מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Memantine hydrochloride
Zentiva
N06DX01
Memantine hydrochloride
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5000283657095
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS 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 hydrochloride is and what it is used for 2. What you need to know before you take memantine hydrochloride 3. How to take memantine hydrochloride 4. Possible side effects 5. How to store memantine hydrochloride 6. Contents of the pack and other information 1. WHAT MEMANTINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR The name of your medicine is Memantine Hydrochloride Film-Coated Tablets (referred to as memantine hydrchloride throughout this leaflet). Memantine hydrochloride is used for the treatment of patients with moderate to severe Alzheimer’s disease. Memantine hydrochloride 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 hydrochloride belongs to a group of medicines called (NMDA)-receptor antagonists. Memantine hydrochloride acts on these (NMDA)-receptors improving the transmission of nerve signals and the memory. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE HYDROCHLORIDE DO NOT TAKE MEMANTINE HYDROCHLORIDE - if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in sect קרא את המסמך השלם
OBJECT 1 MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 08-May-2014 | Zentiva 1. Name of the medicinal product Memantine hydrochloride Zentiva 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). Excipients with known effect: Memantine hydrochloride 10 mg film-coated tablets: Each film-coated tablet contains 133.00 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Memantine hydrochloride 10mg film-coated tablets: 10 mg breakable film-coated tablets. White to off-white, capsule shaped film coated tablets with length approx. 11.1±0.2 mm and width approx.5.1±0.2 mm, with break line on both sides. 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. Memantine hydrochloride 10mg film-coated tablets should be administered once a קרא את המסמך השלם