Package Insert: Information for the User

Ketisal 0.25 mg/mL Eye Drops Solution

Ketotifeno

Read this entire package insert carefully before starting to use this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert.See section 4.

This medication contains the active ingredient ketotifeno, which is an antiallergic molecule.

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

No use Ketisal

• If you are allergic (hypersensitive) to ketotifen or to any of the other components of this medication (included in section 6).

Warnings and precautions

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

Children

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

Other medications and Ketisal

If you need to apply any other medication to your eyes in addition to this medication, wait at least 5 minutes between the application of each product.

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication , including over-the-counter medications. This is especially important in the case of medications used to treat:

- depression , anxiety, and sleep disorders

- allergy (for example, antihistamines)

Ketisal and food, drink, and alcohol

The use of this medication may increase the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding , or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication can be used during breastfeeding.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of 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 night)

Usage Instructions

If you have any other doubts about the use of this medication, 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 ingested this medication. In case of 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 medication and the amount ingested

If you forgot to use Ketisal

If you forgot to usethis medication, 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 compensate for the missed doses

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The following adverse effects have been reported.

Frequent (may affect up to 1 in 10 patients)

• Eye irritation or eye pain
• Eye inflammation

Less frequent (may affect up to 1 in 100 patients)

• Blurred vision when the drops are applied to the eye
• Eye dryness
• Palpebral alteration
• Conjunctivitis
• Increased sensitivity of the eyes to light
• Visible hemorrhage in the white area of the eye
• Headache
• Drowsiness
• Rash (which may also cause itching)
• Eczema (itching, redness, rash with burning sensation)
• Mouth dryness
• Allergic reaction (including facial and eyelid swelling) and worsening of an existing allergic condition such as asthma and eczema

If you experience severe adverse effects,consult your doctor or pharmacist,eveniftheyare adverse effects thatdo not appear in this prospectus

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above25°C.

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

Do not use this medication after the expiration date that appears on the box andthe bottleafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packagingandthe medications you no longer needat the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ketisal Composition

• The active ingredient is ketotifeno(as hydrogen fumarate).

Each mlof solutioncontains 0,345mg ofhydrogen fumarate of ketotifeno, which corresponds to 0,25 mg of ketotifeno.

• The other components (excipients) aresodium hyaluronate,glycerol (E422),sodium hydroxide (E524) and purified water.

Product appearance and packaging contents

This medicationis a transparent and colorless solution.The solution is packaged in a 10 ml white plastic bottle closed 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

Responsible for manufacturing

PHARMASTER

Zone Industrielle de KrafftErstein

FRANCE

This medication is authorized in the member states of the European Economic Area with the followingnames:

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 medication 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

Last review date of this leaflet: April 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/