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KETISAL 0.25 mg/ml EYE DROPS SOLUTION

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About the medicine

How to use KETISAL 0.25 mg/ml EYE DROPS SOLUTION

Translated with AI

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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Contents of the leaflet

  1. Introduction
  2. What is Ketisal and what is it used for
  3. What you need to know before you start using Ketisal
  4. How to Use Ketisal
  5. Possible Side Effects
  6. Storage of Ketisal
  7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Ketisal 0.25 mg/ml Eye Drops Solution

Ketotifen

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

  • Keep this package leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • 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 or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Ketisal 0.25 mg/ml Eye Drops Solution and what is it used for
  2. What you need to know before you start using Ketisal 0.25 mg/ml Eye Drops Solution
  3. How to use Ketisal 0.25 mg/ml Eye Drops Solution
  4. Possible side effects
  5. Storage of Ketisal 0.25 mg/ml Eye Drops Solution
  6. Package Contents and Additional Information

1. What is Ketisal and what is it used for

This medicine contains the active substance ketotifen, which is an antiallergic molecule.

This medicine is used to treat the ocular symptoms of hay fever.

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 start using Ketisal

Do not use Ketisal

  • 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 or pharmacist before you start using this medicine.

Children

Ketisal is not recommended for use in children under 3 years of age.

Other Medicines and Ketisal

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

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including those obtained without a prescription. This is especially important with medicines used to treat:

  • depression, anxiety, and sleep disorders
  • allergies (e.g., antihistamines)

Ketisal with Food, Drink, and Alcohol

Using this medicine may increase the effects of alcohol.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

This medicine can be used during breastfeeding.

Driving and Using Machines

This medicine may cause blurred vision or drowsiness. If this happens, wait until these effects have gone before driving or using machines.

3. How to Use Ketisal

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Instructions for Use

1a

Sterile needle with transparent protector and white cylindrical body with marked rings

Hand holding a vial and a filter tip connecting to it with an arrow indicating direction of insertion1b

  • Take the plastic bottle (image 1a)out of the cardboard box and write the opening date of the bottle on the cardboard box in the space provided.
  • Wash your hands carefully before opening the bottle.
  • Remove the cap (image 1b).

Hand holding a white inhaler with the nozzle facing down and a black arrow indicating direction2

  • Hold the bottle upside down with your thumb on the shoulder of the bottle and your other fingers on the bottom of the bottle.
  • Before the first use, pump the bottle repeatedly, about 20 times, to get a consistent flow of product (image 2).

Hand holding a contact lens over the open eye with the index and thumb fingers3

  • Tilt your head or your child's head back. Pull the lower eyelid down with a clean finger until there is a "space" between the eyelid and the eye. The drop will go into this space (image 3).
  • Bring the tip of the bottle close to the eye. Use a mirror if it helps.

Hand holding a bottle with dropper applying drops directly into the open eye of a person4

5

Index finger gently pressing the lower eyelid of the open eye, showing the technique of applying eye drops

  • Do not touch the eye or eyelid, the surrounding areas, or other surfaces with the dropper tip.The drops could become infected.
  • Press the lower part of the bottle gently to release one drop into the eye (image 4).
  • If a drop does not fall into the eye, try again.
  • After using the medicine, press the corner of your eye near your nose (image 5)with your finger. This prevents the medicine from coming into contact with other parts of your body.

1-5

  • If you need to treat both eyes, repeat these same steps (1 to 5) for the other eye.
  • Close the bottle with the cap immediately after use.
  • Use only one bottle at a time. Do not open the cap until you need to use the medicine.
  • You must discard the bottle 3 months after the first opening (checking the opening date written on the cardboard box),and use a new bottle.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you use more Ketisal than you should

There is no danger if you have used more than one drop in the eye or if you have accidentally ingested this medicine. If in doubt, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ketisal

If you forget to use this medicine, you should apply the treatment as soon as you remember, and at the recommended dose (one drop per eye, twice a day). Do not use 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 (may affect up to 1 in 10 people)

  • eye irritation or pain in the eye
  • inflammation in the eye

Uncommon (may affect up to 1 in 100 people)

  • blurred vision when applying the drops in the eye
  • dryness in the eye
  • alteration in the eyelid
  • 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.

If you experience serious side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketisal

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Once the bottle is opened, it can be stored for 3 months.

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

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. Package Contents and Additional Information

Composition of Ketisal

  • The active substance is ketotifen (as hydrogen fumarate).

Each ml of solution contains 0.345 mg of hydrogen fumarate of ketotifen, equivalent to 0.25 mg of ketotifen.

  • The other ingredients (excipients) are sodium hyaluronate, glycerol (E 422), sodium hydroxide (E 524), and purified water.

Appearance and Package Contents

This medicine is a clear, colorless or slightly yellowish solution. The solution is filled in a 10 ml white plastic bottle with a dropper. Each plastic bottle contains 10 ml of solution.

Marketing Authorization Holder

HORUS PHARMA

22 Allé Camille Muffat

INEDI 5

06200 Nice

France

Manufacturer

PHARMASTER

Zone Industrielle de Krafft Erstein

FRANCE

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

Germany: Ketazed 0.25 mg/ml, Augentropfen, Lösung

Belgium: Ketazed 0.25 mg/ml collyre en solution / Ketazed 0.25 mg/ml oogdruppels, oplossing / Ketazed 0.25 mg/ml Augentropfen, Lösung

Denmark: Ketazed, øjendråber, opløsning

Spain: Ketisal 0.25 mg/ml colirio en solución

Finland: Ketazed 0.25 mg/ml silmätipat, liuos

France: Ketazed 0.25 mg/mL, collyre en solution

Netherlands: Ketazed 0.25 mg/ml oogdruppels, oplossing

Italy: KETAZED 0.25 mg/ml, collirio, soluzione

Luxembourg: Ketazed 0.25 mg/ml collyre en solution

Norway: Ketazed 0.25 mg/ml øyedråper, oppløsning

Romania: Ketazed 0.25 mg/ml picaturi oftalmice, solu?ie

Sweden: Ketazed 0.25 mg/ml ögondroppar, lösning

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6º

08028 Barcelona - Spain

Date of the Last Revision of this Package Leaflet: June 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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Frequently Asked Questions

Is a prescription required for KETISAL 0.25 mg/ml EYE DROPS SOLUTION?
KETISAL 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 KETISAL 0.25 mg/ml EYE DROPS SOLUTION?
The active ingredient in KETISAL 0.25 mg/ml EYE DROPS SOLUTION is ketotifen. This information helps identify medicines with the same composition but different brand names.
How much does KETISAL 0.25 mg/ml EYE DROPS SOLUTION cost in pharmacies?
The average pharmacy price for KETISAL 0.25 mg/ml EYE DROPS SOLUTION is around 7.02 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures KETISAL 0.25 mg/ml EYE DROPS SOLUTION?
KETISAL 0.25 mg/ml EYE DROPS SOLUTION is manufactured by Horus Pharma. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of KETISAL 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 KETISAL 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 KETISAL 0.25 mg/ml EYE DROPS SOLUTION?
Other medicines with the same active substance (ketotifen) include BENTIFEN 0.25mg/ml EYE DROPS SOLUTION, KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS, KETOTIFEN CODRAMOL 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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