ZABAK

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Zabak
0.25 mg/ml, eye drops, solution
Ketotifen
Please read the entire leaflet carefully before using this 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 a
doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, consult a doctor (see section 2).

Table of contents of the leaflet

1. What Zabak is and what it is 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 Zabak is and what it is used for

Zabak is an eye drop solution without preservatives containing ketotifen, an antiallergic agent.
Zabak is used for the treatment of symptoms of seasonal allergic conjunctivitis.
The most common symptoms of seasonal allergic conjunctivitis include intense itching of both eyes, accompanied by redness, swelling, excessive tearing, swelling of the conjunctiva, and light sensitivity. These symptoms are recurrent and begin with the start of the pollen season. Seasonal allergic conjunctivitis may also be associated with other hay fever symptoms such as rhinitis.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor (see section 2).

2. Important information before using Zabak medicine

When not to use Zabak medicine

• 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 medicine, please discuss it with your doctor, pharmacist, or nurse.
If there is no improvement after 7 days of treatment, or if the patient feels worse, medical advice should be sought.
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.

Interaction of Zabak medicine with other medicines
If another eye medicine needs to be used at the same time as Zabak, wait at least 5 minutes between each instillation.
Inform your 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 medicine with food, drink, and alcohol

• the medicine may enhance the effects of alcohol

Pregnancy and breastfeeding
It is recommended to avoid using Zabak medicine 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 should wait until symptoms have resolved before driving or operating machinery.

3. How to use Zabak

This medicine should always be used exactly as described in this patient information 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 (application to 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 tip of the dropper.
• Instill 1 drop into the eye(s) while looking upward and gently pulling down the lower eyelid.
• Close the eye 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.
• After use, close the bottle tightly.

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

Overdose of Zabak
There is no risk if the patient accidentally swallows a few drops of Zabak. Similarly, there is no cause for concern if more than one drop is accidentally administered into the eye.

Missed dose of Zabak
Instill the drop as soon as possible, then return to the recommended dosing schedule.
Ensure that the drop has been properly administered into 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 reactions

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

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

• eye irritation or pain, - eye inflammation.

Uncommon (occurring in fewer 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, stinging rash),
• dry mouth.

Unknown (frequency cannot be estimated from available data):

• allergic reaction (including facial and eyelid swelling) and worsening of pre-existing allergic conditions such as asthma or eczema – dizziness.

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

5. How to store Zabak

Keep this medicine out of the 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 stated month.
No special storage precautions are required.
Period of use after first opening the bottle: 3 months.
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 package and other information

What Zabak contains

• The active substance is: ketotifen 0.25 mg/ml (as ketotifen hydrogen fumarate 0.345 mg/ml).
• 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 container (patented ABAK® system) with a volume 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), which helps protect 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 Bulgaria, the country of export:
LABORATOIRES THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:
EXCELVISION
rue de la Lombardière
07100 Annonay
France
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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Bulgaria, the country of export: 20120164
Parallel Import Licence Number: 270/25