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

Logo STUGERON® TABLETS

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

STUGERON® TABLETS

COMPOSITION:
Cinnarizine 25 mg per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A. 5.7 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.
Prophylaxis of motion sickness.
Adjunct therapy for symptoms of peripheral arterial disease.

CONTRA-INDICATIONS:
In patients with known hypersensitivity to cinnarizine.
The safety of STUGERON 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, STUGERON tablets may cause epigastric distress; taking it after meals may diminish gastric irritation.
Adults and children over the age of 12 years:
Peripheral circulatory disorders: 2-3 x 25 mg tablets three times daily.
Disorders of balance: 1 x 25 mg tablet three times daily.
The maximum recommended dosage should not exceed 225 mg (9 tablets) daily – if necessary the dosage may be divided over 2 or 3 intakes per day. As the effect of STUGERON tablets on vertigo is dose dependent, the dosage should be increased progressively.
Motion Sickness:
Adults: 25 mg may be taken 2 hours before the start of the journey and 12,5 mg to 25 mg may be repeated every 8 hours during the journey when necessary.
Children 8 to 12 years: 12,5 mg (half a tablet) three times daily when necessary.
Children 5 to 7 years: 6,25 mg three times daily when necessary.

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, STUGERON tablets 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:
A white, circular, slightly arched, biconvex tablet, embossed with "S/25" on one side and "JANSSEN" on the other side.

PRESENTATION:
Cartons containing one or more blister packs of 10, 20 or 25 tablets each.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
C/5.7/590

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN - CILAG logo

JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
15th Road
HALFWAY HOUSE, 1685
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 May 1996

                        Code: 023404
                        2003G
                        Britepak

® = TRADEMARK

Updated on this site: March 2004
Source: Pharmaceutical Industry

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