Ref: LTT0023/110314/1/F

Vallergan 10mg Film-coated Tablets

(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

You medicine is called Vallergan 10mg Film-coated Tablets but will be referred to as Vallergan Tablets throught out this Patient Information Leaflet.

In this leaflet:

What Vallergan Tablets are and what they are used for 3 Before you take Vallergan Tablets How to take Vallergan Tablets Possible side effects [m How to store Vallergan Tablets Further information

^ What Vallergan Tablets are and what they are used for

The name of your medicine is Vallergan 10mg Film Coated Tablets. This 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

Before you take Vallergan Tablets

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 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) Paediatric population

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 Vallergan Tablets

Take special care with Vallergan Tablets

Check with your doctor or pharmacist before taking your medicine 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.

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 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

Taking Vallergan Tablets with food and drink

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

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 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.

Important information about some of the ingredients of Vallergan Tablets

This medicine contains:

*    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.

How to take Vallergan Tablets

Always take Vallergan Tablets 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

*    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

Elderly:

*    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

Vallergan10mg Film-coated Tablets

(alimemazine tartrate)

Patient Information Leaflet (continued)

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, Vallergan Tablets can cause side effects, although not everybody gets them.

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.

How to store Vallergan Tablets

*    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 30°C

*    Protect from light

*    Store in the original package

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

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.

Further information

What this medicine contains:

Each tablet contains 10mg of alimemazine tartrate as the active ingredient. Vallergan Tablets also include the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, sodium starch glycollate (type A), hypromellose, macrogol 300, titanium dioxide (E171) and indigo carmine (E132).

What this medicine looks like and contents of the pack

Vallergan Tablets are a circular, film-coated tablet with bevelled edge, dark blue in colour, one face impressed V/10 and plain on the other face. Vallergan Tablets are available in blister packs of 28 Tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Clintex Produtos Farmaceticos SA, Rua Comandante Carvalho Araujo, Sete Casas, Loures PT 2670-540, Portugal and is procured from within the EU.

Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. Repackaged by Lexon (UK) Limited, B98 0RE, UK.

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 33723/0023 Vallergan Tablets

Vallergan is a registered trademark of May & Baker Limited.

Revision date: 11/03/14

Blind or partially sighted?

Is this leaflet hard to see or read?

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

Alimemazine Tartrate 10mg Film-coated Tablets

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

You medicine is called Alimemazine Tartrate 10mg Film-coated Tablets but will be referred to as Alimemazine Tablets throught out this Patient Information Leaflet.

In this leaflet:

^ What Alimemazine Tablets are and what they are used for ^ Before you take Alimemazine Tablets How to take Alimemazine Tablets ^ Possible side effects

How to store Alimemazine Tablets ^ Further information

What Alimemazine Tartrate Tablets are and what they are used for

The name of your medicine is Alimemazine Tartrate 10mg Film Coated Tablets. This 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

3 Before you take Alimemazine Tablets

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 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) Paediatric population

Alimemazine Tablets 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 Tartrate Tablets.

Take special care with Alimemazine Tablets

Check with your doctor or pharmacist before taking your medicine 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.

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 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

Taking Alimemazine Tartrate Tablets with food and drink

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

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 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.

Important information about some of the ingredients of Alimemazine Tablets

This medicine contains:

*    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.

Q How to take Alimemazine Tablets

Always take Alimemazine Tablets 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

*    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

Elderly:

*    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

Alimemazine Tartrate 10mg Film-coated Tablets

Patient Information Leaflet (continued)

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, Alimemazine Tablets can cause side effects, although not everybody gets them.

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.

[5 How to store Alimemazine Tartrate Tablets

*    Keep out of the sight and reach of children

*    Do not use Alimemazine Tartrate 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 30°C

*    Protect from light

*    Store in the original package

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

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.

Further information

What this medicine contains:

Each tablet contains 10mg of alimemazine tartrate as the active ingredient. Alimemazine Tartrate Tablets also include the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, sodium starch glycollate (type A), hypromellose, macrogol 300, titanium dioxide (E171) and indigo carmine (E132).

What this medicine looks like and contents of the pack

Alimemazine Tartrate Tablets are a circular, film-coated tablet with bevelled edge, dark blue in colour, one face impressed V/10 and plain on the other face.

Alimemazine Tartrate Tablets are available in blister packs of 28 Tablets. Manufacturer and Licence Holder

This medicine is manufactured by Clintex Produtos Farmaceticos SA, Rua Comandante Carvalho Araujo, Sete Casas, Loures PT 2670-540, Portugal and is procured from within the EU.

Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. Repackaged by Lexon (UK) Limited, B98 0RE, UK.

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.

[pOmI PL 33723/0023 Alimemazine Tartrate Tablets Revision date: 11/03/14

Blind or partially sighted?

Is this leaflet hard to see or read?

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