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
Ketotifen
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 this leaflet for the patient 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 additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their 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 that does not contain preservatives and contains 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 there is no improvement after 7 days or the patient feels worse, they should contact their doctor (see section 2).

2. Important information before using Zabak

When not to use Zabak

• if the patient is 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, the patient should discuss it with their doctor, pharmacist, or nurse.
If there is no improvement after 7 days or the patient feels worse, they should contact their 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, the patient may have another eye condition than seasonal allergic conjunctivitis. They should consult a doctor.

Zabak and other medicines

If it is necessary to use another eye medicine at the same time as Zabak, the patient should wait at least 5 minutes between consecutive instillations.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is especially important in the 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 the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Zabak can be used during breastfeeding.

Driving and using machines

Zabak may cause vision disturbances or drowsiness.
The patient should not drive or operate machinery until the symptoms have resolved.

3. How to use Zabak

This medicine should always be used exactly as described in this leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their 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, remove the first 5 drops.
Then, with each use of the product:

• 1. Wash your hands thoroughly before using the product.
• 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) while 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.
• 4. After use, close the bottle.

If the patient feels that the effect of Zabak is too strong or too weak, or if they experience any side effects, they should consult their doctor or pharmacist.
If there is no improvement after 7 days or the patient feels worse, they should contact their doctor (see section 2).

Using more than the recommended dose of Zabak

There is no risk if the patient accidentally swallows a few drops of Zabak. Similarly, the patient should not worry if they accidentally instill more than one drop into the eye.

Missing a dose of Zabak

The patient should instill the drop as soon as possible and then return to the recommended dosing schedule.
The patient should make sure the drop gets into the eye. They should not use a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zabak can cause side effects, although not everybody gets them.
If the patient experiences an allergic reaction, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, they should stop using Zabak and contact their 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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, more information can be gathered on the safety of the 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 packaging. The expiry date refers to the last day of the month stated.
Shelf life after first opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 what the pack contains

Zabak is an eye drop solution available in a multidose bottle 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 protects the solution from microbial contamination during use.
For more detailed information, the patient 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
Laboratoires THEA, 12, rue Louis Blériot, 63017 CLERMONT-FERRAND CEDEX 2, France
EXCELVISION, rue de la Lombardière, 07100 ANNONAY, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in France, the country of export: 3400949250318

Parallel import authorization number: 352/19

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, Spain
ZALERG
Belgium, Luxembourg, Netherlands
ALTRIABAK

Date of leaflet approval: 11.09.2024

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