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 on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
Q What Kemadrin is and what it is used for Q Before you take Kemadrin Q How to take Kemadrin Q Possible side effects Q How to store Kemadrin Q Further information
O What Kemadrin is and what it is used for
Your medicine is called Kemadrin 5mg Tablets and will be referred to as Kemadrin throughout this leaflet.
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'.
O 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 Kemadrin 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 Kemadrin 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 Kemadrin.
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.
O 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 i*f
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.
Kemadrin 5mg Tablets
(procyclidine hydrochloride)
Patient Information Leaflet (continued)
Q 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 occuring 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 1000 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 and 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 help provide more information on the safety of this medicine.
Marketing Authorisation Holder and Manufacturer
This medicine is manufactured by Aspen Bad Oldelsoe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM 15184/1206 Kemadrin 5mg Tablets
Kemadrin is a registered trademark of Aspen Global Incorporated. Revision date: 04/02/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Q How to store Kemadrin
* Keep out of the sight and reach of children.
* Do not store above 25°C.
* Do not use Kemadrin after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
* 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.
Q Further information
What Kemadrin contains
* The active substance is procyclidine hydrochloride 5 mg.
* The other ingredients are lactose monohydrate, sodium starch glycollate, povidone and magnesium stearate.
What Kemadrin looks like
Kemadrin 5mg Tablets are 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 comes in bottles of 100 tablets.
Procyclidine hydrochloride 5mg Tablets
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 on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
Q What Procyclidine hydrochloride is and what it is used for ^ Before you take Procyclidine hydrochloride Q How to take Procyclidine hydrochloride Q Possible side effects Q How to store Procyclidine hydrochloride Q Further information
O What Procyclidine hydrochloride is and what it is used for
Your medicine is called Procyclidine hydrochloride 5mg Tablets and will be referred to as Procyclidine hydrochloride throughout this leaflet.
Procyclidine hydrochloride contains a medicine called procyclidine. This belongs to a group of medicines called anticholinergics. They stop a substance called acetylcholine working in your body.
Procyclidine hydrochloride 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'.
Q Before you take Procyclidine hydrochloride
Do not take Procyclidine hydrochloride if:
* you are allergic (hypersensitive) to procyclidine or any of the other ingredients of Procyclidine hydrochloride (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 Procyclidine hydrochloride if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking Procyclidine hydrochloride.
Take special care with Procyclidine hydrochloride
Check with your doctor or pharmacist before taking Procyclidine hydrochloride 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 Procyclidine hydrochloride 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 Procyclidine hydrochloride.
Procyclidine hydrochloride 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 Procyclidine hydrochloride.
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 Procyclidine hydrochloride can affect the way some other medicines work. Also some other medicines can affect the way Procyclidine hydrochloride 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 Procyclidine hydrochloride.
Taking Procyclidine hydrochloride with food
You can take Procyclidine hydrochloride 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 Procyclidine hydrochloride. If this happens do not drive or use any tools or machines.
Q How to take Procyclidine hydrochloride
Always take Procyclidine hydrochloride 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 alomg 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:
Procyclidine hydrochloride 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 Procyclidine hydrochloride 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
Procyclidine hydrochloride tablets are not usually recommended for use in children.
If you take more Procyclidine hydrochloride than you should
If you take more Procyclidine hydrochloride 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 Procyclidine hydrochloride
Take a dose as soon as you remember it and then go on as before.
If you stop taking Procyclidine hydrochloride
Do not stop taking Procyclidine hydrochloride without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Procyclidine hydrochloride 5mg Tablets
Patient Information Leaflet (continued)
o Possible side effects
If you are taking a medicine for mental illness (called a neuroleptic) at the same time as Procyclidine hydrochloride:
* 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 occuring with the medicine for your mental illness can be made worse by the addition of Procyclidine hydrochloride.
If either of these happen, tell your doctor straight away.
Like all medicines, Procyclidine hydrochloride 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
Marketing Authorisation Holder and Manufacturer
This medicine is manufactured by Aspen Bad Oldelsoe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM 15184/1206 Procyclidine hydrochloride 5mg Tablets
Revision date: 04/02/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Rare (affects less than 1 in 1000 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 and 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 help provide more information on the safety of this medicine.
Q How to store Procyclidine hydrochloride
* Keep out of the sight and reach of children.
* Do not store above 25°C.
* Do not use Procyclidine hydrochloride after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
* 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.
G Further information
What Procyclidine hydrochloride contains
* The active substance is procyclidine hydrochloride 5 mg.
* The other ingredients are lactose monohydrate, sodium starch glycollate, povidone and magnesium stearate.
What Procyclidine hydrochloride looks like
Procyclidine hydrochloride 5mg Tablets are 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. Procyclidine hydrochloride comes in bottles of 100 tablets.