EBIXA 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

Available from:

Lundbeck Australia Pty Ltd

INN (International Name):

memantine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the symptoms of moderately severe to severe Alzheimer's disease.

Product summary:

Visual Identification: Pink, oval film-coated tablets with engravings '20' on one side and 'MEM' on the other side.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2009-09-10

Patient Information leaflet

EBIXA
®
_(EE-BIC-SA)_
_Memantine hydrochloride (meh-MAN-teen high-dro-CLOR-ride)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some
common questions about Ebixa.
It does not contain all the information
that is known about Ebixa. 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 EBIXA IS USED FOR
Ebixa 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.
Ebixa 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, e.g. in learning and
memory.
Ebixa should improve your thinking
capacity and your ability to
remember.
Your doctor, however, may prescribe
Ebixa 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.
Ebixa is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EBIXA 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 EBIXA IF YOU HAVE A
SEIZURE DISORDER OR ANY HISTORY OF
SEIZURES (FITS OR EPILEPSY).
DO NOT TAKE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
If you take it after the expiry date ha

Summary of Product characteristics

EBIXA
®
(memantine hydrochloride)
1 of 16
AUSTRALIAN PRODUCT INFORMATION – EBIXA
(MEMANTINE HYDROCHLORIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Memantine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablets containing 10 mg memantine hydrochloride.
Film-coated tablets containing 20 mg memantine hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ebixa 10 mg tablets are pale yellow to yellow, oval shaped film-coated
tablets with break line
and engravings ‘M’ on both parts right and left of the break line
and on the other side, ‘1’ left
and ‘0’ right of the break line.
Ebixa 20 mg tablets are pink to grey-red oval biconvex film-coated
tablets with ’20’
embossed on one side and ‘MEM’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the symptoms of moderately severe to severe Alzheimer's
disease (see Section 5
Pharmacological properties; Section 4.4 Special warnings and
precautions for use).
4.2
DOSE AND METHOD OF ADMINISTRATION
Ebixa 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 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.
EBIXA
®
(memantine hydrochloride)
2 of 16
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
follo