VERTIMED Tablet Ref.[50388] Active ingredients: Betahistine

Revision Year: 2018 

4.1. Therapeutic indications

  • Symptomatic treatment of Meniรฉre’s disease.
  • Symptomatic treatment of vestibular vertigo.

4.2. Posology and method of administration

Posology

Adults

24 mg – 48 mg betahistine dihydrochloride daily, in divided doses.

8 mg tablets 16 mg tablets 24 mg tablets
1-2 tablets 3 times dailyยฝ-1 tablet 3 times daily 1 tablet 2 times daily

The dosage is individualised. Sometimes the improvement of the condition can only be observed after a few weeks of treatment.

The best treatment result is achieved after a few months.

When the treatments is started in early stages, it can prevent the progression of the disease and/or hearing loss in the lates stages of the disease.

Paediatric population

Vertimed is not recommended for use in children and adolescents below the age of 18 years due to a lack of data on safety and efficacy.

Elderly

There are limited data from the clinical trials concerning this group pf patients. According to the post-marketing experience, no dose adjustment is required.

Renal impairment

No specific studies have been performed in this group of patients. According to the postmarketing experience, no dose adjustment is required.

Hepatic impairment

No specific studies have been performed in this group of patients. According to the postmarketing experience, no dose adjustment is required.

Method of administration

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

The duration of treatment depends on the disease pattern and the course of the disease. Normally it is a long term treatment.

4.9. Overdose

Symptoms

Cases of overdose have been reported in rare cases. Up to 640 mg administered betahistine have been reported in some patients with mild or moderate symptoms (eg., nausea, drowsiness, stomach pain). More serious complications (eg., convulsion, pulmonary or cardiac complications) were reported in intentional overdose of betahistine, especially in combination with other drugs overdoses.

Management

Treatment should be managed by 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 20, 24, 30, 48, 50, 60, 90, 96, and 100 tablets are available.

Not all pack sizes may be marketed

6.6. Special precautions for disposal and other handling

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

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