BETA-SYNTO Tablet Ref.[28144] Active ingredients: Betahistine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Codal Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome.

4.2. Posology and method of administration

Posology

The usual daily dose is 24mg-48mg betahistine dihydrochloride, divided into 2 or 3 equal doses.

Paediatric population

There are no dosage recommendations for children.

Method of administration

Tablets should be swallowed whole with sufficient liquid, with or after a meal.

4.9. Overdose

Symptoms

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs.

In case of overdose, the following symptoms, analagous to histamine overdose, might occur: headache, redness of the face, vertigo, tachycardia, hypotension, bronchial spasm, oedema, in particular oedema of the mucosa of the upper respiratory tract (Quincke’s oedema).

Management

There is no specific antidote to betahistine dihydrochloride. In addition to general measures aimed at betahistine elimination (gastric lavage, administration of activated charcoal), treatment should be symptomatic and should include standard supportive measures.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Blisters of PVC / PE / PVDC-aluminium.

Packs of 30 and 50 tablets are available.

Beta-Synto 16mg is also available in a pack of 60 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.