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.
Please read the entire 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 patient leaflet or as directed by the
physician, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if symptoms worsen after 7 days, contact your doctor (see section 2).

Table of contents

What Zabak is and what it is used for
Important information before using Zabak
How to use Zabak
Possible side effects
How to store Zabak
Contents of the pack and other information

1. What Zabak is and what it is used for

Zabak is an eye drop solution without preservatives, containing ketotifen, which is an antiallergic agent.
Zabak is used for the treatment of 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, conjunctival swelling, and light sensitivity. These symptoms are recurrent and begin with the onset of the pollen season.
Seasonal allergic conjunctivitis may also be associated with other hay fever symptoms, such as rhinitis.
If there is no improvement or if symptoms worsen after 7 days, consult your doctor (see section 2).

2. Important information before using Zabak medicine

When not to use Zabak

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

Warnings and precautions
Before starting to use ZABAK, discuss this with a doctor, pharmacist, or nurse.
If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a doctor.
The following objective and subjective symptoms are not usually associated with seasonal allergic conjunctivitis:

purulent discharge,
visual disturbances,
morning eyelid adhesion, difficulty opening eyes in the morning,
swelling of lymph nodes around the ears,
persistent symptoms (symptoms that continue),
unilateral symptoms.
If any of the above symptoms occur, the patient may have an eye condition other than seasonal allergic conjunctivitis. Medical advice should be sought.

Zabak and other medicines
If another eye medicine needs to be used together with Zabak, wait at least 5 minutes between successive instillations.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important for medicines used in the treatment of:

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

Zabak with food, drink, and alcohol

the medicine may enhance the effects of alcohol

Pregnancy and breastfeeding
It is recommended to avoid using Zabak during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Zabak may be used during breastfeeding.

Driving and operating machinery
Zabak may cause visual disturbances or drowsiness.
Patients experiencing such symptoms after administration of the medicine should wait until these symptoms subside before driving or operating machinery.

3. How to use Zabak medicine

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Dosage
Adults, elderly patients, children over 3 years of age
The recommended dose is 1 drop into the affected eye or eyes twice daily (morning and evening).

Method of administration
Do not inject, do not swallow.
This medicine is intended for ophthalmic use (administration into the eye).
Before first use, discard the first 5 drops.
Then, each time the product is used:

Wash hands thoroughly before use.
To avoid contamination of the drops, do not touch the eye, eyelids, or any other surface with the dropper tip.
Instill 1 drop into the eye(s) while looking upward and gently pulling down the lower eyelid. Close the eyelid and gently press with the index finger on the inner corner of the eye for 1–2 minutes. This helps prevent the medicine from spreading throughout the body.
Close the bottle after use.

If the effect of Zabak seems too strong or too weak, or if any adverse effects occur, consult a doctor or pharmacist.
If there is no improvement after 7 days, or if symptoms worsen, consult a doctor (see section 2).

Use of a higher than recommended dose of Zabak
There is no danger if the patient accidentally swallows a few drops of Zabak. Similarly, there is no need for concern if more than one drop is accidentally administered into the eye.

Missed dose of Zabak
Administer the drop as soon as possible, then return to the recommended dosing schedule. Make sure the drop has entered the eye. Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue, and (or)
throat, which may cause difficulty in breathing or swallowing, or other serious adverse effects occur,
treatment with Zabak must be discontinued immediately and medical advice must be sought urgently
from a doctor or the Emergency Department of the nearest hospital.
The following adverse effects have been reported:

Common (affects less than 1 in 10 people):

eye irritation or pain,
eye inflammation.

Uncommon (affects less than 1 in 100 people):

blurred vision,
dry eye syndrome,
eyelid irritation,
conjunctivitis (inflammation of the surface of the eye),
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 available data):

allergic reaction (including swelling of the face and eyelids) and worsening of pre-existing allergic conditions such as asthma or eczema,
dizziness.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Zabak medicine

Keep this medicine 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 specified month.
Shelf-life after first opening the bottle: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 components are: glycerol, sodium hydroxide (for pH adjustment), water for injections.

What Zabak looks like and contents of the pack
Zabak is an eye drop solution available in a multidose bottle with a capacity of 5 ml (providing at least 150 drops without preservatives). It is a colourless to slightly brownish-yellow liquid.
The bottle is equipped with a filtering membrane (0.2 micrometres) that protects the solution from microbiological contamination during use.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in France, the country of export: 3400949250318
Parallel Import Licence Number: 352/19
This medicinal product is authorised for sale in the European Economic Area countries 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