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VALLERGAN FORTE 30MG/5ML SYRUP

Active substance(s): ALIMEMAZINE TARTRATE

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Ref: 1195/080615/1/F

Vallergan® Forte 30mg/5ml Syrup
(alimemazine tartrate)
Patient Information Leaflet
Read all of this leafl et carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet - see section 4.
What is in this leaflet:
1

What Vallergan is and what it is used for

2

What you need to know before you take Vallergan

3

How to take Vallergan

4

Possible side effects

5

How to store Vallergan

6

Contents of the pack and other information

1

What Vallergan is and what it is used for

The name of your medicine is Vallergan Tartrate 7.5mg/5ml Syrup or
Vallergan Tartrate 30mg/5ml Syrup (called Vallergan throughout
this leaflet). It contains the active ingredient alimemazine tartrate and it
belongs to a group of medicines called phenothiazines and works by
blocking a natural substance (histamine) that your body makes during an
allergic reaction. It also works directly on the brain to help you feel more
relaxed.
What Vallergan is used for
* To treat itching (pruritus) or an itchy, lumpy rash (urticaria)
* As a sedative for children aged between 2 and 7 years. This is a medicine
given to reduce awareness or make the child feel relaxed and at
ease before an operation

2

What you need to know before you take Vallergan

Do not take this medicine and tell your doctor if:
You are allergic (hypersensitive) to:
- Vallergan or any of the other ingredients of this medicine
(listed in section 6)
- any other similar medicines (phenothiazines) such as chlorpromazine
The signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
You have liver or kidney problems
You have epilepsy
You have Parkinson’s disease
You have thyroid problems (hypothyroidism)
You have a tumour on the adrenal gland (called phaeochromocytoma)
You have myasthenia gravis (a form of muscle weakness)
You have an enlarged prostate gland
You have increased pressure in the eye (called narrow angle glaucoma)
Children
Vallergan should not be used in children under 2 years of age.
Do not take this medicine if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking alimemazine.

Other medicines and Vallergan
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines you can buy without
prescription, including herbal medicines. This is because alimemazine can
affect the way some medicines work. Also some medicines can affect the
way Vallergan works.
In particular, tell your doctor or pharmacist if you are taking any of the
following:
* Medicines to help you sleep or lower your anxiety
* Lithium – used to treat some types of mental illness
* Amfetamine – used for Attention Deficit Hyperactivity Disorder (ADHD)
* Phenobarbital – used for epilepsy
* Adrenaline - used for life threatening allergic reactions
* Medicines for Parkinson’s disease such as levodopa
* Medicines for depression
* Medicines for severe pain (such as codeine or morphine)
* Medicines for diabetes. Your doctor may need to change the dose of your
medicine
* Medicines for high blood pressure such as doxazosin, terazosin,
guanethidine, clonidine
* Medicines for indigestion and heartburn (antacids)
* Anticholinergic medicines - includes some medicines used for irritable
bowel syndrome, asthma or incontinence
Taking Vallergan with alcohol
Do not drink alcohol or take any medicines containing alcohol while you are
taking Vallergan. This is because alcohol can increase the chances of
you getting side effects. It can also cause serious breathing difficulties.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
You should not take Vallergan if you are breastfeeding. This is because
small amounts may pass into mothers’ milk. This can be harmful to your
baby.
If you are breast-feeding or planning to breast-feed, talk to your doctor or
pharmacist before taking any medicine.
Driving and using machines
You may feel drowsy or sleepy while taking this medicine. If this happens, do
not drive or use any tools or machines.
Vallergan contains sucrose, sodium sulphite, sodium metabisulphite,
ethanol and sodium
* Sucrose. This is a type of sugar. If you have been told by your doctor that
you cannot tolerate or digest some sugars (have an intolerance to some
sugars), talk to your doctor before taking this medicine
* Sodium sulphite and sodium metabisulphite.
These may rarely cause severe allergic (hypersensitivity) reactions and
difficulty breathing, wheezing and tightness in the chest (bronchospasm)
* Ethanol. Vallergan contains 5% ethanol (alcohol) as 96%v/v. Each 5ml
dose contains up to 203mg ethanol. This is equivalent to 5ml beer, 2ml
wine per dose. This can be harmful for those suff ering from alcoholism.
Take this into account if you are pregnant or breast-feeding. Also if you are
giving this medicine to a child or to people who have higher chances of
getting liver problems or epilepsy.
* Sodium. Vallergan contains approximately 28mg of sodium per 5ml
dose. Take this into account if you are on a controlled sodium diet

