INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo STUGERON FORTE® capsules

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

STUGERON FORTE® capsules

COMPOSITION
Cinnarizine 75 mg per capsule.

PHARMACOLOGICAL CLASSIFICATION
A. 5.7.1 Antihistaminics, anti-emetics and antivertigo preparations.

PHARMACOLOGICAL ACTION
Pharmacodynamics
Cinnarizine inhibits contractions of vascular smooth muscle cells by blocking calcium channels. Cinnarizine increases erythrocyte deformability and decreases blood viscosity in vitro. Cinnarizine inhibits stimulation of the vestibular system.
Pharmacokinetics
The peak plasma levels of cinnarizine are obtained 1 to 3 hours after intake. Cinnarizine disappears from plasma with a half-life of 4 hours.
Cinnarizine is completely metabolised. About 1/3 of these metabolites are eliminated in the urine and 2/3 in the faeces.
The plasma protein binding of cinnarizine is 91%.

INDICATIONS
Control of vestibular symptoms of both peripheral and central origin and of labyrinthine disorders including vertigo, dizziness, tinnitus, nystagmus, nausea and vomiting.
Adjunct therapy for symptoms of peripheral arterial disease.

CONTRA-INDICATIONS
In patients with known hypersensitivity to cinnarizine.
The safety of cinnarizine tablets in pregnant and lactating women has not been established.
Parkinson's disease.

WARNINGS
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants. Patients should not operate hazardous machinery or drive motor vehicles or perform potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE
As with other antihistamines, cinnarizine may cause epigastric distress; taking it after meals may diminish gastric irritation.

Adults and children over the age of 12 years:
Peripheral circulatory disorders: 2 to 3 capsules of 75 mg daily.
Disorders of balance: 1 capsule of 75 mg daily.
The maximum recommended dosage should not exceed 225 mg (3 capsules) daily - if necessary the dosage may be divided over 2 or 3 intakes per day. As the effect of cinnarizine on vertigo is dose dependant, the dosage should be increased progressively.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The most common antihistaminic side-effect of cinnarizine is sedation which can vary from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, and inco-ordination. Sedative effects, when they occur, may diminish after a few days.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain.
Somnolence and gastro-intestinal disturbances are usually transient and may often be prevented by achieving the optimum dosage gradually.
Cinnarizine may also produce antimuscarinic effects such as blurred vision, difficulty in micturition, dysuria, dryness of mouth and tightness of chest.
Central effects may include muscular weakness, headache and euphoria.
Weight gain, perspiration or allergic reactions may be observed. Cases of lichen planus and lupus-like symptoms and an isolated case of cholestatic jaundice have been reported.
In elderly people cases of aggravation or an appearance of extrapyramidal symptoms sometimes associated with depressive feelings have been described during prolonged therapy. The treatment should be discontinued in such cases.
Interactions:
Cinnarizine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, tricyclic antidepressants, sedatives and tranquillisers.
The side-effects of anticholinergic substances such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of antihistamines.
Monoamine-oxidase inhibitors may enhance the antimuscarinic effects of antihistamines.
Diagnostic interference:
Because of its antihistamine effect, cinnarizine may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdose may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur within 18 hours. In adults the usual symptoms are central nervous depression with drowsiness, coma and convulsions. Hypertension may also occur.
Treatment is symptomatic and supportive.

IDENTIFICATION
Capsules with a yellow opaque body and an orange opaque cap.

PRESENTATION
Cartons containing one or more blister strips of 10 or 20 capsules.

STORAGE DIRECTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER
G/5.7.1/58

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/11122/07)
15th Road, HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
22 February, 1974.

        Code: 023608
        2001I

® TRADEMARK

Updated on this site: April 2002
Current: March 2004
Source: Pharmaceutical Industry

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