Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BETAHISTINE HYDROCHLORIDE
BGP Products Ltd
N07CA01
BETAHISTINE HYDROCHLORIDE
16 Milligram
Tablets
oral use
10, 20 or 84 tablets
Product subject to prescription which may be renewed (B)
Anti-vertigo preparations
Antivertigo preparations
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
Authorised
2015-03-27
P. Process Black U - Cutting Die (not printed) MKP-00377-2016_d4 Bet ahi stin e d ihyd roc hlor ide REA D ALL O F TH IS L EAFL ET C ARE FU LLY BEF ORE Y OU S TA RT T AKI NG T HIS MEDICIN E. • Kee p thi s lea flet . You m ay n eed t o rea d it a gai n. • If y ou h ave a ny f urt her q ues tion s, ask you r do cto r o r p harm acis t. • Thi s med ici ne h as b een p res crib ed for y ou. D o not p ass i t on t o oth ers . It may h arm t hem , eve n if t hei r sym pto ms a re t he s am e as y our s. • If a ny o f the s ide e ffe cts b eco mes ser iou s, o r if y ou n otic e any sid e eff ect s not l ist ed i n thi s lea flet , ple ase t ell y our d oct or o r pha rm acis t. IN T HIS L EAFL ET: 1. Wha t Ser c is a nd w hat i t is u sed f or 2. Bef ore y ou t ake S erc 3. How t o tak e Ser c 4. Pos sibl e sid e e ffe cts 5. How t o sto re S erc 6. Fur the r inf orm atio n 1. WHA T SER C IS A ND W HAT I T IS U SED F OR Ser c con tai ns b eta his tine . Ser c is a typ e of m ed ici ne c alle d a “hi sta min e ana logu e”. Ser c is u sed f or: Mén ièr e’s d ise ase – t he s ign s of t his inclu de: • fee lin g diz zy ( ver tigo ) • rin gin g in t he e ars (ti nni tus ) • hea rin g los s or h ear ing d iffi cul ty Thi s med ici ne w ork s by i mpr ovi ng blo od fl ow i n the i nne r ear . Thi s low ers the b uild u p of p res sur e. 2. BEF ORE Y OU T AKE S ERC DO N OT T AKE S ERC I F: • you a re a lle rgi c (hy per sen siti ve) to b eta his tine o r any o f the o the r ing red ien ts i n the t abl ets ( see sec tion 6 f or f urt her d eta ils ) • you h ave h igh b loo d pre ssu re due t o an a dre nal g lan d tumo ur(p hae och romo cyt oma ) If a ny o f the a bov e app lie s to y ou, d o not tak e thi s med ici ne a nd t alk t o you r doc tor . TAK E SPE CIA L CAR E AND T ELL Y OUR D OCT OR I F: • you h ave e ver h ad a s tom ach u lce r • you h ave a sth ma • you a re p reg nan t or p lan nin Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 16mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet: Round, biconvex, scored, white to almost white tablets imprinted `267' on one face. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage for adults is 8 -16 mg three times daily taken preferably with meals. Paediatric population: Serc is not recommended for use in children below 18 years due to insufficient data on safety and efficacy. Geriatric population: Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population. Renal impairment: There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary. Hepatic impairment: There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Use in phaeochromocytoma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with bronchial asthma and history of peptic ulcer need to be carefully monitored during the therapy. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/08/2016_ _CRN 2175554_ _page number: 1_ 4.5 INTERACTION WITH Lesen Sie das vollständige Dokument