Tavu 50 mikrogram/ml + 5 mg/ml Ögondroppar, lösning

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
latanoprost; timololmaleat
Tillgänglig från:
Pfizer AB
ATC-kod:
S01ED
INN (International namn):
latanoprost; timolol maleate
Dos:
50 mikrogram/ml + 5 mg/ml
Läkemedelsform:
Ögondroppar, lösning
Sammansättning:
latanoprost 50 mikrog Aktiv substans; timololmaleat 6,83 mg Aktiv substans; bensalkoniumklorid Hjälpämne
Klass:
Apotek
Receptbelagda typ:
Receptbelagt
Terapiområde:
Beta-receptorblockerande medel
Produktsammanfattning:
Förpacknings: Plastflaska, 3 x 2,5 ml; Plastflaska, 2,5 ml
Bemyndigande status:
Godkänd
Godkännandenummer:
16158
Tillstånd datum:
2000-12-15

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

10-06-2020

Produktens egenskaper Produktens egenskaper - engelska

10-06-2020

Läs hela dokumentet

Package Leaflet: Information for the user

Tavu 50 micrograms/mL and 5 mg/mL Eye Drops, Solution

Latanoprost + Timolol

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Tavu is and what it is used for

What you need to know before you use Tavu

How to use Tavu

Possible side effects

How to store Tavu

Contents of the pack and other information

1. What Tavu is and what it is used for

Tavu contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of

medicines known as prostaglandin analogues. Timolol belongs to a group of medicines

known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from

the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.

Tavu is used to reduce the pressure in your eye if you have conditions known as open angle

glaucoma or ocular hypertension. Both these conditions are linked to an increase in the

pressure within your eye, eventually affecting your eyesight. Your doctor will usually

prescribe you Tavu when other medicines have not worked adequately.

2. What you need to know before you use Tavu

Tavu can be used in adult men and women (including the elderly), but is not recommended

for use if you are less than 18 years of age.

Do not use Tavu eye drops solution:

if you are allergic (hypersensitive) to either of the medicines in Tavu (latanoprost or

timolol), beta-blockers, or any of the other ingredients of Tavu (listed in section 6)

if you have now or have had in past respiratory problems such as asthma, severe chronic

obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in

breathing and/or long-standing cough)

if you have serious heart problems or heart rhythm disorders

Warnings and precautions

Talk to your doctor or pharmacist before using Tavu if you have now or have had in the past:

coronary heart disease (symptoms can include chest pain or tightness, breathlessness or

choking), heart failure, low blood pressure

disturbances of heart rate such as slow heart beat

breathing problems, asthma or chronic obstructive pulmonary disease

poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)

diabetes as timolol may mask signs and symptoms of low blood sugar

overactivity of the thyroid gland as timolol may mask signs and symptoms

you are about to have any kind of eye surgery (including cataract surgery) or have had

any kind of eye surgery in the past

you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or

blurred vision)

you know that you suffer from dry eyes

you wear contact lenses. You can still use Tavu but follow the instructions for contact

lens wearers in section 3

you know that you suffer from angina (particularly a type known as Prinzmetal angina)

you know that you suffer from severe allergic reactions that would usually require

hospital treatment

you have suffered or are currently suffering from a viral infection of the eye caused by

the herpes simplex virus (HSV)

Tell your doctor before you have an operation that you are using Tavu

as timolol may change

effects of some medicines used during anaesthesia.

Other medicines and Tavu

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including using eye drops and medicines obtained without a prescription.

Tavu can affect or be affected by other medicines you are using, including other eye drops

for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to

lower blood pressure, heart medicine or medicines to treat diabetes.

In particular, speak to your doctor or pharmacist if you know that you are taking any of the

following types of medicine:

Prostaglandins, prostaglandin analogues or prostaglandin derivates

Beta-blockers

Epinephrine

Drugs used to treat high blood pressure such as oral calcium channel blockers,

guanethidine, antiarrythmics, digitalis glycosides or parasympathomimetics

Quinidine (used to treat heart conditions and some types of malaria)

Antidepressants known as fluoxetine and paroxetine

Tavu with food and drink

Normal meals, food or drink have no effect on when or how you should use Tavu.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not use Tavu if you are pregnant unless your doctor considers it necessary. Tell your

doctor immediately if you are pregnant, think you are pregnant or are planning to become

pregnant.

Breast-feeding

Do not use Tavu if you are breast-feeding. Tavu may get into your milk. Ask your doctor for

advice before taking any medicine during breast-feeding.

Fertility

Latanoprost and timolol have been found to have no effect on male or female fertility in

animal studies.

Driving and using machines

When you use Tavu your vision may become blurred for a short time. If this happens to you,

do not drive or use any tools or machines until your vision becomes clear again.

Tavu contains benzalkonium chloride

Tavu contains a preservative called benzalkonium chloride. This preservative may cause eye

irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and is

known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. See

the instructions for contact lens wearers in section 3.

3. How to use Tavu

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

The recommended dose for adults (including the elderly) is one drop once a day in the

affected eye(s).

Do not use Tavu more than once a day, because the effectiveness of the treatment can be

reduced if you administer it more often.

Use Tavu as instructed by your doctor until your doctor tells you to stop.

Your doctor may want you to have extra checks on your heart and circulation if you use

Tavu.

Contact lens wearers

If you wear contact lenses, you should remove them before using Tavu. After using Tavu you

should wait 15 minutes before putting your contact lenses back in.

Instructions for use

Wash your hands and sit or stand comfortably.

Twist off the outer cap (which can be thrown away).

Figure 1

Unscrew the protective inner cap. The protective cap

should be retained.

