ZADITEN 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

2. What you need to know before using Zaditen

Do not use Zaditen

If you are allergic to ketotifen or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Zaditen.

Using Zaditen with other medicines

If you need to apply any other eye medicine in addition to Zaditen, wait at least 5 minutes between the application of each product.

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine. This is especially important in the case of medicines used to treat:

• depression, anxiety, and sleep disorders

• allergies (e.g., antihistamines)

Using Zaditen with food, drinks, and alcohol

Zaditen may increase the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Zaditen can be used during breastfeeding.

Driving and using machines

Zaditen may cause blurred vision or drowsiness. Do not drive or use machines until these effects have disappeared.

3. How to use Zaditen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults, elderly, and children (3 years or older) is one drop in the affected eye(s) twice a day (morning and evening).

A single-dose container contains enough solution to treat both eyes in one application.

Instructions for use

1. Wash your hands.
2. Open the blister pack and remove the block of single-dose containers.
3. Separate a single-dose container from the strip (Fig. 1).
4. Store the remaining single-dose containers back in the blister pack and close the blister pack by folding the edge. Store the blister pack in the carton.
5. Open the single-dose container by twisting the top. After opening, do not touch the tip of the dropper (Fig. 2).
6. Tilt your head back (Fig. 3).
7. Pull the lower eyelid down with your finger and hold the container with the other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
8. Close your eyes and press the inner corner of the eye with the tip of your finger for 1-2 minutes. This prevents the drop from flowing down the tear duct into the throat, and most of the drop will remain in the eye (Fig. 5). If necessary, repeat steps 6 to 8 with the other eye.
9. Discard the container after use.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

If you use more Zaditen than you should

There is no danger if you accidentally take Zaditen orally, nor if more than one drop accidentally falls into your eye. In case of doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can contact the Toxicological Information Service: Tel.: 91 562 04 20.

If you forget to use Zaditen

If you forget to use Zaditen, apply the treatment as soon as you remember. Then, return to your regular treatment schedule. Do not take a double dose to make up for the forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects have been reported.

Common(affect less than 1 in 10patients)

• eye irritation or eye pain
• eye inflammation

-

Uncommon(affect less than1 in 100patients)

• blurred vision when applying the drops in the eye
• eye dryness
• eyelid changes
• conjunctivitis
• increased sensitivity of the eyes to light
• visible bleeding in the white part of the eye
• headache
• drowsiness
• rash (which can also cause itching)
• eczema (itching, redness, rash with itching)
• dry mouth
• allergic reaction (including swelling of the face and eyelids) and increased severity of an existing allergic condition such as asthma and eczema

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zaditen

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

After opening a blister pack/bag, unused single-dose containers can be stored for 3 months if stored in the outer carton packaging or, if not, for 4 weeks.

The single-dose container itself is not sterile, but its contents are sterile until the container is opened.

Once opened, the contents of the single-dose container should be used immediately and not stored.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Zaditen composition

The active substance is ketotifen (as fumarate). Each ml contains 0.345 mg of ketotifen fumarate, which corresponds to 0.25 mg of ketotifen.

The other ingredients are glycerol (E422), sodium hydroxide (E524), and water for injectable preparations.

Appearance of the product and package contents

Zaditen is a clear, colorless to pale yellow solution. A single-dose container contains 0.4 ml. Zaditen is available in packs containing 5, 10, 20, 30, 50, and 60 single-dose containers.

Not all pack sizes may be marketed in your country.

Marketing authorization holder

Laboratoires THEA – 12, rue Louis Blériot – 63017 Clermont-Ferrand Cedex 2 – France

Manufacturer

EXCELVISION – 27 rue de la Lombardière – 07100 Annonay - France.

Or

Laboratoire UNITHER, 1 rue de l’Arquerie, 50200 COUTANCES, France

Local representative

Laboratorios THEA S.A. – C/ Enric Granados nº 86-88, 2ª planta, 08008 Barcelona

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Zaditen konservierungsmittelfrei 0,025% - Augentropfen in Einzeldosisbehältnissen

Czech Republic Zaditen SDU

Denmark Zaditen

Finland Zaditen 0,25 mg/ml silmätipat, liuos kerta-annospakkauksessa

France Zagrapa, 0,25 mg/ml, collyre en solution en récipient unidose

Germany Zaditen ophtha sine 0,25 mg/ml Augentropfen Lösung in Einzeldosisbehältnissen

Greece Zaditor οφθαλμικές σταγόνες

Iceland Zaditen

Luxembourg Zaditen Unidose, 0,25 mg/ml, collyre en solution en récipient unidose

Norway Zaditen

Portugal Zaditen 0,25 mg/ml colírio, solução em unidoses

Spain Zaditen 0,25 mg/ml colirio en solución en envases unidosis

Sweden Zaditen 0,25 mg/ml, ögondroppar, lösning i endosbehållare

Netherlands Zaditen Unidose 0,25 mg/ml, oogdruppels, oplossing

Date of the last revision of this leaflet:03/07/2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/