দেশ: আর্মেনিয়া
ভাষা: ইংরেজি
সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betahistine (betahistine dihydrochloride)
Accord Healthcare Limited
N07CA01
betahistine (betahistine dihydrochloride)
8mg
tablets
(84/6x14/), in blister
Prescription
Registered
2016-01-13
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 CONTAINS 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 সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 8 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betahistine 2HCl Accord 8 mg tablets Each tablet contains Betahistine dihydrochloride 8 mg Excipient(s) with known effect: Each tablet contains 50 mg lactose monohydrate Betahistine 2HCl Accord 16 mg tablets Each tablet contains Betahistine dihydrochloride 16 mg Excipient(s) with known effect: Each tablet contains 100 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat, 6.5.mm tablets with bevelled edges with the inscription ‘BE’ on one side and a breakline on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine is indicated for treatment of Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage Adults Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals. Maintenance doses are generally in the range 24 - 48 mg daily. Daily dose should not exceed 48 mg. Dosage can be adjusted to suit individual patient needs. Sometimes improvement could be observed only after a couple of weeks of treatment. There is no data available for patients with hepatic impairment. There is no data available for patients with renal impairment. There is limited data in the elderly, betahistine should be used with caution in this population. Children and adolescents: Betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension. Also contraindicated are the following: • hyp সম্পূর্ণ নথি পড়ুন