Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Kent Pharma (UK) Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5015201004530
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT- KENT & ALMUS BETAHISTINE DIHYDROCHLORIDE 8MG AND 16MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR 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 THE LEAFLET. WHAT IS IN THIS LEAFLET 1. What Betahistine Dihydrochloride is and what it is used for 2. What you need to know before you take Betahistine Dihydrochloride 3. How to take Betahistine Dihydrochloride 4. Possible side effects 5. How to store Betahistine Dihydrochloride 6. Contents of the pack and other information 1. WHAT BETAHISTINE DIHYDROCHLORIDE IS AND WHAT IT IS USED FOR The name of your medicine is Betahistine Dihydrochloride 8mg or 16mg Tablets. Betahistine dihydrochloride is a type of medicine called a histamine analogue. It is used as a treatment for Ménière’s syndrome, a condition caused by the pressure of excess fluid in the inner ear. Betahistine dihydrochloride is thought to work by improving blood flow in the inner ear, which reduces the build up of pressure. It is this pressure in the ear which is thought to cause the vertigo (dizziness), tinnitus (ringing in the ears) and hearing loss suffered by people with Ménière’s disease 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE DO NOT TAKE YOUR MEDICINE IF YOU: have ever had an allergic reaction to betahistine dihydrochloride or any of the other ingredients listed in section 6, Further information have phaeochromocytoma (a tumour associated with the adrenal gland which causes high blood pressure)WARNING AND PRECAUTIONS Take special care and tell your doctor if: have or have ever Läs hela dokumentet
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 Läs hela dokumentet