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ZADITEN EYE DROPS SOLUTION

Active substance: KETOTIFEN HYDROGEN FUMARATE

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S1023 LEAFLET Zaditen 20121101

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZADITEN EYE DROPS, SOLUTION
(ketotifen fumarate)

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

Your medicine is known as Zaditen Eye Drops, Solution but will be
referred to as “Zaditen Eye Drops” throughout the following patient
information leaflet.

Always use Zaditen Eye Drops exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.

Read all of this leaflet carefully before you start using this
medicine.

The usual 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).
Instructions for use



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



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

1. Wash your hands.



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

3. Lean your head back (Fig. 1).



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.

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

1. What Zaditen Eye Drops are and what they are used for

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.

2. Before you use Zaditen Eye Drops

6. Close the bottle after use.

In this leaflet:

3. How to use Zaditen Eye Drops
4. Possible side effects
5. How to store Zaditen Eye Drops
6. Further information
Fig. 1
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. 2

Fig. 3

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
If you use more Zaditen Eye Drops than you should
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.

2. BEFORE YOU USE ZADITEN EYE DROPS
Do not use Zaditen Eye Drops

If you forget to use Zaditen Eye Drops

If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of Zaditen Eye Drops.

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.

Using other medicines
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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. This is particularly important for medicines
which are used to treat:


depression



allergy (e.g. antihistamines)

Using Zaditen Eye Drops with food and drink

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zaditen Eye Drops 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

 eye pain, blurred vision, abnormal intolerance to light
Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye



dry eye



eyelid disorder



conjunctivitis



increased sensitivity of the eyes to light



visible bleeding in white of eye



headache

Driving and using machines



drowsiness

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



rash (which may also itch)



eczema (itchy, red, burning rash)



dry mouth



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

Zaditen Eye Drops may increase the effect of alcohol.
Pregnancy and breast-feeding
If you are pregnant or think you might be, ask your doctor or
pharmacist for advice before using Zaditen Eye Drops.
Zaditen Eye Drops can be used during breast-feeding.

Important information about some of the ingredients of Zaditen
Eye Drops
Zaditen Eye Drops contain benzalkonium chloride and may cause
eye irritation.

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.

5. HOW TO STORE ZADITEN EYE DROPS

6. FURTHER INFORMATION



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

What Zaditen Eye Drops contain



Do not store above 25°C.





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

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





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

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



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.

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.
Product Licence holder
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.
POM

PL No: 19488/1023

Leaflet revision date: 01 November 2012
Zaditen is a registered trade mark of Novartis AG, Switzerland.
S1023 LEAFLET Zaditen 20121101

S1023 LEAFLET Ketotifen 20121101

PACKAGE LEAFLET: INFORMATION FOR THE USER

KETOTIFEN 0.25mg/ml EYE DROPS, SOLUTION
(ketotifen fumarate)

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

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.

Always use Ketotifen Eye Drops exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.

Read all of this leaflet carefully before you start using this
medicine.

The usual 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).
Instructions for use



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



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

1. Wash your hands.



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

3. Lean your head back (Fig. 1).



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.

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

1. What Ketotifen Eye Drops are and what they are used for

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.

2. Before you use Ketotifen Eye Drops

6. Close the bottle after use.

In this leaflet:

3. How to use Ketotifen Eye Drops
4. Possible side effects
5. How to store Ketotifen Eye Drops
6. Further information
Fig. 1
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. 2

Fig. 3

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
If you use more Ketotifen Eye Drops than you should
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.

2. BEFORE YOU USE KETOTIFEN EYE DROPS
Do not use Ketotifen Eye Drops

If you forget to use Ketotifen Eye Drops

If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of Ketotifen Eye Drops.

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.

Using other medicines
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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. This is particularly important for medicines
which are used to treat:


depression



allergy (e.g. antihistamines)

Using Ketotifen Eye Drops with food and drink

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ketotifen Eye Drops 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

 eye pain, blurred vision, abnormal intolerance to light
Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye



dry eye



eyelid disorder



conjunctivitis



increased sensitivity of the eyes to light



visible bleeding in white of eye



headache

Driving and using machines



drowsiness

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



rash (which may also itch)



eczema (itchy, red, burning rash)



dry mouth



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

Ketotifen Eye Drops may increase the effect of alcohol.
Pregnancy and breast-feeding
If you are pregnant or think you might be, ask your doctor or
pharmacist for advice before using Ketotifen Eye Drops.
Ketotifen Eye Drops can be used during breast-feeding.

Important information about some of the ingredients of
Ketotifen Eye Drops
Ketotifen Eye Drops contain benzalkonium chloride and may cause
eye irritation.

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.

5. HOW TO STORE KETOTIFEN EYE DROPS

6. FURTHER INFORMATION



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

What Ketotifen Eye Drops contain



Do not store above 25°C.





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

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





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

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



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.

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.
Product Licence holder
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.
POM

PL No: 19488/1023

Leaflet revision date: 01 November 2012

S1023 LEAFLET Ketotifen 20121101

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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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