ZADITEN ELIXIR 1.38MG/5ML

Active substance: KETOTIFEN HYDROGEN FUMARATE

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Transcript
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.

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

ZADITEN Elixir

s. p. a.

I

BOZZA n.
proof

II

50 g/m

III

PANTONE
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

IV

GRAMMATURA weigth
2 ±10%

I

BOZZA n.
proof

V

BOZZA n.
proof

VI

Helvetica - Times

BOZZA n.
proof

CARATTERI UTILIZZA TI fonts type

8 ORIZZONTALE

TIPO PIEGA fold type

1 6 0 ,0

PIEGATA
folded

4 5,5
BOZZA n. X
proof

2 1 0 ,0

20023606

CODICE COMPONENTE material code

4 5,5
VII BOZZA n. VIII BOZZA n. IX
proof
proof

TESO
stiff

200

DIMENSIONI mm size

SOSTITUISCE it replaces

Realizzato

• You are breast-feeding.

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.)

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

4350

G e s ti o n e

R
EST
G
CS

NE
STIO etto
F1
GE og
GE
A
Pr
G
DI

I

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

OF

operator

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

CENT
RO

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.

SI PREGA DI RESTITUIRE IL FILE FIRMATO CON LE CORREZIONI E/O APPROVAZIONI INSERITE IN FORMA DIGITALE
PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

02:04:14 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

BOZZA n.
proof

ik V1264

CODICE A BARRE bar code

Uso mano

CARTA paper

PRODUZIONE manifacturing

FOGLIO ILLUSTRATIVO
leaflet

E

T
AL

NOME PRODOTT O product description

(I)

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

UK
ZADITEN ELIXIR 300ML

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

Orleans - Artworks Center
SIZE 160 x 210 mm
LEAFLET
MATERIAL NUMBER F309856

20023606
SIGMA-TAU MATERIAL NUMBER

Version
Client

2.0
Dimensions
Component type

Minimum font size
Main font type
Safety code

Verso 2
Recto 2
Verso 1
Recto 1

-

NOTF003
NA

NEW PN - 88005 UK

NA
NA
PMS PRO BLUE
PMS PRO BLUE

SIGMA-TAU
160 x 210 mm
F309856

Component number

PLANT: FAMAR
UK

ZADITEN ELIXIR 300ML
PN 714018-UK

Colours

APPROVAL
Version 2
03-12-13
Version 1
25-10-13

PMS PRO BLUE

NUMBER OF COLORS: 1

A print out of this image
should not be used for exact
colour matching but to check
if the layout, spelling, text and
colour references are correct.
Please check thouroughly.

SIGMA-TAU APPROVAL
TECHNICAL APPROVAL
TEXT APPROVAL

ZADITEN Elixir

s. p. a.

I

BOZZA n.
proof

II

50 g/m

III

PANTONE
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

IV

GRAMMATURA weigth
2 ±10%

I

BOZZA n.
proof

V

BOZZA n.
proof

VI

Helvetica - Times

BOZZA n.
proof

CARATTERI UTILIZZA TI fonts type

8 ORIZZONTALE

TIPO PIEGA fold type

1 6 0 ,0

PIEGATA
folded

4 5,5
BOZZA n. X
proof

2 1 0 ,0

20023606

CODICE COMPONENTE material code

4 5,5
VII BOZZA n. VIII BOZZA n. IX
proof
proof

TESO
stiff

200

DIMENSIONI mm size

SOSTITUISCE it replaces

• You are breast-feeding.

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.)

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

4350

G e s ti o n e

R
EST
G
CS

NE
STIO etto
F1
GE og
GE
A
Pr
G
DI

I

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

OF

operator

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

CENT
RO

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.

