymes,

abnormal skin sensation, pain, throat irritation.

Effects of unknown frequency - effects whose

frequency has not yet been determined:

Eye effects: infection in the eye, cloudy eye surface,

corneal swelling, deposits on the eye surface,

increased ocular pressure, scratch on the surface

of eye, eye allergy, eye discharge, increased tear

production, sensitivity to light.

General effects: shortness of breath, irregular heart

rhythm, dizziness, increased allergic symptoms,

itching, rash, skin redness, nausea and stinging

skin rash (urticaria).

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/getseq

uence.aspx?formType=AdversEffectMedic@moh.g

ov.il

5. HOW TO STORE THE MEDICINE?

∙ Avoid poisoning! This medicine, and any other

medicine, must be kept in a safe place out of

the reach of children and/or infants to avoid

poisoning. Do not induce vomiting unless

explicitly instructed to do so by the doctor!

∙ Close tightly to prevent penetration of air and

humidity. Even under recommended packaging/

storage conditions, medicines are kept for a

limited period only.

∙ Do not use the medicine after the expiry date

(exp. date) that appears on the carton/label. The

expiry date refers to the last day of that month

∙ Do not dispose of medicines into the wastewater

or household waste. Consult with the pharmacist

on how to dispose of medicines after using in

order to protect the environment.

∙ Store below 25°C. Do not use the medicine

28 days after first opening.

∙ Do not store different medicines in the same

package.

6. FURTHER INFORMATION

In addition to the active ingredient the medicine

also contains:

Sodium Chloride, Boric Acid, Hydrochloric Acid OR

Sodium Hydroxide, Purified Water

What the medicine looks like and contents of

the package: The medicine is a solution supplied

in a pack containing a 5ml plastic bottle with a

screw-on cap.

Registration Holder and address: Novartis Israel Ltd.,

36 Shacham St., Petach-Tikva.

Manufacturer and address: Alcon Laboratories,

Fort Worth, USA for Alcon Pharmaceuticals Ltd.,

Fribourg, Switzerland

This leaflet was checked and approved by the

Ministry of Health in August 2017

Registration number of the medicine in the

National Drug Registry of the Ministry of Health:

133 10 31054

SH VIG APL AUG17 CL V1 COR MAT CL

.ﺔﻴﻧﺎﺛ ﻝﻭﺎﺣ ـ ﻦﻴﻌﻟﺍ ﻞﺧﺍﺪﻟ ﻂﻴﻘﻨﺘﻟﺍ ﻲﻓ ﺢﺠﻨﺗ ﻢﻟ ﺍﺫﺇ ∙ ﻦﻳﺪﻴﻟﺍ ﻞﺴﻏ ﺐﺠﻳ ،ﺔﻴﻧﺎﺜﻟﺍ ﻦﻴﻌﻟﺍ ﻲﻓ ﺓﺮﻄﻗ ﻂﻴﻘﻨﺗ ﻚﻴﻠﻋ ﺐﺟﻮﺗ ﺍﺫﺇ

ﻚﻟﺫ ﺪﻌﺑﻭ ﻯﺮﺧﻷﺍ ﻰﻟﺇ ﺓﺪﺣﺍﻭ ﻦﻴﻋ ﻦﻣ ﺕﺎﺛﻮﻠﺘﻟﺍ ﻝﺎﻘﺘﻧﺇ ﺐﻨﺠﺘﻟ ﺔﻴﻧﺎﺜﻟﺍ ﻦﻴﻌﻟﺍ ﻲﻓ ﻩﻼﻋﺃ ﺕﺮﻛ

ﺫ ﻲﺘﻟﺍ ﺕﺎﻤﻴﻠﻌﺘﻟﺍ ﺓﺩﻭﺎﻌﻣ ﺐﺠﻳ

ﺎﻀﻳﺃ .ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻌﺑ ﻝﺎﺤﻟﺍ ﻲﻓ

ﺍﺪﻴﺟ ﺔﻨﻴﻨﻘﻟﺍ ﻖﻠﻏﺃ ∙ ،ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗ ﻦﻣ ﺪﺣﺍﻭ ﻉﻮﻧ ﻦﻣ ﺮﺜﻛﺃ ﻞﻤﻌﺘﺴﺗ ﺖﻨﻛ ﺍﺫﺇ ∙ ﺲﻛﻮﻣﺎﭽﯿﭬ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻴﺑ ﻖﺋﺎﻗﺩ ١٠-٥ ﺭﺎﻈﺘﻧﻹﺍ ﺐﺠﻴﻓ ﺔﻴﻨﻴﻌﻟﺍ ﻢﻫﺍﺮﻤﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺐﺠﻳ .ﻯﺮﺧﻷﺍ ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗﻭ .ﻦﻴﻨﻴﻌﻟﺍ ﺕﺍﺮﻄﻗ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻣ ﺀﺎﻬﺘﻧﻹﺍ ﺪﻌﺑ ﻂﻘﻓ ﻦﻴﻌﻟﺍ ﻞﺴﻏ ﻚﻴﻠﻋ ،ﺮﺒﻛﺃ

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ﺎﻴﺋﺍﻭﺩ

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ﺍﺭﺍﺪﻘﻣ ﺄﻄﺨﻟﺎﺑ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ ﻊﻠﺑ ﺍﺫﺇ ﻭﺃ

