Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Memantine Hydrochloride
AS Grindeks
N06DX01
Memantine Hydrochloride
10 milligram(s)
Film-coated tablet
memantine
2021-03-05
PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE GRINDEKS 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 Memantine Grindeks is and what it is used for 2. What you need to know before you take Memantine Grindeks 3. How to take Memantine Grindeks 4. Possible side effects 5. How to store Memantine Grindeks 6. Contents of the pack and other information 1. WHAT MEMANTINE GRINDEKS IS AND WHAT IT IS USED FOR Memantine Grindeks contains the active substance memantine hydrochloride (further memantine). Memantine is an anti-dementia medicine. It helps to ease the symptoms of dementia in Alzheimer’s disease. HOW DOES MEMANTINE GRINDEKS WORK 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 belongs to a group of medicines called ‘NMDA-receptor antagonists’. It acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE GRINDEKS USED FOR Memantine Grindeks is used for the treatment of patients with moderate and severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE GRINDEKS DO NOT TAKE MEMANTINE GRINDEKS • if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Memantine Prečítajte si celý dokument
Health Products Regulatory Authority 22 April 2021 CRN00C82F Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine Grindeks 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film‑coated tablet contains 10 mg memantine hydrochloride equivalent to 8.3 mg memantine. Excipient with known effect: One film‑coated tablet contains 166.44 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film‑coated tablet (tablet). White to off‑white biconvex film‑coated oblong tablets with rounded ends, concave in the middle and breakline on both sides. Tablet size: length approximately 12.7 mm, height 3.7 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moderate and 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. 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: TABLE Prečítajte si celý dokument