SI PREGA DI RESTITUIRE IL FILE FIRMATO CON LE CORREZIONI E/O APPROVAZIONI INSERITE IN FORMA DIGITALE
PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

02:04:14 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

BOZZA n.
proof

ik V1264

CODICE A BARRE bar code

Uso mano

CARTA paper

PRODUZIONE manifacturing

E

T
AL

NOME PRODOTT O product description

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

Version
Client
Dimensions
Component number

Realizzato

Colours

FOGLIO ILLUSTRATIVO
leaflet

Minimum font size
Main font type
Safety code

Component type

Verso 2
Recto 2
Verso 1
Recto 1

(I)

NA
NA
PMS PRO BLUE
PMS PRO BLUE

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

NOTF003
PMS PRO BLUE

A print out of this image
should not be used for exact
colour matching but to check
if the layout, spelling, text and
colour references are correct.
Please check thouroughly.

ZADITEN Elixir

s. p. a.

I

BOZZA n.
proof

II

50 g/m

III

PANTONE
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

IV

GRAMMATURA weigth
2 ±10%

I

BOZZA n.
proof

V

BOZZA n.
proof

VI

Helvetica - Times

BOZZA n.
proof

CARATTERI UTILIZZA TI fonts type

8 ORIZZONTALE

TIPO PIEGA fold type

1 6 0 ,0

PIEGATA
folded

4 5,5
BOZZA n. X
proof

2 1 0 ,0

20023606

CODICE COMPONENTE material code

4 5,5
VII BOZZA n. VIII BOZZA n. IX
proof
proof

TESO
stiff

200

DIMENSIONI mm size

SOSTITUISCE it replaces

• You are breast-feeding.

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.)

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

4350

G e s ti o n e

R
EST
G
CS

NE
STIO etto
F1
GE og
GE
A
Pr
G
DI

I

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

OF

operator

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

CENT
RO

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.

SI PREGA DI RESTITUIRE IL FILE FIRMATO CON LE CORREZIONI E/O APPROVAZIONI INSERITE IN FORMA DIGITALE
PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

02:04:14 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

BOZZA n.
proof

ik V1264

CODICE A BARRE bar code

Uso mano

CARTA paper

PRODUZIONE manifacturing

E

T
AL

NOME PRODOTT O product description

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

Version
Client
Dimensions
Component number

Realizzato

Colours

FOGLIO ILLUSTRATIVO
leaflet

Minimum font size
Main font type
Safety code

Component type

Verso 2
Recto 2
Verso 1
Recto 1

(I)

NA
NA
PMS PRO BLUE
PMS PRO BLUE

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

NOTF003
PMS PRO BLUE

A print out of this image
should not be used for exact
colour matching but to check
if the layout, spelling, text and
colour references are correct.
Please check thouroughly.

ZADITEN Elixir

s. p. a.

I

BOZZA n.
proof

II

50 g/m

III

IV

PANTONE PR blue
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

GRAMMATURA weigth
2 ±10%

I

BOZZA n.
proof

V

BOZZA n.
proof

VI

Helvetica - Times

BOZZA n.
proof

CARATTERI UTILIZZA TI fonts type

8 ORIZZONTALE

TIPO PIEGA fold type

1 6 0 ,0

PIEGATA
folded

4 5,5
BOZZA n. X
proof

2 1 0 ,0

20023606

CODICE COMPONENTE material code

4 5,5
VII BOZZA n. VIII BOZZA n. IX
proof
proof

TESO
stiff

200

DIMENSIONI mm size

SOSTITUISCE it replaces

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.

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

4350

G e s ti o n e

R
EST
G
CS

NE
STIO etto
F1
GE og
GE
A
Pr
G
DI

I

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

OF

operator

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

CENT
RO

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.