ﺎﻃﺮﻔﻣ

ﺎﻴﺋﺍﻭﺩ

ﺍﺭﺍﺪﻘﻣ ﺖﻠﻤﻌﺘﺳﺇ ﺍﺫﺇ .ﺮﺗﺎﻔﻟﺍ ﺀﺎﻤﻟﺎﺑ ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻏ ﻰﻟﺇ

ﻻﺎﺣ ﻪﺟﻮﺗ ،ﺀﺍﻭﺪﻟﺍ ﻦﻣ ﺄﻄﺨﻟﺎﺑ ﻞﻔﻃ .ﺀﺍﻭﺪﻟﺍ ﺔﺒﻠﻋ ﻚﻌﻣ ﺮﻀﺣﺃﻭ ،ﻰﻔﺸﺘﺴﻤﻟﺍ ﺯﻮﺠﻳ ﻻ ،ﺏﻮﻠﻄﻤﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻝﺎﻤﻌﺘﺳﺇ ﺖﻴﺴﻧ ﺍﺫﺇ ﻲﺋﺍﻭﺩ ﺭﺍﺪﻘﻣ ﻝﺎﻤﻌﺘﺳﺇ ﺐﺠﻳ .ﻒﻋﺎﻀﻣ ﻲﺋﺍﻭﺩ ﺭﺍﺪﻘﻣ ﻝﺎﻤﻌﺘﺳﺇ ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺪﻋﻮﻣ ﺏﺮﺘﻗﺇ ﺍﺫﺇ ،ﻚﻟﺫ ﻊﻣ .ﻙﺮﻛﺬﺗ ﻝﺎﺣ ﻡﺎﻈﻨﻟ ﺓﺩﻮﻌﻟﺍﻭ ﻲﺴﻨﻤﻟﺍ ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﺖﻳﻮﻔﺗ ﺐﺠﻴﻓ ،ﻡﺩﺎﻘﻟﺍ .ﻡﺩﺎﻘﻟﺍ ﻝﺎﻤﻌﺘﺳﻹﺍ ﺪﻨﻋ ﻱﺩﺎﻴﺘﻋﻹﺍ ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﺯﻮﺠﻳ ﻻ .ﺐﻴﺒﻄﻟﺍ ﺔﻴﺻﻮﺗ ﺐﺴﺤﺑ ﺝﻼﻌﻟﺍ ﻰﻠﻋ ﺔﺒﻇﺍﻮﻤﻟﺍ ﺐﺠﻳ ﺃﺮﻃ ﻮﻟﻭ ﻰﺘﺣ ،ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﻥﻭﺪﺑ ﺀﺍﻭﺪﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻦﻋ ﻒﻗﻮﺘﻟﺍ .ﺔﻴﺤﺼﻟﺍ ﻚﺘﻟﺎﺣ ﻰﻠﻋ ﻦﺴﺤﺗ ﺀﺍﻭﺪﻟﺍ ﻊﺑﺎﻃ ﺺﻴﺨﺸﺗ ﺐﺠﻳ !ﺔﻤﺘﻌﻟﺍ ﻲﻓ ﺔﻳﻭﺩﻷﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺯﻮﺠﻳ ﻻ ﻊﺿ .ﺀﺍﻭﺩ ﺎﻬﻴﻓ ﻞﻤﻌﺘﺴﺗ ﺓﺮﻣ ﻞﻛ ﻲﻓ ﻲﺋﺍﻭﺪﻟﺍ ﺭﺍﺪﻘﻤﻟﺍ ﻦﻣ ﺪﻛﺄﺘﻟﺍﻭ ﺔﻴﻓﺎﺿﺇ ﺔﻠﺌﺳﺃ ﻚﻳﺪﻟ ﺕﺮﻓﻮﺗ ﺍﺫﺇ .ﻚﻟﺫ ﺮﻣﻷﺍ ﻡﺰﻟ ﺍﺫﺇ ﺔﻴﺒﻄﻟﺍ ﺕﺍﺭﺎﻈﻨﻟﺍ .ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﺮﺸﺘﺳﺇ ،ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﻝﻮﺣ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ (٤ ﺔﻴﺒﻧﺎﺟ

ﺎﺿﺍﺮﻋﺃ ﺐﺒﺴﻳ ﺪﻗ ﺲﻛﻮﻣﺎﭽﯿﭬ ﻝﺎﻤﻌﺘﺳﺇ ﻥﺇ ،ﺀﺍﻭﺩ ﻞﻜﺑ ﺎﻤﻛ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﻦﻣ ﺶﻫﺪﻨﺗ ﻻ .ﻦﻴﻠﻤﻌﺘﺴﻤﻟﺍ ﺾﻌﺑ ﺪﻨﻋ .ﺎﻬﻨﻣ

ﺎﻳﺃ ﻲﻧﺎﻌﺗ ﻻﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ ﺐﻴﺒﻄﻟﺍ ﻰﻟﺇ

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ﻻﺎﺣ ﻪﺟﻮﺘﻟﺍﻭ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﻦﻋ ﻒﻗﻮﺘﻟﺍ ﺐﺠﻳ ﻯﺪﺣﺇ ﻦﻣ ﻭﺃ ﺔﻳ

