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

Version 04SUMMARY OF PRODUCT CHARACTERISTICS1. NAME OF THE MEDICINAL PRODUCTBetahistine Hydrochloride 16 mg Tablets2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach tablet contains 16 mg of betahistine hydrochloride.For excipients, see 6.1.3. PHARMACEUTICAL FORMTablets.White to almost white, cylindrical, bi-plane tablets, imprinted with “B16” on one side andscored on the other side.4. CLINICAL PARTICULARS4.1 Therapeutic indicationsVertigo, tinnitus and hearing loss associated with Ménière’s syndrome.4.2 Posology and method of administrationAdults (including the elderly)Initially 16 mg three times daily, taken preferably with meals. Maintenance doses are generallyin the range 24 – 48 mg daily.ChildrenNot recommended.4.3 Contra-indicationsPhaeochromocytoma. Hypersensitivity to any component of the product.4.4 Special Warnings And Precautions For UseCaution is advised in patients with a history of peptic ulcer. Clinical intolerance to Betahistinehydrochloride in bronchial asthma patients has been shown in relatively few patients andtherefore caution should be exercised when administering betahistine to patients with bronchialasthma.4.5 Interactions with other medicinal products and other forms of interactionAlthough an interaction between Betahistine hydrochloride and antihistamines couldtheoretically be expected, no such interactions have been reported.BetahistineHydrochloride16mgTabletsPL00289_0574v4

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

Version 046.2 IncompatibilitiesNot applicable.6.3 Shelf Life36 months.6.4 Special Precautions for StorageDo not store above 25 o C. Store in the original package.6.5 Nature and Contents of ContainerThe tablets are packed in blister strips. The blister strips are made of PVC/PVdC film withcovering aluminium foil. Each carton of 16 mg Betahistine hydrochloride tablets containseither 60 or 84 tablets.6.6 Instructions for Use & HandlingNot applicable.7. MARKETING AUTHORISATION HOLDERTEVA UK LimitedBrampton RoadHampden ParkEastbourneEast SussexBN22 9AGTrading Address:Leeds, LS27 0JGEngland.8. MARKETING AUTHORISATION NUMBERPL 0289/05749. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION12/12/200810. DATE OF REVISION OF TEXT12/12/2008BetahistineHydrochloride16mgTabletsPL00289_0574v4