Betahistine dihydrochloride, tablets 24 mg 1.3 : SmPC, Labelling and Package Leaflet 1.3.1 : Summary of Product Characteristics

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SUMMARY OF PRODUCTS CHARACTERISTICS 1.

NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride , tablets 24 mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 24 mg Betahistine dihydrochloride Excipients with known effect: One tablet contains 210 mg lactose monohydrate. For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM Tablet. White to off-white, circular, biconvex tablet, one face with a score line. The tablet can be divided into equal doses.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications Betahistine is indicated for treatment of Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea.

4.2

Posology and method of administration Posology Adults (including the Older people): 12-24 mg twice a day, taken with food. Dosage can be adjusted to suit individual patient needs. Sometimes improvement could be observed only after a couple of weeks of treatment. Paediatric population:

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Betahistine dihydrochloride, tablets 24 mg 1.3 : SmPC, Labelling and Package Leaflet 1.3.1 : Summary of Product Characteristics

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The safety and efficacy of Betahistine tablets for use in children and adolescents below age 18 have not yet been established due to insufficient data.

4.3

Contraindications Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumour resulting in severe hypertension. Also contraindicated are the following:  hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use Patients with peptic ulcer or a history of peptic ulcer need to be carefully monitored during the therapy, because of the occasional dyspepsia encountered in patients on betahistine. Patients with bronchial asthma need to be carefully monitored during the therapy. 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.

4.5

Interaction with other medicinal products and other forms of interaction No in vivo interaction studies have been performed. Based on in vitro data no in vivo inhibition on Cytochrome P 450 enzymes is expected. In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.

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Betahistine dihydrochloride, tablets 24 mg 1.3 : SmPC, Labelling and Package Leaflet 1.3.1 : Summary of Product Characteristics

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There is a case report of an interaction with ethanol and a compound containing pyrimethamine with dapsone and another of potentiation of betahistine with salbutamol. As betahistine is an analogue of histamine, interaction with antihistamines is theoretically possible, but none have been reported. 4.6

Fertility,pregnancy and lactation 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 (see section 5.3). The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary Breast-feeding 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.

4.7

Effects on ability to drive and use machines Betahistine is indicated for Morbus Meniere and symptomatic vertigo. Both diseases 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. Rare reports of drowsiness associated with betahistine have been made. Patients should be advised that if they are affected in this way they should avoid activities requiring concentration, such as driving and operating machinery.

4.8

Undesirable effects The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [very common (≥1/10); common (≥1/100 to