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ZADITEN EYE DROPS

Active substance(s): KETOTIFEN HYDROGEN FUMARATE

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S0145 LEAFLET Zaditen 20150721

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZADITEN EYE DROPS
(ketotifen)
Your medicine is known as Zaditen Eye Drops but will be referred to
as Zaditen throughout the following 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.

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

3. HOW TO USE ZADITEN EYE DROPS



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



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

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



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.



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.

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).
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).

What is in this leaflet:
1. What Zaditen Eye Drops are and what they are used for

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).

2. What you need to know before you use Zaditen Eye Drops
3. How to use Zaditen Eye Drops
4. Possible side effects
5. How to store Zaditen Eye Drops
6. Contents of the pack and other information

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. Close the bottle after use.

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

Fig. 1

Fig. 2

Fig. 3

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

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 this medicine (listed in section 6).

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.

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.

If you forget to use Zaditen Eye Drops

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:

Then continue with your normal routine.



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 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.
Zaditen Eye Drops can be used during breast-feeding.

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.
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

Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye

Driving and using machines



dry 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.



eyelid disorder



conjunctivitis



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 contains



eczema (itchy, red, burning rash)





dry mouth

Each ml of solution contains ketotifen hydrogen fumarate
equivalent to 0.25mg ketotifen as the active ingredient.



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



Zaditen also contain the following: benzalkonium chloride,
glycerol, sodium hydroxide and water for injection. These are
the inactive ingredients.

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.

What Zaditen looks like and contents of the pack


Zaditen is a colourless solution.



Zaditen is available in 5ml bottle.

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

5. HOW TO STORE ZADITEN EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Manufacturer



Do not store Zaditen above 25°C. Discard any unused solution
28 days after first opening.

This product is manufactured by either:



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.

POM

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.

Leaflet revision date: 21 July 2015





EXCELVISION, rue de la Lombardiere, 07100 Annonay,
France or



Novartis Pharma GmbH, Vienna, Austria.
PL: 19488/0145

Zaditen is a registered trade mark of Novartis AG, Switzerland.
S0145 LEAFLET Zaditen 20150721

S0145 LEAFLET Ketotifen 20150721

PACKAGE LEAFLET: INFORMATION FOR THE USER

KETOTIFEN 0.25mg/ml EYE DROPS
(ketotifen)
Your medicine is known as Ketotifen 0.25mg/ml Eye Drops but will
be referred to as Ketotifen throughout the following 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.

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

3. HOW TO USE KETOTIFEN EYE DROPS



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



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

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



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.



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.

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).
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).

What is in this leaflet:
1. What Ketotifen Eye Drops are and what they are used for

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).

2. What you need to know before you use Ketotifen Eye Drops
3. How to use Ketotifen Eye Drops
4. Possible side effects
5. How to store Ketotifen Eye Drops
6. Contents of the pack and other information

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. Close the bottle after use.

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

Fig. 1

Fig. 2

Fig. 3

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

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 this medicine (listed in section 6).

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.

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.

If you forget to use Ketotifen Eye Drops

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:

Then continue with your normal routine.



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 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.
Ketotifen Eye Drops can be used during breast-feeding.

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.
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

Uncommon (affecting less than 1 in every 100 patients)


blurred vision when putting drops on the eye

Driving and using machines



dry 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.



eyelid disorder



conjunctivitis



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 contains



eczema (itchy, red, burning rash)





dry mouth

Each ml of solution contains ketotifen hydrogen fumarate
equivalent to 0.25mg ketotifen as the active ingredient.



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



Ketotifen also contain the following: benzalkonium chloride,
glycerol, sodium hydroxide and water for injection. These are
the inactive ingredients.

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.

What Ketotifen looks like and contents of the pack


Ketotifen is a colourless solution.



Ketotifen is available in 5ml bottle.

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

5. HOW TO STORE KETOTIFEN EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Manufacturer



Do not store Ketotifen above 25°C. Discard any unused solution
28 days after first opening.

This product is manufactured by either:



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.

POM

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.

Leaflet revision date: 21 July 2015





EXCELVISION, rue de la Lombardiere, 07100 Annonay,
France or



Novartis Pharma GmbH, Vienna, Austria.
PL: 19488/0145

S0145 LEAFLET Ketotifen 20150721

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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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