Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
MEMANTINE HYDROCHLORIDE
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06DX; N06DX01
MEMANTINE HYDROCHLORIDE
10 milligram(s)/millilitre
Oral solution
Product subject to prescription which may not be renewed (A)
Other anti-dementia drugs; memantine
Not marketed
2013-11-08
No. of colours Colours Non-Print Colours Date: Time: Equate CMYK with Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Pharma Code SAP No. Vendor Job No. Proof No. Client Market Keyline/Drawing No. Barcode Info Dimensions Main Font Body Text Size Page Count Min Text Size used 18 May 2015 1/2 10:51 Memantine Hydrochloride 10mg/ml 50/100ml Leaflet 606325 577176L00 606325 PA 577/176/1 Chanelle Medical N/A N/A N/A 253972 2 Ireland N/A N/A 1 Black Myriad Pro 156 x 487 mm 9 pt 9 pt PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE HYDROCHLORIDE 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 possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What Memantine is and what it is used for 2. What you need to know before you take Memantine 3. How to take Memantine 4. Possible side effects 5. How to store Memantine 6. Contents of the pack and other information 1. WHAT MEMANTINE IS AND WHAT IT IS USED FOR Memantine 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. Memantine belongs to a group of medicines called NMDA-receptor antagonists. Memantine acts on these NMDA-receptors improving the transmissio Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 12 October 2018 CRN008P4C Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine Hydrochloride 10mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pump: Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is 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 10mg of memantine hydrochloride. Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5mg of potassium, see section 4.4. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. The solution is clear to 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. Health Products Regulatory Authority 12 October 2018 CRN008P4C Page 2 of 15 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 do Olvassa el a teljes dokumentumot