ﹼ

ﺪﺟ ﺔﻴﺴﺴﺤﺗ ﻞﻌﻓ ﺩﻭﺩﺭ ﻦﻣ ﻲﻧﺎﻌﺗ ﺖﻨﻛ ﺍﺫﺇ ،ﻦﻴﻠﺣﺎﻜﻟﺍ ﻲﻓ ،ﻦﻴﻠﺟﺮﻟﺍ ﻲﻓ ،ﻦﻳﺪﻴﻟﺍ ﻲﻓ ﺥﺎﻔﺘﻧﺇ :ﺔﻴﻟﺎﺘﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻱﺩﺆﺗ ﺪﻗ ﻲﺘﻟﺍ ﺓﺮﺠﻨﺤﻟﺍ ﻲﻓ ﻭﺃ ﻢﻔﻟﺍ ﻲﻓ ،ﻦﻴﺘﻔﺸﻟﺍ ﻲﻓ ،ﻪﺟﻮﻟﺍ ﻲﻓ ﻱﺪﻠﺟ ﺢﻔﻃ) ﻯﺮﺷ ﻭﺃ ﺢﻔﻃ ،ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﻭﺃ ﻊﻠﺒﻟﺍ ﻲﻓ ﺔﺑﻮﻌﺼﻟ .ﺕﺎﺣﺮﻘﺗﻭ ﺡﻭﺮﺟ ،ﺕﻼﺼﻳﻮﺣ ،(ﺰﺧﺍﻭ :ﺔﻴﻓﺎﺿﺇ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠ - ١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ ـ ﺔﻌﺋﺎﺷ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :ﻞﻤﻌﺘﺴﻣ ١٠٠ ﻦﻴﺑ ﻦﻣ .ﻦﻴﻌﻟﺍ ﻲﻓ ﺞﻴﻬﺗ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﻢﻟﺃ :ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ١٠ - ١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮــﻋﺃ ـ ﺔﻌﺋﺎﺷ ﺮﻴﻏ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮــﻋﺃ :ﻞﻤﻌﺘﺴﻣ ١٠٠٠ ﻦﻴﺑ ﻦﻣ ﻦﻴﻠﻤﻌﺘﺴﻣ ،ﻦﻴﻌﻟﺍ ﺭﺍﺮﻤﺣﺇ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺔﻜﺣ ،ﻦﻴﻌﻟﺍ ﻑﺎﻔﺟ :ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﺮﻴﻏ ﺭﻮﻌﺷ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﻱﻮﻣﺩ ﺀﺎﻋﻭ ﻕﺰﻤﺗ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﺏﺪﻨﺗ ﻭﺃ ﺏﺎﻬﺘﻟﺇ .ﺥﺎﻔﺘﻧﺇ ﻭﺃ ﺭﺍﺮﻤﺣﺇ ،ﺔﻜﺣ ،ﻦﻔﺠﻟﺍ ﻲﻓ ﺏﺍﺮﻄﺿﺇ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﻱﺩﺎﻋ .ﻢﻔﻟﺍ ﻲﻓ ﺀﻲﺳ ﻢﻌﻃﻭ ﻉﺍﺪﺻ :ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ ﻦﻴﻠﻤﻌﺘﺴﻣ ١٠ - ١ ﻯﺪﻟ ﺮﻬﻈﺗ ﺽﺍﺮﻋﺃ ـ ﺓﺭﺩﺎﻧ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ :ﻞﻤﻌﺘﺴﻣ ١٠٠٠٠ ﻦﻴﺑ ﻦﻣ ﺔﻳﺅﺮﻟﺍ ﺵﻮﺸﺗ ،ﺔﻴﻧﺮﻘﻟﺍ ﻲﻓ ﺏﺍﺮﻄﺿﺇ :ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ،ﻦﻴﻨﻴﻌﻟﺍ ﺩﺎﻬﺟﺇ ،ﺔﻤﺤﺘﻠﻤﻟﺍ ﺙﻮﻠﺗ ﻭﺃ ﺏﺎﻬﺘﻟﺍ ،ﺔﻳﺅﺮﻟﺍ ﻲﻧﺪﺗ ﻭﺃ .ﻦﻴﻌﻟﺍ ﻲﻓ ﺥﺎﻔﺘﻧﺇ ﻲﻓ ﺔﻠﺘﻜﺑ ﺭﻮﻌﺸﻟﺍ ،ﻒــﻧﻷﺍ ﻲﻓ ﺝﺎﻋﺰﻧﺇ ،ﺆﻴﻘﺗ :ﺔﻣﺎﻋ ﺽﺍﺮــﻋﺃ ﺞﺋﺎﺘﻧ ﻲﻓ ﺫﻭﺬﺷ ،ﻡﺪﻟﺍ ﻲﻓ ﺪﻳﺪﺤﻟﺍ ﺔﺒﺴﻧ ﺽﺎﻔﺨﻧﺇ ،ﺓﺮﺠﻨﺤﻟﺍ ،ﻢﻟﺃ ،ﺪﻠﺠﻟﺍ ﻲﻓ ﻱﺩﺎﻋ ﺮﻴﻏ ﺭﻮﻌﺷ ،ﺪﺒﻜﻟﺍ ﺕﺎﻤﻳﺰﻧﻹ ﻡﺪﻟﺍ ﺹﻮﺤﻓ .ﺓﺮﺠﻨﺤﻟﺍ ﺞﻴﻬﺗ :ﺪﻌﺑ ﺎﻬﻋﻮﻴﺷ ﺩﺪﺤﻳ ﻢﻟ ﺽﺍﺮﻋﺃ ـ ﻑﻭﺮﻌﻣ ﺮﻴﻏ ﻉﻮﻴﺷ ﺕﺍﺫ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﺥﺎﻔﺘﻧﺇ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﺮﻜﻌﺗ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺙﻮﻠﺗ :ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﺽﺍﺮﻋﺃ ﺵﺪﺧ ،ﻦﻴﻌﻟﺍ ﻂﻐﺿ ﻉﺎﻔﺗﺭﺇ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﻰﻠﻋ ﺕﺎﺒﺳﺮﺗ ،ﺔﻴﻧﺮﻘﻟﺍ ﺝﺎﺘﻧﺇ ،ﻦﻴﻌﻟﺍ ﻦﻣ ﺕﺍﺯﺍﺮﻓﺇ ،ﻦﻴﻌﻟﺍ ﻲﻓ ﺔﻴﺳﺎﺴﺣ ،ﻦﻴﻌﻟﺍ ﺢﻄﺳ ﻰﻠﻋ .ﺀﻮﻀﻠﻟ ﺔﻴﺳﺎﺴﺣ ،ﻉﻮﻣﺪﻠﻟ ﺪﺋﺍﺯ ﺽﺍﺮﻋﺃ ،ﺭﺍﻭﺩ ،ﺐﻠﻘﻠﻟ ﻱﺩﺎﻋ ﺮﻴﻏ ﻢﻈﻧ ،ﺲﻔﻨﺗ ﻖﻴﺿ :ﺔﻣﺎﻋ ﺽﺍﺮﻋﺃ ﺢﻔﻃﻭ ﻥﺎﻴﺜﻏ ،ﺪﻠﺠﻟﺍ ﺭﺍﺮﻤﺣﺇ ،ﺢﻔﻃ ،ﺔﻜﺣ ،ﺲﺴﺤﺘﻟﺍ ﻦﻣ ﺓﺪﻳﺪﺷ .(ﻯﺮﺷ) ﺰﺧﺍﻭ ﻱﺪﻠﺟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻂﻐﻀﻟﺍ ﺔﻄﺳﺍﻮﺑ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻮﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻟﺍ ﻥﺎﻜﻣﻹﺎﺑ ﺩﻮﺟﻮﻤﻟﺍ «ﻲﺋﺍﻭﺩ ﺝﻼﻋ ﺐﻘﻋ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺗ» ﻂﺑﺍﺮﻟﺍ ﻰﻠﻋ

