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ALIMEMAZINE TARTRATE 10 MG FILM COATED TABLETS

Active substance(s): ALIMEMAZINE TARTRATE / ALIMEMAZINE TARTRATE / ALIMEMAZINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Vallergan® 10 mg Film Coated Tablets
Alimemazine tartrate
Read all of this leaflet 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 are and what they are 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 ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Vallergan Tartrate 10mg Film Coated
Tablets (called Vallergan throughout this leaflet). It contains the active
ingredient alimemazine tartrate and belongs to a group of medicines called
phenothiazines. It 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 tablets are 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 tartrate 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 less than 2 years old.
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
Vallergan tablets.
Warning and precautions
Talk to your doctor or pharmacist before taking Vallergan tablets if:
 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 Vallergan tablets.
Other medicines and Vallergan tablets
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 Vallergan tablets can affect the way some medicines work.
Also some medicines can affect the way Vallergan tablets work.
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
 Amphetamine – 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 or clonidine
 Medicines for indigestion and heartburn (antacids)
 Anticholinergic medicines - includes some medicines used for irritable
bowel syndrome, asthma or incontinence
Vallergan tablets with alcohol
Do not drink alcohol or take any medicines containing alcohol while you are
taking Vallergan tablets. 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 are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Vallergan tablets if you are breast-feeding. 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 tablets contain lactose
This medicine contains lactose, a type of sugar.
If you have been told by your doctor that you can not tolerate some sugars,
talk to your doctor before taking Vallergan tablets

3. HOW TO USE 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
 Do not touch the tablets for any longer than is necessary.
This can cause skin redness, swelling and itching (contact skin
sensitisation)
 If you feel the effect 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:
 One tablet (10mg) two or three times each day
 Your doctor may increase your dose in some cases
Older people:
 One tablet (10mg) once or twice each day
Children over 2 years of age:
 Children will normally be given Vallergan syrup.
You should check with your doctor or pharmacist
As a sedative
Children aged between 2 and 7 years:
 Children will normally be given Vallergan syrup.
You should check with your doctor or pharmacist
Exposure to sunlight
Vallergan tablets can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.

If you take more Vallergan tablets than you should
If you take more Vallergan tablets 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 effects 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, light-headed 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 tablets
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.

5. HOW TO STORE VALLERGAN





Keep out of the sight and reach of children.
Do not use Vallergan tablets after the expiry date which is stated on
the carton and blister after ‘EXP’. The expiry date refers to the last day
of that month
Do not store above 25°C.
Protect from light

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vallergan contains
 Each tablet contains 10mg of the active ingredient, alimemazine
tartrate
 The other ingredients are: lactose, microcrystalline cellulose, colloidal
anhydrous silica, magnesium stearate, sodium starch glycollate,
hypromellose, macrogol 200, indigotin (E132), titanium dioxide (E171).
What Vallergan looks like and contents of the pack
Vallergan 10 mg Tablets are dark blue circular tablets with "V10"
embossed on one side and plain on the other.
Available in blister packs containing 25 Tablets.

Stop taking Vallergan tablets 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
 Changes in skin or eye colour
 Problems with your eyesight
 Rigid or stiff muscles, trembling or shaking or difficulty moving
 Feeling dizzy, lightheaded 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
 Stuffy 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.

Manufactured by Farmar Health Care Services Madrid, S.A.U., Alcorcon,
Madrid, Spain and procured from within the EU and repackaged in the UK
by the Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point, Manor
Way, Borehamwood, Herts WD6 1EE.
Vallergan 10 mg Film Coated Tablets
POM

Vallergan is a registered trademark.
Date of preparation: 27th October 2016

PL: 20492/0537

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alimemazine Tartrate 10 mg Film Coated
Tablets
Read all of this leaflet 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 are and what they are used for
2. What you need to know before you take Alimemazine
3. How to take Alimemazine
4. Possible side effects
5. How to store Alimemazine
6. Contents of the pack and other information

1. WHAT ALIMEMAZINE ARE AND WHAT THEY ARE
USED FOR
The name of your medicine is Alimemazine Tartrate 10mg Film Coated
Tablets (called Alimemazine throughout this leaflet). It contains the active
ingredient alimemazine tartrate and belongs to a group of medicines called
phenothiazines. It 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 tablets are 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
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to:
 Alimemazine tartrate 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 should not be used in children less than 2 years old.
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 tablets.
Warning and precautions
Talk to your doctor or pharmacist before taking Alimemazine tablets
if:
 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 tablets.

Other medicines and Alimemazine tablets
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 tablets can affect the way some medicines
work.
Also some medicines can affect the way Alimemazine tablets work.
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
 Amphetamine – 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 or clonidine
 Medicines for indigestion and heartburn (antacids)
 Anticholinergic medicines - includes some medicines used for irritable
bowel syndrome, asthma or incontinence
Alimemazine tablets with alcohol
Do not drink alcohol or take any medicines containing alcohol while you are
taking Alimemazine tablets. 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 are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Alimemazine tablets if you are breast-feeding. 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 tablets contain lactose
This medicine contains lactose, a type of sugar.
If you have been told by your doctor that you can not tolerate some sugars,
talk to your doctor before taking Alimemazine tablets

3. HOW TO USE TAKE ALIMEMAZINE
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
 Do not touch the tablets for any longer than is necessary.
This can cause skin redness, swelling and itching (contact skin
sensitisation)
 If you feel the effect 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:
 One tablet (10mg) two or three times each day
 Your doctor may increase your dose in some cases
Older people:
 One tablet (10mg) once or twice each day
Children over 2 years of age:
 Children will normally be given Alimemazine syrup.
You should check with your doctor or pharmacist
As a sedative
Children aged between 2 and 7 years:
 Children will normally be given Alimemazine syrup.
You should check with your doctor or pharmacist
Exposure to sunlight
Alimemazine tablets can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.

If you take more Alimemazine tablets than you should
If you take more Alimemazine tablets 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 effects 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, light-headed 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 tablets
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.

5. HOW TO STORE ALIMEMAZINE





Keep out of the sight and reach of children.
Do not use Alimemazine tablets after the expiry date which is stated on
the carton and blister after ‘EXP’. The expiry date refers to the last day
of that month
Do not store above 25°C.
Protect from light

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alimemazine contains
 Each tablet contains 10mg of the active ingredient, alimemazine
tartrate
 The other ingredients are: lactose, microcrystalline cellulose, colloidal
anhydrous silica, magnesium stearate, sodium starch glycollate,
hypromellose, macrogol 200, indigotin (E132), titanium dioxide (E171).
What Alimemazine looks like and contents of the pack
Alimemazine 10 mg Tablets are dark blue circular tablets with "V10"
embossed on one side and plain on the other.
Available in blister packs containing 25 Tablets.

Stop taking Alimemazine tablets 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
 Changes in skin or eye colour
 Problems with your eyesight
 Rigid or stiff muscles, trembling or shaking or difficulty moving
 Feeling dizzy, lightheaded 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
 Stuffy 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.

Manufactured by Farmar Health Care Services Madrid, S.A.U., Alcorcon,
Madrid, Spain and procured from within the EU and repackaged in the UK
by the Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point, Manor
Way, Borehamwood, Herts WD6 1EE.
Alimemazine Tartrate 10 mg Film Coated Tablets PL: 20492/0537
POM

Date of preparation: 27th October 2016

Expand Transcript

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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