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

Logo SERC® 16 tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

SERC® 16 tablets

COMPOSITION:
Each tablet contains
betahistine dihydrochloride 16 mg.

PHARMACOLOGICAL CLASSIFICATION:
A. 5.6 Histamine.

PHARMACOLOGICAL ACTION:
Betahistine dihydrochloride is an analogue of histamine. It is completely absorbed after oral administration. The dose is almost completely excreted in the urine in about 24 hours in the form of the metabolite 2 pyridylacetic acid.
The mechanism of action of betahistine is not known. Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear.
In pharmacological studies, betahistine was found to have weak H
1 receptor agonistic and considerable H3 antagonistic properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of this observation in the action against Ménière’s syndrome or vestibular vertigo, however, remains unclear.

INDICATIONS:
Symptomatic treatment of the vertigo associated with Ménière’s Syndrome.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Patients with active peptic ulcer.
Patients with phaeochromocytoma.

DOSAGE AND DIRECTIONS FOR USE:
Adult dosage
The usual initial dose is 8 to 16 mg three times daily to be taken preferably with meals. Maintenance doses of up to 48 mg daily have been recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances, headache and skin rashes have been reported.
Special precautions
Caution should be exercised when betahistine dihydrochloride is given to patients with a history of peptic ulcer or asthmatic patients.
Concomitant use with antihistamines should be avoided. There is insufficient data on the use of this medicine during pregnancy and lactation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side effects and special precautions". Nausea, vomiting and headache are the more common symptoms. Hypotension could possibly occur. There is no specific antidote. Treatment could include stomach emptying by inducing emesis or by lavage. Further treatment is symptomatic and supportive.

IDENTIFICATION:
Round, biconvex, scored, white to almost white tablets.

PRESENTATION:
Blister packs containing 30 tablets.

STORAGE INSTRUCTIONS:
Store in original pack, below 30°C. Protect from moisture.
Keep out of reach of children.

REGISTRATION NUMBER:
32/5.6/0035

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Schering (Pty) Ltd.
(Reg No.: 1964/009072/07)
106 Sixteenth Road
Randjespark Midrand 1685
P.O. Box 5278
Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 July 2001.

Solvay Pharmaceuticals BV Weesp The Netherlands
Applicant:
Schering (Pty) Ltd
(Reg No: 1964/009072/07)

1021299

New addition to this site: September 2003
Source: Community Pharmacy

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