3
Warnings and precautions
Talk to your doctor or pharmacist before taking Vallergan if:
▲ The person taking the medicine is under 2 years of age
▲ You are diabetic. This medicine contains sucrose, a type of sugar
▲ You have heart problems
▲ You are elderly and are dehydrated or have been told you have a low
blood volume
▲ You are elderly and have had constipation for some time
▲ You are an elderly male and have problems when passing water (urine)
▲ You are elderly and it is very hot or cold. Your body may find it harder to
control its temperature when taking this medicine If you are not sure if
any of the above apply to you, talk to your doctor or pharmacist before
taking alimemazine.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Vallergan.

How to take Vallergan

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Taking this medicine
* Take this medicine by mouth
* Avoid the syrup touching any part of your skin. This can cause skin
redness, swelling and itching (contact skin sensitisation)
* If you feel the eff ect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor
* Do not take more than the recommended dose
How much to take
The usual dose is:
For itching or an itchy lumpy rash
Adults:
* 10 mg two or three times each day
* Your doctor may increase your dose depending on your illness

Vallergan® Forte 30mg/5ml Syrup

Ref: 1195/080616/1/B

(alimemazine tartrate)
Patient Information Leaflet (continued)
Older people
* 10 mg once or twice each day
Children over 2 years of age
* Vallergan should be used
* 2.5 to 5 mg three or four times each day
As a sedative
Children aged between 2 and 7 years:
Vallergan should be used
* Your child’s doctor will decide the amount to give
* The maximum dose is 2 mg per kg of bodyweight
* Alimemazine is given 1-2 hours before the operation
Exposure to sunlight
Vallergan can make your skin more sensitive to sunlight. Keep out of direct
sunlight while taking this medicine.
If you take more Vallergan than you should
If you take more Vallergan than you should, tell a doctor or go to a
hospital casualty department straight away. Take the medicine pack with
you. This is so the doctor knows what you have taken. Also do this if a child
under 2 years of age swallows some of this medicine.
The following eff ects may happen: feeling drowsy, loss of consciousness,
increased or rapid heartbeat, changes in heart beat, uneven heart beats and
feeling very cold. You may also feel dizzy, lightheaded or faint (due to low
blood pressure) and you may notice that you cannot control your
movements (for example of the eyes, neck, arms and legs).
If you forget to take Vallergan
If you forget a dose, take it as soon as you remember it. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a double
dose to make up for a forgotten dose
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Vallergan and see a doctor or go to a hospital
straight away if you notice any of the following side effects:
* An allergic reaction. The signs may include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
* Liver problems that may cause the eyes or skin to go yellow (jaundice)
* High temperature, sweating, stiff muscles, fast heartbeat, fast breathing
and feel confused, drowsy or agitated
These could be signs of a serious side effect called ‘neuroleptic malignant
syndrome’
* Very fast, uneven or forceful heartbeat (palpitations). You may also have
breathing problems such as wheezing, shortness of breath, tightness in
the chest and chest pain
* Convulsions/fits and movements that you cannot control, mainly of the
tongue, mouth, jaw, arms and legs
* You may get infections more easily than normal such as fever, severe
chills, sore throat or mouth ulcers. These could be signs of a blood
problem
Tell a pharmacist or doctor as soon as possible if you have any of the
following side effects:
* Breathing more slowly or less deeply than normal
* Feeling restless and not being able to keep still (akathisia)
* Changes in skin or eye colour
* Problems with your eyesight
* Rigid or stiff muscles, trembling or shaking or diffi culty moving
* Feeling dizzy, light-headed or faint when you stand or sit up quickly (due to
low blood pressure)
* Unexpected excitement or hyperactivity
Tell your doctor or pharmacist if any of the following side effects gets
serious or lasts longer than a few days or if you notice any side effects
not listed in this leaflet:
* Dry mouth
* Stuff y nose
* Difficulty sleeping (insomnia)
* Feeling agitated
* Being more sensitive to the sun than usual
* Unusual production of breast milk in men and women
* Breast enlargement in men
* Loss of menstrual periods
* Difficulty in getting or maintaining an erection or in ejaculating (impotence)
* Skin redness, swelling and itching (contact skin sensitisation)
* Skin rashes

