Menivert 24mg Tablet

MENIVERT 24 mg TABLETS is indicated for the symptomatic treatment of the vertigo associated with M u00e9niu00e8reu2019 s syndrome.

The usual daily dose is 24 mg to 48 mg of MENIVERT 24 mg TABLETS in divided doses. One 24 mg tablet can be administered twice daily. The dosage should be individually adapted according to the response. MENIVERT 24 mg TABLETS are not recommended for use in children and adolescents below the age of 18 years due to a lack of data on safety and efficacy.

MENIVERT 24 mg TABLETS is contraindicated in:

• Patients with hypersensitivity to betahistine or to any of the ingredients contained in MENIVERT 24 mg TABLETS (see COMPOSITION).
• 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.

Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the occasional dyspepsia encountered in patients on MENIVERT 24 mg TABLETS. Patients with bronchial asthma should be monitored carefully during the treatment with MENIVERT 24 mg TABLETS. Caution is advised in prescribing MENIVERT 24 mg TABLETS 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. Caution is advised in patients with porphyria.

If MENIVERT 24 mg TABLETS are to be administered subsequent to the treatment with an antihistamine and this treatment is stopped abruptly, withdrawal symptoms such as sleep disorders and agitation could appear because of the sedative action of antihistamines. Treatment with the antihistamine should be tapered over approximately six days.

There are no studies on the interactions with the following medicines: vasodilators, psychotropic medicines, in particular sedatives, tranquillisers and neuroleptics, parasympatholytics, and vitamins. MENIVERT 24 mg TABLETS should not be concomitantly administered with antihistamines. MENIVERT 24 mg TABLETS metabolism may be inhibited by medications that inhibit monoamine-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using MENIVERT 24 mg TABLETS and MAO inhibitors (including MAO-B selective) concomitantly.

The safety of MENIVERT 24 mg TABLETS during pregnancy and lactation has not been established.

Since adverse reactions such as drowsiness have been reported in patients receiving MENIVERT 24 mg TABLETS, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that MENIVERT 24 mg TABLETS does not adversely affect their ability to do so (see SIDE EFFECTS).

MENIVERT 24 mg TABLETS can cause the following side effects:

Immune system disorders

• Frequency unknown: Hypersensitivity reactions, e.g. anaphylaxis

Nervous system disorders

• Frequent: Headache
• Less frequent: Head pressure
• Frequency unknown: Occasional drowsiness

Cardiac disorders

• Less frequent: Palpitations, tightness of the chest

Respiratory, thoracic and mediastinal disorders

• Less frequent: Exacerbation of pre-existing bronchial asthma

Gastrointestinal disorders

• Frequent: Nausea, dyspepsia
• Less frequent: Retching, heartburn, gastric discomfort and pain, flatulence

Gastric disorders can normally be avoided by taking MENIVERT 24 mg TABLETS with or after a meal, or by reducing the dosage.

Skin and subcutaneous tissue disorders

• Frequency unknown: Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticaria rash, and pruritus

Symptoms

In case of overdose, the following symptoms, analogous to histamine overdose, might occur: headache, redness of the face, vertigo, tachycardia, hypotension, bronchial spasm, oedema, in particular oedema of the mucosa of the upper respiratory tract (Quinckeu2019s oedema).

Treatment

There is no specific antidote to MENIVERT 24 mg TABLETS.