Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
memantine hydrochloride
H. Lundbeck A/S
N06DX01
memantine
Other anti-dementia drugs
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer's disease.
Revision: 26
Authorised
2002-05-15
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE USER EBIXA 10 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 Ebixa is and what it is used for 2. What you need to know before you take Ebixa 3. How to take Ebixa 4. Possible side effects 5. How to store Ebixa 6. Contents of the pack and other information 1. WHAT EBIXA IS AND WHAT IT IS USED FOR Ebixa 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. Ebixa belongs to a group of medicines called NMDA- receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Ebixa is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBIXA DO NOT TAKE EBIXA - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ebixa: - 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 pressur Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ebixa 10 mg film-coated tablets Ebixa 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. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Ebixa 10 mg film-coated tablets Pale yellow to yellow, oval shaped film-coated tablets with breaking line and imprint “1 0” on one side and “M M” on the other side. The tablet can be divided into equal doses. Ebixa 20 mg film-coated tablets Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and “MEM” on the 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 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 per day. In order to reduce the Pročitajte cijeli dokument