Ketazed 0.25 mg/ml ophthalmic drops

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

Package leaflet: Information for the user

Ketazed 0,25 mg/ml eye drops, solution

Ketotifen

– Keep this 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 signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ketazed 0,25 mg/ml eye drops, solution is and what it is used for

2. What you need to know before you use Ketazed 0.25 mg/ml eye drops, solution

3. How to use Ketazed 0.25 mg/ml eye drops, solution

4. Possible side effects

5. How to store Ketazed 0.25 mg/ml eye drops, solution

6. Contents of the pack and other information

1. What Ketazed 0.25 mg/ml eye drops, solution is and what it is used for

Ketazed 0.25 mg/ml eye drops, solution contains the active substance ketotifen hydrogen fumarate, which is an anti-allergic molecule.

Ketazed 0.25 mg/ml eye drops, solution is used to treat the symptoms of seasonal allergic conjunctivitis.

2. What you need to know before you use Ketazed 0.25 mg/ml eye drops, solution Do not use Ketazed :

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

Warnings and precautions

Not applicable.

Using other medicines

If you need to apply any other medicines to the eye together with this medicine, you must wait at least 5 minutes between using each medicine.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important in the case of medicines used to treat:

·depression, anxiety, and sleep disorders

·allergies (for example, antihistamines)

Use with food, drink and alcohol

Use of this medicine may increase the effect of ethyl alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant, 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 to you, you must wait before driving or using machines, until these symptoms have disappeared.

3. How to use Ketazed 0,25 mg/ml eye drops, solution

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose
for adults, elderly, adolescents and children (aged 3 years and over) is one drop in the affected eye (affected eyes), twice a day (morning and evening).

Instructions for use

Ketazed – instructions for use, image 1a

Ketazed – instructions for use, image 1b

· Remove the plastic multidose bottle (picture 1a) from the carton and write the date of opening on the carton in the space provided.

· Wash your hands carefully before opening the bottle.

· Remove the cap (picture 1b).

Ketazed – instructions for use, image 2

· Hold the container upside down, place your thumb on the top part of the container and your other fingers on the bottom of the bottle. Before the first use, pump the bottle repeatedly, approximately 20 times, to obtain a consistent flow of medicine (image 2).

Ketazed – instructions for use, image 3

· Tilt your head or your child’s head backwards. Pull down the eyelid with a clean finger until a “pocket” is created between the eyelid and the eye. The drop will fall into this space (image 3).

· Bring the tip of the container close to the eye. Use a mirror, if it helps you.

Ketazed – instructions for use, image 4

Ketazed – instructions for use, image 5

· Do not touch the eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.

· Gently press the bottom part of the bottle to release one drop of medicine at a time (image 4).

· If a drop misses the eye, try again.

· After using the medicine, press with a finger into the corner of the eye, by the nose (image 5). This helps to stop the medicine from getting into the rest 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 of medicine at a time. Do not open the cap until you need to use the medicine.

· You must discard the bottle 3 months after first opening (check the opening date written on the carton) and use a new container.

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

If you use more Ketazed than you should

There is no danger if you have used more than one drop in your eye or if you have accidentally swallowed this medicine. If you are unsure, contact your doctor or pharmacist for advice.

If you forget to use Ketazed

If you forget to use this medicine, you should treat your eyes as soon as you remember, using the recommended dose (one drop per eye, twice a day). Do not use a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Ketazed can cause side effects, although not everybody gets them.

The following side effects have been reported.

Common (affects less than 1 in 10 people)

· eye irritation or pain

· eye inflammation

Uncommon (affects less than 1 in 100 people)

· blurred vision when applying drops to the eye

· dry eye

· eyelid disorder

· conjunctivitis

· increased sensitivity of the eyes to light

· visible bleeding in the white of the eye

· headache

· sleepiness

· skin rash (possibly accompanied by itching)

· eczema (a red rash accompanied by itching and a burning sensation)

· dry mouth

· allergic reaction (including swelling of the face and eyelids) and increased severity of existing allergic conditions, such as bronchial asthma and eczema.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 to the National Agency for Medicines and Medical Devices of Romania, Aviator Sănătescu Street no. 48, sector 1, Bucharest 011478- RO e-mail: adr@anm.ro Website: www.anm.ro

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ketazed 0,25 mg/ml eye drops, solution

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

After opening the bottle, it can be stored for up to 3 months.

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.

6. Contents of the pack and other information

What Ketazed 0.25 mg/ml eye drops, solution contains

– The active substance is ketotifen (as ketotifen hydrogen fumarate). One ml of solution contains ketotifen hydrogen fumarate 0.345 mg, equivalent to ketotifen 0.25 mg.

– The other ingredients are sodium hyaluronate, glycerol (E 422), sodium hydroxide (E 524), purified water

What Ketazed looks like and contents of the pack

This medicine is a clear, colourless solution. The solution is packed in a 10 ml white plastic container closed with a 28 µl 3K® dropper. Each plastic container contains 10 ml of sterile solution.

Marketing Authorisation Holder

HORUS PHARMA

148 avenue
Georges Guynemer
Cap Var D2

06700 Saint-Laurent-du-Var 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 trade names:

Netherlands Ketazed 0.25 mg/ml, oogdruppels, oplossing Italy Ketazed®

Romania Ketazed 0.25 mg/ml, eye drops, solution Germany Ketazed 0.25 mg/ml, Augentropfen, Lösung Norway Ketazed 0.25 mg/ml, øyedråper, oppløsning Sweden Ketazed 0.25 mg/ml, ögondroppar, lösning Finland Ketazed 0.25 mg/ml, silmätipat, liuos Denmark Ketazed 0.25 mg/ml, øjendråber, opløsning

This leaflet was last revised in July 2025.

Detailed information about this medicine is available on the website of the National Agency for Medicines and Medical Devices of Romania, www.anm.ro

Ketazed 0.25 mg/ml ophthalmic drops

Product description

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

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