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5

How to store Vallergan

* Keep out of the sight and reach of childern
* Do not use Vallergan after the expiry date which is stated on the carton

and bottle label after EXP. The expiry date refers to the last day of that
month
* Do not use Vallergan after the bottle has been opened for more than a
month
* Do not store above 25°C
* Protect from light
* Keep the bottle in the outer carton
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

Contents of the pack and other information

What Vallergan contains
* Each 1ml of Vallergan Forte Syrup contains 6mg of the active substance,
alimemazine tartrate
* The other ingredients are sucrose, apricot flavour (no. 1NS), ethanol 96%,
citric acid anhydrous, sodium citrate, sodium benzoate, sodium sulphite
anhydrous (E221), sodium metabisulphite (E223), ascorbic acid and
purified water.
What Vallergan looks like and contents of the pack
Vallergan Forte Syrup is a clear colourless to very pale yellow syrupy liquid
with a smell of apricots. Vallergan Forte Syrup is available in glass bottles of
100ml.
Manufacturer and Licence Holder
This medicine is manufactured by Aventis Pharma Limited, Waterford
Industrial Estate, Waterford, Republic of Ireland 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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 15184/1195 Vallergan Forte 30mg/5ml Syrup

Vallergan is a registered trademark of May & Baker Limited.
Revision date: 08/06/16

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

Ref: 1195/080616/2/F

Alimemazine tartrate 30mg/5ml Syrup
Patient Information Leaflet
Read all of this leafl et carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet - see section 4.
What is in this leaflet:
1 What Alimemazine Syrup is and what it is used for
2 What you need to know before you take Alimemazine Syrup
3 How to take Alimemazine Syrup
4 Possible side effects
5 How to store Alimemazine Syrup
6 Contents of the pack and other information

1

What Alimemazine Syrup is and what it is used for

The name of your medicine is Alimemazine Tartrate 7.5mg/5ml Syrup or
Alimemazine Tartrate 30mg/5ml Syrup (called Alimemazine Syrup throughout
this leaflet). It contains the active ingredient alimemazine tartrate and it
belongs to a group of medicines called phenothiazines and works by
blocking a natural substance (histamine) that your body makes during an
allergic reaction. It also works directly on the brain to help you feel more
relaxed.
What Alimemazine Syrup is used for
* To treat itching (pruritus) or an itchy, lumpy rash (urticaria)
* As a sedative for children aged between 2 and 7 years. This is a medicine
given to reduce awareness or make the child feel relaxed and at
ease before an operation

2 What you need to know before

you take Alimemazine

Syrup
Do not take this medicine and tell your doctor if:
You are allergic (hypersensitive) to:
- Alimemazine Syrup or any of the other ingredients of this medicine
(listed in section 6)
- any other similar medicines (phenothiazines) such as chlorpromazine
The signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
You have liver or kidney problems
You have epilepsy
You have Parkinson’s disease
You have thyroid problems (hypothyroidism)
You have a tumour on the adrenal gland (called phaeochromocytoma)
You have myasthenia gravis (a form of muscle weakness)
You have an enlarged prostate gland
You have increased pressure in the eye (called narrow angle glaucoma)
Children
Alimemazine Syrup should not be used in children under 2 years of age.
Do not take this medicine if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking alimemazine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alimemazine Syrup if:
▲ The person taking the medicine is under 2 years of age
▲ You are diabetic. This medicine contains sucrose, a type of sugar
▲ You have heart problems
▲ You are elderly and are dehydrated or have been told you have a low
blood volume
▲ You are elderly and have had constipation for some time
▲ You are an elderly male and have problems when passing water (urine)
▲ You are elderly and it is very hot or cold. Your body may fi nd it harder to
control its temperature when taking this medicine
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking alimemazine.

