MEMANXA memantine hydrochloride 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

memantine hydrochloride, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

memantine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; hypromellose; microcrystalline cellulose; lactose monohydrate; magnesium stearate; macrogol 6000

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the symptoms of moderately severe to severe Alzheimer's disease (see Pharmacology and Precautions).

Product summary:

Visual Identification: White to off-white, oval tablets, embossed with a scoreline on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-11-17

Patient Information leaflet

Memanxa
memantine hydrochloride
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MEMANXA.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking
MEMANXA against the benefits
they expect it will have for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
WHAT MEMANXA IS
USED FOR
MEMANXA is used to treat the
symptoms of moderately severe
to severe Alzheimer’s Disease
(AD).
AD can be described as a
general decline in all areas of
mental ability.
MEMANXA belongs to a group of
medicines called N-methyl-D-
aspartate (NMDA) receptor
antagonists. It is thought to
work by protecting NDMA
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, for example in
learning and memory.
MEMANXA should improve your
thinking capacity and your ability
to remember.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE IT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE MEMANXA IF YOU
ARE ALLERGIC TO MEDICINES
CONTAINING MEMANTINE OR
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
skin rash, itching or hives,
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing, wheezing or
shortness of breath.
DO NOT TAKE MEMANXA IF YOU
HAVE:
•
severe kidney problems
•
a seizure disorder or any
history of seizures (fits or
epilepsy).
DO NOT TAKE THIS MEDICINE IF
THE EXPIRY DATE (EXP.)
PRINTED ON THE PACK HAS
PASSED.
DO NOT TAKE IT IF THE
PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT GIVE YOUR MEDICINE TO
CHILDREN.
The safety and effectiveness in
children has not

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – MEMANXA (MEMANTINE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Memantine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Memanxa tablets contain 10 mg of memantine hydrochloride.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MEMANXA tablets are oval, white scored tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of the symptoms of moderately severe to severe Alzheimer's
disease (see SECTION 5.1
PHARMACODYNAMIC PROPERTIES and SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Memantine tablets 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.
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.
2
_Week 2 (day 8 – 14) _
The patient should take 10 mg (1 x 10 mg tablet) per day.
_Week 3 (day 15 – 21) _
The patient should take 15 mg (1½ x 10 mg tablet) per day.
_MAINTENANCE DOSE FROM WEEK 4 _
The recommended maintenance dose is 20 mg per day.
Children
The use of memantine tablets in children is not recommended.
Hepatic impairment
In patients with mild or moderate hepatic impairment (Child-Pugh A and
Child-Pugh B), no dosage
adjustment is required. No data on the use of memantine in patients
with severe hepatic
impairment is available. Administration of memantine tablets is not
recommended in patients with
severe hepatic impairment.
Renal impairment
In patients with mildly impaired renal function (creatinine clearance
50 – 80 mL/min), no dosage
adjustment is required.
In patients with moderate renal impairment (creatinine clearance 30
– 49 mL/min), the daily dose
should be 10 mg per day. If toler