MEMANTINE GENERICHEALTH memantine hydrochloride 20mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

memantine hydrochloride, Quantity: 20 mg (Equivalent: memantine, Qty 16.62 mg)

Available from:

Lupin Australia Pty Limited

INN (International Name):

memantine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; purified talc; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

28 tablets, 56 tablets, 14 tablets, 42 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the symptoms of moderately severe to severe Alzheimer's disease (See PHARMACOLOGY; PRECAUTIONS).

Product summary:

Visual Identification: Brownish pink coloured, oval shaped, film-coated tablets, debossed with "20" on one side and "scoreline" on the other side which contain Memantine Hydrochloride 20 mg; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-17

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
MEMANTINE GENERICHEALTH
(MEMANTINE HYDROCHLORIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
Memantine generichealth.
It does not contain all the
information that is known about
Memantine generichealth. It
does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you using
this medicine against the
benefits he/she expects it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT MEMANTINE
GENERICHEALTH IS USED FOR
Memantine generichealth is
used to treat moderately severe
to severe Alzheimer's disease
(AD). AD can be described as a
general decline in all areas of
mental ability.
Memantine belongs to a group
of medicines called N-methyl-D-
aspartate (NMDA) receptor
antagonists. It is thought to work
by protecting NMDA receptors in
the brain against high levels of
the chemical glutamate, which
could be the cause of brain
degeneration. NMDA receptors
are involved in the transmission
of nerve signals within the brain,
eg. in learning and memory.
Memantine generichealth should
improve your thinking capacity
and your ability to remember.
Your doctor, however, may
prescribe it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
Memantine generichealth are
not addictive.
BEFORE YOU TAKE
MEMANTINE GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MEMANTINE
GENERICHEALTH IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue
or other parts of the body, or
rash, itching or hives on the
skin.
DO NOT TAKE MEMANTINE
GENERICHEALTH IF YOU HAVE A
SEIZURE DISORD

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – MEMANTINE GENERICHEALTH
(MEMANTINE HYDROCHLORIDE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Memantine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 15 mg or 20 mg memantine (as
hydrochloride).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Memantine generichealth tablets 5 mg: White to off-white coloured,
capsule-shaped, biconvex, film-
coated tablets, debossed with "5" on one side and plain on the other
side which contain memantine
hydrochloride 5 mg.
Memantine generichealth tablets 10 mg: White to off-white coloured,
oval-shaped, film-coated tablets,
debossed
with
"10"
on
one
side
and
"scoreline"
on
the
other
side
which
contain
memantine
hydrochloride 10 mg
Memantine generichealth tablets 15 mg: Mustard yellow coloured,
oval-shaped, film-coated tablets,
debossed with "15" on one side and plain on the other side which
contain memantine hydrochloride 15
mg.
Memantine generichealth tablets 20 mg: Brownish pink coloured,
oval-shaped, film-coated tablets,
debossed
with
"20"
on
one
side
and
"scoreline"
on
the
other
side
which
contain
memantine
hydrochloride 20 mg
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the symptoms of moderately severe to severe Alzheimer's
disease (see SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE and SECTION 5.1 PHARMACODYNAMIC
PROPERTIES).
4.2 DOSE AND METHOD OF ADMINISTRATION
Memantine generichealth should be administered once a day and should
be taken at the same time
every day. Tablets should be taken with a little liquid, with or
without food.
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