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Meprobamate Tablets 400mg

Document: label-leaflet MAH GENERIC_PL 17225-0003 change

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GENUS PHARMACEUTICALS


Meprobamate


400mg


Meprobamate


Each tablet contains 400mg Meprobamate


84 Tablets





GENUS PHARMACEUTICALS


Meprobamate


Tablets I


400mg


• •

• •


Meprobamate

•    • •    •

• • •• •

•••    •    •••

•    •

•••    •    ••

Each tablet contains 400mg Meprobamate

• • •

• •    ••    ••


84 Tablets


To be taken by mouth.

Use as directed by your doctor.

Keep out of the reach and sight of children.

Store at room temperature (at gr^elow 25°C).

Rea? &e package leaflet before use.

MA^olSer:

Genus Pharmaceuticals,

Park View House,

65 London Road,

Newbnry,

Berk^re RG14 1JN, UK.


POM


PL 1^225/0003 PM*XX/XXXX

* Trademark


Braille Text:

meprobamate tablets #400 mg


Batch:

Exp.:





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LEAFLET FACE


Meprobamate

Tablets 400mg

Each tablet contains 400mg Meprobamate BP


Meprobamate Tablets also contain microcrystalline cellulose.

Use as directed by your doctor.

To be taken by mouth.

Keep out of reach and sight of children.

Store at room temperature (at or below 25°C).


84 tablets


MA holder:

Genus Pharmaceuticals, Park View House,

65 London Road, Newbury, Berkshire RG14 1JN. PM/01/736 PIP 106 2819 *Trademark


| POM I


PL 17225/0003


Braille Text:

meprobamate #400 mg


If you have been taking Meprobamate Tablets for more than a month, talk to your doctor. They should not usually be taken long-term.

Do not take more tablets than stated on the label of your medicine. If you take too much, seek medical attention immediately.

If you miss a dose, do not worry, just take your next dose when it is due. Do not take more than one dose at once to make up for any missed. Stopping your medicine

Some patients experience withdrawal effects when stopping treatment with Meprobamate Tablets. For this reason your doctor may ask you to slowly reduce the number of tablets you take before stopping treatment. Withdrawal effects, if any, are usually mild provided the drug is reduced

gradually before stopping. You must seek the advice of your doctor before decreasing or stopping your dose of Meprobamate Tablets. If Meprobamate Tablets are stopped suddenly after they have been taken in high doses for a long period of time, withdrawal effects may be severe. Withdrawal effects may include:

Anxiety, shaking, excitement, restlessness, confusion and hallucinations, sweating, stomach upsets, difficulty in sleeping, and occasionally convulsions. You should tell your doctor if you believe you are suffering from any of these or other symptoms when you stop taking Meprobamate Tablets. Things to be aware of whilst taking your medicine

Occasionally you may have unwanted effects while taking meprobamate. These

are usually not serious and do not last for long. However, you should tell your doctor if any of the following symptoms are severe or become troublesome: Drowsiness, dizziness, feeling sick, clumsiness, vomiting, over-excitement or strange feelings such as pins and needles.

Meprobamate can also cause a drop in blood pressure which may make you feel weak and light-headed. If this happens, tell your doctor or pharmacist. You should tell your doctor immediately if you experience any of the following more rare unwanted effects:

•    Bruising or bleeding (e.g. nose bleeds) with no apparent cause.

•    Anaemia (feeling unusually tired, or short of breath and looking pale).

•    Unexplained damage to skin or mucous membranes such as the throat.

•    Skin rashes which may or may not be bumpy or itchy, blisters, shaking, chills, fever, fainting, swelling, severe difficulty in breathing, passing little or no urine, sore or swollen mouth, mouth ulcers, sore rectum.

Tell your doctor or pharmacist if you experience any other unwanted effect not mentioned here.

Storing your medicine

You should not take your medicine after the expiry date shown on the label. Meprobamate Tablets should be stored at room temperature (at or below 25°C).

