Memantine 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Memantine hydrochloride

זמין מ:

Accord Healthcare Ltd

קוד ATC:

N06DX01

INN (שם בינלאומי):

Memantine hydrochloride

כמות:

10mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04110000; GTIN: 5055565708798 5055565708804

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE ACCORD 5 MG FILM-COATED TABLETS
MEMANTINE ACCORD 10MG FILM-COATED TABLETS
MEMANTINE ACCORD 15MG FILM-COATED TABLETS
MEMANTINE ACCORD 20MG 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 Memantine Accord is and what it is used for
2.
What you need to know before you take Memantine Accord
3.
How to take Memantine Accord
4.
Possible side effects
5.
How to store Memantine Accord
6.
Contents of the pack and other information
1.
WHAT MEMANTINE ACCORD IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE ACCORD WORK
Memantine Accord contains the active substance memantine
hydrochloride.
Memantine Accord 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 Accord belongs to
a group of medicines called
NMDA-receptor antagonists. Memantine Accord acts on these
NMDA-receptors improving the
transmission of nerve signals and the memory.
WHAT IS MEMANTINE ACCORD USED FOR
Memantine Accordis used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE ACCORD
DO NOT TAKE MEMANTINE ACCORD:
-
if you are allergic to memantine hydrochloride or any of the other
ingredients of this medicine
(listed

מאפייני מוצר

OBJECT 1
MEMANTINE ACCORD 5, 10, 15, & 20MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 17-Aug-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Memantine Accord 5 mg film-coated tablets
Memantine Accord 10 mg film-coated tablets
Memantine Accord 15 mg film-coated tablets
Memantine Accord 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg of memantine hydrochloride
equivalent to 4.15 mg memantine.
Excipientwith known effect: each film-coated tablet contains 73.80 mg
lactose (asmonohydrate).
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg memantine.
Excipientwith known effect:each film-coated tablet contains 183.13 mg
lactose (asmonohydrate)
Each film-coated tablet contains 15 mg of memantine hydrochloride
equivalent to 12.46 mg memantine.
Excipientwith known effect:each film-coated tablet contains 221.39 mg
lactose (as monohydrate)
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
Excipientwith known effect:each film-coated tablet contains 295.18 mg
lactose (asmonohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
The 5 mg film-coated tablets are white, oblong, coated tablets,
debossed with "MT" on one side and "5"
on the other side.
The 10 mg film-coated tablets are white, oblong, coated and scored
tablets, debossed with "MT" divided
by the score on one side and "10" divided by the score on the other
side. The tablets can be divided into
equal doses.
The 15 mg film-coated tablets are orange to grey-orange, oblong,
coated tablets debossedwith "MT" on
one side and "15" on the other side.
The 20 mg film-coated tablets are pale red to grey-red, oblong,
scored, coated tablets, debossed with
"MT" divided by the score on one side and "20" divided by the score on
the other side. The tablets can be
divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of pat