KETOTIFEN STULLN

Patient Information Leaflet

Ketotifen Stulln, 0.25 mg/ml, eye drops, solution
Ketotifeni hydrogenofumaras
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Ketotifen Stulln is and what it is used for
2. Important information before using Ketotifen Stulln
3. How to use Ketotifen Stulln
4. Possible side effects
5. How to store Ketotifen Stulln
6. Contents of the pack and other information

1. What Ketotifen Stulln is and what it is used for

Ketotifen Stulln contains the active substance ketotifen hydrogen fumarate, which is an
antiallergic agent. Ketotifen Stulln is used in the treatment of ocular symptoms of allergic rhinoconjunctivitis (hay fever).

2. Important information before using Ketotifen Stulln

When not to use Ketotifen Stulln:

• if the patient is allergic to ketotifen hydrofumarate or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Before starting treatment with Ketotifen Stulln, discuss it with your doctor or pharmacist.
Children
The safety and efficacy of Ketotifen Stulln in children under 3 years of age have not been established.
Ketotifen Stulln and other medicines
If another eye medicine needs to be used at the same time as Ketotifen Stulln,
wait at least 5 minutes between instilling each medicine.
Tell your doctor or pharmacist about all medicines the patient is currently taking
or has recently taken, as well as any medicines the patient plans to take.
This is particularly important for medicines used in the treatment of:

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

Ketotifen Stulln and alcohol

• the medicine may enhance the effects of alcohol

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
consult her doctor or pharmacist before using this medicine.
Ketotifen Stulln may be used during breastfeeding.
Driving and operating machinery
Ketotifen Stulln may cause visual disturbances or drowsiness.
Patients experiencing such symptoms after administration of the medicine should wait until these symptoms have subsided before driving or operating machinery.

3. How to use Ketotifen Stulln

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults, elderly patients, and children (aged 3 years and older) is 1 drop in the affected eye or eyes twice daily (morning and evening).

Use in children under 3 years of age
The safety and efficacy of this medicine in children under 3 years of age have not been established.

Instructions for use

1. Wash your hands.
2. Remove the safety ring by pulling the protruding strip (Fig. 1).
3. Open the bottle by removing the cap (Fig. 2).
4. Discard the first drop by inverting the bottle and squeezing it once to release one drop.
5. Tilt your head backward and gently pull down the lower eyelid with your finger to create a pocket between the eyelid and the eye (Fig. 3).
6. Invert the bottle. Squeeze the inverted bottle to release one drop into the eye (Fig. 4). Do not touch the eye or eyelid with the dropper tip.
7. Close your eyes and press gently with the tip of one finger against the inner corner of the eye for about 1 to 2 minutes. This prevents the drop from draining through the tear duct into the throat, ensuring most of the drop remains in the eye. If necessary, repeat steps 4 to 7 for the other eye.
8. After use, shake off any remaining liquid from the dropper tip. Do not touch the dropper tip to avoid microbiological contamination.
9. Replace the cap to close the bottle (Fig. 5).

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Use of a higher than recommended dose of Ketotifen Stulln
There is no danger if the patient accidentally swallows a few drops of Ketotifen Stulln. Similarly, there is no cause for concern if more than one drop is accidentally administered into the eye. If the patient has any doubts, they should contact their doctor for advice.

Missed dose of Ketotifen Stulln
If a dose of Ketotifen Stulln is missed, instill the drop as soon as possible, then return to the recommended dosing schedule. Make sure the drop has entered the eye. Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported:
Common (occurring in fewer than 1 in 10 people)

• eye irritation or eye pain,
• inflammation of the eye,
• corneal epithelial damage.

Uncommon (occurring in fewer than 1 in 100 people)

• blurred vision after eye drop application,
• dry eye syndrome,
• eyelid irritation,
• conjunctivitis (inflammation of the eye surface),
• increased sensitivity of eyes to light,
• visible bleeding in the sclera of the eye,
• headache,
• drowsiness,
• rash (which may also be itchy),
• skin eruption (itchy, red, burning rash),
• dry mouth,
• allergic reaction (including facial and eyelid swelling) and worsening of existing allergic conditions such as asthma or eczema.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Ketotifen Stulln

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C. Do not store in the refrigerator or freeze.
Ketotifen Stulln is a sterile, multi-dose medicine without preservatives.
Do not use this medicine after the expiry date stated on the cardboard box and
on the bottle label after: EXP. The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use Ketotifen Stulln for longer than 2 months.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Ketotifen Stulln contains

• The active substance is ketotifen (in the form of ketotifen hydrogen fumarate). Each ml contains 0.345 mg of ketotifen hydrogen fumarate, equivalent to 0.25 mg of ketotifen.
• The other ingredients are: glycerol, sodium hydroxide 1M (for pH adjustment), and water for injections.

What Ketotifen Stulln looks like and contents of the pack
Ketotifen Stulln is a clear, colourless solution in a transparent bottle.
Ketotifen Stulln is available in packs containing 1 bottle with 10 ml of eye drops solution.
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:
Pharm Supply Sp. z o.o.
ul. Marconich 2/9
02-954 Warsaw
Tel. (+48) 22 6423331
E-mail: [email protected]
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Ketotifen Stulln Austria
Ketotifen Stulln Finland
Ketotifen Stulln Germany
URPEM Multi Greece
Omnifen Italy
Ketotifen Stulln Netherlands
Ketotifen Stulln Poland
Lidinafree Portugal