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PROCYCLIDINE 5MG TABLETS BP

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-70131-A LEA PROCYCLIDINE 5mg TAB TUK
PROCYCLIDINE 5 mg
TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 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.
IN THIS LEAFLET:

1 What Procyclidine is and what it is
used for
2.Before you take Procyclidine
3.How to take Procyclidine
4.Possible side effects
5.How to store Procyclidine
6.Further information

1

WHAT PROCYCLIDINE IS AND
WHAT IT IS USED FOR

• Procyclidine 5 mg tablets are part of a
group of drugs known as
anti-cholinergics. These drugs block
the action of a particular chemical
called acetylcholine, which allows
nerve impulses to be sent
• Procyclidine is used to treat:
• the symptoms of Parkinson’s
disease (Parkinsonism). These
symptoms include tremor, shaky
movements and rigid limbs
• symptoms such as restlessness
caused by drugs such as
antipsychotics (neuroleptics).

2

BEFORE YOU TAKE
PROCYCLIDINE

DO NOT take Procyclidine if you:
• are allergic (hypersensitive) to
procyclidine or any of the other
ingredients of this medicine
• have ever suffered from “closed angle
glaucoma” (loss of vision due to
abnormally high pressure in the eye)
• have an obstructive disease of the
stomach or intestines
• (in men) have trouble passing urine
because of an enlarged prostate gland
• suffer from urinary retention (have
difficulty in passing urine), that is
untreated
• have rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose
malabsorption.
Take special care with Procyclidine
Tell your doctor before you start to take
this medicine if you:
• are elderly. Your dose may need to be
carefully monitored to prevent any
side effects
• you have an enlarged prostate gland
• suffer from cardiac disorders or from
cardiovascular disease (disease of the
heart)
• have ever had any problems with your
liver or kidneys
• suffer from stomach cramps,
abdominal pains or constipation
• have ever suffered from glaucoma or
may be predisposed to glaucoma or
obstructive disease of the stomach or
intestines (e.g. you may have been
told in the past that you are more at
risk of these conditions, or have a
family history of them)
• suffer from psychotic episodes
(experience delusions, hallucinations,
speech difficulty or unusual behaviour)

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2

09 November 2015

• suffer from tardive dyskinesia, which
are uncontrollable movements
particularly of the face, mouth and
tongue
• have a history of alcohol or drug
abuse.
Taking other medicines
Talk to your doctor if you are taking any
of the following:
• antidepressants (e.g. amitriptyline,
paroxetine) or monoamine oxidase
inhibitors (MAOIs) (e.g. moclobemide)
• antipsychotics (neuroleptics) such as
the phenothiazines group (e.g.
thioridazine – for severe anxiety of
schizophrenia)
• clozapine, to treat schizophrenia
• amantadine or levodopa (for
Parkinson’s disease)
• disopyramide (to control heart rhythm)
• quinidine (to treat irregular heartbeat)
• ketoconazole (for fungal infection)
• antihistamines, to relieve allergies
such as hay fever (e.g. cetirizine,
loratadine)
• cisapride, metoclopramide or
domperidone (to treat feeling sick or
being sick)
• sublingual nitrates for angina (e.g.
glyceryl trinitrate, isosorbide dinitrate)
• tacrine, memantine (to treat the
symptoms of Alzheimer’s disease)
• nefopam, used to treat pain.
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines obtained without a
prescription.
Important information about some of
the ingredients of Procyclidine
• Patients who are intolerant to lactose
should note that Procyclidine tablets
contain a small amount of lactose. If
your doctor has told you that you have
an intolerance to some sugars, contact
your doctor before taking this
medicine.
Pregnancy and breast-feeding
• If you are pregnant, planning to
become pregnant or are
breast-feeding, ask your doctor for
advice before taking any medicine.
Driving and using machines
• Procyclidine may cause blurred vision,
dizziness, mental confusion, impaired
thinking and memory, disorientation
and hallucinations. If you are affected,
DO NOT drive or operate machinery.

