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KETOFALL 0.25 MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): KETOTIFEN HYDROGEN FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
KeWRIDOO 0.25 mg/ml eye drops, solutionLQVLQJOHGRVHFRQWDLQHU
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Read all of this leaflet carefully before you start using this medicine
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• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor pharmacistRUQXUVH.
• This medicine has been prescribed for youRQO\. Do not pass it on to others. It
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In this leaflet:
1. What KHWRIDOO is and what it is used for
2. :KDW\RXQHHGWRNQRZEHIRUH\RXXVH.HWRIDOO
3. How to use .HWRIDOO
4. Possible side effects
5. How to store KHWRIDOO
6. &RQWHQWVRIWKHSDFNDQGRWKHULQIRUPDWLRQ

1. WKDW.HWRIDOOLVDQGZKDWLWLVXVHGIRU
.HWRIDOO contains the active substance ketotifen hydrogen fumarate, which is an
anti-allergic substance. .HWRIDOO is used totreat eye symptoms of hay fever

2. :KDW\RXQHHGWRNQRZEHIRUH\RXXVH.HWRIDOO
Do not use .HWRIDOO
- if you are allergicto ketotifen hydrogen fumarate or any of theRWKHULQJUHGLHQWV
of WKLVPHGLFLQH OLVWHGLQVHFWLRQ 
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- depression
- allergy (e.g. antihistamines)
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.HWRIDOOmay cause blurred vision or drowsiness. If this happens to you,ZDLW
XQWLOWKLVKDVFOHDUHGEHIRUHGULYLQJRURSHUDWLQJPDFKLQHV

3. HRZWRXVH.HWRIDOO
Always use WKLVPHGLFLQHH[DFWO\DV\RXUGRFWRURUSKDUPDFLVWKDVWROG\RX&KHFN
ZLWK\RXUGRFWRUSKDUPDFLVWRUQXUVHLI\RXDUHQRWVXUH
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LQWRWKHDIIHFWHGH\H V WZLFHDGD\RQFHLQWKHPRUQLQJDQGRQFHLQWKHHYHQLQJ
Use in children below the age of 3 years
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One single-dose container contains enough solution to treat both eyes in one XVH
Instructions for use
1. Wash your hands.
2. Open the aluminium pouch and pull out the block of single-dose containers.
3. Remove one of the single-dose containers from the strip (Fig. 1).
4. Place the remaining single-dose containers back and close the pouch by
folding the edge over. Place the pouch in the carton.
5. Open the single-dose container by twisting off the tip. Do not touch the tip after
opening the container (Fig 2).
6. Lean your head back (Fig. 3).
7. Pull down your lower eyelid with your finger and hold the single-dose container
in your other hand. Squeeze the container so that one drop falls into the eye
(Fig 4).
8. Close your eyes and press the tip of one finger against the inner corner of the
eye for around 1-2 minutes. This will prevent the drop running through the tear
duct into your throat and most of the drop will remain in the eye (Fig 5). If
necessary repeat steps 6 to 8 with your other eye.
9. 7KURZDZD\the single-dose container after use.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

Fig. 5

Art.-Nr. XX.XXXX.XX

If you have any further questions on the use of this product, ask your doctor
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If you use more .HWRIDOOthan you should
There is no danger if you have accidentally WDNHQ.HWRIDOOE\PRXWKor if you
have used more than one drop in the eye. If you have any doubt contactyour
doctor for advice.
If you forget to use KHWRIDOO
If you forget to use .HWRIDOOtreat your eyes as soonas you remember. Then
continue with your normal routine. Do not XVH a doubledose to make up for a
forgotten dose.

4. PRVVLEOHVLGHHIIHFWV
Like all medicines, WKLVPHGLFLQHFDQFDXVHVLGHHIIHFWVDOWKRXJKQRWHYHU\ERG\
JHWVWKHP
7KHIROORZLQJVLGHHIIHFWVKDYHEHHQUHSRUWHG
CommonVLGHHIIHFWV PD\DIIHFWXSWRLQSDWLHQWV
- eye irritation or eye pain
- inflammation in the eye SDLQUHGQHVVRUVZHOOLQJ
- corneal epithelial damage GDPDJHWRWKHOD\HUWKDWFRYHUVWKHIURQWRQWKHH\H
UncommonVLGHHIIHFWV PD\DIIHFWXSWRLQSDWLHQWV
- blurred vision when putting drops on the eye
- dry eye GU\LWFKLQJEXUQLQJRUIHHOLQJWKDWWKHUHLVVRPHWKLQJLQ\RXUH\H 
- eyelid disorder DFRQGLWLRQZKLFKDIIHFWVWKHH\HOLG
- conjunctivitis UHGVRUHVWLFN\H\H
- increased sensitivity of the eyes to light
- visible bleeding in white of eye
- headache
- drowsiness
- rash (which may also itch)
- eczema (itchy, red, burning rash)
- dry mouth
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5. HRZWRVWRUH.HWRIDOO
Keep WKLVPHGLFLQHout of the VLJKWDQGUHDFKof children.
Do not store above 25°C.'RQRWUHIULJHUDWHRUIUHH]H
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KHWRIDOOcontains no preservative. Once WKHVLQJOHGRVHFRQWDLQHULVRSHQXVH
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Do not use WKLVPHGLFLQH after the expiry date, which isstated on the cartonWKH
SRXFK DQG WKH VLQJOHGRVH FRQWDLQHU DIWHU (;3 The expiry date refers to the
last day of the month.
After opening the aluminium pouch, do not use KetRIDOO formore than 4 weeks.
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What KeWRIDOOcontains
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What KHWRIDOO looks like and contents of the pack
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln, Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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