www.health.gov.il

) ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻊﻗﻮﻤﻟ ﺔﻴﺴﻴﺋﺮﻟﺍ ﺔﺤﻔﺼﻟﺍ ﻰﻠﻋ ،ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻋ ﻎﻴﻠﺒﺘﻠﻟ ﺮﺷﺎﺒﻤﻟﺍ ﺝﺫﻮﻤﻨﻟﺍ ﻰﻟﺇ ﻚﻬﺟﻮﻳ ﻱﺬﻟﺍ :ﻂﺑﺍﺮﻟﺍ ﺢﻔﺼﺗ ﻖﻳﺮﻃ ﻦﻋ ﻭﺃ

https://forms.gov.il/globaldata/getsquence/getse-

quence.aspx?formType=AdversEffectMedic@moh.gov.il

؟ﺀﺍﻭﺪﻟﺍ ﻦﻳﺰﺨﺗ ﺔﻴﻔﻴﻛ (٥ ﻖﻠﻐﻣ ﻥﺎﻜﻣ ﻲﻓ ﺀﺍﻭﺩ ﻞﻛﻭ ﺀﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻆﻔﺣ ﺐﺠﻳ !ﻢﻤﺴﺘﻟﺍ ﺐﻨﺟ

ﻢﻬﺘﺑﺎﺻﺇ ﻱﺩﺎﻔﺘﻟ ﻚﻟﺫﻭ ،ﻊﺿﺮﻟﺍ ﻭﺃ/ﻭ ﻝﺎﻔﻃﻷﺍ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ ﻦﻋ

ﺍﺪﻴﻌﺑ .ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺔﺤﻳﺮﺻ ﺕﺎﻤﻴﻠﻌﺗ ﻥﻭﺪﺑ ﺆﻴﻘﺘﻟﺍ ﺐﺒﺴﺗ ﻻ .ﻢﻤﺴﺘﻟﺎﺑ ﺔﻳﻭﺩﻷﺍ ﻰﻘﺒﺗ .ﺔﺑﻮﻃﺮﻟﺍﻭ ﺀﺍﻮﻬﻟﺍ ﺫﺎﻔﻧ ﻊﻨﻣﺍﻭ

ﺍﺪﻴﺟ ﺓﻮﺒﻌﻟﺍ ﻖﻠﻏﺃ ∙ ﺐﺟﻮﻤﺑ ﺎﻬﻨﻳﺰﺨﺗ ﻢﺗ ﻮﻟﻭ ﻰﺘﺣ ،ﻂﻘﻓ ﺓﺩﻭﺪﺤﻣ ﺓﺮﺘﻔﻟ ﺔﺤﻟﺎﺻ .ﺎﻬﺑ ﻰﺻﻮﻤﻟﺍ ﻦﻳﺰﺨﺘﻟﺍ /ﺔﺌﺒﻌﺘﻟﺍ ﻁﻭﺮﺷ

exp.

