Zaditen 0.25 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zaditen 0.25 mg/ml eye drops solution

Ketotifen

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Zaditen is and what it is used for
2. What you need to know before using Zaditen
3. How to use Zaditen
4. Possible side effects
5. How to store Zaditen
6. Contents of the pack and other information

1. What Zaditen is and what it is used for

Zaditen contains the active substance ketotifen, which is an antiallergic agent. Zaditen is used to treat ocular symptoms of seasonal allergic conjunctivitis.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before using Zaditen

Do not use Zaditen

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

Warnings and precautions

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

Using Zaditen with other medicines

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

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is especially important for 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Zaditen may be used during breastfeeding.

Driving and using machines

Zaditen may cause blurred vision, drowsiness, or dizziness. Do not drive or operate machinery until these effects have disappeared.

Zaditen contains benzalkonium chloride.

This medicine contains 2.6 micrograms of benzalkonium chloride per drop.

Benzalkonium chloride can be absorbed by soft contact lenses and may cause discoloration of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Zaditen

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Instructions for use

1. Wash your hands.
2. Open the bottle. Do not touch the dropper tip after opening the bottle.
3. Tilt your head backwards (Fig. 1).
4. Pull the lower eyelid downwards 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 with the fingertip on the inner corner of the eye for approximately 1-2 minutes. This prevents the drop from draining through the tear duct into the throat and ensures that most of the drop remains in the eye (Fig. 3). If necessary, repeat steps 3 to 5 for the other eye.
6. Close the bottle after use.

Fig. 1 Fig. 2 Fig. 3

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 Zaditen is accidentally swallowed, or if more than one drop accidentally falls into your eye. If in doubt, consult your doctor. In case of overdose or accidental ingestion, you may contact the Toxicology Information Service at Tel.: 91 562 04 20.

If you forget to use Zaditen

If you forget to use Zaditen, apply the drop as soon as you remember. Then continue with your regular treatment schedule.

Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported.

Frequent: may affect up to 1 in 10 patients

• eye irritation or eye pain
• eye inflammation

Uncommon: may affect up to 1 in 100 patients

• blurred vision when drops are applied to the eye
• dry eye
• eyelid disorder
• conjunctivitis
• increased sensitivity of the eyes to light
• visible bleeding in the white part of the eye
• headache
• somnolence
• rash (which may also cause itching)
• eczema (itching, redness, stinging rash)
• dry mouth
• allergic reaction (including swelling of the face and eyelids) and worsening of pre-existing allergic conditions such as asthma and eczema

Frequency unknown: frequency cannot be estimated from the available data

• dizziness

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 first opening the bottle, the eye drops may be kept for only 4 weeks.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at a SIGRE collection point in your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zaditen

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

The other components are glycerol (E422), sodium hydroxide (E524), water for injections, and benzalkonium chloride.

Appearance of the product and contents of the container

Zaditen is a transparent solution, colourless to pale yellow. The solution is supplied in a container containing a 5 ml bottle.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states under the following names:

Austria Zaditen 0.025% - Augentropfen

Denmark Zaditen

Finland Zaditen 0.25 mg/ml silmätipat, liuos

Germany Zaditen ophtha 0.25 mg/ml Augentropfen

Greece Zaditor οfθaλµικ?ς staγ?νeς

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 the most recent revision of this leaflet: 09/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/