Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE
Laboratorio STADA, S.L. Frederic Mompou, 5 08960 SANT JUST DESVERN-BARCELONA (SPANJE)
MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2020-02-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Lonrela 20 mg filmomhulde tabletten 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. Whatis and what it is used for 2. What you need to know before you take Preberite celoten dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR HOW DOES WORK contains the active substance 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. belongs to a group of medicines called NMDA-receptor antagonists. acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS USED FOR is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE 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 if you have a history of epileptic seizures
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lonrela 20 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipient with known effect One film-coated tablets contains 1.09 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, oval, biconvex, 13.5 mm – 7.3 mm, film-coated tablet. 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 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. _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. For up-titration other tablet strengths are available. Week 1 (day 1-7) 2 The patient should take 5 mg per day for 7 days. Week 2 (day 8-14) The patient should take 10 mg per day for 7 days. Week 3 (day 15-21) The patient should take 15 mg p Preberite celoten dokument