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Meprobamate Tablets 400mg

Document: leaflet MAH GENERIC_PL 33414-0058 change

PATIENT INFORMATION LEAFLET

MEPROBAMATE TABLETS 400 mg

What is in your medicine?

The name of this medicine is Meprobamate Tablets 400 mg. Each tablet contains 400 mg Meprobamate together with the ingredients maize starch, pre-gelatinised maize starch, sodium lauryl sulphate, sodium starch glycollate, and magnesium stearate.

Your tablets are white, round, flat with bevelled edges and a break-line on one face and are 11 mm in diameter.

Meprobamate is available in plastic pots of 100 and 500 tablets.

How does Meprobamate work?

Meprobamate belongs to a group of medicines known as tranquilisers and sedatives.

The name and address of the Product Licence holder of Meprobamate is: Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus.

The manufacturer of Meprobamate is: DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, Battersea, London SW11 3SE.

Treatment with Meprobamate

Meprobamate is used in the short-term treatment for the symptoms of anxiety states and where muscle tension is prominent.

Check before you take these Meprobamate tablets

Before taking these tablets, tell your doctor if you have ever had any unusual or allergic reactions to Meprobamate or any of the other ingredients of these tablets.

Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.

Do not take Meprobamate if you have a known sensitivity to medicines related to Meprobamate such as Carisoprodol or Carbromal.

Do not take this medicine if you suffer from a condition known as porphyria, if you are breast-feeding, if you suffer from breathing problems such as asthma, if you are inclined to use any so-called drugs of abuse, or if you indulge in excessive amounts of alcohol.

Tell your doctor if you suffer from epilepsy, muscle weakness, liver or kidney problems.

Because the presence of other medicines may affect the action of these tablets, make sure to tell your doctor if you are taking any other medicines such as anti-coagulants (blood thinners); steroids (including oral contraceptives); phenytoin (used in epilepsy); griseofulvin (used for fungal infections); a group of drugs known as the phenothiazines (which include medicines such as chlorpromazine, trifluoperazine, promethazine and others); rifampicin (an antibiotic); a group of drugs known as the tri-cyclic antidepressants which include imipramine, amitriptyline and others.

Use in pregnancy

Meprobamate passes into the breast milk and may cause drowsiness in babies or mothers taking this medicine.

Let your doctor know if you are pregnant, planning to become pregnant or are breast-feeding.

Effects of Meprobamate on the ability to drive and use machines

Performance at skilled tasks and alertness may be impaired and, because these tablets may cause drowsiness, they may affect the ability to drive or operate machinery. These effects may be increased by the use of alcohol. For this reason, avoid driving or operating machinery whilst taking this medicine.

Proper use of this medicine

Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it and do not take it more often or for a longer time than your doctor ordered.

If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not take two doses at once.

Dosage: This medicine is to be taken by mouth.

Adults: The usual dosage is 400-1600 mg daily in divided doses. Higher doses are not recommended.

Elderly: Half the normal adult dose or less may be sufficient in the elderly.

Children: Not recommended.

Dependence may occur when Meprobamate is taken in higher than recommended doses, for long periods. It may also occur in persons dependent on alcohol or other drugs of dependence.

Withdrawal reactions may occur which vary in severity from insomnia and confusion to convulsions (seizures) and coma.

Treatment should be withdrawn gradually.

Overdosage

If you think you may have taken too many of your tablets, either call your doctor straight away, or go to the nearest hospital casualty department. Always keep any remaining tablets in the container in which they were given to you, and also the label so that the medicine can be identified by the doctor or pharmacist in the hospital.

Also tell them whether you have taken any other medicines.

The symptoms of overdose are shock, coma, difficulty in breathing.

Undesirable effects that may occur with the use of this medicine

The most common undesirable effects that have been described are drowsiness and sedation, unsteadiness,

dizziness, fainting, inco-ordination, sickness, vomiting, diarrhoea and constipation, alteration of speech, headache, heart palpitations, fainting, pins and needles in the fingers and toes, blurred vision, excitement, undue feeling of elation, rapid heartbeat.

Hypersensitivity reactions may occur after a single tablet and in patients who have not previously taken this medicine. These reactions may include skin reactions such as urticaria (hives), itchy small red nodules or patches of red rashes which may cover parts of the body or the whole body.

Occasionally reactions with shaking, chills and fever, nausea, vomiting, a fall in blood pressure.

Meprobamate can reduce the number of certain types of blood cells. If you get a bad sore throat or high fever or become gradually more tired or tired and pale, or notice bruises or nosebleeds, stop taking Meprobamate and contact your doctor at once.

Rarely, the following hypersensitivity reactions may occur:

Raised temperature, swelling of the soft tissues of the mouth and throat, breathing difficulty caused by spasm of the lungs, scanty passage of urine and absence of urine. Also shock, a skin condition known as erythema multiforme, an eczema type of skin condition, inflammation of the mouth.

If you notice any of the above symptoms, contact your doctor immediately.

Storing your medicine

You must keep this medicine in a safe place where children cannot get it. Your medicine could harm them.

Keep your medicine in a dry place and store below 25°C. Keep container well-closed and protect from light.

If your doctor tells you to stop the treatment, return any remaining tablets to the doctor or pharmacist.

On the label you will find the words “Expiry Date” followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their condition is the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

PL 33414/0058

This Leaflet was revised in February 2009