Memantine Aurobindo 20mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEMANTINE HYDROCHLORIDE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2013-08-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE AUROBINDO 10 MG FILM-COATED TABLETS
MEMANTINE AUROBINDO 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 Aurobindo is and what it is used for
2.
What you need to know before you take Memantine Aurobindo
3.
How to take Memantine Aurobindo
4.
Possible side effects
5.
How to store Memantine Aurobindo
6.
Contents of the pack and other information
1.
WHAT MEMANTINE AUROBINDO IS AND WHAT IT IS USED FOR
Memantine Aurobindo 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. Memantine Aurobindo
belongs to a group of
medicines called NMDAreceptor antagonists. Memantine Aurobindo acts on
these NMDA-
receptors improving the transmission of nerve signals and the memory.
Memantine Aurobindo is used for the treatment of patients with
moderate to severe Alzheimer’s
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE AUROBINDO
DO NOT TAKE MEMANTINE AUROBINDO:
-
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 Memantine Aurobindo
-

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Aurobindo 10 mg film-coated tablets
Memantine Aurobindo 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg
memantine.
Excipients with known Effect:
Each 10 mg film-coated tablet contains 0.41 mg of sodium.
Each 20 mg film-coated tablet contains 0.81 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Memantine Aurobindo 10 mg film-coated tablets _
White to off-white, centrally tapered oblong, biconvex, film-coated
tablets with a single break line
on both sides and debossed with ‘Z’ and ‘03’ on either side of
break line on one side and plain on
other side. The tablet can be divided into equal doses.
_Memantine Aurobindo 20 mg film-coated tablets _
Pale-red to grey-red, oval oblong, film-coated tablets debossed with
'Z' on one side and '06' on 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
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guidelines. Maintenance treatment can be continued for as long as a
therapeutic benefit is
favourable and the pat