SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE ...

Version 044.6 Pregnancy and lactationHigh dosage animal studies have shown no teratogenic properties, but the usual precautionsshould be observed when administering Betahistine hydrochloride to patients duringpregnancy.4.7 Effects on ability to drive and use machinesBetahistine does not affect driving or psychomotor ability, even at over four times therecommended daily dose.4.8 Undesirable effectsRelatively few undesirable effects have been reported. These include gastro-intestinal upset(including dyspepsia), headache, skin rash and pruritus.4.9 OverdoseNo specific antidote. Gastric lavage and symptomatic treatment is recommended.5. PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic PropertiesATC code: N07C A01Pharmacotherapeutic group: Antivertigo preparations.Betahistine hydrochloride is a specific histamine agonist with virtually no H 2 -activity. It seemsto act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing thepressure in the endolymphatic space.5.2 Pharmacokinetic PropertiesBetahistine is rapidly and completely absorbed after oral administration of the drug in tabletform. It is excreted almost quantitatively in urine as 2-pyridylacetic acid for 24 hoursfollowing administration. No unchanged Betahistine has been detected.5.3 Preclinical Safety DataThere are no pre-clinical data of relevance to the prescriber which are additional to informationalready included in other sections of the SPC.6. PHARMACEUTICAL PARTICULARS6.1 List of ExcipientsPovidone K90Microcrystalline cellulose (E460)Lactose monohydrateColloidal anhydrous silicaCrospovidoneStearic acid (E570).BetahistineHydrochloride16mgTabletsPL00289_0574v4