Medication Guide App

ZADITEN ELIXIR 1.38MG/5ML

Active substance: KETOTIFEN HYDROGEN FUMARATE

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UK

Famar

Zaditen Elixir 1mg in 5ml
DESIGN No

LEAFLET

REF. No

SIZE

148 x 210 mm

NUMBER OF COLORS : 1

41933-03200801/GB

Pantone
Process Blue C

Patient Information Leaflet
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.
What you need to know about Zaditen Elixir
Your doctor has decided that you need this medicine to help
treat your condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information. Keep the leaflet
in a safe place because you may want to read it again.
If you have any other questions, or if there is something you
don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even
if their symptoms seem to be 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.
In this leaflet:
1. What Zaditen Elixir is, and what it’s used for
2. Things to consider before you start to take Zaditen Elixir
3. How to take Zaditen Elixir
4. Possible side effects
5. How to store Zaditen Elixir
6. Further information
1. What Zaditen Elixir is and what it’s used for
Zaditen Elixir contains the active ingredient, ketotifen.
Ketotifen is an antihistamine with anti-allergy properties.
In allergic conditions certain substances are released in the
body. These trigger inflammatory responses. Zaditen Elixir
acts to dampen down these responses and can therefore be
used to treat various allergic conditions such as rhinitis
(inflammation of the mucous membranes in the nose) and
conjunctivitis (inflammation of the mucous membranes in the
eye).
2. Things to consider before you start to take Zaditen
Elixir
Some people MUST NOT take Zaditen Elixir. Talk to
your doctor if:
• You think you may be allergic to ketotifen or to any of the
other ingredients of Zaditen Elixir. (These are listed in Section
6 of the leaflet.)
• You are pregnant, or planning to become pregnant. Tell
your doctor straight away if you become pregnant whilst
taking Zaditen Elixir.
• You are breast-feeding.
You should also ask yourself these questions before
taking Zaditen Elixir. If the answer to any of these
questions is YES, tell your doctor or pharmacist
because Zaditen Elixir might not be the right
medicine for you.

• Do you have epilepsy?
• Do you have an inherited intolerance to some sugars? (The
Elixir contains a small amount of maltitol.)
Are you taking other medicines?
Some medicines can interfere with your treatment. Make sure
your doctor knows if you are taking any of the following:
• Oral medicines for diabetes
• Medicines to treat sleeplessness or anxiety
• Anti-histamines to treat allergic reactions such as itching,
rash or runny nose.
Always tell your doctor about all the medicines you are taking.
This means medicines you have bought yourself as well as
medicines on prescription from your doctor.
Will there be any problems with driving or using
machinery?
• During the first few days of treatment you may feel that your
reactions are slower than usual. Some people can feel drowsy
or dizzy. If you are affected in any way you should not drive or
do anything where you need to be alert (such as operate tools
or machinery) until any problems clear up.
Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimes
cause allergic reactions which might appear some time after
first taking the elixir.
• Zaditen Elixir contains ethanol (alcohol). 5 ml of the elixir
contains nearly 0.1 g of ethanol. A daily dose of 20 ml (4 mg
ketotifen), will contain nearly 0.4 g of ethanol. This is less
than a glass of wine or a pint of beer, but will affect your blood
alcohol levels.
• The effects of alcohol may be increased by Zaditen Elixir.
Do not drink alcohol if you are taking Zaditen.
3. How to take Zaditen Elixir
The doctor will decide what dose of Zaditen Elixir you should
take. Always take the Elixir exactly as your doctor has told you
to. The dose will be on the pharmacist’s label. Check the label
carefully. It should tell you how much Elixir to take, and how
often. If you are not sure, ask your doctor or pharmacist. Keep
taking the Elixir for as long as you have been told unless you
have any problems. In that case, check with your doctor.
Take at the same time as you are eating.
Adults
The usual dose is 1 or 2 mg (One or two 5 ml spoonsful) twice
a day.
Children (aged over 3 years)
The usual dose is 1 mg (One 5 ml spoonful) twice a day.
Zaditen Elixir should not be given to children under 3 years of
age.
The doctor may decide to start with a lower dose.
41933-03200801/GB

UK

Famar

Zaditen Elixir 1mg in 5ml
DESIGN No

LEAFLET

REF. No

SIZE

148 x 210 mm

NUMBER OF COLORS : 1

41933-03200801/GB

Pantone
Process Blue C

What if you forget to take a dose?
If you forget to take a dose of Zaditen, take another one as soon
as you remember, unless it is almost time for your next dose.
If it is almost time for your next dose, just take the next dose as
you would do normally, and miss out the dose that you have
forgotten to take. Do not take a double dose of Zaditen to make
up for the dose you forgot.
What if you take too much?
All medicines can be risky if you take too much. If you take too
much Zaditen Elixir, tell your doctor or hospital casualty
department as soon as possible. Take your medicine pack with
you so that people can see what you have taken.
4. Possible side effects
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.
Some side effects can be serious
Stop taking the Elixir and tell your doctor immediately if you notice any of the following rare symptoms:
• A severe skin reaction with blistering or peeling. These
might be the symptoms of an allergic reaction.
Tell your doctor immediately if you have a fit.
The side effects listed below have also been
reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

destroyed. Only keep it if the doctor tells you to. Do not throw
it away with your normal household water or waste. This will
help to protect the environment.
6. Further information
Zaditen Elixir is a clear, strawberry-flavoured liquid containing
1 mg of the active ingredient ketotifen (as 1.38 mg of ketotifen
hydrogen fumarate) in each 5 ml. The Elixir also contains
methyl and propyl hydroxybenzoate, citric acid, disodium
phosphate, 96%v/v ethanol, maltitol liquid and purified water.
It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.
The product licence holder is Defiante Farmacêutica, S.A., Rua
dos Ferreiros, 260, 9000-082 Funchal, Portugal.
Zaditen Elixir is made by Famar France, Site Industriel
d’Orleans, Avenue du Champ de Mars, F-45072 Orleans,
France.
This leaflet was revised in August 2008.
If you would like any more information, or would like the leaflet
in a different format, please contact Swedish Orphan
International (UK) Ltd., 1 Fordham House Court, Fordham
House Estate, Newmarket Road, Fordham, Cambridge CB7
5LL, telephone number 01638 722 380.
ZADITEN is a registered trade mark
Licensed to Defiante Farmacêutica, S.A.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.
Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.
Very rare side effects (likely to affect fewer than 1 in
10,000 people):
Severe skin reactions including rashes, blistering or peeling,
convulsions (fits) or problems with their liver including
hepatitis or an increase in liver enzymes (this will only show in
a blood test).
The sleepiness, dry mouth and dizziness usually go away a few
days after you have started taking Zaditen. If any of the
symptoms become troublesome, or if you notice
anything else not mentioned here, please go and see
your doctor. He/she may want to give you a different
medicine.
5. How to store Zaditen Elixir
Store below 25oC.
Keep all medicines out of the reach and sight of children.
Do not take the Elixir after the expiry date which is printed on
the outside of the pack.
If your doctor tells you to stop taking Zaditen Elixir, please take
any which you haven’t used back to your pharmacist to be

41933-03200801/GB

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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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