Zabak

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ZABAK(Zalerg)

0.25 mg/ml, eye drops, solution

Ketotifenum
ZABAK and Zalerg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor (see section 2).

Table of contents of the leaflet

• 1. What is ZABAK and what is it used for
• 2. Important information before using ZABAK
• 3. How to use ZABAK
• 4. Possible side effects
• 5. How to store ZABAK
• 6. Contents of the pack and other information

1. What is ZABAK and what is it used for

ZABAK is an eye drop solution without preservatives, containing ketotifen, which is an antiallergic agent.
ZABAK is used to treat the symptoms of seasonal allergic conjunctivitis.
The most common symptoms of seasonal allergic conjunctivitis are intense itching of both eyes, accompanied by redness, swelling, excessive tearing, swelling of the conjunctiva, and sensitivity to light. These symptoms are recurring and start with the beginning of the pollen season.
Seasonal allergic conjunctivitis may also be associated with other symptoms of hay fever, such as rhinitis.
If after 7 days there is no improvement or you feel worse, you should contact your doctor (see section 2).

2. Important information before using ZABAK

When not to use ZABAK

• if you are allergic (hypersensitive) to ketotifen (active substance) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use ZABAK, you should discuss it with your doctor, pharmacist, or nurse.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.
The following objective and subjective symptoms do not usually occur in seasonal allergic conjunctivitis:

• purulent discharge,
• vision disturbances,
• morning sticking of the eyelids, difficulty opening the eyes in the morning,
• swelling of lymph nodes in the ear area,
• persistent symptoms (persistence of symptoms),
• unilateral symptoms. If one of the above symptoms occurs, you may have another eye condition than seasonal allergic conjunctivitis. You should consult your doctor.

ZABAK and other medicines

In case you need to use another eye medicine at the same time as ZABAK, you should wait at least 5 minutes between each administration.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important in case of medicines used to treat:

• depression, anxiety, and sleep disorders,
• allergies (e.g., antihistamines)

ZABAK with food, drink, and alcohol

• the medicine may enhance the effect of alcohol

Pregnancy and breastfeeding

It is recommended to avoid using ZABAK during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before using this medicine. ZABAK may be used during breastfeeding.

Driving and using machines

ZABAK may cause vision disturbances or drowsiness.
If you experience such symptoms after using the medicine, you should wait until they resolve before driving or operating machinery.

3. How to use ZABAK

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Dosage
Adults, elderly, children over 3 years old
The recommended dose is 1 drop into the affected eye(s) twice a day (morning and evening).
Method of administration
Do not inject, do not swallow.
The medicine is intended for administration into the eye (eye administration).
Before the first use, you shouldremove the first 5 drops.
Then, with each use of the product:
1.
Before using the product, wash your hands thoroughly.
2.
To avoid contaminating the drops, do not touch the eye, eyelids, or other surfaces with the dropper tip.
3.
Instill 1 drop into the eye (eyes) looking up and gently pulling down the lower eyelid.
Close the eyelid and gently press the inner corner of the eye with your index finger for 1-2 minutes. This will help prevent the medicine from spreading throughout the body.
After use, close the bottle.
If you feel that the effect of ZABAK is too strong or too weak, or if you experience any side effects, you should ask your doctor or pharmacist.
If after 7 days there is no improvement or you feel worse, you should contact your doctor (see section 2).

Using a higher dose of ZABAK than recommended

There is no risk if you accidentally swallow a few drops of ZABAK. Similarly, you should not worry if you accidentally administer more than one drop into the eye.

Missing a dose of ZABAK

You should instill the medicine as soon as possible and then return to the recommended dosing schedule.
You should make sure that the drop gets into the eye. Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ZABAK can cause side effects, although not everybody gets them.
If you experience allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, you should stop using ZABAK and contact your doctor or the Emergency Department of the nearest hospital immediately.
The following side effects have been reported:

Common (occurring in less than 1 in 10 people):

• eye irritation or pain,
• eye inflammation.

Uncommon (occurring in less than 1 in 100 people):

• blurred vision,
• dry eye syndrome,
• eyelid irritation,
• conjunctivitis (inflammation of the eye surface),
• increased sensitivity of the eyes to light,
• visible bleeding in the sclera of the eye,
• headache,
• drowsiness,
• rash (which may also be itchy),
• eruption (itchy, red, burning rash),
• dry mouth.

Unknown (frequency cannot be estimated from the available data)

• allergic reaction (including face and eyelid swelling) and increased severity of existing allergic conditions, such as asthma or eczema - dizziness.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZABAK

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the month stated.
Shelf life after first opening of the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ZABAK contains

• The active substance is: ketotifen 0.25 mg/ml (as ketotifen hydrogen fumarate 0.345 mg/ml).
• The other ingredients are: glycerol, sodium hydroxide (to adjust pH), water for injections.

What ZABAK looks like and contents of the pack

ZABAK is an eye drop solution available in a multidose bottle (patented ABAK system) of 5 ml (at least 150 drops without preservatives). It is a colorless to light brown-yellow liquid.
The bottle is equipped with a filter membrane (0.2 microns), which allows protection of the solution against microbial contamination during use of the medicine.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Laboratoires Thea
12 Rue Louis Blériot
63017 Clermont Ferrand Cedex 2
France

Manufacturer:

Farmila-Thea Farmaceutici S.p.A.
Via E. Fermi, 50
20019 Settimo Milanese (MI)
Italy
Excelvision
27 Rue de la Lombardière
F-07100 Annonay
France
Laboratoires Thea
12 Rue Louis Blériot
63017 Clermont Ferrand Cedex 2
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export:
34009 492 503 1 8
492 503-1
Parallel import authorization number: 373/19

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
ZADITEN OPHTHA ABAK
Italy
ZADITEN OFTABAK
Bulgaria, Greece, Poland, Portugal, Romania
ZABAK
Denmark, France
ZALERG
Belgium, Luxembourg, Netherlands
ALTRIABAK

Date of approval of the leaflet: 20.09.2024

[Information about the trademark]