Figure 2

Use your finger to gently pull down the lower eyelid

of your affected eye.

Place the tip of the bottle close to, but not touching

your eye.

Squeeze the bottle gently so that only one drop goes

into your eye, then release the lower eyelid.

After using Tavu, press a finger into the corner of

your eye, by the nose (figure 4) for 2 minutes. This

helps to stop latanoprost + timolol getting into the

rest of the body.

Figure 3

Figure 4

Repeat in your other eye if your doctor has told you to do this.

Put the protective inner cap back on the bottle.

If you use Tavu with other eye drops

Wait at least 5 minutes between using Tavu and using the other eye drops.

If you use more Tavu than you should

If you put too many drops in your eye you may experience some minor irritation in your eye

and your eyes may water and turn red. This should pass but if you are worried contact your

doctor for advice.

If you swallow Tavu

If you swallow Tavu accidentally you should contact your doctor for advice. If you swallow

a lot of Tavu you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to

sweat.

If you forget to use Tavu

Carry on with the usual dosage at the usual time. Do not use a double dose to make up to the

dose you have forgotten. If you are unsure about anything talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

You can usually carry on using the drops, unless the effects are serious. If you're worried,

talk to a doctor or pharmacist. Do not stop using Tavu without speaking to your doctor.

Listed below are the known side effects of using Tavu. The most important side-effect is the

possibility of a gradual, permanent change in your eye colour. It is also possible that Tavu

might cause serious changes in the way your heart works. If you notice changes in your heart

rate or heart function you should speak to a doctor and tell them you have been using Tavu.

The following are known side effects of using Tavu:

Very common (may affect more than 1 in 10 people):

A gradual change in your eye colour by increasing the amount of brown pigment in the

coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown,

grey-brown, yellow-brown or green-brown) you are more likely to see this change than if

you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye

colour may take years to develop. The colour change may be permanent and may be more

noticeable if you use Tavu in only one eye. There appears to be no problems associated

with the change in eye colour. The eye colour change does not continue after Tavu

treatment is stopped.

Common (may affect up to 1 in 10 people):

Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a

foreign body in the eye) and eye pain.

Uncommon (may affect up to 1 in 100 people):

Headache

Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes,

inflammation of the eyelids, irritation or disruption of the surface of the eye

Skin rashes or itching (pruritus)

Other side effects

Like other medicines used in the eyes, Tavu (latanoprost and timolol) is absorbed into the

blood. The incidence of side effects after using eye drops is lower than when medicines are,

for example, taken by mouth or injected.

Although not seen with Tavu, the following additional side effects have been seen with the

medicines in Tavu (latanoprost and timolol) and therefore might occur when you use Tavu.

The listed side effects include reactions seen within the class of beta-blockers (e.g. timolol)

when used for treating eye conditions:

Developing a viral infection of the eye caused by the herpes simplex virus (HSV)

Generalized allergic reactions including swelling beneath the skin that can occur in areas

such as the face and limbs and can obstruct the airway which may cause difficulty

swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness,

severe sudden life-threatening allergic reaction.

Low blood glucose levels.

Dizziness.

Difficulty sleeping (insomnia), depression, nightmares, memory loss.

Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of

myasthenia gravis (muscle disorder), unusual sensations like pins and needles, and

headache.

Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured

part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance

(deepening of the eye sulcus).

Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness),

inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of

the layer below the retina that contains blood vessels following filtration surgery which

may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion

(damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye

stay half closed), double vision.

Darkening of the skin around the eyes, changes to the eyelashes and fine hairs around the

eye (increased number, length, thickness and darkening), changes to the direction of

eyelash growth, swelling around the eye, swelling of the coloured part of the eye

(iritis/uveitis), scarring of the surface of the eye.

Whistling/ringing in the ears (tinnitus).

Angina, worsening of angina in patients who already have heart disease

Slow heart rate, chest pain, palpitations (awareness of heart rhythm), oedema (fluid build

up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart

disease with shortness of breath and swelling of the feet and legs due to fluid build up), a

type of heart rhythm disorder, heart attack, heart failure.

Low blood pressure, poor blood circulation which makes the fingers and toes numb and

pale, cold hands and feet.

Shortness of breath, constriction of the airways in the lungs (predominantly in patients

with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.

Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.

Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or

worsening of psoriasis, skin rash.

Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness.

Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye

(the cornea) have developed cloudy patches on the cornea due to calcium build-up during

treatment.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible

side effect not listed in this leaflet.

You can also report side effects directly via the national

reporting system listed in Appendix V. By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Tavu

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated after EXP on the carton and

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

Store the unopened bottle of Tavu in a refrigerator (between 2°C to 8°C). After opening the

bottle it is not necessary to store it in a refrigerator but do not store it above 25°C. After

opening do not use this bottle for more than 4 weeks. When you are not using Tavu, keep the

bottle in the outer carton, in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6. Contents of the pack and other information

What Tavu contains

The active substances are latanoprost 50 micrograms/mL and timolol (as timolol maleate)

5 mg/mL.

The other ingredients are:

Sodium chloride

Benzalkonium chloride

Sodium dihydrogen phosphate monohydrate (E399i)

Disodium phosphate anhydrous (E399ii)

Hydrochloric acid solution (for adjustment to pH 6.0)

Sodium hydroxide solution (for adjustment to pH 6.0)

Water for injections

What Tavu looks like and contents of the pack

This pack contains one bottle containing 2.5 mL of Tavu Eye Drops, Solution.

Tavu is a clear, colourless liquid.

Tavu is available in pack sizes of 1and and 3 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: <To be completed nationally>Manufacturer: Pfizer

Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

This leaflet was last revised 2017-06-16

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