Betahistine dihydrochloride.
This tablet is for oral administration (to be taken by mouth) and contains 24mg of betahistine dihydrochloride. The 24mg tablet can be divided into equal halves. However, the purpose of the scoreline is only to facilitate breaking for ease of swallowing and doses not divide the tablet into equal doses.
Excipients/Inactive Ingredients: Non-medicinal ingredients: Microcrystalline cellulose, mannitol (E421), citric acid monohydrate, colloidal anhydrous silica and talc.
Pharmacology: Pharmacodynamics: ANTI-VERTIGO PREPARATIONS.
(N: central nervous system).
Betahistine's mechanism of action is partly known.
In vitro: betahistine facilitates histaminergic transmission due to its partial agonist effect on H1 receptors and the antagonist effect of H3 receptors. Betahistine reduces the electrical activity of the polysynaptic neurones of vestibular nuclei after I.V. administration to animals. Betahistine does not have a sedative effect.
Pharmacokinetics: Betahistine is rapidly and completely absorbed following administration via the oral route.
Food intake significantly reduces betahistine absorption without amending the quantities absorbed.
It is eliminated in the urine in the form of a metabolite: 2-pyridyl acetic acid.
The elimination half-life is approximately 3.5 hours.
Elimination is virtually complete in 24 hours.
Symptomatic treatment of recurrent vertigo with or without cochlear involvement.
Posology: This pharmaceutical form is reserved for patients requiring a daily dose of 48 mg betahistine. Use a lower dose in other cases. Betaserc 24 mg tablets will be administered at the dose of 1 tablet, twice daily, preferably with food.
Children and adolescents: Betaserc 24 mg is not recommended for children and adolescents under 18 years of age given the lack of safety and efficacy data.
Elderly subjects: Since data are limited in this patient group, betahistine must be used with caution in the elderly.
Renal impairment: No data are available on patients with renal impairment.
Hepatic impairment: No data are available on patients with hepatic impairment.
Duration of treatment: The recommended duration of treatment is 2 to 3 months. This can be repeated as continuous or discontinuous treatment, depending on the clinical course of the condition.
Method of administration: The tablets must be swallowed whole with a glass of water.
Symptoms similar to those triggered by histamine.
Administer antihistamine treatment.
Hypersensitivity to one of the ingredients of this medicinal product.
Episodes of gastroduodenal ulcer.
Pheochromocytoma.
Patients with asthma should be carefully monitored during administration of betahistine (risk of bronchoconstriction).
The ingestion of this medicinal product with food prevents gastralgia.
Betahistine is not suitable for the treatment of the following conditions: Benign paroxystic vertigo; Vertigo accompanied by a central nervous system disorder.
Effects on the ability to drive and use machines: Betahistine is indicated for Morbus Meniere and Vertigo. Both diseases can negative affect the ability to drive and use machines.
In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects.
Pregnancy: Laboratory animal studies have not highlighted any teratogenic effects. In the absence of teratogenic effects in animals, no deformities are anticipated in humans. In fact, to date, substances causing malformations in humans have proved teratogenic in animals during studies performed on both species.
There are no relevant or adequate data available at the present time to assess whether betahistine causes deformities or is foetotoxic when administered during pregnancy.
Consequently, betahistine should not be administered during pregnancy as a precautionary measure.
Lactation: There are no data to confirm whether or not betahistine passes into breast milk. The risk is unknown. Therefore, lactation should not be carried out during the administration of betahistine.
Common: Gastralgia, nausea, vomiting, dry mouth and diarrhoea.
Uncommon: Headaches, asthenia, drowsiness, hypersensitivity reactions.
Rare: Thrombopenia, elevated transaminase levels.
In vitro data have shown that MAO inhibitors including MAO B (eg. selegiline) inhibit betahistine metabolism, so be careful when using betahistine and MAO inhibitors.
As betahistine is similar in structure to histamine, interaction of betahistine with antihistamines may affect the efficacy of one of these drugs.
Incompatibilities: Not applicable.
Further information: Any unused product or waste material should be disposed of in accordance with local requirements.
Shelf life: 3 years from the manufacturing date.
Do not store above 30°C.
Store in the original package in order to protect from light.
N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.
Betaserc Viên nén 24 mg
5 × 10's;5 × 20's
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