Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEMANTINE HYDROCHLORIDE
PAHANG PHARMACY SDN. BHD.
MEMANTINE HYDROCHLORIDE
56 Tablets
KRKA, d.d., Novo mesto
MARIXINO Memantine hydrochloride film-coated tablets (10 mg) _ _ 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Marixino_ is use for 2. How _Marixino_ works 3. Before you use _Marixino_ 4. How to use _Marixino_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Marixino_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MARIXINO_ IS USED FOR _Marixino_ contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti- dementia medicines. _Marixino_ is used for the treatment of patients with moderate to severe Alzheimer’s disease. HOW _MARIXINO_ WORKS Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so- called N-methyl-D-aspartate (NMDA)- receptors that are involved in transmitting nerve signals important in learning and memory. _Marixino_ belongs to a group of medicines called NMDA-receptor antagonists. _Marixino_ acts on these NMDA-receptors improving the transmission of nerve signals and the memory. BEFORE YOU USE _MARIXINO_ _ _ - _When you must not use it _ if you are allergic to memantine or any of the other ingredients of this medicine. _Pregnancy and lactation _ Do not take _Marixino _if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking _Marixino_, stop taking it immediately and contact your doctor. The use of memantine in pregnant women is not recommended. Do not take _Marixino_ if you are breast- feeding. Women taking _Marixino_ should not breast-feed. Ask your doctor or pharmacist for advice before taking any medicine._ _ _ _ - _Before you start use it _ Talk to your doctor or pharmacist before taking _Marixino_: if you have a history of epileptic seizures if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood press Přečtěte si celý dokument
1.3.1 Memantine hydrochloride SPC, Labeling and Package Leaflet MY SmPCPIL132273_1 14.05.2019 – Updated: 14.05.2019 Page 1 of 7 MARIXINO _Memantine hydrochloride_ NAME OF THE MEDICINAL PRODUCT Marixino 10 mg film-coated tablets COMPOSITION Each film-coated tablet contains 10 mg memantine hydrochloride. PRODUCT DESCRIPTION White, oval shaped, biconvex film-coated tablets scored on one side. The tablet can be divided into equal doses. THERAPEUTIC INDICATIONS Treatment of adult patients with moderate to severe Alzheimer's disease. POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Posology Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidelines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. _Adults:_ DOSE TITRATION The maximum daily dose is 20 mg daily. In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days. Week 2 (day 8-14): 1.3.1 Memantine hydrochloride SPC, Labeling and Package Leaflet MY SmPCPIL132273_1 14.05.2019 – Updated: 14.05.2019 Page 2 of 7 The patient should take one 10 mg film-coated tablet (10 mg) per day Přečtěte si celý dokument