Serc^®-16/Betahistine Tablets 16 mg

Each tablet contains 16 mg betahistine dihydrochloride.

Tablet:

Round, biconvex, scored, white to almost white tablets imprinted '267' on one face and '' on the reverse.

Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

Adults (including the elderly): initially two tablets three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.

Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

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

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

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.

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 regarded to have 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.

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

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.

Nervous System disorders

Headache

Skin and subcutaneous tissue disorders

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

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.

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

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

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

Microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and talc.

Not applicable.

5 years.

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

PVC/PVdC blister packs containing 84 tablets.

HDPE tablet containers containing 500 or 1000 tablets.

None.

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

PL 00512/0088

14 October 2002

May 2012