Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MEMANTINE HYDROCHLORIDE
Pinewood Laboratories Ltd
N06DX; N06DX01
MEMANTINE HYDROCHLORIDE
20 milligram(s)
Film-coated tablet
Other anti-dementia drugs; memantine
Marketed
2014-07-18
PA 0281/166/001-002 November 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE HYDROCHLORIDE PINEWOOD 10 MG FILM-COATED TABLETS MEMANTINE HYDROCHLORIDE PINEWOOD 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 hydrochloride Pinewood is and what it is used for 2. What you need to know before you take Memantine hydrochloride Pinewood 3. How to take Memantine hydrochloride Pinewood 4. Possible side effects 5. How to store Memantine hydrochloride Pinewood 6. Contents of the pack and other information 1. WHAT MEMANTINE HYDROCHLORIDE PINEWOOD IS AND WHAT IT IS USED FOR Memantine hydrochloride Pinewood contains the active substance memantine hydrochloride. 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. Memantine hydrochloride is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE HYDROCHLORIDE PINEWOOD DO NOT TAKE MEMANTINE HYDROCHLORIDE PINEWOOD: - if you are allergic to memant Přečtěte si celý dokument
Health Products Regulatory Authority 03 June 2021 CRN00C8SH Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine hydrochloride Pinewood 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 tablets. Off white oval shaped film-coated tablets debossed with “U” on one side and plain on the other side. 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. 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 hydrochloride should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine hydrochloride 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 hydrochloride. Discontinuation of memantine hydrochloride 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 risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days. Week 2 (day 8-14): The pati Přečtěte si celý dokument