Ketobrill 0.25 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ketobrill 0.25 mg/ml eye drops solution in single-dose container
Ketotifen
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, 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 effects not listed in this leaflet. See section 4.
Leaflet contents
- What Ketobrill is and what it is used for
- What you need to know before using Ketobrill
- How to use Ketobrill
- Possible side effects
- How to store Ketobrill
- Contents of the pack and other information
1. What Ketobrill is and what it is used for
Ketobrill contains the active substance ketotifene hydrogen fumarate, which is an antiallergic agent. Ketobrill is used to treat ocular symptoms of seasonal allergic conjunctivitis (hay fever).
2. What you need to know before using Ketobrill
Do not use Ketobrill
- If you are allergic to ketotifen hydrogen fumarate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Ketobrill.
Children
Safety and efficacy have not been established in children under 3 years of age.
Other medicines and Ketobrill
If you need to apply any other eye medication in addition to Ketobrill, wait at least 5 minutes between the application of each product.
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is especially important for medicines used to treat:
- depression, anxiety, and sleep disorders
- allergies (e.g., antihistamines)
Use of Ketobrill with alcohol
Ketobrill may enhance the effects of alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Ketobrill can be used during breastfeeding.
Driving and using machines
Ketobrill may cause blurred vision or drowsiness. If this occurs, wait until these effects have disappeared before driving or operating machinery.
3. How to use Ketobrill
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose in adults, elderly patients, and children (3 years of age and older) is one drop into the affected eye(s) twice daily (in the morning and at night).
Use in children under 3 years of age
The efficacy and safety of Ketobrill have not been established in children under 3 years of age.
A single-dose container contains enough solution to treat both eyes in one application.
Instructions for use
- Wash your hands.
- Open the aluminum pouch and remove a strip of single-dose containers.
- Separate one single-dose container from the strip (Fig. 1).
- Store the remaining single-dose containers back in the aluminum pouch and close it by folding the edge. Keep the pouch in the carton.
- Open the single-dose container by twisting and removing the top end. After opening, do not touch the tip of the dropper (Fig. 2).
- Tilt your head backwards (Fig. 3).
- Pull the lower eyelid downwards with your finger and hold the container with the other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
- Close your eyes and press with the fingertip against the inner corner of the eye for approximately 1–2 minutes. This prevents the drop from draining through the tear duct into the throat and ensures that most of the drop remains in the eye (Fig. 5). If necessary, repeat steps 6 to 8 for the other eye.
- Discard the single-dose container after use.
Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5
If you have any further questions about the use of this product, ask your doctor or pharmacist.
If you use more Ketobrill than you should
If Ketobrill is accidentally taken orally, it is not dangerous, nor is it harmful if more than one drop accidentally gets into your eye. In case of doubt, consult your doctor. In the event of overdose or accidental ingestion, you may contact the Toxicology Information Service at Tel.: 91 596 04 20.
If you forget to use Ketobrill
If you forget to use Ketobrill, apply the dose as soon as you remember. Then continue with your regular treatment schedule. Do not use a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects have been reported.
Frequent (may affect up to 1 in 10 people)
- eye irritation or eye pain
- eye inflammation
- corneal epithelial defect
Uncommon (may affect up to 1 in 100 people)
- blurred vision when drops are applied to the eye
- dry eye
- eyelid disorder
- conjunctivitis
- increased sensitivity of the eyes to light
- visible bleeding in the white part of the eye
- headache
- somnolence
- rash (which may also cause itching)
- eczema (itching, redness, stinging rash)
- dry mouth
- allergic reaction (including swelling of the face and eyelids) and worsening of the severity of an existing allergic condition such as asthma and eczema
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ketobrill
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the aluminium pouch after EXP and on the single-dose container after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C. Do not refrigerate or freeze.
Keep the single-dose container in the aluminium pouch.
Ketobrill does not contain preservatives. After opening, the contents of the single-dose container must be used immediately and must not be stored. Discard any remaining solution in the single-dose container after administration.
Discard Ketobrill 4 weeks after opening the aluminium pouch.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ketobrill
-
The active substance is ketotifen (as hydrogen fumarate). Each ml contains 0.25 mg of ketotifen, equivalent to 0.345 mg of ketotifen hydrogen fumarate.
-
The other components (excipients) are glycerol (E422), sodium hydroxide (E524) (to adjust pH), and water for injections.
Appearance of the product and contents of the pack
Ketobrill is a clear, colourless solution. A single-dose container contains 0.4 ml.
Ketobrill is available in packs containing 5, 10, 20, 30, 50 and 60 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
(Germany)
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BRILL PHARMA, S.L.
C/ Munner, 8
08022 Barcelona
(Spain)
This medicinal product 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 eye drops, solution in single-dose container
Austria: Ketotifen Stulln 250 micrograms/ml eye drops in single-dose container
Spain: Ketobrill 0.25 mg/ml eye drops, solution in single-dose container
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 the most recent revision of this leaflet: July 2022.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/