Ketisal 0.25 mg/ml eye drops solution

Spain
Brand name Ketisal 0.25 mg/ml eye drops solution
Form solution, ophthalmic
Active substance / Dosage
KETOTIFEN FUMARATE · 0,345 mg/ml
Prescription type Prescription Only Medicine
ATC code
S01G S01GX S01GX08
Registration number 85755
Manufacturer Horus Pharma
Ketisal 0.25 mg/ml eye drops solution solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ketisal 0.25 mg/ml eye drops solution

Ketotifen

Read the entire 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 or pharmacist.
  • 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 be harmful to them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

  1. What Ketisal 0.25 mg/ml eye drops solution is and what it is used for
  2. What you need to know before 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. How to store Ketisal 0.25 mg/ml eye drops solution
  6. Contents of the pack and other information

1. What Ketisal is and what it is used for

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

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

2. What you need to know before starting to use Ketisal

Do not use Ketisal

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Children

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

Other medicines and Ketisal

If you need to use any other eye medication together with this medicine, wait at least 5 minutes between the application of each product.

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

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

Ketisal with food, drink, and alcohol

The use of 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 become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine may be used during breastfeeding.

Driving and using machines

This medicine may cause blurred vision or drowsiness. If this occurs, wait until these effects have disappeared before driving or operating machinery.

3. How to use Ketisal

Follow exactly the instructions for use of 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 (from 3 years of age) is one drop in the affected eye(s) twice daily (morning and night).

Instructions for use

1a

Black and white line drawing of a cylindrical medical device with a conical upper tip and an articulated base

A hand holding a vial while the1b

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

A hand holding a bottle with a nozzle pointing downward, and a black arrow indicates the opening motion toward the2

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

Line drawing of a hand gently holding the lower edge of the3

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

Line drawing of a hand holding a bottle with an applicator to instill drops directly into the4

5

Line drawing of a closed eye with visible eyelashes and a finger gently pressing the

  • Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. The drops could become contaminated.
  • Gently press the bottom part of the bottle to release one drop into the eye (image 4).
  • If a drop does not fall into the eye, try again.
  • After using the medication, press gently with a finger at the inner corner of the eye near the nose (image 5). This helps prevent the medication from draining into other parts of the body.

1-5

  • If you need to treat both eyes, repeat the 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 medication.
  • Discard the bottle 3 months after first opening (check the opening date written on the cardboard box), and use a new bottle.

If you have any further questions about using this medicine, consult 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 swallowed 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ketisal

If you forget to use this medicine, apply the treatment as soon as you remember, using the recommended dose (one drop per eye, twice daily). Do not use a double dose to make up for missed doses.

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 people)

  • eye irritation or eye pain
  • eye inflammation

Uncommon (may affect up to 1 in 100 people)

  • 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
  • drowsiness
  • 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 or eczema.

If you experience serious adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketisal

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

After opening the bottle, it may be kept for 3 months.

Do not use this medicine after the expiry date stated on the carton and bottle 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ketisal

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

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

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

Appearance of the medicine and contents of the container

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

Marketing Authorisation Holder

HORUS PHARMA

22 Allée Camille Muffat

INEDI 5

06200 Nice

France

Manufacturer

PHARMASTER

Zone Industrielle de Krafft Erstein

FRANCE

This medicine is authorised 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

Further information on this medicine is available from the local representative of the Marketing Authorisation Holder:

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6º

08028 Barcelona - Spain

Date of the most recent review of this leaflet: June 2025

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