Description

Product Overview

What is Betahistine Tablet?

Betahistine dihydrochloride (Beeta-hist-een dye-hi-droh-clor-ride) is a medicine which is used in Ménière’s syndrome.
Each tablet contains 8mg, 16mg, 24mg, 32 mg betahistine dihydrochloride.
Excipient(s) with known effect: lactose monohydrate.
Tablet
Betahistine Dihydrochloride Tablets are white, circular, flat, bevelled edged tablets.

Therapeutic indications

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

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 to 48 mg daily. Dosage should be altered according to clinical response.
Children: No dosage recommendations are made for children.

Contraindications

Use in patients with hypersensitivity to betahistine dihydrochloride or any component of the tablet. Use in patients with phaeochromocytoma.

Special warnings and precautions for use

Betahistine dihydrochloride is considered to be unsafe in patients with porphyria.
Betahistine dihydrochloride should be administered with caution to patients with bronchial asthma or a history of peptic ulcer.
Betahistine dihydrochloride is not recommended for use in children.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
Betahistine dihydrochloride should not be used concurrently with antihistamines.

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.
Effects on ability to drive and use machines
No adverse effects known.

Undesirable effects

The following undesirable effects have been experienced with the below indicated frequencies in betahistine dihydrochloride-treated patients in placebo-controlled clinical trials (very common (≥ /100 to < 1/10); uncommon (≥ /1,000 to < 1/100); rare (≥ /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 systems 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 systems disorders Headache Skin and subcutaneous tissue disorders Cutaneous and subcutaneous hypersensitivity reactions have been reported in particular angioneurotic oedema, urticaria, rash and pruritus Overdose 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. There is no specific antidote to betahistine dihydrochloride. Gastric lavage and symptomatic treatment is recommended.

POSSIBLE SIDE EFFECTS

Like all medicines, Betahistine Dihydrochloride Tablets can cause side effects although not everybody gets
them.
STOP taking Betahistine Dihydrochloride Tablets and see your doctor or nearest hospital casualty
department IMMEDIATELY if you experience:
• an allergic reaction. Symptoms of an allergic reaction include; skin rashes, inflamed itchy skin, swelling of
the lips, face, throat or tongue, difficulty breathing or swallowing.
Other common side effects (may affect up to 1 in 10) are:
• feeling sick (nausea)
• headaches
• indigestion (dyspepsia)

Other side effects
• mild gastric complaints such as being sick (vomiting)
• abdominal pain and bloating
• stomach upsets
• itching and skin rashes
• Swelling of the skin (angioneurotic oedema)
• Hives
Taking this medicine with food can help reduce any
stomach problems.

HOW TO STORE YOUR MEDICINE

Keep this medicine out of the sight and reach of children.
Do not use your medicine after the expiry date printed on the package. The expiry date refers to the last day of
that month.
Do not store above 25°C. Store the tablets in the original package.
This medicine should preferably be locked in a cupboard or medicine cabinet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.