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.
Please 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 that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, consult your doctor (see section 2).

Contents of the leaflet

1. What Zabak is and what it is used for
2. What you need to know 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, 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, 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 or if you feel worse after 7 days, consult your doctor (see section 2).

2. Important information before using Zabak

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, 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 the eyes in the morning,
• swollen lymph nodes around the ears,
• persistent symptoms (symptoms that continue),
• unilateral symptoms.
  If any of the above symptoms occur, the patient may have a different eye condition than seasonal allergic conjunctivitis. Medical advice should be sought.

Zabak and other medicines
If another eye medicine needs to be used at the same time as Zabak, wait at least 5 minutes between successive eye drops.
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
Use of Zabak during pregnancy is not recommended.
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 who experience such symptoms after taking the medicine should wait until these symptoms subside 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 in doubt, consult your doctor or pharmacist.
Dosage
Adults, elderly patients, children aged over 3 years
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 ocular administration (administration into the eye).
Before first use, discard the first 5 drops.
Then, with each use of the medicine:

1. Wash your hands thoroughly before using the medicine.
2. To avoid contamination of the dropper, do not touch the eye, eyelids or any other surface with the tip of the dropper.
3. Instill 1 drop into the eye(s) by looking upward and gently pulling down the lower eyelid.
4. 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.
5. 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.
Use of a higher than recommended dose of Zabak
There is no danger if the patient has accidentally swallowed a few drops of Zabak. Similarly, there is no need for concern if more than one drop has been 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 entered the eye. Do not use a double dose to make up for a missed dose.
If you have any further doubts 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 if other serious adverse effects occur,
treatment with Zabak should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse effects have been reported:

Common (affecting less than 1 in 10 people):

• eye irritation or pain,
• eye inflammation.

Uncommon (affecting 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),
• rash (itchy, red, stinging 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 adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 stated month.
Shelf-life after first opening the bottle: 3 months.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 5 ml multidose bottle (containing at least 150 drops, preservative-free). 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 further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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 in:
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
Marketing authorisation number in France, the country of export: 492 503-1
34009 492 503 1 8
Parallel import authorisation number: 368/18
This medicinal product is authorised 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 ZALERG
Belgium, Luxembourg, the Netherlands ALTRIABAK