Veserc Tablet 8mg

Product Information

VESERC

Veserc® Betahistine Dihydrochloride

Presentation

Veserc 8 tablet: White, round-shaped tablet, each tablet contains Betahistine Dihydrochloride BP 8mg.

Veserc 16 tablet: White, shield-shaped scored tablet, each tablet contains Betahistine Dihydrochloride BP 16mg.

Indications

Betahistine is indicated for the treatment of Meniere’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss

and nausea.

Dos age and administration

Adults: Initial oral treatment is 8 to 16mg three times daily, taken preferably with meals. Maintenance doses are generally in the

range 24 – 48mg daily . Daily dose should not exceed 48mg. Dosage can be adjusted to suit individual patient needs.

Sometimes improvement could be observed only after a couple of weeks of treatment. There is no data available for patients with

hepatic impairment. There is no data available for patients with renal impairment. There is limited data in the elderly,

betahistine should be used with caution in this population.

Children and adolescents: Betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of

data on safety and efficacy .

Contra-indications , warnings , etc.

Contra-indications: Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of

histamine it may induce the release of catecholamines from the tumour resulting in severe hypertension. Hypersensitivity to the

active substance.

Warnings: Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the

occasional dyspepsia encountered in patients on betahistine.

Precautions: Caution should be exercised in patients with bronchial asthma. Caution is advised in prescribing betahistine to

patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms. Caution is

advised in patients with severe hypotension. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines: Rare reports of drowsiness associated with betahistine have been made. Patients

should be advised that they are affected in this way they should avoid activities requiring concentration, such as driving and

operating machinery .

Drug interactions: There are no proven cases of hazardous interactions. There is a case report of an interaction with ethanol and

a compound containing pyrimethamine with dapsone and another of potentiation of betahistine with salbutamol. Betahistine is a

histamine analogue, concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents.

Pregnancy and lactation: Pregnancy: There is a very limited amount of data from the use of betahistine in pregnant women. Animal

studies, though insufficient do not indicate direct or indirect harmful effects with respect to reproductive toxicity . As a

precautionary measure, it is preferable to avoid the use of Betahistine during pregnancy . Lactation: There is insufficient

information on the excretion

of betahistine in human milk. Betahistine should not be used during breast-feeding.

Side-effects: Immune system disorders: Very rare (<1/10,000): skin rashes and pruritus. Nervous system disorders: Unknown:

headaches, and occasional drowsiness. Gastrointestinal disorders: Rare(>1/10,000, <1/1,000): gastro-intestinal upset, nausea and

dyspepsia. Cardiac disorders: Rare (>1/10,000, <1/1,000): palpitations. Skin and subcutaneous tissue disorders: Rare

(>1/10,000, <1/1,000): urticaria.

Overdose: The symptoms of betahistine overdose are nausea, vomiting, dyspepsia, ataxia and seizures. More serious complications

(convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in

combination with other overdosed drugs. No specific antidote. Gastric lavage and symptomatic treatment are recommended.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.\

Packaging quantities

Veserc 8 tablet: Each box contains 50 tablets in Alu-Alu blister.

Veserc 16 tablet: Each box contains 50 tablets in Alu-Alu blister.