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ZADITEN EYE DROPS SOLUTION

Active substance(s): KETOTIFEN HYDROGEN FUMARATE

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S1023 LEAFLET Zaditen 20160620

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.

Important information about some of the ingredients of Zaditen
Eye Drops
Zaditen Eye Drops contains 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.


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



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



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.



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.

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.
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
1. Wash your hands.
2. Open the bottle. Do not touch the tip after opening the bottle.
3. Lean your head back (Fig. 1).

In this leaflet:
1. What Zaditen Eye Drops are and what they are used for
2. Before you use Zaditen Eye Drops

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).

5. How to store Zaditen Eye Drops

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.

6. Further information

6. Close the bottle after use.

3. How to use Zaditen Eye Drops
4. Possible side effects

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

Fig. 2

Fig. 3

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
2. BEFORE YOU USE ZADITEN EYE DROPS
Do not use Zaditen Eye Drops

If you use more Zaditen Eye Drops than you should

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

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.

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.

If you forget to use Zaditen Eye Drops

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:

Then continue with your normal routine.



depression

4. POSSIBLE SIDE EFFECTS



allergy (e.g. antihistamines)

Like all medicines, Zaditen Eye Drops can cause side effects,
although not everybody gets them.

Using Zaditen Eye Drops with food and drink

If you forget to use Zaditen Eye Drops you should treat your eyes
as soon as you remember.
Do not take a double dose to make up for a forgotten dose.

The following side effects have been reported.

Zaditen Eye Drops may increase the effect of alcohol.
Common (affecting less than 1 in every 10 patients)
Pregnancy and breast-feeding



eye irritation or pain

If you are pregnant or think you might be, ask your doctor or
pharmacist for advice before using Zaditen Eye Drops.



inflammation in the eye



eye pain, blurred vision, abnormal intolerance to light

Zaditen Eye Drops can be used during breast-feeding.
Uncommon (affecting less than 1 in every 100 patients)
Driving and using machines



blurred vision when putting drops on the eye

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



dry eye



eyelid disorder



conjunctivitis



increased sensitivity of the eyes to light



visible bleeding in white of eye



headache



drowsiness



rash (which may also itch)

6. FURTHER INFORMATION



eczema (itchy, red, burning rash)

What Zaditen Eye Drops contain



dry mouth





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

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



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.
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.

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

By reporting side effects, you can help provide more information on
the safety of this medicine.

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

5. HOW TO STORE ZADITEN EYE DROPS

Manufacturer



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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

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.

Leaflet revision date: 20 June 2016



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.

Zaditen is a registered trade mark of Novartis AG, Switzerland.



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: 19488/1023

S1023 LEAFLET Zaditen 20160620

S1023 LEAFLET Ketotifen 20160620

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.

Important information about some of the ingredients of
Ketotifen Eye Drops
Ketotifen Eye Drops contains 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.


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



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



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.



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.

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.
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
1. Wash your hands.
2. Open the bottle. Do not touch the tip after opening the bottle.
3. Lean your head back (Fig. 1).

In this leaflet:
1. What Ketotifen Eye Drops are and what they are used for
2. Before you use Ketotifen Eye Drops

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).

5. How to store Ketotifen Eye Drops

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.

6. Further information

6. Close the bottle after use.

3. How to use Ketotifen Eye Drops
4. Possible side effects

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

Fig. 2

Fig. 3

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
2. BEFORE YOU USE KETOTIFEN EYE DROPS
Do not use Ketotifen Eye Drops

If you use more Ketotifen Eye Drops than you should

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

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.

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.

If you forget to use Ketotifen Eye Drops

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:

Then continue with your normal routine.



depression

4. POSSIBLE SIDE EFFECTS



allergy (e.g. antihistamines)

Like all medicines, Ketotifen Eye Drops can cause side effects,
although not everybody gets them.

Using Ketotifen Eye Drops with food and drink

If you forget to use Ketotifen Eye Drops you should treat your eyes
as soon as you remember.
Do not take a double dose to make up for a forgotten dose.

The following side effects have been reported.

Ketotifen Eye Drops may increase the effect of alcohol.
Common (affecting less than 1 in every 10 patients)
Pregnancy and breast-feeding



eye irritation or pain

If you are pregnant or think you might be, ask your doctor or
pharmacist for advice before using Ketotifen Eye Drops.



inflammation in the eye



eye pain, blurred vision, abnormal intolerance to light

Ketotifen Eye Drops can be used during breast-feeding.
Uncommon (affecting less than 1 in every 100 patients)
Driving and using machines



blurred vision when putting drops on the eye

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



dry eye



eyelid disorder



conjunctivitis



increased sensitivity of the eyes to light



visible bleeding in white of eye

6. FURTHER INFORMATION



headache

What Ketotifen Eye Drops contain



drowsiness





rash (which may also itch)

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



eczema (itchy, red, burning rash)





dry mouth

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



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

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.
Product Licence holder

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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.



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.

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: 19488/1023

Leaflet revision date: 20 June 2016

S1023 LEAFLET Ketotifen 20160620

Expand view ⇕

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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