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KEMADRIN TABLETS 5 MG

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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PHARMA CODE N° xxxx

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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 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
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.

• 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.

2. What you need to know before you take Kemadrin

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

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

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Children
Do not give this medicine to children.

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.

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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 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).

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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 this medicine 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 foil and carton. The expiry date refers to
the last day of that month.
• 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
• The active substance is procyclidine
hydrochloride 5 mg.
• The other ingredients are lactose, sodium starch
glycollate, povidone and magnesium stearate.
What Kemadrin looks like and contents of the pack
Kemadrin Tablets 5 mg 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 Tablets 5 mg come in bottles of 50, 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
This leaflet was last revised in 08/2015
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:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Kemadrin 5 mg tablets
PL 39699/0046
Reference number
This is a service provided by the Royal National Institute
of Blind People.
Kemadrin is a registered trademark of Aspen.

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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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