APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-10-2021
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
memantine hydrochloride, Quantity: 20 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
memantine hydrochloride
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: hyprolose; iron oxide red; iron oxide yellow; microcrystalline cellulose; hypromellose; methylcellulose; magnesium stearate; macrogol 8000; titanium dioxide; croscarmellose sodium
Administration route:
Oral
Units in package:
28
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: Pale red, oval, biconvex coated tablet. Engraved 'MEM 20' on one side, 'APO' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-04-24
Patient Information leaflet
APO-MEMANTINE
1
APO-MEMANTINE
_Contains the active ingredient memantine hydrochloride (meh-MAN-teen
high-dro-CLOR-ride) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about memantine. It does
not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits expected for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Memantine.
It contains the active ingredient,
memantine (as memantine
hydrochloride).
This medicine 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.
Ask your doctor if you have any
questions about why it has been
prescribed for you. Your doctor may
have prescribed this medicine for
another reason.
This medicine is only available with
a doctor's prescription.
_HOW IT WORKS _
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
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO- MEMANTINE (MEMANTINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Memantine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg memantine hydrochloride as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-MEMANTINE 10 MG TABLETS
White, peanut shaped, biconvex film coated tablet. Engraved “APO”
bisect “APO” on one side,
“MEM” bisect “10” on the other side.
APO-MEMANTINE 20 MG TABLETS
Pale red, oval, biconvex, film coated tablet. Engraved “MEM 20” on
one side, “APO” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the symptoms of moderately severe to severe Alzheimer's
disease (see sections
5 PHARMACOLOGICAL PROPERTIES and 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Memantine tablets are intended for oral administration.
DOSAGE
Memantine tablets should be administered once a day and should be
taken at the same time
every day 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 guideline. 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
The recommended maintenance dose is 20 mg per day. This is achieved by
upward titration
of 5 mg per week. The 10 mg tablet is required for titration as
follows:
Dose Titration
Week 1 (Day 1 - 7)
The patient should take 5 mg (½ x 10 mg tablet) per day.
Week
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