Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
Azure Pharmaceuticals Ltd 12 Hamilton Drive, The Rock Road, Blackrock, Co. Louth A91 T997, Ireland
N07CA01
BETAHISTINE DIHYDROCHLORIDE 8 mg
TABLET
BETAHISTINE DIHYDROCHLORIDE 8 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2022-06-23
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Betahistine Tablets are and what they are used for _2._ _ _ What you need to know before you take Betahistine Tablets _ _ _3._ _ _ How to take Betahistine Tablets _ _ 4. Possible side effects _5._ _ _ How to store Betahistine Tablets _ _ 6. Contents of the pack and other information 1. WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Betahistine Tablets. This medicine is called a histamine analogue. It is used to treat the following symptoms of Ménière's disease: • Dizziness (vertigo) • Ringing in the ears (tinnitus) • Hearing loss. 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 TABLETS DO NOT TAKE BETAHISTINE TABLETS: • If you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6). • If you have high blood pressure due to an adrenal tumour (phaeochromocytoma). If any of the above applies to you, do not take this medicine and talk to your doctor. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Betahistine Tablets if: • You have a stomach ulcer • You have asthma • You are pregnant or planning to become pregnant • You are breast-feeding. Your doctor will t Baca dokumen lengkapnya
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, round, flat, bevel-edged tablet debossed ‘8’ on one side and ‘B’ on other side with a diameter of 7 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine dihydrochloride 8 mg tablet is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly): _ The usual dose is 8 to 16 mg, three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. _Paediatric population: _ Betahistine should not be used in children aged below 18 years due to insufficient data on safety and efficacy. _Elderly: _ 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. Page 2 of 6 Method of administration. Oral use. The tablets should be swallowed without being chewed with a glass of water during meals. 4.3 CONTRAINDICATIONS • Phaeochromocytoma. • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to betahistine dihydrochloride in bronchial asthma patients has been shown in a relatively f Baca dokumen lengkapnya