Other medicines and Alimemazine Syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines you can buy without
prescription, including herbal medicines. This is because alimemazine can
affect the way some medicines work. Also some medicines can affect the
way alimemazine works.
In particular, tell your doctor or pharmacist if you are taking any of the
following:
* Medicines to help you sleep or lower your anxiety
* Lithium – used to treat some types of mental illness
* Amfetamine – used for Attention Deficit Hyperactivity Disorder (ADHD)
* Phenobarbital – used for epilepsy
* Adrenaline - used for life threatening allergic reactions
* Medicines for Parkinson’s disease such as levodopa
* Medicines for depression
* Medicines for severe pain (such as codeine or morphine)
* Medicines for diabetes. Your doctor may need to change the dose of your
medicine
* Medicines for high blood pressure such as doxazosin, terazosin,
guanethidine, clonidine
* Medicines for indigestion and heartburn (antacids)
* Anticholinergic medicines - includes some medicines used for irritable
bowel syndrome, asthma or incontinence
Taking Alimemazine Syrup with alcohol
Do not drink alcohol or take any medicines containing alcohol while you are
taking alimemazine. This is because alcohol can increase the chances of
you getting side eff ects. It can also cause serious breathing difficulties.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
You should not take alimemazine if you are breastfeeding. This is because
small amounts may pass into mothers’ milk. This can be harmful to your
baby.
If you are breast-feeding or planning to breast-feed, talk to your doctor or
pharmacist before taking any medicine.
Driving and using machines
You may feel drowsy or sleepy while taking this medicine. If this happens, do
not drive or use any tools or machines.
Alimemazine Syrup contains sucrose, sodium sulphite, sodium
metabisulphite, ethanol and sodium
* Sucrose. This is a type of sugar. If you have been told by your doctor that
you cannot tolerate or digest some sugars (have an intolerance to some
sugars), talk to your doctor before taking this medicine
* Sodium sulphite and sodium metabisulphite.
These may rarely cause severe allergic (hypersensitivity) reactions and
difficulty breathing, wheezing and tightness in the chest (bronchospasm)
* Ethanol. Alimemazine contains 5% ethanol (alcohol) as 96%v/v. Each 5ml
dose contains up to 203mg ethanol. This is equivalent to 5ml beer, 2ml
wine per dose. This can be harmful for those suff ering from alcoholism.
Take this into account if you are pregnant or breast-feeding. Also if you are
giving this medicine to a child or to people who have higher chances of
getting liver problems or epilepsy.
* Sodium. Alimemazine contains approximately 28mg of sodium per 5ml
dose. Take this into account if you are on a controlled sodium diet

3

How to take Alimemazine Syrup

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Taking this medicine
* Take this medicine by mouth
* Avoid the syrup touching any part of your skin. This can cause skin
redness, swelling and itching (contact skin sensitisation)
* If you feel the eff ect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor
* Do not take more than the recommended dose
How much to take
The usual dose is:
For itching or an itchy lumpy rash
Adults:
* 10 mg two or three times each day
* Your doctor may increase your dose depending on your illness

