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PROCYCLIDINE HYDROCHLORIDE 5MG TABLETS

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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Ref: 1206/240216/1/F

®

Kemadrin 5mg Tablets
(procyclidine hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information top you.
* 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 signs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1 What Kemadrin is and what it is used for
2 What you need to know before you take Kemadrin
3 How to take Kemadrin
4 Possible side effects
5 How to store Kemadrin
6 Contents of the pack and other information

1

What Kemadrin is and what it is used for

Other medicines and Kemadrin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take 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.
* paroxetine
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Kemadrin.

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.

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

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 called ‘extrapyramidal effects’, which are caused by some
medicines. These may include signs similar to the Parkinson’s disease or
restlessness and unusual head and body movements.

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.

2

What you need to know 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)
* 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 applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Kemadrin.
Warnings and precautions
Talk to 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 suffer from a problem caused by too much pressure in your eye called
‘narrow angle glaucoma’ or if you have a higher chance to get glaucoma
* you have an obstructive disease of your bowel
* 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
* In some patients who use Kemadrin to control side effects of other
medicines, involuntary repetitive body movements may occur. If this
happens to you, your doctor may decide to give you lower doses.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Kemadrin.
Children
Do not give this medicine to children.

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.

3

How to take Kemadrin

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
* Swallow the tablets with a drink of water.
* 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.
* 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 recommended starting dose is half a tablet three times a day.
* This can be increased by half or one 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 recommended 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 three or four months
to see if your side effects return.
* If you need Kemadrin for a longer period of time, your doctor may decide
to stop every now and then.
Elderly
If you are elderly, your dose may need to be carefully monitored to prevent
any side effects.
Use in children
Kemadrin tablets are not usually recommended for use in children.

Ref: 1206/240216/1/B

®

Kemadrin 5mg Tablets
(procyclidine hydrochloride)
Patient Information Leaflet (continued)
6
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

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following side effects may happen with this medicine:
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 happens, tell your doctor straight away.
Common (affects less than 1 in 10 people)
* problems passing water (urinary retention)
* blurred vision
* dry mouth
* constipation.
Uncommon (affects less than 1 in 100 people)
* feeling sick (nausea) or being sick (vomiting)
* inflamed gums (gingivitis)
* dizziness, nervousness, feeling confused, not knowing where you are
(feeling disoriented), 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 disorder’, which includes 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 or pharmacist. 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
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.

Contents of the pack and other 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.
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: 24/02/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1206/240216/2/F

Procyclidine hydrochloride 5mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information top you.
* 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 signs of illness are the same as yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1 What Procyclidine hydrochloride is and what it is used for
2 What you need to know before you take Procyclidine hydrochloride
3 How to take Procyclidine hydrochloride
4 Possible side effects
5 How to store Procyclidine hydrochloride
6 Contents of the pack and other information

1

What Procyclidine hydrochloride is and what it is
used for

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 called ‘extrapyramidal effects’, which are caused by some
medicines. These may include signs similar to the Parkinson’s disease or
restlessness and unusual head and body movements.

2

What you need to know 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)
* 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 applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Procyclidine hydrochloride.
Warnings and precautions
Talk to 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 suffer from a problem caused by too much pressure in your eye called
‘narrow angle glaucoma’ or if you have a higher chance to get glaucoma
* you have an obstructive disease of your bowel
* 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
* In some patients who use Procyclidine hydrochloride to control side effects
of other medicines, involuntary repetitive body movements may occur. If
this happens to you, your doctor may decide to give you lower doses.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Procyclidine hydrochloride.
Children
Do not give this medicine to children.

Other medicines and Procyclidine hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might
take 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.
* paroxetine
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Procyclidine hydrochloride.
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.
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 this medicine.

3

How to take Procyclidine hydrochloride

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
* Swallow the tablets with a drink of water.
* 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.
* 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 recommended starting dose is half a tablet three times a day.
* This can be increased by half or one 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 recommended 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 three
or four months to see if your side effects return.
* If you need Procyclidine hydrochloride for a longer period of time, your
doctor may decide to stop every now and then.
Elderly
If you are elderly, your dose may need to be carefully monitored to prevent
any side effects.
Use in children
Procyclidine hydrochloride tablets are not usually recommended for use in
children.

Ref: 1206/240216/2/B

Procyclidine hydrochloride 5mg Tablets
Patient Information Leaflet (continued)
6
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.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following side effects may happen with this medicine:
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 occurring with the medicine for your mental
illness can be made worse by the addition of Procyclidine hydrochloride.
If either of these happens, tell your doctor straight away.
Common (affects less than 1 in 10 people)
* problems passing water (urinary retention)
* blurred vision
* dry mouth
* constipation.
Uncommon (affects less than 1 in 100 people)
* feeling sick (nausea) or being sick (vomiting)
* inflamed gums (gingivitis)
* dizziness, nervousness, feeling confused, not knowing where you are
(feeling disoriented), 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 disorder’, which includes 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 or pharmacist. 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 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.

Contents of the pack and other 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.
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: 24/02/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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