ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Zaditen

Do not use Zaditen

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Zaditen.

Using Zaditen with other medicines

If you need to apply any other eye medicine besides Zaditen, wait at least 5 minutes between applying each product.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important with 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 or breastfeeding, 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 gone.

Zaditen contains benzalkonium chloride.

This medicine contains 2.6 micrograms of benzalkonium chloride in each drop.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on the front of the eye). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Zaditen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again if you have any doubts.

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

Instructions for use

1. Wash your hands.
2. Open the bottle. Do not touch the tip of the dropper after opening the bottle.
3. Tilt your head back (Fig. 1).
4. Pull the lower eyelid down with your finger and hold the bottle with the other hand. Squeeze the bottle so that one drop falls into the eye (Fig. 2).
5. Close your eyes and press the inner corner of the eye with the tip of one finger for 1-2 minutes. This prevents the drop from flowing down the tear duct to the throat, and most of the drop will remain in the eye (Fig. 3). If necessary, repeat steps 3 to 5 with the other eye.
6. Close the bottle after use.

Fig. 1 Fig. 2 Fig. 3

If you have any further questions on 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. If in doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can consult the Toxicology 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, go back to your regular treatment schedule.

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

The following side effects have been reported.

Common(affects less than 1 in 10patients)

• eye irritation or eye pain
• eye inflammation

Uncommon(affects less than1 in 100 patients)

• 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 out of the sight and reach of children.

Do not store above 25°C.

The bottle itself is not sterile, but its contents are sterile until the bottle is opened.

After the first opening of the bottle, the eye drops can only be stored for 4 weeks.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other 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), water for injections, and benzalkonium chloride.

Appearance and pack contents

Zaditen is a clear, colorless to pale yellow solution. The solution is presented in a pack containing a 5 ml bottle.

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.

Local representative

Laboratorios THEA S.A. – Pg. Sant Joan 91, 08009 Barcelona

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

Austria Zaditen 0,025% - Augentropfen

Denmark Zaditen

Finland Zaditen 0,25 mg/ml silmätipat, liuos

France Zalergonium, 0,25 mg/ml, collyre en solution

Germany Zaditen ophtha 0,25 mg/ml Augentropfen

Greece Zaditor οφθαλμικές σταγόνες

Iceland Zaditen

Ireland Zaditen 0.25mg/ml, eye drops, solution

Luxembourg Zaditen 0,25 mg/ml, collyre en solution

Norway Zaditen

Portugal Zaditen 0,25 mg/ml colírio, solução

Spain Zaditen 0,25 mg/ml colirio en solución

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

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

United Kingdom Zaditen 0.25 mg/ml, eye drops, solution

Date of last revision of this leaflet:10/2020

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/