) ﺔﻴﺣﻼﺼﻟﺍ ﺦﻳﺭﺎﺗ ﺀﺎﻀﻘﻧﺇ ﺪﻌﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ ﺯﻮﺠﻳ ﻻ ∙ ﺦﻳﺭﺎﺗ ﺮﻴﺸﻳ .ﺔﻘﺼﻠﻤﻟﺍ/ﻥﻮﺗﺮﻜﻟﺍ ﺮﻬﻇ ﻰﻠﻋ ﺮﻬﻈﻳ ﻱﺬﻟﺍ (

date

.ﺮﻬﺸﻟﺍ ﺲﻔﻧ ﻦﻣ ﺮﻴﺧﻷﺍ ﻡﻮﻴﻟﺍ ﻰﻟﺇ ﺔﻴﺣﻼﺼﻟﺍ ﻭﺃ ﺔﻴﺤﺼﻟﺍ ﻱﺭﺎﺠﻤﻟﺍ ﺔﻣﻮﻈﻨﻣ ﻰﻟﺇ ﺔﻳﻭﺩﻷﺍ ﻲﻣﺭ ﺯﻮﺠﻳ ﻻ ∙ ﺔﻴﻔﻴﻛ ﻦﻋ ﻲﻟﺪﻴﺼﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﺐﺠﻳ ،ﺔﻴﻟﺰﻨﻤﻟﺍ ﺔﻣﺎﻤﻘﻟﺍ ﺀﺎﻋﻮﻟ ﻅﺎﻔﺤﻠﻟ ﻚﻟﺫﻭ ﺎﻬﻟﺎﻤﻌﺘﺳﺇ ﻦﻣ ﺀﺎﻬﺘﻧﻹﺍ ﺪﻌﺑ ﺔﻳﻭﺩﻷﺍ ﻦﻣ ﺺﻠﺨﺘﻟﺍ .ﺔﺌﻴﺒﻟﺍ ﻰﻠﻋ ﺯﻮﺠﻳ ﻻ .ﺔﻳﻮﺌﻣ ﺔﺟﺭﺩ ٢٥ ﻥﻭﺩ ﺓﺭﺍﺮﺣ ﺔﺟﺭﺪﺑ ﻦﻳﺰﺨﺘﻟﺍ ﺐﺠﻳ ∙ .ﺓﺮﻣ ﻝﻭﻷ ﻪﺤﺘﻓ ﺬﻨﻣ

ﺎﻣﻮﻳ ٢٨ ﺪﻌﺑ ﺀﺍﻭﺪﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ .ﺔﺒﻠﻌﻟﺍ ﺲﻔﻨﺑ ﺔﻔﻠﺘﺨﻣ ﺔﻳﻭﺩﺃ ﻦﻳﺰﺨﺗ ﺯﻮﺠﻳ ﻻ ∙ ﺔﻴﻓﺎﺿﺇ ﺕﺎﻣﻮﻠﻌﻣ (٦

ﺎﻀﻳﺃ ﺔﻟﺎﻌﻔﻟﺍ ﺓﺩﺎﻤﻠﻟ ﺔﻓﺎﺿﻹﺎﺑ ﺀﺍﻭﺪﻟﺍ ﻱﻮﺘﺤﻳ

Sodium

Chloride,

Boric

Acid,

Hydrochloric

Acid

Sodium Hydroxide, Purified Water

ﻦﻋ ﺓﺭﺎﺒﻋ ﻮﻫ ﺀﺍﻭﺪﻟﺍ :ﺔﺒﻠﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ﺀﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ ﻚﻴﺘﺳﻼﭙﻟﺍ ﻦﻣ ﺔﻨﻴﻨﻗ ﻰﻠﻋ ﻱﻮﺘﺤﺗ ﺔﺒﻠﻋ ﻦﻤﺿ ﺮﻓﻮﺘﻣ ﻝﻮﻠﺤﻣ .ﺔﺒﻟﻮﻟ ﺀﺎﻄﻏ ﻊﻣ ﻞﻠﻣ ٥ ﻢﺠﺤﺑ ﻉﺭﺎﺷ ،.ﺽ.ﻡ ﻞﻴﺋﺍﺮﺳﺇ ﺲﻴﺗﺭﺎﭬﻮﻧ :ﻪﻧﺍﻮﻨﻋﻭ ﺯﺎﻴﺘﻣﻹﺍ ﺐﺣﺎﺻ .ﺎﭭﻜﺗ ـ ﺢﺘﻴﭘ ،٣٦ ﻡﺎﺣﺎﺷ ﺓﺪﺤﺘﻤﻟﺍ ﺕﺎﻳﻻﻮﻟﺍ ،ﺙﺭﻭﻭ ﺕﺭﻮﻓ ،ﺕﺍﺮﺒﺘﺨﻣ ﻥﻮﻜﻟﺃ :ﻪﻧﺍﻮﻨﻋﻭ ﺞﺘﻨﻤﻟﺍ ﻢﺳﺇ .ﺍﺮﺴﻳﻮﺳ ،چﺭﻮﺒﻳﺮﻓ ،.ﺽ.ﻡ ﺲﻟﺎﻜﻴﺗﻮﺳﺎﻣﺭﺎﻓ ﻥﻮﻜﻟﺃ ﻞﺟﺃ ﻦﻣ ﺺﺧ

