País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
Accord Healthcare Ireland Ltd.
N07CA; N07CA01
Betahistine dihydrochloride
8 milligram(s)
Tablet
Antivertigo preparations; betahistine
Marketed
2011-10-07
PACKAGE LEAFLET: INFORMATION FOR THE USER BETAHISTINE DIHYDROCHLORIDE 8 MG TABLETS BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS Betahistine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINTS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Betahistine dihydrochloride tablets is and what it is used for 2. What you need to know before you take Betahistine dihydrochloride tablets 3. How to take Betahistine dihydrochloride tablets 4. Possible side effects 5. How to store Betahistine dihydrochloride tablets 6. Contents of the pack and other information 1. WHAT BETAHISTINE DIHYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR Betahistine is a histamine analogue medicine that is used to treat symptoms of Ménière’s syndrome such as dizziness (vertigo) , ringing in the ears (tinnitus), loss of hearing and nausea. This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS: • If you are allergic (hypersensitive) to betahistine dihydrochloride or any of the other ingredients of Betahistine dihydrochloride tablets (see section 6, Contents of the pack and other information). • if you have high blood pressure due to adrenal tumour (phaeochromocytoma), a rare tumour of the adrenal gland. WARNING AND PRECAUTIONS • if have a stomach ulcer (peptic ulcer) • if you have asthma • if you have nettle rash, skin rash or a cold in the nose caused by an allergy, s Llegiu el document complet
HealthProductsRegulatoryAuthority 04March2019 CRN008NJC Page1of5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistinedihydrochloride8mgtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachtabletcontains Betahistinedihydrochloride8mg Excipient(s)withknowneffect: Eachtabletcontains50mglactosemonohydrate Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Tablet White,round,flat,6.5.mmtabletswithbevellededgeswiththeinscription‘BE’ononesideandabreaklineontheotherside. Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BetahistineisindicatedfortreatmentofMénière’ssyndrome,symptomsofwhichmayincludevertigo,tinnitus,hearingloss andnausea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage Adults Initialoraltreatmentis8to16mgthreetimesdaily,takenpreferablywithmeals. Maintenancedosesaregenerallyintherange24-48mgdaily.Dailydoseshouldnotexceed48mg.Dosagecanbeadjusted tosuitindividualpatientneeds.Sometimesimprovementcouldbeobservedonlyafteracoupleofweeksoftreatment. Thereisnodataavailableforpatientswithhepaticimpairment. Thereisnodataavailableforpatientswithrenalimpairment. Thereislimiteddataintheelderly,betahistineshouldbeusedwithcautioninthispopulation. Children and adolescents: Betahistinetabletsarenotrecommendedforuseinchildrenand adolescentsbelowage18duetolackofdataonsafetyand efficacy. 4.3 CONTRAINDICATIONS Llegiu el document complet