Kemadrin Tablets 5 Mg
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Package Leaflet: Information for the User
Kemadrin® tablets 5 mg
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 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. Beforeyou take Kemadrin
3. How totake 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 sufferfrom a problem caused bytoo much pressure in your eye called 'closed angle glaucoma'
• you have stomach cramps and pains or constipation.
Do nottake if any of the above applytoyou. If you are not sure,
talk to your doctor or pharmacist before taking Kemadrin.
Take special care with Kemadrin
Check with yourdoctor 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 ofyour medicines. Occasionally peoplewho 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 ofsugar). If you have been told byyourdoctor thatyou cannottolerate or digest some sugars, talkto your doctor before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken anyother medicines, including medicines obtained withouta prescription.This includes herbal medicines.This is because Kemadrin can affecttheway some other medicines work. Also some other medicines can affect the way Kemadrin works.
In particular tell your doctororpharmacist 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 hayfeverand 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 ofday, with orwithoutfood.
Some people find they feel less sick if they take it at meal times.
Pregnancy and breast-feeding
Talkto your doctorbefore 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 yourdoctor has told you. You
should checkwith your doctororpharmacist 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, everytwo or three days until an effect is seen. This is known asthe '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 askyou to take a fourth dose before bedtime.
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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 usuallytwoto six tablets.
• Your doctor may decide to stopyour Kemadrin after 3or4 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 doctoror goto a hospital straightaway. Take the medicine packwith 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 toyourdoctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
5. How to store Kemadrin
6. Further information
If you are taking a medicine for mental illness (called a neuroleptic) at the same time as Kemadrin:
• you can develop uncontrolled movements ofyourface 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 madeworse 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 yourdoctor or pharmacist.
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use Kemadrin after the expiry date which is stated on the foil and carton. The expiry date refers to the last day of that month.
• Medicines should not be disposed ofviawastewateror household waste.Askyourpharmacist howto dispose of medicines no longer required. These measureswill help to protect the environment.
What Kemadrin contains
• The active substance is procyclidine hydrochloride 5 mg.
• The other ingredients are lactose, sodium starch glycollate, povidone and magnesium stearate.
What Kemadrin looks like
Kemadrin Tablets 5mgare 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 Tablets 5 mg come in bottles of 100 or 500 tablets. Marketing Authorisation Holder and Manufacturer Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Manufacturer: Aspen Bad Oldesloe GmbH Industriestrasse 32-36,
D-23843 Bad Oldesloe,
Germany
Medical Information Enquiries
For any Medical Information enquires about this product, please contact: 24 Hour Helpline +441748 828 391 (free phone UK only 0800 0087 392)
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
Braille RNIB Helpline 0303 123 9999 (UKOnly)
Please be ready to give the following information:
Product name Kemadrin 5 mg tablets
Reference number PL 39699/0046
This is a service provided by the Royal National Institute of Blind
People.
Leaflet date: March 2014
Kemadrin is a registered trademark of Aspen.
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