ﺭﻭ ﺺﺤ

ﻓ ﺎﻫﺍﻮﺘﺤﻣﻭ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻐﻴﺻ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﺕﺮﻗﺃ ٢٠١٧ ﺏﺁ :ﺦﻳﺭﺎﺗ ﻲﻓ :ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻲﻓ ﻲﻣﻮﻜﺤﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻞﺠﺳ ﻲﻓ ﺀﺍﻭﺪﻟﺍ ﻞﺠﺳ ﻢﻗﺭ ١٣٣ ١٠ ٣١٠٥٤ .ﺮﻛﺬﻤﻟﺍ ﺔﻐﻴﺼﺑ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺔﻏﺎﻴﺻ ﺖﻤﺗ ،ﺓﺀﺍﺮﻘﻟﺍ ﻦﻳﻮﻬﺗﻭ ﺔﻟﻮﻬﺳ ﻞﺟﺃ ﻦﻣ .ﻦﻴﺴﻨﺠﻟﺍ ﻼﻜﻟ ﺺﺼﺨﻣ ﺀﺍﻭﺪﻟﺍ ﻥﺈﻓ ،ﻚﻟﺫ ﻦﻣ ﻢﻏﺮﻟﺍ ﻰﻠﻋ

Alcon MAT

VIG API AUG17 CL V2 COR NOV17 CL

ב ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ

טסוגוא

2017

1.

NAME OF THE MEDICINAL PRODUCT

VIGAMOX

(moxifloxacin hydrochloride ophthalmic solution) 0.5% as base

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each mL of VIGAMOX

solution contains 5.45 mg moxifloxacin hydrochloride equivalent to

5 mg moxifloxacin base.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

VIGAMOX (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile topical ophthalmic

solution.

4.

Clinical particulars

4.1

Therapeutic indications

VIGAMOX Solution is indicated for the treatment of bacterial conjunctivitis caused by

susceptible strains or organisms.

For a full list of susceptible strains and organisms, see sections 5.1

4.2

Posology and method of administration

For ocular use only. Not for injection. VIGAMOX 5 mg/ml eye drops, solution should not be

injected subconjunctivally or introduced directly into the anterior chamber of the eye.

Dosage and administration: Instill one drop in the affected eye 3 times a day for 4 days.

Pediatric Use: VIGAMOX Solution has been shown to be safe and effective in pediatric

patients including neonates. There is no evidence that the ophthalmic administration of

VIGAMOX Solution has any effect on weight bearing joints, even though oral administration

of some quinolones has been shown to cause arthropathy in immature animals.

No dosage adjustment is necessary.

Geriatric Use: No overall differences in safety and effectiveness have been observed between

elderly and other adult patients.

Special Populations:

Patients with renal impairment:

The pharmacokinetic parameters of oral moxifloxacin are not significantly altered by mild,

moderate or severe renal impairment. No dosage adjustment of VIGAMOX Solution is

necessary in patients with renal impairment.

Patients with hepatic impairment:

Pharmacokinetic parameters of oral moxifloxacin were not significantly altered in patients

with mild to moderate hepatic insufficiency (Child Pugh Classes A and B).

Studies were not preformed in patients with severe hepatic impairment (Child Pugh Class C).

Because of the low systemic exposure by the topical route of administration, no dosage

adjustment of VIGAMOX Solution is needed in patients with hepatic impairment.

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In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-

born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with

the fingers after administering the drops. After cap is removed, if tamper evident snap collar

is loose, remove before using the product.

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

must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.3

Contraindications

Hypersensitivity to the active substance, to other quinolones, or to any of the excipients listed

in section 6.1.

4.4

Special warnings and precautions for use

Warnings:

In patients receiving systemically administered quinolones, serious and occasionally fatal

hypersensitivity (anaphylactic) reactions have been reported, some following the first dose.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness,

angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnoea

, urticaria and itching (see section 4.8).

If an allergic reaction to VIGAMOX occurs, discontinue use of the

medicinal product.

Serious acute hypersensitivity reactions

to moxifloxacin or any other product ingredient may

require immediate emergency treatment. Oxygen and airway management should be

administered as clinically indicated.

Precautions:

In patients receiving systemically administered quinolones, serious and occasionally fatal

hypersensitivity (anaphylactic) reactions have been reported, some following the first dose.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness,

angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction,

dyspnoea, urticaria, and itching (see section 4.8).

If an allergic reaction to VIGAMOX occurs, discontinue use of the medicinal product.

Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may

require immediate emergency treatment. Oxygen and airway management should be

administered where clinically indicated.

As with other anti-invectives, prolonged use may result in overgrowth of non-susceptible

organisms, including fungi. If superinfection occurs, discontinue use and institute alternative

therapy.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including

moxifloxacin, particularly in older patients and those treated concurrently with corticosteroid.

