ZADITEN 0.25MG/ML EYE DROPS SOLUTION

Active substance: KETOTIFEN HYDROGEN FUMARATE

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Zaditen ® 0.25mg/ml Eye Drops Solution

Ref: 0922/080713/1/F

(ketotifen)
Patient Information 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 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.
3

Your medicine is called Zaditen 0.25mg/ml Eye
Drops Solution but will be referred to as Zaditen
throughout the leaflet.

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
1

What Zaditen is and what it is used for

Zaditen contains the active substance ketotifen,
which is an anti-allergic substance.
Zaditen is used to treat eye symptoms of hay fever.

2

Before you use Zaditen

How to use Zaditen

Always use Zaditen 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).
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.

Do not use Zaditen
If you are allergic (hypersensitive) to ketotifen or any
of the other ingredients of Zaditen.
Using other medicines
If you need to apply any other medicinal products to
your eyes together with Zaditen, wait at least 5
minutes between applying each product.
Fig. 1
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 with food and drink
Zaditen may increase the effect of alcohol.

Fig. 2

Pregnancy and breast-feeding
If you are pregnant or think you might be, ask your
doctor or pharmacist for advice before using
Zaditen.
Zaditen can be used during breast-feeding.
Driving and using machines
Zaditen may cause blurred vision or drowsiness. If
this happens to you, wait until this has cleared
before driving or operating machinery.

Fig. 3
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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 forget to use Zaditen
If you forget to use Zaditen 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, Zaditen 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
• drowsiness
• 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
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

EXPIRY DATE
Do not use this medicine after date shown on the
carton label or bottle label. Only keep this medicine
if your doctor tells you to. If your eye drops becomes
discoloured or shows any other signs of
deterioration, consult your pharmacist (chemist) who
will tell you what to do. This medicine must be
thrown away four weeks after first opening the
bottle.
HOW TO STORE
• Do not store above 25°C.
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further Information

What Zaditen contains
Each ml of eye drops contains 0.345mg ketotifen
hydrogen fumarate corresponding to 0.25mg
ketotifen as the active ingredient. The eye drops
also contain benzalkonium chloride, glycerol (E422),
sodium hydroxide (E524), water for injections.
What Zaditen looks like and contents of the pack
The eye drops are a clear, colourless to faintly
yellow solution. They are available in bottles of 5ml.
Manufacturer and Licence Holder
Zaditen Eye Drops are manufactured by
EXCELVISION, Rue de la Lombardière, 07100
Annonay Cedex, France and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL 15184/0922

Leaflet revision date: 08/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 0922/080713/1/B

Ref: 0922/080713/2/F

Ketotifen 0.25mg/ml Eye Drops Solution
Patient Information 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.
Your medicine is called Ketotifen 0.25mg/ml Eye
Drops Solution but will be referred to as Ketotifen
throughout the leaflet.

In this leaflet:
1 What Ketotifen is and what it is used for
2 Before you use Ketotifen
3 How to use Ketotifen
4 Possible side effects
5 How to store Ketotifen
6 Further information

1

What Ketotifen is and what it is used for

Ketotifen contains the active substance ketotifen,
which is an anti-allergic substance.
Ketotifen is used to treat eye symptoms of hay fever.
2

Before you use Ketotifen

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

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.
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).
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.

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.
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)

Fig. 1

Using Ketotifen with food and drink
Ketotifen may increase the effect of alcohol.
Fig. 2
Pregnancy and breast-feeding
If you are pregnant or think you might be, ask your
doctor or pharmacist for advice before using
Ketotifen.
Ketotifen can be used during breast-feeding.
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.

Fig. 3
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

If you use more Ketotifen than you should
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
If you forget to use Ketotifen 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, Ketotifen 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
• drowsiness
• 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
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

EXPIRY DATE
Do not use this medicine after date shown on the
carton label or bottle label. Only keep this medicine
if your doctor tells you to. If your eye drops becomes
discoloured or shows any other signs of
deterioration, consult your pharmacist (chemist) who
will tell you what to do. This medicine must be
thrown away four weeks after first opening the
bottle.
HOW TO STORE
• Do not store above 25°C.
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 Further Information
What Ketotifen contains
Each ml of eye drops contains 0.345mg ketotifen
hydrogen fumarate corresponding to 0.25mg
ketotifen as the active ingredient. The eye drops also
contain benzalkonium chloride, glycerol (E422),
sodium hydroxide (E524), water for injections.
What Ketotifen looks like and contents of the
pack
The eye drops are a clear, colourless to faintly
yellow solution. They are available in bottles of 5ml.
Manufacturer and Licence Holder
Ketotifen Eye Drops are manufactured by
EXCELVISION, Rue de la Lombardière, 07100
Annonay Cedex, France and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL 15184/0922

Leaflet revision date: 08/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 0922/080713/2/B

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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