Patient Information Leaflet

ZADITEN OFTABAK 0.25 mg/ml, eye drops, solution

Ketotifene
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has instructed you.

Keep this leaflet. You may need to read it again. If you need further information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

What ZADITEN OFTABAK is and what it is used for
What you need to know before using ZADITEN OFTABAK
How to use ZADITEN OFTABAK
Possible side effects
How to store ZADITEN OFTABAK
Contents of the pack and other information

1. What ZADITEN OFTABAK is and what it is used for

ZADITEN OFTABAK is a preservative-free eye drop solution containing ketotifene, which is an
antiallergic substance.
ZADITEN OFTABAK is used for the treatment of symptoms of seasonal allergic conjunctivitis.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before using ZADITEN OFTABAK

Do not use ZADITEN OFTABAK
if you are allergic (hypersensitive) to ketotifen (the active substance), or to any of the other
components of this medicine (listed in section 6).

Other medicines and ZADITEN OFTABAK
If you need to apply any other eye drops together with ZADITEN OFTABAK, wait at least 5 minutes between applications.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important in case of medicinal products used to treat:

depression,
allergies (e.g. antihistamines).

ZADITEN OFTABAK with food, drinks and alcohol

ZADITEN OFTABAK may increase the effect of alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
ZADITEN OFTABAK may be used during breastfeeding.

Driving and using machines
ZADITEN OFTABAK may cause blurred vision or drowsiness.
If this occurs, wait until your vision returns to normal before driving or operating machinery.

3. How to use ZADITEN OFTABAK

Use this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dosage
Adults, elderly, and children aged 3 years and older
The recommended dose is one drop into the affected eye(s) twice daily (morning and evening).

Method of administration
Do not inject. Do not swallow.
This medicine is intended for ocular administration (ophthalmic use).

Before first use, discard the first 5 drops.
Then, each time you use the product:
 Wash your hands thoroughly before using the product.
 To avoid contamination of the eye, do not touch the eye, eyelids, or any other surface with the tip of the dropper.
 Instill one drop into the affected eye(s), looking upward and gently pulling down the lower eyelid.
Close the eyelids and press gently with the index finger at the inner corner of the eye for 1-2 minutes. This helps prevent the medicine from spreading into the rest of the body.
Close the bottle after use.

If you find that the effects of ZADITEN OFTABAK are too strong or too weak, or if you experience unexpected reactions, contact your doctor or pharmacist.

If you use more ZADITEN OFTABAK than you should
There is no danger if you accidentally swallow a few drops of ZADITEN OFTABAK. Likewise, do not worry if more than one drop is accidentally instilled into the eye.

If you forget to use ZADITEN OFTABAK
Apply one drop as soon as possible, then return to your regular dosing schedule. Make sure the drop goes into the eye.
Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience allergic reactions, including skin rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty breathing or swallowing, or if other serious side effects occur,
stop using Zaditen oftabak immediately and contact your doctor or the nearest hospital emergency
department right away.

The following side 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,
- Eyelid disorder,
- Conjunctivitis (inflammation of the surface of the eye),
- Increased sensitivity of the eyes to light,
- Visible bleeding in the white of the eye,
- Headache,
- Drowsiness,
- Rash (which may also cause itching),
- Eczema (itching, redness, burning sensation of the rash),
- Dry mouth.
Not known: Frequency cannot be estimated from the available data
- Allergic reactions (including swelling of the face and eyelids) and worsening of pre-existing allergic conditions, such as asthma and eczema;
- Dizziness.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: “www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”. By reporting side effects, you can help provide more information on the safety of this medicine.
Adverse reactions may also be reported to the marketing authorization holder.

5. How to store ZADITEN OFTABAK

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 month.
ZADITEN OFTABAK can be used up to 3 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZADITEN OFTABAK contains

The active substance is: Ketotifen hydrogen fumarate ……………………………………………………………………0.345 mg equivalent to Ketotifen………………………………………………………………………………… 0.25 mg per 1 ml
The other components are glycerol, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of ZADITEN OFTABAK and package contents
ZADITEN OFTABAK is an ophthalmic solution supplied in a 5 ml multidose bottle (providing at least 150 drops, without preservative). It is a liquid, colourless to slightly yellowish-brown.

Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Manufacturer
LABORATOIRES EXCELVISION
rue de la Lombardière
07100 ANNONAY
FRANCE
or
FARMILA-THEA Farmaceutici S.p.A.
Via E. Fermi, 50
20019 Settimo Milanese (MI)
ITALY
or
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: ZADITEN OPHTHA ABAK
Bulgaria, Greece, Poland, Portugal, Romania: ZABAK
Italy: ZADITEN OFTABAK
Belgium, Luxembourg, Netherlands: ALTRIABAK
France, Denmark, Spain: ZALERG

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