SERC® 16 tablets
(and dosage form):
SERC® 16 tablets
Each tablet contains betahistine dihydrochloride 16 mg.
A. 5.6 Histamine.
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 H1 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 Ménières syndrome or vestibular vertigo, however, remains unclear.
Symptomatic treatment of the vertigo associated with Ménières Syndrome.
Hypersensitivity to any of the ingredients. Patients with active peptic ulcer.
Patients with phaeochromocytoma.
DOSAGE AND DIRECTIONS FOR USE:
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.
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.
Round, biconvex, scored, white to almost white tablets.
Blister packs containing 30 tablets.
Store in original pack, below 30°C. Protect from moisture.
Keep out of reach of children.
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
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
New addition to this site: September 2003
Source: Community Pharmacy
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