País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
MEMANTINE HYDROCHLORIDE
Niche Generics Limited
N06DX; N06DX01
MEMANTINE HYDROCHLORIDE
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Other anti-dementia drugs; memantine
Marketed
2014-07-18
WHAT IS IN THIS LEAFLET 1. What Memantine Hydrochloride Niche is and what it is used for 2. What you need to know before you take Memantine Hydrochloride Niche 3. How to take Memantine Hydrochloride Niche 4. Possible side effects 5. How to store Memantine Hydrochloride Niche 6. Contents of the pack and other information 1.WHAT MEMANTINE HYDROCHLORIDE NICHE IS AND WHAT IT IS USED FOR Memantine Hydrochloride Niche contains the active substance memantine hydrochloride. Memantine Hydrochloride Niche 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 NICHE DO NOT TAKE MEMANTINE HYDROCHLORIDE NICHE: ■ 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 Memantine Hydrochloride Niche if you: ■ have a history of epileptic seizures ■ have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure). In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Hydrochloride Niche reassessed by your doctor on a regular basis. If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the Memantine Hydrochloride Niche doses according Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine Hydrochloride Niche 10mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Off white capsule shaped biconvex, film-coated tablets debossed with “M” and “10” on either side of the breakline on one side and breakline on the other side. The tablet can be divided into equal halves. 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 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. Memantine hydrochloride should be administered once a day and should be taken at the same time every day. The film- coated tablets can be taken with or without food. _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 tit Leer el documento completo