KETOBRILL 0.25 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

2. What you need to know before you use Ketobrill

Do not use Ketobrill

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

Warnings and precautions

Consult your doctor or pharmacist before you start using Ketobrill.

Children

Safety and efficacy in children under 3 years have not been established.

Other medicines and Ketobrill

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

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important with medicines used to treat:

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

Using Ketobrill with alcohol

Ketobrill may increase the effects of alcohol.

Pregnancy and breastfeeding

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

Ketobrill can be used during breastfeeding.

Driving and using machines

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

3. How to use Ketobrill

Follow exactly the administration instructions of this medicine given by your doctor. Ask your doctor or pharmacist if you have any doubts.

The recommended dose in adults, elderly and children (from 3 years onwards) is one drop in the affected eye(s) twice daily (in the morning and at night).

Use in children under 3 years

Safety and efficacy in children under 3 years have not been established.

A single-dose container contains a sufficient amount of solution to treat both eyes in one application.

Instructions for use

1. Wash your hands.
2. Open the aluminum bag and take out a strip of single-dose containers.
3. Separate one single-dose container from the strip (Fig. 1).
4. Put the remaining single-dose containers back in the aluminum bag and fold the edge of the bag. Keep the bag in the box.
5. Open the single-dose container by twisting the top end. After opening the container, do not touch the tip of the dropper (Fig. 2).
6. Tilt your head back (Fig. 3).
7. Pull the lower eyelid down with your finger and hold the container with the other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
8. Close your eyes and press the inner corner of your eye with the tip of your finger for 1-2 minutes. This prevents the drop from flowing down the tear duct into the throat and most of the drop stays in the eye (Fig. 5). If necessary, repeat steps 6 to 8 in the other eye.
9. Discard the single-dose container after use.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

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

If you use more Ketobrill than you should

If you accidentally take Ketobrill orally, it will not cause any harm, nor will it if more than one drop accidentally falls into your eye. In case of doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can contact the Toxicology Information Service Tel.: 91 596 04 20.

If you forget to use Ketobrill

If you forget to use Ketobrill, apply the treatment as soon as you remember. Then go back to your normal treatment schedule. Do not use a double dose to make up for forgotten doses.

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
• corneal epithelium injury

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

Reporting of side effects

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

5. Storage of Ketobrill

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the aluminum bag after EXP and on the single-dose container after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Do not refrigerate or freeze.

Keep the single-dose container in the aluminum bag.

Ketobrill does not contain preservatives. Once opened, the contents of the single-dose container should be used immediately and not stored. Discard the remaining solution in the single-dose container after application.

Discard Ketobrill 4 weeks after opening the aluminum bag.

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. Contents of the pack and further information

Composition of Ketobrill

-The active substance is ketotifen (as hydrogen fumarate). Each ml contains 0.25 mg of ketotifen, corresponding to 0.345 mg of ketotifen hydrogen fumarate.

-The other ingredients (excipients) are glycerol (E422), sodium hydroxide (E524) (for pH adjustment) and water for injections.

Appearance and pack contents

Ketobrill is a clear, colorless solution. One single-dose container contains 0.4 ml.

Ketobrill is available in packs containing 5, 10, 20, 30, 50 and 60 single-dose containers.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

(Germany)

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

(Spain)

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Allergo-Vision sine 0,25 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

Austria Ketotifen Stulln 250 Mikrogramm/ml Augentropfen im Einzeldosisbehältnis

Spain Ketobrill 0,25 mg/ml colirio en solución en envase unidosis

Ireland Ketofall 0.25 mg/ml eye drops, solution in single-dose container

Netherlands Ketotifen Stulln Unit Dose 0,25 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik

United Kingdom Ketofall 0.25 mg/ml eye drops, solution in single-dose container

(Northern Ireland)

Date of last revision of this leaflet: July 2022.

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