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ZADITEN EYE DROPS

Active substance(s): KETOTIFEN HYDROGEN FUMARATE

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S0145 LEAFLET Zaditen 20160620

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.

Important information about some of the ingredients of Zaditen
Zaditen contains benzalkonium chloride and may cause eye
irritation.
If you wear soft contact lenses you should remove them before
using Zaditen as it can discolour your soft contact lenses. You
should wait at least 15 minutes after using Zaditen before
reinserting your contact lenses into your eyes.

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

3. HOW TO USE ZADITEN



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



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

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



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.

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 is and what it is used for
2. Before you use Zaditen
3. How to use Zaditen
4. Possible side effects
5. How to store Zaditen
6. Further information

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. 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 IS AND WHAT IT IS USED FOR
Zaditen contains the active substance ketotifen, which is an antiallergic substance. Zaditen is used to treat eye symptoms of hay
fever.
Fig. 1
2. BEFORE YOU USE ZADITEN

Fig. 2

Fig. 3

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

Do not use Zaditen
If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of Zaditen.
Using other medicines

If you use more Zaditen than you should
There is no danger if you have accidentally taken Zaditen 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 need to apply any other medicinal products to your eyes
together with Zaditen, wait at least 5 minutes between applying
each product.

If you forget to use Zaditen

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



allergy (e.g. antihistamines)

If you forget to use Zaditen 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

Using Zaditen with food and drink

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

Zaditen may increase the effect of alcohol.

The following side effects have been reported.

Pregnancy and breast-feeding

Common (affecting less than 1 in every 10 patients)

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



eye irritation or pain



inflammation in the eye

Zaditen can be used during breast-feeding.



eye pain, blurred vision, abnormal intolerance to light

Driving and using machines

Uncommon (affecting less than 1 in every 100 patients)

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



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



drowsiness



rash (which may also itch)



eczema (itchy, red, burning rash)

6. FURTHER INFORMATION



dry mouth

What Zaditen contains



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 ketotifen hydrogen fumarate
equivalent to 0.25mg ketotifen as the active ingredient.



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

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:

What Zaditen looks like and contents of the pack

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.



Zaditen is a colourless solution.



Zaditen is available in 5ml bottle.

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

Product Licence holder

5. HOW TO STORE ZADITEN

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.



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.



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.



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



Novartis Pharma GmbH, Vienna, Austria.

POM

PL: 19488/0145

Leaflet revision date: 20 June 2016
Zaditen is a registered trade mark of Novartis AG, Switzerland.
S0145 LEAFLET Zaditen 20160620

S0145 LEAFLET Ketotifen 20160620

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.
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.

Important information about some of the ingredients of
Ketotifen
Ketotifen contains benzalkonium chloride and may cause eye
irritation.
If you wear soft contact lenses you should remove them before
using Ketotifen as it can discolour your soft contact lenses. You
should wait at least 15 minutes after using Ketotifen before
reinserting your contact lenses into your eyes.
3. HOW TO USE KETOTIFEN
Always use Ketotifen 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.

In this leaflet:

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

1. What Ketotifen is and what it is 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. Before you use Ketotifen
3. How to use Ketotifen
4. Possible side effects
5. How to store Ketotifen
6. Further 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 IS AND WHAT IT IS USED FOR
Ketotifen contains the active substance ketotifen, which is an antiallergic substance. Ketotifen is used to treat eye symptoms of hay
fever.
2. BEFORE YOU USE KETOTIFEN

Fig. 1

Fig. 2

Fig. 3

Do not use Ketotifen

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

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

If you use more Ketotifen than you should

Using other medicines
If you need to apply any other medicinal products to your eyes
together with Ketotifen, wait at least 5 minutes between applying
each product.

There is no danger if you have accidentally taken Ketotifen 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

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:

If you forget to use Ketotifen you should treat your eyes as soon as
you remember.



depression

Do not take a double dose to make up for a forgotten dose.



allergy (e.g. antihistamines)

Then continue with your normal routine.

4. POSSIBLE SIDE EFFECTS
Using Ketotifen with food and drink
Ketotifen may increase the effect of alcohol.

Like all medicines, Ketotifen can cause side effects, although not
everybody gets them.
The following side effects have been reported.

Pregnancy and breast-feeding
If you are pregnant or think you might be, ask your doctor or
pharmacist for advice before using Ketotifen.

Common (affecting less than 1 in every 10 patients)


eye irritation or pain

Ketotifen can be used during breast-feeding.



inflammation in the eye



eye pain, blurred vision, abnormal intolerance to light

Driving and using machines
Ketotifen may cause blurred vision or drowsiness. If this happens to
you, wait until this has cleared before driving or operating
machinery.

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

6. FURTHER INFORMATION



headache

What Ketotifen contains



drowsiness





rash (which may also itch)

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



eczema (itchy, red, burning rash)





dry mouth

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



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 looks like and contents of the pack


Ketotifen is a colourless solution.



Ketotifen is available in 5ml bottle.

Reporting of side effects:

Product Licence holder

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.

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.

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

Manufacturer
This product is manufactured by either:


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



Novartis Pharma GmbH, Vienna, Austria.

5. HOW TO STORE KETOTIFEN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



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.

POM

PL: 19488/0145

Leaflet revision date: 20 June 2016

S0145 LEAFLET Ketotifen 20160620

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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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