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Kemadrin 5mg Tablets

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KEMADRIN® 5mg TABLETS (procyclidine hydrochloride)

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 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 Kemadrin is and what it is used for

2.    Before you take Kemadrin

3.    How to take Kemadrin

4.    Possible side effects

5.    How to store Kemadrin

6.    Further information

1. What Kemadrin is and what it is used for

Kemadrin contains a medicine called procyclidine. This belongs to a group of medicines called anticholinergics. They stop a substance called acetylcholine working in your body.

Kemadrin is used to:

•    treat and relieve the signs of Parkinson's disease such as:

-    stiff muscles, paralysis and tremor

-    problems talking, writing and walking

-    producing too much saliva and dribbling

-    sweating and uncontrolled eye movements

-    depression

•    stop side effects similar to the signs of Parkinson's disease or restlessness and unusual head and body movements caused by some medicines. Some people call these 'extrapyramidal effects'.

2. Before you take Kemadrin

Do not take Kemadrin if:

•    you are allergic (hypersensitive) to procyclidine or any of the other ingredients of Kemadrin (see Section 6: Further information)

•    you have problems passing water (urinary retention)

•    you suffer from a problem caused by too much pressure in your eye called 'closed angle glaucoma'

•    you have stomach cramps and pains or constipation.

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Kemadrin.

Take special care with Kemadrin

Check with your doctor or pharmacist before taking your medicine if:

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

•    you have an enlarged prostate gland

•    you have a mental illness and are taking Kemadrin to control the side effects of your medicines. Occasionally people who take this medicine may have a psychotic episode

•    you have kidney or liver problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Kemadrin.

Kemadrin contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Kemadrin can affect the way some other medicines work. Also some other medicines can affect the way Kemadrin works. In particular tell your doctor or pharmacist if you are taking any of the following:

•    medicines used to treat mental health problems (including Alzheimer's disease and dementia)

•    levodopa and amantadine, used in Parkinson's disease

•    disopyramide, quinidine and nitrate tablets (including tablets that dissolve under the tongue), used to treat heart problems

•    cisapride, domperidone and metoclopramide, used to treat sickness, indigestion and feeling sick (nausea)

•    antihistamines, used to treat hayfever and allergies

•    nefopam, used to treat pain

•    ketoconazole, used to treat fungal infections.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Kemadrin.

Taking Kemadrin with food

You can take Kemadrin at any time of day, with or without food.

Some people find they feel less sick if they take it at meal times.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

You may have blurred vision, dizziness, confusion or disorientation while taking Kemadrin. If this happens do not drive or use any tools or machines.

3. How to take Kemadrin

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

•    Swallow the tablets with a drink of water.

•    The tablet may be cut or broken in half along the break-line to divide the dose in two equal halves.

To treat Parkinson's disease:

•    The usual starting dose is half a tablet three times a day.

•    This can be increased by half or 1 tablet each day, every two or three days until an effect is seen. This is known as the 'maintenance dose'. The daily maintenance dose is usually three to six tablets.

•    The maximum your doctor may decide to prescribe is 12 tablets.

•    Although the dose is usually taken three times a day, your doctor may ask you to take a fourth dose before bedtime.

To treat uncontrolled body movements (extrapyramidal symptoms) caused by taking other medicines:

Kemadrin can be used to control side effects caused by other medicines.

•    The usual starting dose is half a tablet three times a day.

•    This can be increased by half a tablet each day until an effect is seen.

•    The daily maintenance dose is usually two to six tablets.

•    Your doctor may decide to stop your Kemadrin after 3 or 4 months to see if your side effects return.

Elderly

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

Kemadrin tablets are not usually recommended for use in children.

If you take more Kemadrin than you should

If you take more Kemadrin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Kemadrin

Take a dose as soon as you remember it and then go on as before.

If you stop taking Kemadrin

Do not stop taking Kemadrin without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

If you are taking a medicine for mental illness (called a neuroleptic) at the same time as Kemadrin:

•    you can develop uncontrolled movements of your face and tongue (tardive dyskinesia).

The dose of either of your medicines may need to be adjusted.

•    unusual body movements, particularly of your hands, arms and legs which may have previously been occurring with the medicine for your mental illness can be made worse by the addition of Kemadrin.

If either of these happen, tell your doctor straight away.

Like all medicines, Kemadrin can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Common (affects less than 1 in 10 people)

•    problems passing water (urinary retention)

•    blurred vision

•    dry mouth or constipation.

Uncommon (affects less than 1 in 100 people)

•    feeling sick (nausea) or being sick (vomiting)

•    inflamed gums (gingivitis)

•    dizziness, nervousness, feeling confused, reduced concentration or memory, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable)

•    skin rash.

Rare (affects less than 1 in 1,000 people)

•    'psychotic' symptoms occurring together such as dizziness, confusion, reduced concentration or memory, disorientation, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable).

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.

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 Kemadrin

•    Do not store above 25°C.

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not use after the expiry date printed on the carton label or bottle label.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.

6. Further information

Your medicine is called Kemadrin 5mg tablets. It contains 5 milligrams of the active ingredient, procyclidine hydrochloride in a white, round biconvex tablets, one face with a break-line and coded KT above the break-line and 05 below the break-line with a score-line on the other face.

Kemadrin 5mg tablets also contain the following:

Lactose monohydrate, sodium starch glycollate, povidone and magnesium stearate.

Kemadrin 5mg tablets are available as bottles of 100 tablets.

POM    PL No: 6464/0197

This product is manufactured by Aspen Bad Oldesloe GmbH, 23843 Bad Oldesloe ,Germany and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 14.11.2014

Kemadrin is a registered trademark of Aspen Global Incorporated