Nemdatine 20mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Memantine hydrochloride

Disponible desde:

Actavis UK Ltd

Código ATC:

N06DX01

Designación común internacional (DCI):

Memantine hydrochloride

Dosis:

20mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: ; GTIN: 5690528203158

Información para el usuario

T00075-01 Malta Zejtun 190x380 PIL
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
NEMDATINE 20 MG
FILM-COATED TABLETS
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 Nemdatine is and what it is used for
2. What you need to know before you take
Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Contents of the pack and other information
1. WHAT NEMDATINE IS AND WHAT IT IS USED FOR
HOW DOES NEMDATINE WORK
Nemdatine 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.
Nemdatine belongs to a group of medicines called
NMDA- receptor antagonists. Nemdatine acts on
these NMDA-receptors improving the transmission
of nerve signals and the memory.
WHAT IS NEMDATINE USED FOR
Nemdatine is used for the treatment of patients with
moderate to severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NEMDATINE
DO NOT TAKE NEMDATINE
•
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
Nemdatine
•
if you have a history of epileptic seizures
•
if you have recently experienced a myocardial
infarction (heart attack), or if you are suffering

Ficha técnica

OBJECT 1
NEMDATINE 20 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 22-Sep-2015 | Accord-UK Ltd
1. Name of the medicinal product
Nemdatine 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
Excipient(s) with known effect:
Each film-coated tablet contains 1.89 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in
size, with the marking “M20“
engraved on one side.
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.
Posology
_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):
The patient should take one 5 mg film-coated tablet per day f