Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Memantine hydrochloride
Actavis UK Ltd
N06DX01
Memantine hydrochloride
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5690528203080 5690528203059
T00075-01 Malta Zejtun 190x380 PIL PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEMDATINE 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 Nemdatine is and what it is used for 2. What you need to know before you take Nemdatine 3. How to take Nemdatine 4. Possible side effects 5. How to store Nemdatine 6. Contents of the pack and other information 1. WHAT NEMDATINE IS AND WHAT IT IS USED FOR HOW DOES NEMDATINE WORK Nemdatine 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. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS NEMDATINE USED FOR Nemdatine is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEMDATINE DO NOT TAKE NEMDATINE • 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 Nemdatine • if you have a history of epileptic seizures • if you have recently experienced a myocardial infarction (heart attack), or if you are suffering Lees het volledige document
OBJECT 1 NEMDATINE 10 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 22-Sep-2015 | Accord-UK Ltd 1. Name of the medicinal product Nemdatine 10 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. Excipient(s) with known effect: Each film-coated tablet contains 0.95 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking M 10 engraved on the scored side. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Treatment of 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. 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. Posology _Adults:_ Dose titration The maximum daily dose is 20 mg per day. 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. To facilitate Lees het volledige document