Memantine 20mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Memantine hydrochloride

זמין מ:

Mylan

קוד ATC:

N06DX01

INN (שם בינלאומי):

Memantine hydrochloride

כמות:

20mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5016695005461

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE MYLAN 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 Memantine Mylan is and what it is used for
2.
What you need to know before you take Memantine Mylan
3.
How to take Memantine Mylan
4.
Possible side effects
5.
How to store Memantine Mylan
6.
Contents of the pack and other information
1.
WHAT MEMANTINE MYLAN IS AND WHAT IT IS USED FOR
Memantine Mylan contains the active substance memantine. 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 Mylan belongs to a group
of medicines called NMDA-
receptor antagonists. Memantine Mylan acts on these NMDA-receptors
improving the transmission of nerve
signals and the memory.
Memantine Mylan is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE MYLAN
DO NOT TAKE MEMANTINE MYLAN:
-
if you are allergic to memantine or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Memantine Mylan
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infarction (heart
attack), or if you are

מאפייני מוצר

OBJECT 1
MEMANTINE MYLAN 20 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Memantine Mylan 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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
A red film-coated, oval, biconvex, bevelled edge tablet debossed with
“ME” on one side of the tablet and
“20” 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 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:
For up-titration other tablet strengths are available.
Week 1 (day 1-7):
The patient should take half a 10 mg film-coated tablet (5 mg) per day