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Vallergan Forte 30mg/5ml Syrup

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Leaflet

Vallergan Forte 30mg/5ml Syrup Ref: 1195/020714/1 /F

(alimemazine tartrate)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or pharmacist.

* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

0 What Vallergan is and what it is used for 0 Before you take Vallergan Q How to take Vallergan Q Possible side effects 0 How to store Vallergan 0 Further information

Q What Vallergan is and what it is used for

The name of your medicine is Vallergan Forte 30mg/5ml Syrup (called Vallergan in this leaflet). 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

0 Before you take Vallergan

Do not take this medicine and tell your doctor if:

_* You are allergic (hypersensitive) to:

- alimemazine tartrate or any of the other ingredients in this medicine (listed in Section 6 below)

- 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)

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.

Take special care with Vallergan

Check with your doctor or pharmacist before taking your medicine 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 Vallergan.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Vallergan 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 food and drink

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

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

You should not take Vallergan 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.

Important information about some of the ingredients of Vallergan

This medicine contains:

* 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 Forte Syrup 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 suffering 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 Forte Syrup contains approximately 28mg of sodium per 5ml dose. Take this into account if you are on a controlled sodium diet.

0 How to take Vallergan

Always take Vallergan exactly as your doctor has told you. You should 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 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:

* 10 mg two or three times each day

* Your doctor may increase your dose depending on your illness Elderly:

* 10 mg once or twice each day Children over 2 years of age

* Vallergan Forte syrup should be used

* 2.5 to 5 mg three or four times each day

(alimemazine tartrate)

Patient Information Leaflet (continued)

As a sedative

Children aged between 2 and 7 years:

Vallergan Forte 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

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 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

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.

o Possible side effects

Like all medicines, Vallergan 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 difficulty 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

_* 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.

Q 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.

Q Further 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: 02/07/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or pharmacist.

* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

Q What Alimemazine Syrup is and what it is used for Q Before you take Alimemazine Syrup ^ How to take Alimemazine Syrup Q Possible side effects 0 How to store Alimemazine Syrup Q Further information

o What Alimemazine Syrup is and what it is used for

The name of your medicine is Alimemazine Tartrate 30mg/5ml Syrup (called Alimemazine Syrup throughout this leaflet). 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

0 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 in this medicine (listed in Section 6 below)

_* 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)

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 Syrup.

Take special care with Alimemazine Syrup

Check with your doctor or pharmacist before taking your medicine 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 Syrup.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Alimemazine Syrup can affect the way some medicines work. Also some medicines can affect the way Alimemazine Syrup 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 food and drink

Do not drink alcohol or take any medicines containing alcohol while you are taking Alimemazine Syrup. This is because alcohol can increase the chances of you getting side effects. It can also cause serious breathing difficulties.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

You should not take Alimemazine Syrup 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.

Important information about some of the ingredients of Alimemazine Syrup

This medicine contains:

_* 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 syrup contains 5% ethanol (alcohol) (as96%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 suffering 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 syrup contains approximately 28mg of sodium per 5ml dose. Take this into account if you are on a controlled sodium diet.

0 How to take Alimemazine Syrup

Always take Alimemazine Syrup exactly as your doctor has told you. You should 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 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:

* 10 mg two or three times each day

* Your doctor may increase your dose depending on your illness Elderly:

* 10 mg once or twice each day

Patient Information Leaflet (continued)

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 Tartrate 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 Syrup is given 1-2 hours before the operation

Exposure to sunlight

Alimemazine Syrup 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.

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.

Q Possible side effects

Like all medicines, Alimemazine Syrup 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 difficulty 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

_* 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

By reporting side effects, you can help provide more information on the safety of this medicine.

Q 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.

Q Further Information

What Alimemazine syrup contains

* Each 1ml of Alimemazine tartrate Syrup contains 6mg of the active substance, alimemazine tartrate

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.