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ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

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About the medicine

How to use ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Zaditen 0.25mg/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. You may need to read it again.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

  1. What Zaditen is and what it is used for
  2. What you need to know before you use Zaditen
  3. How to use Zaditen
  4. Possible side effects
  5. Storage of 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 substance. Zaditen is used to treat the ocular symptoms of seasonal allergic conjunctivitis.

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

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Head profile showing injection point, hand holding applicator device, and face with closed eyes during application

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for ZADITEN 0.25 mg/ml EYE DROPS SOLUTION

Discuss questions about ZADITEN 0.25 mg/ml EYE DROPS SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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General surgery 12 years exp.

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Doctor

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General medicine 6 years exp.

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Frequently Asked Questions

Is a prescription required for ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?
ZADITEN 0.25 mg/ml EYE DROPS SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?
The active ingredient in ZADITEN 0.25 mg/ml EYE DROPS SOLUTION is ketotifen. This information helps identify medicines with the same composition but different brand names.
Who manufactures ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?
ZADITEN 0.25 mg/ml EYE DROPS SOLUTION is manufactured by Laboratoires Thea. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ZADITEN 0.25 mg/ml EYE DROPS SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ZADITEN 0.25 mg/ml EYE DROPS SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ZADITEN 0.25 mg/ml EYE DROPS SOLUTION?
Other medicines with the same active substance (ketotifen) include BENTIFEN 0.25mg/ml EYE DROPS SOLUTION, KETISAL 0.25 mg/ml EYE DROPS SOLUTION, KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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