Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Memantine hydrochloride
Lundbeck Ltd
N06DX01
Memantine hydrochloride
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5702157127405 5702157127504
PACKAGE LEAFLET: INFORMATION FOR THE USER EBIXA 5 MG/PUMP ACTUATION 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 possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ebixa is and what it is used for 2. What you need to know before you take Ebixa 3. How to take Ebixa 4. Possible side effects 5. How to store Ebixa 6. Contents of the pack and other information 1. WHAT EBIXA IS AND WHAT IT IS USED FOR Ebixa contains the active substance memantine hydrochloride. It 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. Ebixa belongs to a group of medicines called NMDA- receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Ebixa is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBIXA DO NOT TAKE EBIXA - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ebixa: - if you have a history of epileptic seizures - if you 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 situ Läs hela dokumentet
OBJECT 1 EBIXA 5MG/PUMP ACTUATION ORAL SOLUTION Summary of Product Characteristics Updated 06-Mar-2017 | Lundbeck Limited 1. Name of the medicinal product Ebixa 5 mg/pump actuation oral solution. 2. Qualitative and quantitative composition Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine Excipients with known effect_:_ Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg potassium, see section 4.4. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution. The solution is clear and colourless to light yellowish. 4. Clinical particulars 4.1 Therapeutic indications Treatment of adult 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 once daily. 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 0.5 ml solution (5 mg Läs hela dokumentet