Following ophthalmic administration of VIGAMOX plasma concentrations of moxifloxacin

are much lower than after therapeutic oral doses of moxifloxacin (see section 4.5 and 5.2),

however caution should be exercised and treatment with VIGAMOX should be discontinued

at the first sign of tendon inflammation (see section 4.8).

Data are very limited to establish efficacy and safety of VIGAMOX in the treatment of

conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in

neonates is not recommended.

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VIGAMOX should not be used for the prophylaxis or empiric treatment of gonococcal

conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of

fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by

Neisseria gonorrhoeae should receive appropriate systemic treatment.

The medicinal product is not recommended for the treatment of Chlamydia trachomatis in

patients less than 2 years of age as it has not been evaluated in such patients. Patients older

than 2 years of age with eye infections caused by Chlamydia trachomitis should receive

appropriate systemic treatment.

Neonates with ophthalmia neonatorum should receive appropriate treatment for their

condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria

gonorrhoeae.

4.5

Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed with VIGAMOX 5 mg/ml Eye Drops,

Solution. Given the low systemic concentration of moxifloxacin following topical ocular

administration of the medicinal product (see Section 5.2), drug interactions are unlikely to

occur.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of VIGAMOX in pregnant women. However, no

effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is

negligible. The medicinal product can be used during pregnancy.

Breastfeeding

It is unknown whether moxifloxacin/metabolites are excreted in human milk. Animal studies

have shown excretion of low levels in breast milk after oral administration of moxifloxacin.

However, at therapeutic doses of VIGAMOX no effects on the suckling child are anticipated.

The medicinal product can be used during breast-feeding.

Fertility

Studies have not been performed to evaluate the effect of ocular administration of

VIGAMOX on fertility.

4.7

Effects on the ability to drive and use machines

VIGAMOX has no or negligible influence on the ability to drive and use machines, however,

as with any eye drops, temporary blurred vision or other visual disturbances may affect the

ability to drive or use machines. If blurred vision occurs at instillation, the patient should

wait until their vision clears before driving or using machinery.

4.8

Undesirable effects

Summary of the safety profile

In clinical studies involving 2,252 patients, VIGAMOX was administered up to 8 times a day,

with over 1,900 of these patients receiving treatment 3 times daily. The overall safety

population that received the medicinal product consisted of 1,389 patients from the United

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States and Canada, 586 patients from Japan and 277 patients from India. No serious

ophthalmic or systemic undesirable effects related to the medicinal product were reported in

any of the clinical studies. The most frequently reported treatment-related undesirable effects

with the medicinal product were eye irritation and eye pain, occurring at an overall incidence

of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with

only 1 patient discontinuing therapy as a result.

The following adverse reactions are 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, undesirable effects are presented in

decreasing order of seriousness.

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System Organ Classification

Frequency

Adverse reactions

Blood and lymphatic system

disorders

Rare

haemoglobin decreased

Immune system disorders

Not known

hypersensitivity

Nervous system disorders

Uncommon

headache

Rare

paresthesia

Not known

dizziness

Eye disorders

Common

eye pain, eye irritation

Uncommon

punctate keratitis, dry eye,

conjunctival haemorrhage,

ocular hyperaemia, eye

pruritus, eyelid oedema,

ocular discomfort,

Rare

corneal epithelium defect,

corneal disorder,

conjunctivitis, blepharitis,

eye swelling, conjunctival

oedema, vision blurred,

visual acuity reduced,

asthenopia, erythema of

eyelid

Not known

endophthalmitis, ulcerative

keratitis, corneal erosion,

corneal abrasion, intraocular

pressure increased, corneal

opacity, corneal infiltrates,

corneal deposits, eye allergy,

keratitis, corneal oedema,

photophobia, eyelid oedema,

lacrimation increased, eye

discharge, foreign body

sensation in eyes

Cardiac disorders

Not known

palpitations

Respiratory, thoracic and

mediastinal disorders

Rare

nasal discomfort,

pharyngolaryngeal pain,

sensation of foreign body

(throat)

Not known

dyspnoea

Gastrointestional disorders

Uncommon

dysgeusia, vomiting

Not known

nausea

Hepatobiliary disorders

Rare

alanine aminotransferase

increased, gamma-

glutamyltransferase

increased

Skin and subcutaneous tissue

disorders

Not known

erythema, rash, pruritus,

urticaria

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Description of selected adverse reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first

dose, have been reported in patients receiving systemic quinolone therapy. Some reactions

were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including

laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria and itching

(see section 4.4).

Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or

resulted in prolonged disability have been reported in patients receiving systemic

fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate

that a risk of these ruptures may be increased in patients receiving corticosteroids, especially

geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).

Paediatric population

In clinical trials, VIGAMOX has shown to be safe in paediatric patients, including neonates. In

patients under 18 years old, the two most frequent adverse reactions were eye irritation and

eye pain, both occurring at an incidence rate of 0.9%.

Based on data from clinical trials involving paediatric patients, including neonates (see section

5.1), the type and severity of adverse reactions in the paediatric population are similar to

those in adults.

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.health.gov.il ).

4.9

Overdose

The limited holding capacity of the conjunctival sac for ophthalmic products practically

precludes any overdosing of the medicinal product.

