Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
MEMANTINE HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06DX01
MEMANTINE HYDROCHLORIDE 10 mg
FILM-COATED TABLET
MEMANTINE HYDROCHLORIDE 10 mg
POM
PSYCHOANALEPTICS
Authorised
2013-08-28
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE AUROBINDO 10 MG FILM-COATED TABLETS MEMANTINE AUROBINDO 20 MG FILM-COATED TABLETS Memantine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or 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 this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Memantine Aurobindo is and what it is used for 2. What you need to know before you take Memantine Aurobindo 3. How to take Memantine Aurobindo 4. Possible side effects 5. How to store Memantine Aurobindo 6. Contents of the pack and other information 1. WHAT MEMANTINE AUROBINDO IS AND WHAT IT IS USED FOR Memantine Aurobindo contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medicines. 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. Memantine Aurobindo belongs to a group of medicines called NMDAreceptor antagonists. Memantine Aurobindo acts on these NMDA- receptors improving the transmission of nerve signals and the memory. Memantine Aurobindo is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE AUROBINDO DO NOT TAKE MEMANTINE AUROBINDO: - if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Memantine Aurobindo - Izlasiet visu dokumentu
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Memantine Aurobindo 10 mg film-coated tablets Memantine Aurobindo 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipients with known Effect: Each 10 mg film-coated tablet contains 0.41 mg of sodium. Each 20 mg film-coated tablet contains 0.81 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet _Memantine Aurobindo 10 mg film-coated tablets _ White to off-white, centrally tapered oblong, biconvex, film-coated tablets with a single break line on both sides and debossed with ‘Z’ and ‘03’ on either side of break line on one side and plain on other side. The tablet can be divided into equal doses. _Memantine Aurobindo 20 mg film-coated tablets _ Pale-red to grey-red, oval oblong, film-coated tablets debossed with 'Z' on one side and '06' on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with moderate to severe Alzheimer’s disease. 4.2 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 Page 2 of 9 guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the pat Izlasiet visu dokumentu