Leaflet: Information for the User

Ketobrill 0.25 mg/ml Eye Drops in Single-Use Vial

Ketotifeno

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only 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 side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.See section 4.

1. What isKetobrilland what is it used for

2. What you need to know before usingKetobrill

3. How to useKetobrill

4. Possible side effects

5. Storage ofKetobrill

6. Contents of the pack and additional information

Ketobrillcontains the active ingredient hydrogen fumarate of ketotifeno, which is an antiallergic substance.Ketobrillis used to treat the ocular symptoms of seasonal allergic conjunctivitis (hay fever).

Do not use Ketobrill

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketobrill.

Children

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

Other medications and Ketobrill

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

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

- depression, anxiety, and sleep disorders

- allergy (for example, antihistamines)

Use of Ketobrill with alcohol

Ketobrill may increase the effects of alcohol.

Pregnancy and breastfeeding

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

Ketobrill can be used during breastfeeding.

Driving and operating machinery

Ketobrill 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 for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose in adults, elderly, and children (3 years or older), is one drop in the affected eye(s) twice a day (morning and night).

Use in children under 3 years

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

One 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 foil pouch and remove a strip of single-dose containers.
3. Separate one single-dose container from the strip (Fig. 1).
4. Store the remaining single-dose containers back in the aluminum foil pouch and close by folding the edge of the pouch. Store the pouch in the box.
5. Open the single-dose container by twisting its upper end. After opening the container, do not touch the tip of the dropper (Fig. 2).
6. Incline your head backward (Fig. 3).
7. Pull the lower eyelid down with your finger and hold the container with the other hand. Press 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 a finger for 1-2 minutes approximately. This prevents the drop from flowing down the tear duct into the throat and most of the drop remains in the eye (Fig. 5). If necessary, repeat steps 6 to 8 in the other eye.
9. Dispose of the single-dose container after use.

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

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

If you use more Ketobrill than you should

If you accidentally takeKetobrillby mouth, it poses no danger, nor does it if you accidentally put more than one drop in your eye. In case of doubt, consult your doctor. Likewise, in case of overdose or accidental ingestion, you can consult the Toxicological Information Service Tel.: 91 596 04 20.

If you forgot to use Ketobrill

If you forgot to useKetobrill, apply the treatment as soon as you remember. Then return to your regular treatment schedule. Do not use a double dose to compensate for the missed doses.

Like all medications, this medication may 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
• Corneal epithelial injury

Rare (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 stinging)
• Mouth dryness
• Allergic reaction (including facial and eyelid swelling) and increased severity of an existing allergic condition such as asthma and eczema

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 Medicinal Products for Human Use,https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and bag after CAD and on the single-dose container after CAD. The expiration date is the last day of the month indicated.

Do not store above25°C. Do not refrigerate or freeze.

Keep the single-dose container in the aluminum bag.

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

DiscardKetobrillafter 4 weeks after opening the aluminum bag.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Ketobrill

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

-The other components (excipients) are glycerol (E422), sodium hydroxide (E524) (to adjust the pH) and water for injectable preparations.

Appearance of the product and contents of the packaging

Ketobrillis a transparent and colorless solution. A single-dose container contains 0.4 ml.

Ketobrillis presented in containers that contain 5, 10, 20, 30, 50 and 60 single-dose containers.

It may only be marketed in some sizes of packaging.

Holder of the marketing authorization and responsible manufacturer

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

(Germany)

You can requestmore information about this medication by contacting the local representative of the marketing authorization holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

(Spain)

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyAllergo-Vision sine 0.25 mg/ml eye drops, solution in single-dose container

AustriaKetotifen Stulln 250 Micrograms/ml eye drops in single-dose container

SpainKetobrill0.25 mg/ml eye drops in solution in single-dose container

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

NetherlandsKetotifen Stulln Unit Dose 0.25 mg/ml eye drops, solution in packaging for single use

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

(Northern Ireland)

Date of the last review of this leaflet: July 2022.

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