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ZADITEN EYE DROPS SOLUTION

Active substance: KETOTIFEN HYDROGEN FUMARATE

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S1023 LEAFLET Zaditen 20150423

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZADITEN EYE DROPS, SOLUTION
(ketotifen fumarate)
Your medicine is known as Zaditen Eye Drops, Solution but will be
referred to as “Zaditen Eye Drops” throughout the following patient
information leaflet.

Zaditen Eye Drops contains benzalkonium chloride
Zaditen Eye Drops contain benzalkonium chloride and may cause
eye irritation.
If you wear soft contact lenses you should remove them before
using Zaditen Eye Drops as it can discolour your soft contact
lenses. You should wait at least 15 minutes after using Zaditen Eye
Drops before reinserting your contact lenses into your eyes.
3. HOW TO USE ZADITEN EYE DROPS

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

Always use this medicine exactly as your doctor or pharmacist have
told you. Check with your doctor or pharmacist if you are not sure.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, pharmacist
or nurse.

The recommended dose for adults, elderly and children (age 3 and
older) is one drop into the affected eye(s) twice a day (in the
morning and evening).



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

Instructions for use



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

2. Open the bottle. Do not touch the tip after opening the bottle.

1. Wash your hands.
3. Lean your head back (Fig. 1).
4. Pull down your lower eyelid with your finger and hold the bottle
in your other hand.
Squeeze the bottle so that one drop falls into the eye (Fig. 2).

What is in this leaflet:

4. Possible side effects

5. Close your eyes and press the tip of one finger against the
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. 3). If necessary repeat
steps 3 to 5 with your other eye.

5. How to store Zaditen Eye Drops

6. Close the bottle after use.

1. What Zaditen Eye Drops are and what they are used for
2. What you need to know before you use Zaditen Eye Drops
3. How to use Zaditen Eye Drops

6. Contents of the pack and other information
1. WHAT ZADITEN EYE DROPS ARE AND WHAT THEY ARE
USED FOR
Zaditen Eye Drops contain the active substance ketotifen, which is
an anti-allergic substance. Zaditen Eye Drops are used to treat eye
symptoms of hay fever.

Fig. 1

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZADITEN
EYE DROPS

If you use more Zaditen Eye Drops than you should

Do not use Zaditen Eye Drops
If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of this medicine (listed in section 6).

Fig. 2

Fig. 3

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

There is no danger if you have accidentally taken Zaditen Eye
Drops by mouth or if you have used more than one drop in the eye.
If you have any doubt contact your doctor for advice.
If you forget to use Zaditen Eye Drops

Other medicines and Zaditen Eye Drops
If you need to apply any other medicinal products to your eyes
together with Zaditen Eye Drops, wait at least 5 minutes between
applying each product.
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This is particularly important for
medicines which are used to treat:


depression



allergy (e.g. antihistamines)

Zaditen Eye Drops with food, drink and alcohol
Zaditen Eye Drops may increase the effect of alcohol.
Pregnancy and breast-feeding

If you forget to use Zaditen Eye Drops you should treat your eyes
as soon as you remember.
Then continue with your normal routine.
Do not take a double dose to make up for a forgotten dose.
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 (affecting less than 1 in every 10 patients)


eye irritation or pain



inflammation in the eye

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.

Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye

Zaditen Eye Drops can be used during breast-feeding.



dry eye



eyelid disorder

Driving and using machines



conjunctivitis

Zaditen Eye Drops may cause blurred vision or drowsiness. If this
happens to you, wait until this has cleared before driving or
operating machinery.



increased sensitivity of the eyes to light



visible bleeding in white of eye



headache



drowsiness

6. CONTENTS OF THE PACK AND OTHER INFORMATION



rash (which may also itch)

What Zaditen Eye Drops contain



eczema (itchy, red, burning rash)





dry mouth

Each ml of solution contains 0.345mg ketotifen hydrogen
fumarate equivalent to 0.25mg ketotifen.



allergic reaction (including swelling of the face and eyelids) and
increase in severity of existing allergic conditions such as
asthma and eczema



Also contains benzalkonium chloride, glycerol, sodium
hydroxide and water for injections.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

What Zaditen Eye Drops look like and contents of the pack
It is a clear, colourless to faintly yellow solution.
Zaditen Eye Drops are available in bottles of 5ml.

Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ZADITEN EYE DROPS


Do not store above 25°C.



This medicine must be thrown away four weeks after first
opening of the bottle.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Excelvision, rue de la
Lombardiere, 07100 Annonay, France.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Product Licence holder



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

POM

PL No: 19488/1023

Leaflet revision date: 23 April 2015
Zaditen is a registered trade mark of Novartis AG, Switzerland.
S1023 LEAFLET Zaditen 20150423

S1023 LEAFLET Ketotifen 20150423

PACKAGE LEAFLET: INFORMATION FOR THE USER

KETOTIFEN 0.25mg/ml EYE DROPS, SOLUTION
(ketotifen fumarate)
Your medicine is known as “Ketotifen 0.25mg/ml Eye Drops,
Solution” but will be referred to as “Ketotifen Eye Drops” throughout
the following patient information leaflet.