Ref: 1195/080616/B

Alimemazine tartrate 30mg/5ml Syrup
Patient Information Leaflet (continued)
Older people
* 10 mg once or twice each day
Children over 2 years of age
* Alimemazine Syrup should be used
* 2.5 to 5 mg three or four times each day
As a sedative
Children aged between 2 and 7 years:
Alimemazine Syrup should be used
* Your child’s doctor will decide the amount to give
* The maximum dose is 2 mg per kg of bodyweight
* Alimemazine is given 1-2 hours before the operation
Exposure to sunlight
Alimemazine can make your skin more sensitive to sunlight. Keep out of
direct sunlight while taking this medicine.
If you take more Alimemazine Syrup than you should
If you take more Alimemazine Syrup than you should, tell a doctor or go to a
hospital casualty department straight away. Take the medicine pack with
you. This is so the doctor knows what you have taken. Also do this if a child
under 2 years of age swallows some of this medicine.
The following eff ects may happen: feeling drowsy, loss of consciousness,
increased or rapid heartbeat, changes in heart beat, uneven heart beats and
feeling very cold. You may also feel dizzy, lightheaded or faint (due to low
blood pressure) and you may notice that you cannot control your
movements (for example of the eyes, neck, arms and legs).
If you forget to take Alimemazine Syrup
If you forget a dose, take it as soon as you remember it. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Alimemazine Syrup and see a doctor or go to a hospital
straight away if you notice any of the following side effects:
* An allergic reaction. The signs may include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
* Liver problems that may cause the eyes or skin to go yellow (jaundice)
* High temperature, sweating, stiff muscles, fast heartbeat, fast breathing
and feel confused, drowsy or agitated
These could be signs of a serious side effect called ‘neuroleptic malignant
syndrome’
* Very fast, uneven or forceful heartbeat (palpitations). You may also have
breathing problems such as wheezing, shortness of breath, tightness in
the chest and chest pain
* Convulsions/fits and movements that you cannot control, mainly of the
tongue, mouth, jaw, arms and legs
* You may get infections more easily than normal such as fever, severe
chills, sore throat or mouth ulcers. These could be signs of a blood problem
Tell a pharmacist or doctor as soon as possible if you have any of the
following side effects:
* Breathing more slowly or less deeply than normal
* Feeling restless and not being able to keep still (akathisia)
* Changes in skin or eye colour
* Problems with your eyesight
* Rigid or stiff muscles, trembling or shaking or diffi culty moving
* Feeling dizzy, light-headed or faint when you stand or sit up quickly (due to
low blood pressure)
* Unexpected excitement or hyperactivity
Tell your doctor or pharmacist if any of the following side eff ects gets
serious or lasts longer than a few days or if you notice any side effects
not listed in this leaflet:
* Dry mouth
* Stuff y nose
* Difficulty sleeping (insomnia)
* Feeling agitated
* Being more sensitive to the sun than usual
* Unusual production of breast milk in men and women
* Breast enlargement in men
* Loss of menstrual periods
* Difficulty in getting or maintaining an erection or in ejaculating (impotence)
* Skin redness, swelling and itching (contact skin sensitisation)
* Skin rashes

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5

How to store Alimemazine Syrup

* Keep out of the sight and reach of children
* Do not use Alimemazine syrup after the expiry date which is stated on the

carton and bottle label after EXP. The expiry date refers to the last day of
that month
* Do not use Alimemazine syrup after the bottle has been opened for more
than a month
* Do not store above 25°C
* Protect from light
* Keep the bottle in the outer carton
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

Contents of the pack and other information

What Alimemazine Syrup contains
* Each 1ml of Alimemazine tartrate Syrup contains 6mg of the active
substance, alimemazine tartrate
* The other ingredients are sucrose, apricot flavour (no. 1NS), ethanol 96%,
citric acid anhydrous, sodium citrate, sodium benzoate, sodium sulphite
anhydrous (E221), sodium metabisulphite (E223), ascorbic acid and
purified water.
What Alimemazine Syrup looks like and contents of the pack
Alimemazine tartrate Syrup is a clear colourless to very pale yellow syrupy
liquid with a smell of apricots. Alimemazine tartrate Syrup is available in glass
bottles of 100ml.
Manufacturer and Licence Holder
This medicine is manufactured by Aventis Pharma Limited, Waterford
Industrial Estate, Waterford, Republic of Ireland 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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 15184/1195 Alimemazine tartrate 30mg/5ml Syrup

Revision date: 08/06/16

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

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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