Ketazed 0.25 mg/ml, eye drops, solution – patient leaflet, side effects, dosage

1. What Ketazed is and what it is used for

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

Ketazed eye drops solution is used to treat eye symptoms of hay fever.

2. What you need to know before you use Ketazed

Do not use Ketazed:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Ketazed

Children

The safety and efficacy of Ketazed in children aged from birth to 3 years have not yet been established.

Other medicines and Ketazed

If you need to apply any other medicinal products to your eyes together with this medicine, you must wait at least 5 minutes between applying each product.

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

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

Ketazed with food, drink and alcohol

Ketazed may increase the effect of alcohol.

Pregnancy and breast-feeding

If you are pregnant or think you might 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 breast-feeding.

Driving and using machines

This medicine Pharma may cause blurred vision or drowsiness. If this happens to you, you should wait before driving or operating machines until these symptoms have disappeared.

3. How to use Ketazed

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

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

Instructions for use

1a 1b	Take the multidose plastic bottle (picture 1a) out of the carton box and write the date of opening of the bottle on the carton box in the intended space. Carefully wash your hands before opening the bottle. Remove the cap (picture 1b).
2	Hold the bottle upside down with the thumb on the shoulder of the bottle and the other fingers on the bottom of the bottle. Before the first use, pump the bottle repeatedly, approximately 20 times to reach a consistent product flow (picture 2).

3	Tilt your head or your child’s head back. Pull down the eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and the eye. The drop will go in here (picture 3). Bring the bottle tip close to the eye. Use the mirror if it helps.
4 5	Do not touch the eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. Gently press down on the bottom side of the bottle to release one drop of medicine at a time (picture 4). If a drop misses the eye, try again. After using the medicine, press a finger into the corner of the eye, by the nose (picture 5). This helps to stop the medicine getting into the rest of the 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 cap immediately after use. Only use one bottle of medicine at a time. Do not open the cap until you need to use the medicine. You must throw away the bottle 3 months after the first opening (checking the opening date written on the carton box) and use a new bottle.

If you have any other questions about the use of this medicine, contact 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 the eye or if you have accidentally taken this medicine by mouth. If you have any doubt, 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 at the recommended posology (one drop per eye, twice daily). Do not take 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 (affecting less than 1 in every 10 patients)

• eye irritation or pain
• inflammation in the eye

Uncommon (affecting less than 1 in every 100 patients)

• blurred vision when putting drops on 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 (possibly itchy)
• eczema (itchy, red, and burning rash)
• dry mouth
• allergic reaction (including swelling of the face and eyelids) and increase in severity of existing allergic conditions such as 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketazed

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 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 to protect the environment.

6. Contents of the pack and other information

What Ketazed contains

• The active substance is ketotifen (as hydrogen fumarate)

One ml of solution contains 0.345 mg ketotifen hydrogen fumarate corresponding to 0.25 mg ketotifen.

• 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 to faintly yellow solution. The solution is packed in a 10 ml white plastic bottle closed with a 28 µl 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 leaflet was last revised in January 2026.