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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.
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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.
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
Code: 023404
2003G
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