Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Zaditen 0.25 mg/ml, eye drops, solution.
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ketotifen fumarate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Zaditen contains the active substance ketotifen, which is an anti-allergic substance. Zaditen is used to treat eye symptoms of hay fever.
What you need to know before you take it
e 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 using Zaditen. Other medicines and Zaditen If you need to apply any other medicinal products to your eyes together with Zaditen, wait at least 5 minutes between applying each product. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important for medicines which are used to treat: depression, anxiety and sleep disorders allergy (e.g. antihistamines) Zaditen with food, drink and alcohol
Zaditen may increase the effect of alcohol. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Zaditen can be used during breast-feeding. Driving and using machines Zaditen may cause blurred vision, drowsiness or dizziness. If this happens to you, wait until this has cleared before driving or operating machinery.
Zaditen contains benzalkonium chloride This medicine contains 2.6 micrograms benzalkonium chloride in each drop. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
How to take it
Zaditen Always use this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults, elderly and children (age 3 and older) is one drop into the affected eye(s) twice a day (in the morning and evening). Instructions for use 1. Wash your hands. 2. Open the bottle. Do not touch the tip after opening the bottle. 3. Lean your head back (Fig. 1). 4 Pull down your lower eyelid with your finger and hold the bottle in your other hand. Squeeze the bottle so that one drop falls into the eye (Fig. 2). 5. Close your eyes and press the tip of one finger against the corner of the eye for around 1-2 minutes. This will prevent the drop running through the tear duct into your throat and most of the drop will remain in the eye (Fig. 3). If necessary repeat steps 3 to 5 with your other eye. 6. Close the bottle after use.
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| Fig. 1
Fig. 2
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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 have accidentally taken Zaditen by mouth or if you have used more than one drop in the eye. If you have any doubt contact your doctor for advice. If you forget to use Zaditen If you forget to use Zaditen you should treat your eyes as soon as you remember. Then continue with your normal routine. Do not take a double dose to make up for a forgotten dose.
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: may affect up to 1 in 10 people eye irritation or pain inflammation in the eye Uncommon: may affect up to 1 in 100 people blurred vision when putting drops on the eye dry eye eyelid disorder conjunctivitis
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increased sensitivity of the eyes to light visible bleeding in white of eye headache drowsiness rash (which may also itch) eczema (itchy, red, burning rash) dry mouth allergic reaction (including swelling of the face and eyelids) and increase in severity of existing allergic conditions such as asthma and eczema
Not known: frequency cannot be estimated from the available data dizziness Reporting of side effects If you get 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 via the national reporting system: United Kingdom Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland HPRA Pharmacovigilance Website: www.hpra.ie By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Zaditen Keep this medicine out of the sight and reach of children. Do not store above 25°C. The bottle is not sterile itself, but its contents are sterile until the bottle is opened. After opening 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 and bottle after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Zaditen contains The active substance is ketotifen (as fumarate). Each ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen. The other ingredients are glycerol (E422), sodium hydroxide (E524), water for injections and benzalkonium chloride. What Zaditen looks like and contents of the pack Zaditen is a clear, colourless to faint yellow solution. The solution is available in a pack containing one bottle of 5 ml. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Laboratoires THEA 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France. The manufacturer responsible for release onto the market is: EXCELVISION,
27 rue de la Lombardiére, 07100 Annonay, France.
3
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at THEA Pharmaceuticals Ltd in UK, telephone number 0345 521 1290 or THEA Pharma Ltd in Ireland, telephone number +44 (0)345 521 1290. This medicinal product is authorised in the Member States of the EEA under the following names:
Greece Iceland Ireland
Zaditen 0,025% – Augentropfen Zaditen Zaditen 0,25 mg/ml silmatipat, liuos Zaditen ophtha 0,25 mg/ml Augentropfen Zaditor ofOadptkéc stayOvec Zaditen Zaditen 0.25mg/ml, eye drops, solution
Austria Denmark Finland
Germany
Luxembourg
Zaditen 0,25 mg/ml, collyre en solution
Norway
Zaditen
Portugal Spain
Zaditen 0,25 mg/ml colirio, solugao
Sweden The Netherlands
Zaditen colirio Zaditen 0,25 mg/ml, Sgondroppar, lésning Zaditen 0,25 mg/ml, oogdruppels, oplossing
This leaflet was last revised in 06/2025
Frequently asked questions about Zaditen 0.25 mg/ml, eye drops, solution.
How do I take Zaditen 0.25 mg/ml, eye drops, solution.?
Zaditen 0.25 mg/ml, eye drops, solution. comes as eye drops containing 0.25mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Zaditen 0.25 mg/ml, eye drops, solution.?
The active substance in Zaditen 0.25 mg/ml, eye drops, solution. is ketotifen fumarate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Zaditen 0.25 mg/ml, eye drops, solution., as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Zaditen 0.25 mg/ml, eye drops, solution. without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ketotifen fumarate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic treatment of seasonal allergic conjunctivitis.
4.2. Posology and method of administration
Posology
Adults, elderly and children (age 3 and older): one drop of Zaditen into the conjunctival sac twice a day.
Paediatric population
The safety and efficacy of Zaditen in children aged from birth to 3 years have not yet been established.
Method of administration
The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
4.4. Special warnings and precautions for use
This medicine contains 2.6 micrograms benzalkonium chloride in each drop.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in dry eyes or disorders of the cornea.
4.5. Interaction with other medicinal products and other forms of interaction
If Zaditen is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.
The use of oral dosage forms of ketotifen may potentiate the effect of CNS depressants, antihistamines and alcohol. Although this has not been observed with Zaditen eye drops, the possibility of such effects cannot be excluded.
4.6. Pregnancy and lactation
Pregnancy
There are no adequate data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality, but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women.
Breast-feeding
Although animal data following oral administration show excretion into breast milk, topical administration to human is unlikely to produce detectable quantities in breast milk. Zaditen eye drops can be used during lactation.
Fertility
There are no data available on the effect of ketotifen fumarate on fertility in humans.
4.7. Effects on ability to drive and use machines
Any patient who experiences blurred vision, somnolence or dizziness should not drive or operate machines.
4.8. Undesirable effects
Adverse reactions are ranked under heading of frequency, using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Uncommon: Hypersensitivity
Nervous system disorders
Uncommon: Headache
Eye disorders
Common: Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion.
Uncommon: Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.
Gastrointestinal disorders
Uncommon: Dry mouth
Skin and subcutaneous tissue disorders
Uncommon: Rash, eczema, urticaria
General disorders and administration site conditions
Uncommon: Somnolence
Adverse drug reactions from post-marketing experience (Frequency not known):
The following post marketing events have also been observed:
- hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.
- dizziness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No case of overdose has been reported.
Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of ketotifen which is 60% of a recommended oral daily dose for a 3 year old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of ketotifen.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- KETAZED 0,25 mg/ml prescriptionKETOTIFENUM · eye / ear / nose
- ZABAK 0,25 mg/ml prescriptionKETOTIFENUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- ZabakKetotifenum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Zaditen 0.25 mg/ml, eye drops, solution.. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.