País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
(REFER BETA1697)
ABBOTT LABORATORIES (M) SDN. BHD.
(REFER BETA1697)
60Tablet Tablets
Abbott Healthcare SAS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ BETASERC ® TABLETS Betahistine dihydrochloride (16mg, 24mg) Page no. 1 HAT IS IN THIS LEAFLET 1. What Betaserc® is used for 2. How Betaserc® works 3. Before you use Betaserc® 4. How to use Betaserc® 5. While you are using it 6. Side effects 7. Storage and disposal of Betaserc® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT BETASERC® IS USED FOR Betaserc® is used to treat Ménière's syndrome that has the following symptoms • Dizziness (vertigo) with nausea and vomiting • Ringing in ears (tinnitus) • Hearing loss Betaserc® is also used to treat vestibular vertigo. HOW BETASERC® WORKS Betaserc® contains betahistine which improves blood flow in the ear that lowers the buildup of pressure. BEFORE YOU USE BETASERC® _- When you must not use it_ Do not take Betaserc® if: • You are allergic (hypersensitive) to betahistine or any of the other ingredients of Betaserc® • You have high blood pressure due to adrenal tumor. (Phaeochromocytoma) Do not use Betaserc® if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Betaserc®. _ _ _ _ _- Before you start to use it _ Talk to your doctor or pharmacist before taking Betaserc® if you suffer from any medical conditions or illnesses, in particular: • if you have stomach ulcer • if you have asthma Your doctor may want to monitor your asthma while you take Betaserc®. _- Taking other medicines _ It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also concerns medicines obtained without a prescription including herbal medicines. Tell your doctor or pharmacist if you are taking any of the following medicines: • antihistamines (drug commonly used in allergies) • Monoamine-oxidase inhibitors (MAOIs) (drug used to treat depression or Parkinson’s disease) HOW TO USE BETASERC® _- How much to use _ Follow all dir Llegiu el document complet
_BETASERC_® _16 MG _ _ _ 16MG BETAHISTINE DIHYDROCHLORIDE Betaserc 16 mg is a round, biconvex, scored, white tablet with beveled edges. On the one side, the tablet is scored and the number 267 is engraved on either side of the score line.This tablet is for oral administration (to be taken by mouth) and contains 16 mg of betahistine dihydrochloride. The tablet can be divided into equal halves. Excipients (non-medicinal ingredients): Microcrystalline cellulose, mannitol (E421), citric acid monohydrate, colloidal anhydrous silica and talc. INDICATIONS Ménière’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. DOSAGE AND ADMINISTRATION Always take Betaserc 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 24–48 mg divided over the day. 16 mg tablets ½ – 1 tablet 3 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. _Pediatric population: _ Betaserc is not recommended for use in children under the age of 18 years due to insuffi cient data on safety and efficacy. _ _ _Geriatric population: _ No dose adjustment is required in elderly. _ _ _Renal impairment: _ No dose adjustment is required in renal impaired patients. _ _ _Hepatic impairment: _ No dose adjustment is required in hepatic impaired patients. CONTRAINDICATIONS Do not take Betaserc if you are hypersensitive (allergic) to the active substance or to any Llegiu el document complet