Betahistine STELLA 16 mg

Rx

Indications

Treatment of Ménière’s syndrome. Symptoms of which may include vertigo, tinnitus, hearing loss and nausea.

Dosage

Adults

• Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals.
  Maintenance doses are generally in the range 24 – 48 mg daily.
  Daily dose should not exceed 48 mg.
• There is no data available for patients with hepatic impairment and renal impairment.
• The elderly: Betahistine should be used with caution in this population.

Children and adolescents
Betahistine is not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.

Usage

Betahistine STELLA 16 mg is orally administered.

• Hypersensitivity to betahistine or to any of the excipients.
• Patients with phaeochromocytoma.

Common

• Headache;
• Dyspepsia, nausea.

Others

• Hypersensitivity reactions;
• Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating);
• Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticarial, rash, and pruritus.

• Caution is advised in patients with a history of peptic ulcer; patients with bronchial asthma; patients with urticaria, rashes or allergic rhinitis; patients with severe hypotension.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not use.
• Pregnancy unless clearly necessary.
• The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
• Patients should be aware of how they react to drug before driving or operating machinery.