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PROCYCLIDINE HYDROCHLORIDE 5 MG TABLETS

Active substance(s): PROCYCLIDINE HYDROCHLORIDE / PROCYCLIDINE HYDROCHLORIDE / PROCYCLIDINE HYDROCHLORIDE

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Package Leaflet: Information for the User

Kemadrin® 5 mg Tablets
(procyclidine hydrochloride)

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for 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.
Your medicine is known as Kemadrin 5 mg Tablets but
will be referred to as Kemadrin throughout this leaflet.
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
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 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
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.
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.
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.
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.
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 this medicine after the expiry date which
is stated on the bottle label and carton after EXP.
The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any
other signs of deterioration, you should seek the
advice of your pharmacist who will advise you what
to do.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Kemadrin contains
• Each tablet contains 5 mg procyclidine
hydrochloride.
• The other ingredients are lactose, sodium starch
glycollate, povidone and magnesium stearate.
What Kemadrin looks like and contents of the pack
Kemadrin 5 mg 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 scoreline on the other face.

Kemadrin 5 mg Tablets come in bottles of: 100 Tablets
Manufactured by:
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe, Germany.
Procured from within the EU by the Product
Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0151 - Kemadrin® 5 mg Tablets
Revision date: 18.04.2016
Ref: 795
Kemadrin® is a registered trademark of Aspen.

POM

Package Leaflet: Information for the User

Procyclidine Hydrochloride
5 mg Tablets
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for 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.
Your medicine is known as Procyclidine Hydrochloride
5 mg Tablets but will be referred to as Procyclidine
Hydrochloride throughout this leaflet.
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.
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 this medicine after the expiry date which
is stated on the bottle label and carton after EXP.
The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any
other signs of deterioration, you should seek the
advice of your pharmacist who will advise you what
to do.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Procyclidine Hydrochloride contains
• Each tablet contains 5 mg procyclidine
hydrochloride.
• The other ingredients are lactose, sodium starch
glycollate, povidone and magnesium stearate.
What Procyclidine Hydrochloride looks like and
contents of the pack
Procyclidine Hydrochloride 5 mg 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 scoreline on the other face.

Procyclidine Hydrochloride 5 mg Tablets come in
bottles of: 100 Tablets
Manufactured by:
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe, Germany.
Procured from within the EU by the Product
Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0151 - Procyclidine Hydrochloride 5 mg
Tablets
POM
Revision date: 18.04.2016
Ref: 794

Expand Transcript

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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