Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
N06DX01
MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE
Drank
KALIUMSORBAAT (E 202) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; WATER, GEZUIVERD,
Oraal gebruik
Memantine
Hulpstoffen: KALIUMSORBAAT (E 202); SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420); WATER, GEZUIVERD;
2013-11-12
PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE STADA 10 MG/ML DRANK 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 side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Memantine STADA 10 mg/ml drank is and what it is used for 2. What you need to know before you take Memantine STADA 10 mg/ml drank 3. How to take Memantine STADA 10 mg/ml drank 4. Possible side effects 5. How to store Memantine STADA 10 mg/ml drank 6. Contents of the pack and other information Memantine STADA 10 mg/ml drank contains the active substance memantine hydrochloride. WHAT IS MEMANTINE STADA 10 MG/ML DRANK USED FOR Memantine STADA 10 mg/ml drank is used to treat patients with moderate to severe Alzheimer’s disease in adults. HOW MEMANTINE STADA 10 MG/ML DRANK WORKS Memantine STADA 10 mg/ml drank 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 STADA 10 mg/ml drank belongs to a group of medicines called NMDA-receptor antagonists. Memantine STADA 10 mg/ml drank acts on these NMDA-receptors improving the transmission of nerve signals and the memory. • DO NOT TAKE MEMANTINE STADA 10 MG/ML DRANK if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of this medicine. (See section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Memantine STADA 10 mg/ml drank 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pump: Each actuation of the pump (one downward pump) delivers 0.5 ml of solution containing 5 mg of memantine hydrochloride equivalent to 4.16 mg of memantine. Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride equivalent to 4.16 mg of memantine. Each millilitre of solution contains 10 mg of memantine hydrochloride. Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol, liquid (non-crystallising) (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTCAL FORM Oral Solution. The solution is clear to colourless to light yellowish 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. This medicinal product should be taken once daily at the same time each day. The solution must not be poured, pumped or pipetted into the mouth directly from the bottlepump or pipette, but should be dosed onto a spoon or i Leggi il documento completo