Pays: Malte
Langue: anglais
Source: Medicines Authority
MEMANTINE HYDROCHLORIDE
Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland
N06DX01
MEMANTINE HYDROCHLORIDE 10 mg/ml
ORAL SOLUTION
MEMANTINE HYDROCHLORIDE 10 mg/ml
POM
PSYCHOANALEPTICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-04-15
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE CLONMEL 10MG/ML ORAL SOLUTION 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 Clonmel is and what it is used for 2. What you need to know before you take Memantine Clonmel 3. How to take Memantine Clonmel 4. Possible side effects 5. How to store Memantine Clonmel 6. Contents of the pack and other information 1. WHAT MEMANTINE CLONMEL IS AND WHAT IT IS USED FOR Memantine Clonmel contains the active substance memantine hydrochloride. WHAT IS MEMANTINE CLONMEL USED FOR Memantine Clonmel is used to treat patients with moderate to severe Alzheimer’s disease in adults. HOW MEMANTINE CLONMEL WORKS Memantine Clonmel 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 Clonmel belongs to a group of medicines called NMDA-receptor antagonists. Memantine Clonmel acts on these NMDA-receptors improving the transmission of nerve signals and the memory. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE CLONMEL DO NOT TAKE MEMANTINE CLONMEL 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 Memantine Clonmel • if y Lire le document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Memantine Clonmel 10 mg/ml oral solution 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 (E420) and 0.5 mg of potassium, see section 4.4. 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. 2 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 bottle pump or pipette, but sho Lire le document complet