Your medicine should be stored safely, where children cannot see it. Return any unused medicine to your pharmacist. Only keep it if your doctor tells you to.

Remember: This medicine is for you only. Never give it to others, even if their symptoms are the same as yours. It may harm them.

Leaflet prepared: October 2007.

Meprobamate Tablets also contain microcrystalline cellulose.

Use as directed by your doctor.

To be taken by mouth.

Meprobamate •• • Keep ut of re*h nd sight of children.

Store at room temperature (at or below 25°C).

Tabl%ts 400mg • • MA holder: *

Genus Pharmaceuticals,

Each tablet contains Park View House,

400mg Meprobamate BP 65 London Road, Newbury,

Berkshire RG14 1JN.

PM/01/736 PIP 106 2819

84 tablets "Trademark PL 17225/0003


LEAFLET REVERSE

Patient Information Leaflet Meprobamate Tablets 400mg

Please read this leaflet carefully before you start to take your medicine. This leaflet provides information about your medicine. If you have any questions, or are not sure about anything ask your doctor or pharmacist.

What is in your medicine?

The name of your medicine is Meprobamate Tablets 400mg. Each tablet contains 400mg of the active ingredient meprobamate.

The tablets also contain polacrilin potassium, microcrystalline cellulose, methylcellulose and magnesium stearate.

Meprobamate Tablets 400mg are round, white and flat and are marked with GP035 on one side. They are usually supplied in bottles of 84 (although you may only be given as many tablets as prescribed by your doctor).

Meprobamate is a sedative which can relieve anxiety and muscle tension.

Marketing Authorisation holder: Manufacturer:

Genus Pharmaceuticals, Custom Pharmaceuticals Limited,

Park View House, Conway Street,

65 London Road, Newbury, Hove,

Berkshire RG14 1JN, East Sussex BN3 3LW,

England. England.

What does your medicine do?

Meprobamate Tablets are usually prescribed to relieve anxiety or relieve muscle tension.

Before taking your medicine

You should not take Meprobamate Tablets if:

•    You have been prescribed a medicine containing meprobamate or a similar ingredient before and have found it unsuitable.

Ask your doctor if you are not sure.

•    You are or have been addicted to drugs or alcohol.

•    You suffer from acute intermittent porphyria. Your doctor will have told you if you suffer from this rare disease.

•    You are breast-feeding.

•    You are pregnant, unless your doctor tells you to.

•    You have severe breathing or chest problems.

You should tell your doctor or pharmacist if:

•    You become pregnant.

•    You are allergic to meprobamate or any of the ingredients in Meprobamate Tablets.

•    You suffer from epilepsy, since Meprobamate Tablets may induce seizures in patients with epilepsy.

•    You have liver or kidney problems.

•    You suffer from depression.

•    You suffer from muscle weakness or breathing problems.

•    You are taking any other medicines, since these may affect the way Meprobamate Tablets work. Meprobamate Tablets may also affect the way

other drugs work. In particular, you should tell your doctor if you are taking steroid drugs (e.g. for asthma), the contraceptive Pill, drugs which thin your blood (e.g. warfarin), the antibiotic rifampicin, drugs for mood or mental disorders (e.g. chlorpromazine), a drug for fungal infections called griseofulvin, or drugs for epilepsy (e.g. phenytoin) or depression.

Things to note before taking your medicine

Tell your doctor or pharmacist that you are taking Meprobamate Tablets before taking any other medicine, if you become pregnant, or if you enter hospital for treatment.

Some people feel sleepy when taking Meprobamate Tablets. Do not drive, or operate machinery, until you are sure you are not affected. You should avoid alcohol when taking Meprobamate Tablets.

Taking your medicine

Your doctor will tell you how much to take and how often. This information will also be given on the label of your medicine. Ask your pharmacist if you are not sure.

The usual dose for adults is one 400mg tablet three times daily with an extra 400mg tablet before going to bed.

If you are elderly you may need a lower dose. Half the normal adult dose or less may be enough.

You should swallow your tablets with a glass of water.

Meprobamate Tablets are not recommended for children