3

HOW TO TAKE PROCYCLIDINE

Always take Procyclidine exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
The tablets should be swallowed whole
with a drink of water after meals. The
usual dose is:
• Adults
Initially 2.5 mg three times a day after
meals. Your doctor will increase this
dose by 2.5 mg to 5 mg a day every
2 to 3 days until he or she finds a dose
which works best for you.
The maximum dose is usually 20 mg a
day if you are taking your tablets to
control symptoms caused by other
drugs. The maximum dose may be
higher, 30 to 60 mg a day if your
Parkinsonism is not caused by drugs.
• Elderly
A reduced dose may be required.
• Children
Procyclidine is not recommended for
use in children.

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TEVA UK Ref:

231-30-70131-A LEA PROCYCLIDINE 5mg TAB TUK
If you take more Procyclidine than you
should
If you (or someone else) swallow a lot of
the tablets all together or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause mood
disturbance, mental confusion,
restlessness, agitation, hallucinations
and sleeplessness lasting up to
twenty-four hours.
Please take this leaflet, any remaining
tablets, and the container with you to
the hospital or doctor so that they know
which tablets were consumed.
If you forget to take Procyclidine
If you forget to take a tablet, take one as
soon as you remember, unless it is
nearly time to take the next one. DO
NOT take a double dose to make up for
a forgotten dose.
If you stop taking Procyclidine
DO NOT stop taking your medicine
without talking to your doctor first even
if you feel better.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4

Version:

Rare (affecting less than one person in
1,000 but more than one person in
10,000)
• psychotic symptoms occurring
together such as dizziness, mental
confusion, excitement, reduced
concentration or memory,
disorientation, you lose touch with
what's real and what's not, seeing,
hearing or feeling things that aren't
there (Hallucinations), anxiety,
agitation (feeling irritable insomnia
(difficulty sleeping).
Other side effects
• rapid heart beats (tachycardia).
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

Stop taking the tablets and tell your
doctor immediately or go to the
casualty department at your nearest
hospital if the following happens
• an allergic reaction (swelling of the
lips, face or neck leading to severe
difficulty in breathing; skin rash or
hives).
If you are taking a medicine for mental
illness (called a neuroleptic) at the same
time as Procyclidine:
• you can develop uncontrolled
movements of your face and tongue
(tardive dyskinesia). The dose of either
of the 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 addition
of Procyclidine.
If either of these happen, tell your
doctor straight away.
These are very serious but rare side
effects. You may need urgent medical
attention or hospitalisation.
The following side effects have been
reported at the approximate frequencies
shown:
Common (affecting less than one person
in 10 but more than one person in 100)
• blurred vision
• a dry mouth
• constipation
• difficulty in passing water.
Uncommon (affecting less than one
person in 100 but more than one person
in 1,000)
• agitation (feeling irritable)
• anxiety
• nervousness
• feeling confused
• disorientation
• you lose touch with what's real and
what's not, seeing, hearing or feeling
things that aren't there
(Hallucinations)
• dizziness
• impaired thinking or memory

09 November 2015

• nausea (feeling sick) or vomiting
(being sick)
• gingivitis (inflammation of the gum)
• skin rash.

POSSIBLE SIDE EFFECTS

Like all medicines, Procyclidine can
cause side effects, although not
everybody gets them.

2

HOW TO STORE PROCYCLIDINE

Keep out of the reach and sight of
children.
Do not store above 25ºC. Store in the
original package.
Do not use Procyclidine after the expiry
date that is stated on the outer
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.

6

FURTHER INFORMATION

What Procyclidine Tablets contain(s):
• The active ingredient is procyclidine
hydrochloride 5 mg
• The other ingredients are lactose,
microcrystalline cellulose,
pregelatinised starch, magnesium
stearate, talc and sodium starch
glycolate.
What Procyclidine Tablets look like and
contents of the pack:
• Procyclidine 5 mg Tablets are white,
round biconvex tablets engraved with
“PDE” and “5” on each side of a
scoreline on one side, and twin
triangle logo on the reverse
• The tablets are available in packs of 7,
14, 21, 28, 30, 50, 56, 60, 84, 90, 100,
112 and 120.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder: TEVA
UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
Teva Operations Poland Sp. z o.o. Ul.
Mogilska 80, 31-546 Kraków, Poland.
This leaflet was last revised:
November 2015
PL 00289/1645

70131-A

160 x 395

REG0069220

Version 1.8

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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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