Betahistine Dihydrochloride 8 Mg Tablets

Document: spc-doc_PL 00289-0573 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Betahistine Dihydrochloride 8 mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 8mg of betahistine dihydrochloride.

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Tablets.

White to almost white, cylindrical, bi-plane tablets, imprinted with “B8” on one side

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

Adults (including the elderly)

Initially 16 mg three times daily, taken preferably with meals. Maintenance doses are generally in the range 24 - 48 mg daily.

Paediatric population:

Not recommended.

Betahistine Dihydrochloride is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

4.3 Contraindications

Phaeochromocytoma. Hypersensitivity to active substance or to any of the excipients.

4.4

Special warnings and precautions for use

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Betahistine dihydrochloride 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 and history of peptic ulcer need to be carefully monitored during the therapy.

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 P450 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.

As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.

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. 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.

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 machine. In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.

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 <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000)].

Gastrointestinal disorders Common: nausea and dyspepsia

Nervous system disorders Common: headache

In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.

Immune System disorders

Hypersensitivity reactions, e.g. anaphylaxis have been reported.

Gastrointestinal disorders

Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.

4.9 Overdose

No specific antidote. Gastric lavage and symptomatic treatment is recommended.

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. Treatment of overdose should include standard supportive measures.

5.1 Pharmacodynamic Properties

ATC code: N07C A01

Pharmacotherapeutic group: Antivertigo preparations.

Betahistine dihydrochloride is a specific histamine agonist with virtually no H₂-activity. It seems to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.

Pharmacokinetic properties

5.2.

Betahistine is rapidly and completely absorbed after oral administration of the drug in tablet form. It is excreted almost quantitatively in urine as 2-pyridylacetic acid for 24 hours following administration. No unchanged Betahistine has been detected.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to information already included in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Povidone K90

Microcrystalline cellulose (E460)

Lactose monohydrate Colloidal anhydrous silica Crospovidone Stearic acid (E570)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5

Nature and Contents of Container

6.6.

The tablets are packed in blister strips. The blister strips are made of PVC/PVdC film with covering aluminium foil. Each carton of 8 mg Betahistine dihydrochloride tablets contains 84 or 120 tablets.

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