SI PREGA DI RESTITUIRE IL FILE FIRMATO CON LE CORREZIONI E/O APPROVAZIONI INSERITE IN FORMA DIGITALE
PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

02:04:14 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

BOZZA n.
proof

ik V1264

CODICE A BARRE bar code

Uso mano

CARTA paper

PRODUZIONE manifacturing

E

T
AL

NOME PRODOTT O product description

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

Version
Client
Dimensions
Component number

Realizzato

Colours

FOGLIO ILLUSTRATIVO
leaflet

Minimum font size
Main font type
Safety code

Component type

Verso 2
Recto 2
Verso 1
Recto 1

(I)

NA
NA
PMS PRO BLUE
PMS PRO BLUE

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

NOTF003
PMS PRO BLUE

A print out of this image
should not be used for exact
colour matching but to check
if the layout, spelling, text and
colour references are correct.
Please check thouroughly.

ZADITEN Elixir

s. p. a.

I

BOZZA n.
proof

II

50 g/m

III

PANTONE
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

IV

GRAMMATURA weigth
2 ±10%

I

BOZZA n.
proof

V

BOZZA n.
proof

VI

Helvetica - Times

BOZZA n.
proof

CARATTERI UTILIZZA TI fonts type

8 ORIZZONTALE

TIPO PIEGA fold type

1 6 0 ,0

PIEGATA
folded

4 5,5
BOZZA n. X
proof

2 1 0 ,0

20023606

CODICE COMPONENTE material code

4 5,5
VII BOZZA n. VIII BOZZA n. IX
proof
proof

TESO
stiff

200

DIMENSIONI mm size

SOSTITUISCE it replaces

• You are breast-feeding.

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.)

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
Zaditen Elixir

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).

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 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

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.

PATIENT INFORMATION LEAFLET
This medicine will usually be referred to as Zaditen Elixir or
Zaditen in this leaflet.

ZADITEN Elixir 1 ng/5 ml
(ketotifen)

4350

G e s ti o n e

R
EST
G
CS

NE
STIO etto
F1
GE og
GE
A
Pr
G
DI

I

The doctor may decide to start with a lower dose.

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.

Adults
The usual dose is 1 or 2 mg (one or two 5 ml spoonsful) twice
a day.

Take at the same time as you are eating.

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.

Other special warnings
• Zaditen Elixir contains small amounts of the preservatives
methyl and propyl hydroxybenzoate. These can sometimescause 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.

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.

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.

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.

5. HOW TO STORE ZADITEN ELIXIR
Store below 25°C.
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
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.

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.

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).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
or having a dry mouth.

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

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.

4. POSSIBLE SIDE EFFECTS
Zaditen Elixir is suitable for most people, but, like all
medicines, it can sometimes cause side effects.

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.

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.)

OF

operator

PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

CENT
RO

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.

SI PREGA DI RESTITUIRE IL FILE FIRMATO CON LE CORREZIONI E/O APPROVAZIONI INSERITE IN FORMA DIGITALE
PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

02:04:14 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06 06:09:06

BOZZA n.
proof

ik V1264

CODICE A BARRE bar code

Uso mano

CARTA paper

PRODUZIONE manifacturing

E

T
AL

NOME PRODOTT O product description

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.

F309856

20023606

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Famaceutiche Riunite S.p.A.

This leaflet was revised in December 2013.

Zaditen Elixir is made by Famar Orleans, 5 avenue de Concyr,
450071 Orléans, Cedex 2, France.

The product licence holder is
Sigma-Tau
Industrie Famaceutiche Riunite S.p.A.,
Viale Shakespeare 47, 00144 Rome, Italy

It comes in bottles of 150 or 300 ml. Some of the pack sizes
may not be available.

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.

Version
Client
Dimensions
Component number

Realizzato

Colours

FOGLIO ILLUSTRATIVO
leaflet

Minimum font size
Main font type
Safety code

Component type

Verso 2
Recto 2
Verso 1
Recto 1

(I)

NA
NA
PMS PRO BLUE
PMS PRO BLUE

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

NOTF003
PMS PRO BLUE

A print out of this image
should not be used for exact
colour matching but to check
if the layout, spelling, text and
colour references are correct.
Please check thouroughly.

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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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