Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAHISTINE DIHYDROCHLORIDE
HEALOL PHARMACEUTICALS SDN. BHD.
BETAHISTINE DIHYDROCHLORIDE
10x10'stablet Tablets
Aurobindo Pharma Limited
® BETAQUIL TABLETS Betahistine Dihydrochloride (8 mg, 16 mg) _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What BETAQUIL is used for 2. How BETAQUIL works 3. Before you use BETAQUIL 4. How to use BETAQUIL 5. While you are using it 6. Side effects 7. Storage and Disposal of BETAQUIL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS BETAQUIL USED FOR The active substance of BETAQUIL is Betahistine Dihydrochloride. Betahistine is a type of medicine called a “histamine analogue”. Betahistine is used for: Ménière’s disease – the signs of this include: • feeling dizzy (vertigo) • ringing in the ears (tinnitus) • hearing loss or hearing difficulty HOW BETAQUIL WORKS Betahistine dihydrochloride is thought to work by improving blood flow in the inner ear, which reduces the build up of pressure. BEFORE YOU USE BETAQUIL -When you must not use it Do not take BETAQUIL tablet if • you are allergic to betahistine or to any of the other ingredients of this medicine. • you have a pheochromocytoma, a rare tumour of the adrenal gland. _Pregnancy and lactation: _ Do not take BETAQUIL if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take BETAQUIL if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. -Before you start to use it • if you 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, since these complaints may be exacerbated. • if you have low blood pressure If you suffer from any of the above conditions, consult your doctor about whether you may take Betahistine tablets. These groups of patients should be monitored by a doctor during treatment. CHILDREN Betahistine is not recommended for those under 18 years old. -Taking other medications Tell your doctor if you are taking any other medicines, including any that you buy without a prescription f Lue koko asiakirja
NAME OF DRUG PRODUCT: Betahistine Dihydrochloride Tablets BP 8 mg Betahistine Dihydrochloride Tablets BP 16 mg (TRADE) NAME OF PRODUCT: BETAQUIL 8 BETAQUIL 16 STRENGTH: 8 mg and 16 mg PHARMACEUTICAL DOSAGE FORM: Tablet. QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Betahistine Dihydrochloride Tablets BP 8 mg:_ Each un-coated tablet contains Betahistine Dihydrochloride Ph.Eur. 8 mg. _Betahistine Dihydrochloride Tablets BP 16 mg:_ Each un-coated tablet contains Betahistine Dihydrochloride Ph.Eur. 16 mg. PHARMACEUTICAL FORM: _Betahistine Dihydrochloride Tablets BP 8 mg:_ White to off-white round, flat uncoated tablets debossed with ‘X’ on one side and ‘87’ on the other side. _Betahistine Dihydrochloride Tablets BP 16 mg:_ White to off-white round uncoated tablets debossed with ‘X’ and a break line on one side and ‘88’on the other side. CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS Meniere’s Syndrome as defined by the following core symptoms: - Vertigo (with nausea/vomiting) - Hearing loss (hardness of hearing) - Tinnitus (ringing in the ears) - Symptomatic treatment of vestibular vertigo POSOLOGY AND METHOD OF ADMINISTRATION Always take Betahistine dihydrochloride tablets exactly as your doctor has prescribed. If you have any questions, contact your doctor or pharmacist. If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice. The dosage for adults is 8 mg – 16 mg three times daily. Your doctor will adjust the dosage according to your response to the medication. Improvement of symptoms may take up to two weeks and the best results are sometimes obtained only after a few months. There are indications that treatment from the onset of the disease prevents its progression and/or the loss of hearing in later phases of the disease. Paediatric population: Betahistine dihydrochloride tablets is not recommended for use in children under the age of 18 years due to insufficient data on safety and Lue koko asiakirja