Zaditen 0.25 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Zaditen 0.25 mg/ml eye drops solution in single-dose containers
Ketotifen
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor, pharmacist or nurse.
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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.
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If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Zaditen is and what it is used for
- What you need to know before using Zaditen
- How to use Zaditen
- Possible adverse effects
- How to store Zaditen
- 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 starting to use Zaditen
Do not use Zaditen
If you are allergic to ketotifen or to any of the other ingredients 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:
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depression, anxiety, and sleep disorders
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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 are planning 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, drowsiness, or dizziness. Do not drive or operate machinery until these effects have subsided.
3. How to use Zaditen
Follow exactly the instructions for using 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 (3 years of age or older) is one drop in the affected eye(s) twice daily (in the morning and at night).
A single-dose unit contains enough solution to treat both eyes in one application.
Instructions for use
- Wash your hands.
- Open the blister pack and remove the strip of single-dose units.
- Separate one single-dose unit from the strip (Fig. 1).
- Store the remaining single-dose units back in the blister pack, and close the blister by folding its edge. Keep the blister pack inside the carton.
- Open the single-dose unit by twisting off the top end. After opening, do not touch the dropper tip (Fig. 2).
- Tilt your head backwards (Fig. 3).
- Pull the lower eyelid downwards with your finger and hold the unit in the other hand. Squeeze the unit so that one drop falls into the eye (Fig. 4).
- Close your eyes and press with the fingertip on the inner corner of the eye for about 1–2 minutes. This helps prevent the drop from draining through the tear duct into the throat, ensuring most of the drop remains in the eye (Fig. 5). If needed, repeat steps 6 to 8 for the other eye.
- Discard the single-dose unit 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 Zaditen is accidentally swallowed, or if more than one drop accidentally gets 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 experiences them.
The following adverse effects have been reported.
Frequent: may affect up to 1 in 10 patients
- Eye irritation or eye pain
- Inflammation in the eye
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 an existing allergic condition such as asthma and eczema
Frequency unknown: frequency cannot be estimated from available data
- Dizziness
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Zaditen Storage
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
After opening a blister pack/bag, unused single-dose containers may be stored for 3 months if kept in the outer cardboard packaging, or otherwise 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 must not be stored.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps 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, corresponding to 0,25 mg of ketotifen.
The other components are glycerol (E422), sodium hydroxide (E524) and water for injections.
Appearance of the product and contents of the pack
Zaditen is a transparent, colourless to pale yellow solution. A single-dose unit contains 0,4 ml. Zaditen is available in packs containing 5, 10, 20, 30, 50 and 60 single-dose units.
Only certain 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, 2nd floor, 08008 Barcelona, Spain
This medicinal product is authorised in the Member States of the European Economic Area (EEA) 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 οfθaλµικ?ς staγ?νeς
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 most recent review of this leaflet: 09/2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/