The total amount of moxifloxacin in a single container is too small to induce adverse effects

after accidental ingestion.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives,

ATC code: S01AE07

Mode of Action:

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and

topoisomerase IV required for bacterial DNA replication, repair, and recombination.

Resistance to fluoroquinolones, including moxifloxacin generally occurs by chromosomal

mutations in genes encoding DNA gyrase and topoisomerase IV. In Gram-negative bacteria,

moxifloxacin resistance can be due to mutations in mar (multiple antibiotic resistance) and the

qnr (quinolone resistance) gene systems. Resistance is also associated with expression of

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bacteria efflux proteins and inactivating enzymes. Cross-resistance with beta-lactams,

macrolides and aminoglycosides is not expected due to differences in mode of action.

Susceptibility Testing Breakpoints: There are no pharmacological data correlated with clinical

outcome for moxifloxacin administered as a topical agent. As a result, the European

Committee on Antimicrobial Susceptibility Testing (EUCAST) suggests the following

epidemiological cut-off values (ECOFF mg/l) derived from MIC distribution curves to

indicate susceptibility to topical moxifloxacin:

Corynebacterium

Staphylococcus aureus

0.25 mg/l

Staphylococcus, coag-neg.

0.25 mg/l

Streptococcus pneumoniae

0.5 mg/l

Streptococcus pyogenes

0.5 mg/l

Streptococcus, viridans group

0.5 mg/l

Enterobacter spp.

0.25 mg/l

Haemophilus influenzae

0.125 mg/l

Klebsiella spp.

0.25 mg/l

Moraxella catarrhalis

0.25 mg/l

Morganella morganii

0.25 mg/l

Neisseria gonorrhoeae

0.032 mg/l

Pseudomonas aeruginosa

4 mg/l

Serratia marcescens

1 mg/l

The prevalence of acquired resistance may vary geographically and with time for selected

species and local information on resistance is desirable, particularly when treating severe

infections. As necessary, expert advice should be sought when the local prevalence of

resistance is such that the utility of moxifloxacin in at least some types of infections is

questionable.

COMMONLY SUSCEPTIBLE SPECIES

Aerobic Gram positive micro organisms:

Corynebacterium species including

Corynebacterium diphtheriae

Staphylococcus aureus (methicillin susceptible)

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus viridans Group

Aerobic Gram negative micro organisms:

Enterobacter cloacae

Haemophilus influenzae

Klebsiella oxytoca

Moraxella catarrhalis

Serratia marcescens

Anaerobic micro-organisms:

Proprionibacterium acnes

Other micro organisms:

Chlamydia trachomatis

SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM

Aerobic Gram positive micro organisms:

Staphylococcus aureus (methicillin resistant)

Staphylococcus, coagulase-negative species (methicillin resistant)

Aerobic Gram negative micro organisms:

Neisseria gonorrhoeae

Other micro organisms:

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None

INHERENTLY RESISTANT ORGANISMS

Aerobic Gram negative micro organisms:

Pseudomonas aeruginosa

Other micro organisms:

None

5.2

Pharmacokinetic properties

Following topical ocular administration of VIGAMOX, Moxifloxacin was absorbed into the

systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and

female subjects who received bilateral topical ocular doses of VIGAMOX solution 3 times a

day for 4 days. The mean steady-state C

and AUC were 2.7ng/mL and 41.9ng-hr/mL,

respectively. These exposure values are approximately 1,600 and 1,200 times lower than the

mean C

and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The

plasma half-life of moxifloxacin was estimated to be 13 hours.

5.3

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in

excess of the maximum human exposure following administration to the eye indicating little

relevance to clinical use.

As with other quinolones, moxifloxacin was also genotoxic in vitro in bacteria and

mammalian cells. As these effects can be traced to the interaction with bacterial gyrase and in

considerably higher concentrations to the interaction with topoisomerase II in mammalian

cells, a threshold level for genotoxicity can be assumed. In in vivo tests, no evidence of

genotoxicity was found, despite high doses of moxifloxacin. The therapeutic doses for human

use therefore provide adequate safety margin. No indication of a carcinogenic effect was

observed in an initiation promotion model in rats.

Unlike other quinolones, moxifloxacin showed no phototoxic or photogenotoxic properties in

extensive in vitro and in vivo studies.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium chloride

Boric Acid

Hydrochloric Acid OR Sodium Hydroxide

Purified Water

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Shelf life after opening: 28 days

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6.4

Special precautions for storage

Store below 25°C

6.5

Nature and content of container

How supplied: VIGAMOX

(moxifloxacin ophthalmic solution) 0.5% is supplied as a sterile

ophthalmic solution in Alcon’s DROP-TAINER

dispensing system consisting of a natural

low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper

evidence is provided with 3 shrink band around the closure and neck area of the package.

6.6

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local

requirements.

7.

MANUFACTURER

Manufacturer:

Alcon Laboratories, Fort Worth, USA for Alcon Pharmaceuticals Ltd., Fribourg, Switzerland.

8.

MARKETING AUTHORISATION HOLDER

License Holder:

Novartis Israel Ltd., 36 Shacham St., Petach-Tikva.

9. MARKETING AUTHORISATION NUMBER

133 10 31054