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PROCYCLIDINE SYRUP 5MG/5ML

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

Name of the Medicinal Product
Procyclidine Syrup 5mg/5ml

2.

Qualitative and Quantitative Composition

Each 5ml dose contains 5mg Procyclidine Hydrochloride BP.

3.

Pharmaceutical Form
Syrup

4

Clinical Particulars

4.1

Therapeutic indications

Procyclidine is indicated in all forms of Parkinson’s disease: idiopathic (paralysis
agitans), postencephalitic and arteriosclerotic. Symptoms often responding well to
Procyclidine include: rigidity, akinesia, tremor, speech and writing difficulties, gait,
sialorrhoea and drooling, sweating, oculogyric crises and depressed mood.
Tardive dyskinesia is not improved by Procyclidine and may be made worse.
Procyclidine is also used to control troublesome extrapyramidal symptoms induced by
neuroleptic drugs including pseudo-parkinsonism, acute dystonic reactions and
akathisia.

4.2.

Posology and Method of Administration
For oral administration only.
Adults Only:
All forms of Parkinsonism
Treatment is usually started at 2.5mg three times a day, increasing by 2.5 to
5mg daily at intervals of two or three days until the optimum clinical response

is achieved. The usual maximum total daily dose is 30mg. However, at the
discretion of the attending physician where appropriate this total may be as
high as 60mg.
Drug induced Parkinsonism-like symptoms
As above but the daily dosage used in the control of neuroleptic-induced
extrapyramidal symptoms is usually not more than 20mg daily. After a period
of 3 to 4 months Procyclidine should be stopped and the patient observed to
see if the neuroleptic-induced extrapyramidal symptoms recur. Cessation of
treatment periodically is to be recommended even in patients who appear to
require the drug for longer periods.
Elderly: Elderly patients are more sensitive to anticholinergics, and a reduced
dose may be required.
Children: Not recommended
Avoid abrupt discontinuation of treatment.
When changing from one drug to another, withdraw the one in small amounts
whilst gradually increasing the dose of the other.
Procyclidine tablets may be given with other drugs employed for the relief of
parkinsonism e.g. other antimuscarinic drugs, levodopa and amantadine; dose
reduction may be required.

4.3.

Contra-indications
Procyclidine is contra-indicated in patients with: Untreated urinary retention,
closed angle glaucoma and gastrointestinal obstruction.

4.4.

Special Warnings and Precautions for Use
Since treatment is to be continued for an indefinite period, the patient should
be carefully supervised over the long term.
Incipient glaucoma may be precipitated by Procyclidine.
Caution should be exercised in patients with obstructive disease of the gastrointestinal tract, those with urinary symptoms associated with prostatic
hypertrophy and in hepatic and renal impairment, and those with hypertension
and cardiac disorders.
In a proportion of patients undergoing neuroleptic treatment, tardive
dyskinesias will occur. While anticholinergic agents do not cause this

syndrome, when given in combination with neuroleptics they may reduce the
threshold at which dyskinesias appear in patients predisposed to this
abnormality. In such individuals subsequent adjustment of neuroleptic therapy
is indicated.

4.5.

Interactions with other Medicaments and other forms of Interaction
Concurrent use of Procyclidine with drugs possessing anticholinergic effects
increases the side effects such as dry mouth, urine retention and constipation,
concomitant use can lead to confusion in the elderly. Such drugs include
antidepressants (e.g. amitriptyline), phenothiazines (e.g. thioridazine),
amantadine and disopyramide.
The absorption of ketoconazole may be reduced by concomitant
administration of Procyclidine.
Concurrent use of Procyclidine with
antihistamines however can increase the anticholinergic side-effects.

4.6.

Pregnancy and Lactation
The safety of using Procyclidine during pregnancy has not been established.
However, extensive clinical use has not given any evidence that it in any way
compromises the normal course of pregnancy. No data are available on the
excretion of this drug in breast milk.

4.7.

Effects on Ability to Drive and Use Machines
May effect performance of skilled tasks e.g. driving therefore the patient
should be warned.

4.8.

Undesirable Effects
The main side-effects are those to be expected from any anticholinergic agent:
dry mouth, blurring of vision and constipation are most commonly recorded.
Less commonly tachycardia, hypersensitivity, nervousness and with high
doses dizziness, mental confusion and hallucinations may occur. The
unwanted anticholinergic effects are easily reversed by reducing the dosage.
In rare instances Procyclidine administered for the treatment of neurolepticinduced symptoms was associated with an apparent worsening of the patient’s
state.

4.9.

Overdose
Toxic doses result in tachycardia, rapid respiration, hyperpyrexia and CNS
stimulation marked by restlessness, confusion, excitement, paranoid and
psychotic reactions, hallucination and delirium and occasionally seizures or
convulsions. A rash may appear on the face and upper trunk. In severe
intoxication central stimulation may give way to CNS depression, coma,
circulatory and respiratory failure and death. Treatment entails gastric lavage,
emetic and high enema as there is no specific antidote. General supportive
treatment should be carried out. Cold compresses and extra fluid are advised.
Atropine antagonists may be useful.

5

Pharmacological Properties

5.1

Pharmacodynamic properties

Procyclidine is a synthetic anticholinergic agent which blocks the excitatory effects of
acetylcholine at the muscarinic receptor.

5.2.

Pharmacokinetic Properties
Procyclidine is adequately absorbed from the gastro-intestinal tract and
disappears rapidly from the tissues. After oral dosing the mean values for
volume of distribution, total body clearance and plasma elimination half-life
of Procyclidine were of the order of 1 litre/kg, 68ml/min and 12 hours
respectively.

5.3.

Preclinical Safety Data
There are no preclinical safety data of relevance to the prescriber which are
additional to those already included in other sections of the SPC.

6

Pharmaceutical Particulars

6.1

List of excipients

The syrup contains Sorbitol Solution (70%) BP, Sucrose BP, Raspberry Flavour (PPF
31/78/360), Nipasept Sodium, Potassium Sorbate BP, Cetamacrogol 1000 BP,
Trisodium Citrate EP, Citric Acid Monohydrate EP and Deionised Water.

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
36 months.

6.4.

Special Precautions for Storage
Store in a cool, dark place, not exceeding 25°C.

6.5.

Nature and Contents of Container
Amber glass winchester with ropp aluminium closure with steran-lined wad in
packs of 200ml.

6.6.

Instruction for Use/Handling
None.

Administrative Data
7.

Marketing Authorisation Holder

Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire
EN6 1TL

8.

Marketing Authorisation Number
PL 04569/0124

9.

Date of First Authorisation/Renewal of the Authorisation
Date MA Granted:
Last Renewal Date:

10.

07 March 1986
15 December 1994

Date of (Partial) Revision of the Text
July 1999

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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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