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Muscinil

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Muscinil Tablets

Procyclidine hydrochloride

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:

1. What Muscinil tablets are and what they are used for

2. Before you take Muscinil Tablets

3. How to take Muscinil Tablets

4. Possible side effects

5. How to store Muscinil Tablets

6. Further information

1. What Muscinil tablets are and what they are used for

Procyclidine belongs to a group of medicines called antimuscarinics (anticholinergics). It is most commonly used for Parkinson’s disease or symptoms (parkinsonism) due to other causes, including drug induced parkinsonism.

2. BEFORE YOU TAKE MUSCINIL TABLETS

Do not take Muscinil Tablets if you:

• are hypersensitive (allergic) to procyclidine or any of the other ingredients in Muscinil Tablets.

• have an obstruction of the intestine and/or stomach

• have difficulty urinating

• suffer from glaucoma (eye disease caused by too much pressure within the eye).

Take special care with Muscinil Tablets:

If you have had any of the following you should tell your doctor before taking this medicine:

• pregnant or may become pregnant, or breast-feeding.

• chronic kidney or liver disease

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■ difficulty passing water, which in some men may be due to an enlarged prostate.

• suffer from a movement disorder called tardive dyskinesia, in which movements (especially of the limbs) are slow or difficult, or uncontrolled and jerky. This condition may be made worse if you are given procyclidine whilst being treated with neuroleptic drugs.

• If you are elderly, your dose may need to be carefully monitored to prevent any side effects.

Taking other medicines:

If taken with some other medicines the effects of Muscinil tablets or the effects of other medicines may be changed. Please check with your doctor if you are taking any of the following:

• antihistamines

• antidepressants

• phenothiazines (for mental illness)

■ Amantadine or levodopa (used in Parkinson's disease or some viral infections)

• Ketoconazole (used for fungal infections such as athlete’s foot or thrush)

• Quinidine or disopyramide (used for conditions of the heart)

• Tacrine (for treating symptoms of Alzheimer’s disease)

Taking with food and drink:

Swallow the tablets with a little water after meals.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning on becoming pregnant or are breast-feeding. Driving and using machinery:

Do not drive or operate machinery as Muscinil Tablets may make you feel dizzy, confused, disorientated or affect your eyesight.

Important Information about some of the Ingredients In Muscinil Tablets:

If you have been told by your doctor that you have an intolerance to some sugars as these tablets contain lactose, contact your doctor before taking this medicinal product.

3. How to take Muscinil tablets

Always take Muscinil Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults:

The usual dose is between 2 and 6 tablets a day, depending on your condition and how you respond. The tablets should be taken in 3 or 4 divided doses, after meals with a little water. Your doctor will usually start you on a low dose and increase it slowly (every day or every few days) to the best dose for you.

Children:

Muscinil Tablets are not recommended for use in children.

150 x 200 mm

If you take more Musclnil Tablets than you should:

An overdose of this medicine may be harmful. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, or go to the nearest hospital casualty department immediately.

If you forget to take Musclnll Tablets:

If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. Do not take a double dose to make up for the forgotten dose.

If you stop taking Muscinil Tablets:

You should finish all the tablets your doctor has prescribed even if you feel better. You should still take all the tablets you have been given, it may be dangerous to stop taking the medicine without your doctor's advice.

4. Possible side effects

Like all medicines Muscinil Tablets can cause side effects, although not everybody gets them.

If you are also taking medicines for schizophrenia, mania or mental conditions, you may experience uncontrolled jerky movements of your limbs when you first start to take procyclidine tablets. If this happens talk to your doctor immediately - it may be necessary for your doctor to reduce the dose of your other medicine.

Other unwanted side effects may include:

Commonly occurring side effects include:

• Dry mouth

• Blurred vision

• Constipation

■ Urinary retention

Other side effects which occur less frequently include:

• Vomiting

• Gingivitis (inflammation of the gums)

■ Skin rashes

• Feeling nervous

• Stomach upsets

Side effects that have been reported on rare occasions:

• Psychotic-like symptoms (e.g. hallucinations or personality changes)

Higher doses of procyclidine may cause disorientation, anxiety, agitation, dizziness, confusion or hallucinations and may affect your mental processes or memory.

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.

5. How to store Muscinil tablets Keep out of the reach and sight of children.

Do not store these tablets above 25C.

Do not use Muscinil Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

Store them in the original container to protect from light.

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.

6. Further information

What Muscinil Tablets contain: I

These tablets contain 5mg of the active ingredient Procyclidine Hydrochloride. ■

The tablets also contain maize starch, magnesium stearate and anhydrous lactose.

What Muscinil Tablets look like and the contents of the pack:

The tablets are white, with ‘PR5’ on one side and a breakline on the other.

Muscinil Tablets are available in packs of 28, 84 and 100 tablets. ■

Not all pack sizes may be marketed. I

Marketing Authorisation Holder

Co-Pharma Limited Unit 4, Metro Centre,

Tolpits Lane, Watford,

Herts.