SUMMARY OF PRODUCT CHARACTERISTICS

1 Name of the Medicinal Product

Procyclidine Syrup 5mg/5ml

2. Qualitative and Quantitative Composition

Each 5ml dose contains 2.5mg 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 neuroleptic-induced symptoms was associated with an apparent worsening of the patient’s state.

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, Amaranth (E123), 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 200 and 500ml.

6.6.    Instruction for Use/Handling

None.

Administrative Data

7. Marketing Authorisation Holder

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

Marketing Authorisation Number

PL 04569/0123

9.    Date of First Authorisation/Renewal of the Authorisation

Date MA Granted:    07 March 1986

Last Renewal Date:    15 December 1994

10.    Date of (Partial) Revision of the Text

July 1999