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KEMADRIN 5MG TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kemadrin 5mg Tablets /
Procyclidine Hydrochloride 5mg Tablets
This product is available in the above names but will be referred to as
Kemadrin throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information to 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

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.

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 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 this medicine out of the sight and reach of children.
Do not store above 25ºC.
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. Each tablet
contains 5mg per unit dose.
• The other ingredients are lactose monohydrate, sodium starch
glycollate, povidone and magnesium stearate.
What Kemadrin looks like and contents of the pack
Kemadrin Tablets 5mg 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 Tablets 5mg come in bottles of 100 tablets.

Manufacturer
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843 Bad
Oldesloe, Germany.
Procured from within the EU by the Product Licence Holder: Millsdale
Pharmaceuticals, John Street, Warrington, Cheshire, WA2 7UB. UK.
Medical Information Enquiries
For any Medical Information enquiries about this product, please
contact: 24 hour helpline +441748 828391 (free phone UK only 0800
0087 392)
Other formats

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01925-652176 (Millsdale
Pharmaceuticals), to obtain the
leaflet in a format suitable for you.
Kemadrin is a registered trademark of Aspen.
PL No. 08811/ 0055
POM
This leaflet was prepared 18th April 2017

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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