Procyclidine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Procyclidine hydrochloride

Available from:

Sandoz Ltd

ATC code:

N04AA04

INN (International Name):

Procyclidine hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090200

Patient Information leaflet

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.
Your medicine is called Procyclidine hydrochloride 5mg Tablets, but
will be
referred to as Procyclidine hydrochloride throughout this leaflet.
WHAT IS IN THIS LEAFLET:
What Procyclidine hydrochloride is and what it is used for
What you need to know before you take Procyclidine hydrochloride
How to take Procyclidine hydrochloride
Possible side effects
How to store Procyclidine hydrochloride
Contents of the pack and other information
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.
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Procyclidine 5 mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg procyclidine hydrochloride
Excipient with known effect:
Each tablet contains 137.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White, round 8.5 mm diameter biconvex tablets scored on one side
debossed with “PDE” and
“5” on each side of the score, and debossed with twin triangle
logo on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Symptomatic
treatment
of
arteriosclerotic,
idiopathic,
and
post-
encephalitic parkinsonism.
2.
Control of troublesome extra-pyramidal symptoms induced by neuroleptic
drugs,
including
pseudo-parkinsonism,
acute
dystonic
reactions
and
akathisia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The
variation
in
optimum
dosage
from
one
patient
to
another
should
be
taken
into
consideration by the physician.
ADULT DOSE
Initially 2.5mg three times daily after meals. Maybe increased by 2.5
– 5mg daily at intervals
of two to three days, until optimum clinical response is reached.
Usual maximum daily dose is
20 – 30mg but occasionally 60mg may be required.
In general younger patients or those with postencephalitic
parkinsonism may require higher
doses
for
a
therapeutic
response
than
older
patients
and
those
with
arteriosclerotic
parkinsonism.
Procyclidine may be combined with levodopa or amantadine in patients
who are inadequately
controlled on a single agent.
When used for the control of neuroleptic-induced extra-pyramidal
symptoms the dose should
not exceed 20mg daily. Treatment should be stopped after 3-4 months to
see if these
symptoms recur. Periodic cessation of treatment is to be recommended
even in patients who
appear to require longer term treatment.
USE IN CHILDREN
Not recommended.
USE IN THE ELDERLY
A reduced dose may be required as elderly patients are more sensitive
to anticholinergics.
Method of administration
For oral use. The tab