ALFINOR Tablet Ref.[28109] Active ingredients: Betahistine

• Betahistine dihydrochloride should be given with caution to patients with a history or active peptic ulcer.
• Betahistine has caused bronchoconstriction when inhaled. Since there is a possibility for the drug to cause bronchoconstriction it should be administered with caution to asthmatic patients.

Alfinor contains mannitol, which may have a mild laxative effect.

Although theoretical antagonism between betahistine and antihistamines may occur, clinical practice did not show any interactions.

Betahistine does not produce false positive results in standard diagnostic urine tests.

Pregnancy

Animal studies showed no adverse effects neither to the mother nor to the foetus. Since there are no well-controlled studies in pregnant women the drug should be administered with caution and only if clearly needed during pregnancy.

Lactation

There are no data about the distribution of betahistine into breast milk. Therefore lactation is not advisable to mothers receiving the drug.

Betahistine does not affect the patient’s ability to drive or operate machinery.

Betahistine is well tolerated.

The main adverse reactions are gastro-intestinal disturbances (including dyspepsia), headache, skin rash and pruritus.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.