Ebixa 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Memantine hydrochloride

Available from:

Lundbeck Ltd

ATC code:

N06DX01

INN (International Name):

Memantine hydrochloride

Dosage:

20mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5702157141357

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EBIXA 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 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.
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 situations the treatment should

Summary of Product characteristics

OBJECT 1
EBIXA 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Mar-2017 | Lundbeck
Limited
1. Name of the medicinal product
Ebixa 5 mg film-coated tablets.
Ebixa 10 mg film-coated tablets.
Ebixa 15 mg film-coated tablets.
Ebixa 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.
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15 mg of memantine hydrochloride
equivalent to 12.46 mg memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
The 5 mg film-coated tablets are white to off-white, oval-oblong
film-coated tablets with imprint '5' on
one side and imprint 'MEM' on the other side.
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped
film-coated tablet with breaking line
and imprint '1 0' on one side and 'M M' on the other side. The tablet
can be divided into equal doses.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong
film-coated tablets with imprint '15'
on one side and imprint 'MEM' on the other side.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong
film-coated tablets with imprint '20'
on one side and imprint 'MEM' on the other 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