ZABAK eye drops 0.25 mg/ml 5 ml
Leaflet : user information
ZABAC 0.25 mg/ ml eye drops , solution
Z A BAK 0.25 mg/ml eye drops, solution
Ketotifen (Ketotifen)
Read all of this leaflet carefully before you start using this medicine as it contains important information for you.
This medicine is available without a prescription. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 7 days you do not feel better or your condition worsens, you should seek medical attention (see point 2).
What this leaflet contains:
1. What is ZABAC and what is it used for?
2. What you need to know before you use ZABAC
3. How to use ZABAC
4. Possible side effects
5. How to store ZABAC
6. Contents of the package and additional information
1. What is zabac and what is it used for
Zabac is eye drops, solution, without preservative, containing ketotifen, which is an anti-allergy medicine.
Zabac is used to treat the symptoms caused by seasonal allergic conjunctivitis.
The most common symptoms of seasonal allergic conjunctivitis are intense itching of both eyes associated with redness, swelling, excessive tearing, chemosis, and sensitivity to light. Symptoms recur and appear at the beginning of the pollen season. Seasonal allergic conjunctivitis can also be associated with other hay fever symptoms such as rhinitis.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention (see point 2).
2. What you need to know before you use ZABAC
Do not use ZABAC:
- if you are allergic (hypersensitive) to ketotifen (the active substance) or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
The following signs and symptoms are not common for seasonal allergic conjunctivitis:
- purulent discharge,
- visual impairment,
- the appearance of morning crust, difficulty opening the eyelids in the morning,
- swollen lymph nodes around the ears,
- persistent symptoms,
- unilateral symptoms .
If you have one of these signs or symptoms, you may be suffering from another eye disease other than seasonal allergic conjunctivitis.
You should seek medical attention.
Other medicines and ZABAC:
If you have to use another medicinal product for your eyes together with Zabac, wait at least 5 minutes between the application of each of the two products.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
This is especially important for medicines used to treat:
- depression, anxiety and sleep disorders,
- allergy (e.g. antihistamine).
Zabak with food, drinks and alcohol :
- Zabac can increase the effects of alcohol.
Pregnancy and breastfeeding
It is preferable to avoid the use of Zabac during pregnancy.
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Zabac can be used during breastfeeding.
Driving and using machines
Zabac may cause blurred vision or dizziness. If this happens to you, wait until it passes before driving or using machines.
3. How to use ZABAC
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor, pharmacist or nurse.
Dosage
Adults, elderly patients, children aged 3 years or older
The usual dose is one drop in the irritated eye or eyes twice a day (morning and evening) .
Application method
Do not inject or swallow this medicine.
ZABAC is intended for use in the eye (ocular application).
Before the first use of this medicine, discard the first 5 drops of the solution.
And then, each time you use this medicine:
Wash your hands thoroughly before use.
‚ To avoid contamination of the drops, you should not touch your eye or eyelids or any other surface with the tip of the guttator.
ƒ Place one drop in the eye(s), looking up and gently pulling on the lower eyelid with a finger.
Close the eyelids 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 to the rest of the body.
Close the bottle after use.
If you feel that the effect of Zabac eye drops is too strong, or too much
weak or if you experience any form of adverse reaction, contact your
doctor or pharmacist.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention (see point 2).
If you have used more than the required dose of ZABAC
There is no risk if a few drops of Zabac accidentally get into the mouth. Similarly, you should not worry if more than one drop gets into the eye.
If you forgot to use ZABAC
Place one drop in the eye(s) as soon as you remember and continue treatment as per the usual prescribed dosage. Make sure the drop gets into your eye. Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you suffer from allergic reactions, including rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, or if other serious side effects occur, you should stop taking Zabac and contact your doctor immediately. Your doctor or the emergency department of the nearest hospital.
The following side effects have been reported:
Common (affecting less than 1 in 10 patients) :
- eye irritation or pain
- inflammation of the eyes.
Uncommon (affects less than 1 in 100 patients) :
- blurred vision,
- dry eyes,
- eyelid disease,
- conjunctivitis (inflammation of the surface of the eye)
- sensitivity of the eye to light
- visible hemorrhages on the whites of the eyes
- headache
- drowsiness
- rash (which may also itch)
- eczema (itchy, red, burning rash) - dry mouth.
Not known (frequency cannot be estimated from the available data):
- allergic reaction (including swelling of the face and eyelids) and worsening of existing allergic conditions such as asthma and eczema,
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Bulgaria
Tel.: +359 2 8903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5 . How to store ZABAC
Keep out of the reach of children.
Do not use Zabac after the expiration date marked on the carton and bottle label after "Expiry date:" The expiration date corresponds to the last day of the indicated month.
Zabac can be used up to 3 months after the initial opening of the package.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What ZABAC contains
The active substance is:
- ketotifen hydrogen fumarate 0.345 mg
in the form of ketotifen 0.25 mg
for 1 ml
- , sodium hydroxide (for pH adjustment), water for injections.
What ZABAC looks like and what the package contains
Zabac is eye drops, a solution supplied in a multi-dose bottle of 5 ml (at least 150 drops without preservative). It is a colorless to pale brownish-yellow solution.
Marketing Authorization Holder and Manufacturer
License holder
LABORATORIES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Manufacturer and
EXCELVISION
rue de la Lombardière
07100 Annonay
France
or
FARMILA-THEA Farmaceutici SpA
Via E. Fermi, 50
20019 Settimo Milanese (MI)
Italy
or
LABORATORIES THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
This medicinal product is authorized for use in the member countries under the following names :
Austria, ZADITEN OPHTHA ABAK
Bulgaria ZABAC
Italy ZADITEN OFTABAK
Greece, Poland, Portugal, Romania ZABAK
Denmark, France, ZALERG
Belgium, Luxembourg, Netherlands ALTRIABAK
Date of last revision of leaflet : 01/2022
