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Sedatives

Betahistine STADA® 16mg

 

Pack size:

Box of 10 blisters x 10 tablets.


Composition:

Each tablet contains betahistine dihydrochloride 16 mg.


Shelf-life:         

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light and moisture.

Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of Ménière's syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea.
     
  • Administered orally.
     
  • 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.


Or as prescribed by physicians.

 

  • Hypersensitivity to betahistine or to any ingredient of the drug.
  • Patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension.

     

Common:

  • Headache, dyspepsia, nausea.

Not known:

  • Hypersensitivity reactions, e.g. anaphylaxis.
  • Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.
  • Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticarial, rash, and pruritus.

     

  • Caution is advised in patients with a history of peptic ulcer. Clinical intolerance to betahistine in bronchial asthma patients has been shown in relatively few patients and therefore caution should be exercised when administering betahistine to patients with bronchial asthma.
  • Patients with bronchial asthma should be monitored carefully during the treatment with betahistine.
  • 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.
  • Pregnancy: There are no adequate data from the use of betahistine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary.
  • Lactation: It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
  • Betahistine is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome which can negatively 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.

     

 

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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