Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Memantine hydrochloride
Dr Reddy's Laboratories (UK) Ltd
N06DX01
Memantine hydrochloride
20mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 05036072006195
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VALIOS 10 MG ORODISPERSIBLE TABLETS VALIOS 20 MG ORODISPERSIBLE TABLETS VALIOS 5 MG/10 MG/15 MG/20 MG ORODISPERSIBLE TABLETS (INITIATION PACK) 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 VALIOS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALIOS 3. HOW TO TAKE VALIOS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE VALIOS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT VALIOS IS AND WHAT IT IS USED FOR Valios 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. Valios belongs to a group of medicines called NMDA-receptor antagonists. Valios acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Valios is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALIOS DO NOT TAKE VALIOS: • 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 Valios • if you have a history of epileptic seizures • if you have recently experienced a myocardial infarcti Прочитајте комплетан документ
OBJECT 1 VALIOS 20MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 13-Apr-2016 | Dr. Reddy's Laboratories (UK) Ltd 1. Name of the medicinal product Valios 20 mg Orodispersible Tablets 2. Qualitative and quantitative composition Each orodispersible tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipients with known effect: Each 20 mg tablet contains 25 mg lactose monohydrate and 5 mg aspartame. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible tablet Light pink, round, flat, speckled tablets with beveled edges, with a diameter of 12 mm and engraved with 20 on one side. 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 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: Week 1 (day 1-7) One 5 mg tablet per day for 7 d Прочитајте комплетан документ