देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAHISTINE DIHYDROCHLORIDE
ABBOTT LABORATORIES (M) SDN. BHD.
BETAHISTINE DIHYDROCHLORIDE
20Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets
Mylan Laboratories SAS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ BETASERC® TABLETS Betahistine dihydrochloride (16mg, 24mg) Page no. 1 WHAT 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 पूरा दस्तावेज़ पढ़ें
_BETASERC_® _24MG TABLET _ 24MG BETAHISTINE DIHYDROCHLORIDE PRODUCT DESCRIPTION Betaserc® 24mg Tablet is a round, biconvex, scored, white to almost white tablet with beveled edges. The diameter is 10mm; the tablet weight is about 375mg. The inscription is 289 on either side of the score on one tablet-side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 triad of core symptoms: • vertigo (with nausea/vomiting) • hearing loss (hardness of hearing) • tinnitus (ringing in the ears) Symptomatic treatment of vestibular vertigo. DOSAGE AND ADMINISTRATION The dosage for adults is 48mg divided over the day. 24 mg tablets 1 tablet 2 times/day Method of administration: Betaserc® 24mg Tablet: Should be swallowed with water. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease. Pediatric population: Betaserc® 24mg Tablet is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy. _ _ Geriatric population: Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population. _ _ Renal 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. Hepatic impairment: There are no specific clinical trials available in this patient group, but according to post- marketin पूरा दस्तावेज़ पढ़ें