Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Viatris UK Healthcare Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5016695280042
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 signs of illness 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 is and what it is used for. 2. What you need to know before you take Betahistine. 3. How to take Betahistine. 4. Possible side effects. 5. How to store Betahistine. 6. Contents of the pack and other information. 1. WHAT BETAHISTINE IS AND WHAT IT IS USED FOR Betahistine belongs to a group of medicines known as histamine analogues. It works by improving blood flow in the inner ear, which reduces the build up of pressure. It is this pressure in the inner ear which is thought to cause nausea, vertigo (dizziness), tinnitus (ringing in the ears) and hearing loss suffered by people with Meniere's disease. Betahistine is used in the treatment of these symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DO NOT TAKE BETAHISTINE: • if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6) • if you are taking an antihistamine to treat allergy. Betahistine may lower the effect of antihistamines. • if you have a tumour of the adrenal gland called a phaeochromocytoma. WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Betahistine: • if you suffer from bronchial asthma • if you have a peptic ulcer (ulcer in stomach or upper part of the intestine, known as the duodenum), or have ever suffered from pepti Read the complete document
PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 16mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16mg of betahistine dihydrochloride. One Betahistine dihydrochloride 16mg Tablet contains 140mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, circular, flat bevelled-edge uncoated tablets, impressed B16 on one face with a score line on the reverse. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Betahistine tablets are indicated in the treatment of vertigo, tinnitus and hearing loss associated with Ménière's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _ _Initial dosage:_ 1 tablet, 3 times daily, preferably with food. _Maintenance dose:_ The dose may be adjusted according to response to a maintenance dose of between 24 and 48mg daily. _Elderly:_ No adjustment in dosage is necessary. _Paediatric population: _Betahistine is not recommended for use in children below 18 years due to insufficient data on safety and efficacy. _Renal impairmen_t: 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. For oral use. Betahistine dihydrochloride tablets should be taken with a glass of water, preferably with food. 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 tumour resulting in severe hypertension. Hypersensitivity to betahistine dihydrochloride or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Betahistine tablets should be administered with caution in patients with a history of peptic ulcer. Clinical intolerance to betahistine has been demonstr Read the complete document