Zabak

Package Leaflet: Information for the User

ZABAK, 0.25 mg/ml, eye drops, solution
Ketotifen

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor (see section 2).

Package Leaflet Contents

• 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. Package contents and other information

1. What is ZABAK and what is it used for

ZABAK is an eye drop solution, preservative-free, 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 edema, 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, you should 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, you should discuss it with your doctor, pharmacist, or nurse.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.
The following objective and subjective symptoms do not usually occur in seasonal allergic conjunctivitis:

• purulent discharge,
• visual 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. You should consult a doctor.

ZABAK and other medicines

If you need to use another eye medicine at the same time as ZABAK, you should wait at least 5 minutes between each administration.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 effects of alcohol

Pregnancy and breastfeeding

ZABAK should be avoided during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
ZABAK can be used during breastfeeding.

Driving and using machines

ZABAK may cause visual disturbances or drowsiness.
If you experience such symptoms after administration, you should wait until they resolve before driving or operating machinery.

3. How to use ZABAK

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, you should consult your 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).
Administration method
Do not inject, do not swallow.
The medicine is intended for administration into the eye (eye administration).
Before the first use, you shouldremove 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 (eyes) 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.
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, you should consult your doctor or pharmacist.
If after 7 days there is no improvement or you feel worse, you should contact your doctor (see section 2).

Using more than the recommended dose of ZABAK

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

Missing a dose of ZABAK

You should instill the drop as soon as possible and then return to the recommended dosing schedule.
You should ensure that 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, you should 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, face, lip, tongue, and/or
throat swelling, which may cause difficulty breathing or swallowing, or other serious
side effects, you should 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 eye sensitivity 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 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 you experience any side effects, including those not listed in this package leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 carton and bottle after: EXP.
The expiry date refers to the last day of the month.
Shelf-life after first opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 contents of the pack

ZABAK is an eye drop solution, preservative-free, available in a multidose bottle (patented ABAK system) with a capacity of 5 ml (at least 150 drops). It is a colorless to light brown-yellow liquid.
The bottle is equipped with a 0.2-micron filter membrane, which protects the solution from microbial contamination during use.

Marketing authorization holder

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

To obtain more detailed information, you should contact the representative of the marketing authorization holder:

THEA Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Phone: +48 22 642 87 77

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
ZALERG
Belgium, Luxembourg, Netherlands
ALTRIABAK

Date of last revision of the package leaflet: 06-10-2021