Zabak

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging 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.

Read the Leaflet Carefully Before Using the Medicine, as it Contains Important Information for the Patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, 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 Packaging 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 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, 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, discuss it with your doctor, pharmacist, or nurse.
If after 7 days there is no improvement or you feel worse, contact your doctor.
The following objective and subjective symptoms do not usually occur in seasonal allergic conjunctivitis:

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

Zabak and Other Medicines

If you need to use another eye medicine at the same time as Zabak, wait at least 5 minutes between applications.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
This is especially important for 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 child, consult your doctor or pharmacist before using this medicine.
Zabak can be used during breastfeeding.

Driving and Using Machines

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

3. How to Use Zabak

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Dosage
Adults, Elderly, Children Over 3 Years
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, remove the first 5 drops.
Then, with Each Use of the Medicine:

• 1. Before using the medicine, 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(s), looking up and gently pulling down the lower eyelid.
• 4. 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.
• 5. 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, consult your doctor or pharmacist.

Using More Than the Recommended Dose of Zabak

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

Missing a Dose of Zabak

Instill the medicine as soon as possible, and then return to the recommended dosing schedule.
Make sure 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, consult 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, 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),
• erythema (itchy, red, burning rash),
• dry mouth.

Unknown (frequency cannot be estimated from 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 those not listed in the leaflet, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Zabak

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Shelf life after first opening the bottle: 3 months.
No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Packaging 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 (for pH adjustment), water for injections.

What Zabak Looks Like and What the Packaging Contains

Zabak is an eye drop solution available in a 5 ml multidose bottle (at least 150 drops without preservatives). It is a colorless to light brown-yellow liquid.
The bottle has a filter membrane (0.2 microns), which protects the solution from microbial contamination during use.
For more detailed information, 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:

EXCELVISION
27, rue de la Lombardiere
F-07100 Annonay
France
FARMILA-THEA Farmaceutici S.p.A
Via E. Fermi, 50
20019 Settimo Milanese (MI)
Italy
Laboratoires THEA
12, rue Louis Blériot
F-63017 Clermont-Ferrand Cedex 2
France

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization Number in France, the Country of Export:492 503-1
34009 492 503 1 8
Parallel Import Authorization Number:368/18

This Medicinal Product is Authorized for Sale 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: 01.12.2023

[Information about the Trademark]