Ketotifen Eye Drops contains benzalkonium chloride
Ketotifen Eye Drops contain benzalkonium chloride and may cause
eye irritation.
If you wear soft contact lenses you should remove them before
using Ketotifen Eye Drops as it can discolour your soft contact
lenses. You should wait at least 15 minutes after using Ketotifen
Eye Drops before reinserting your contact lenses into your eyes.
3. HOW TO USE KETOTIFEN EYE DROPS

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

Always use this medicine exactly as your doctor or pharmacist have
told you. Check with your doctor or pharmacist if you are not sure.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, pharmacist
or nurse.

The recommended dose for adults, elderly and children (age 3 and
older) is one drop into the affected eye(s) twice a day (in the
morning and evening).



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

Instructions for use



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

2. Open the bottle. Do not touch the tip after opening the bottle.

1. Wash your hands.
3. Lean your head back (Fig. 1).
4. Pull down your lower eyelid with your finger and hold the bottle
in your other hand.
Squeeze the bottle so that one drop falls into the eye (Fig. 2).

What is in this leaflet:

4. Possible side effects

5. Close your eyes and press the tip of one finger against the
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. 3). If necessary repeat
steps 3 to 5 with your other eye.

5. How to store Ketotifen Eye Drops

6. Close the bottle after use.

1. What Ketotifen Eye Drops are and what they are used for
2. What you need to know before you use Ketotifen Eye Drops
3. How to use Ketotifen Eye Drops

6. Contents of the pack and other information
1. WHAT KETOTIFEN EYE DROPS ARE AND WHAT THEY ARE
USED FOR
Ketotifen Eye Drops contain the active substance ketotifen, which is
an anti-allergic substance. Ketotifen Eye Drops are used to treat
eye symptoms of hay fever.

Fig. 1

2. WHAT YOU NEED TO KNOW BEFORE YOU USE KETOTIFEN
EYE DROPS

If you use more Ketotifen Eye Drops than you should

Do not use Ketotifen Eye Drops
If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of this medicine (listed in section 6).

Fig. 2

Fig. 3

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

There is no danger if you have accidentally taken Ketotifen Eye
Drops by mouth or if you have used more than one drop in the eye.
If you have any doubt contact your doctor for advice.
If you forget to use Ketotifen Eye Drops

Other medicines and Ketotifen Eye Drops
If you need to apply any other medicinal products to your eyes
together with Ketotifen Eye Drops, wait at least 5 minutes between
applying each product.
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This is particularly important for
medicines which are used to treat:


depression



allergy (e.g. antihistamines)

Ketotifen Eye Drops with food, drink and alcohol
Ketotifen Eye Drops may increase the effect of alcohol.
Pregnancy and breast-feeding

If you forget to use Ketotifen Eye Drops you should treat your eyes
as soon as you remember.
Then continue with your normal routine.
Do not take a double dose to make up for a forgotten dose.
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 (affecting less than 1 in every 10 patients)


eye irritation or pain



inflammation in the eye

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.

Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye

Ketotifen Eye Drops can be used during breast-feeding.



dry eye



eyelid disorder

Driving and using machines



conjunctivitis

Ketotifen Eye Drops may cause blurred vision or drowsiness. If this
happens to you, wait until this has cleared before driving or
operating machinery.



increased sensitivity of the eyes to light



visible bleeding in white of eye



headache



drowsiness

6. CONTENTS OF THE PACK AND OTHER INFORMATION



rash (which may also itch)

What Ketotifen Eye Drops contain



eczema (itchy, red, burning rash)





dry mouth

Each ml of solution contains 0.345mg ketotifen hydrogen
fumarate equivalent to 0.25mg ketotifen.



allergic reaction (including swelling of the face and eyelids) and
increase in severity of existing allergic conditions such as
asthma and eczema



Also contains benzalkonium chloride, glycerol, sodium
hydroxide and water for injections.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

What Ketotifen Eye Drops look like and contents of the pack
It is a clear, colourless to faintly yellow solution.
Ketotifen Eye Drops are available in bottles of 5ml.

Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE KETOTIFEN EYE DROPS


Do not store above 25°C.



This medicine must be thrown away four weeks after first
opening of the bottle.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Manufacturer
This product is manufactured by Excelvision, rue de la
Lombardiere, 07100 Annonay, France.

Do not use after the expiry date printed on the carton or bottle
label.



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Product Licence holder

POM

PL No: 19488/1023

Leaflet revision date: 23 April 2015

S1023 LEAFLET Ketotifen 20150423

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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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