Ebixa

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Memantine hydrochloride 10mg; Memantine hydrochloride 10mg

제공처:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Memantine hydrochloride 10 mg

복용량:

10 mg

약제 형태:

Film coated tablet

구성:

Active: Memantine hydrochloride 10mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Methacrylic acid - ethyl acrylate copolymer Microcrystalline cellulose Polysorbate 80 Purified talc   Purified water Simeticone Sodium laurilsulfate Triacetin Active: Memantine hydrochloride 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Titanium dioxide

패키지 단위:

Blister pack, PP/Al, Starter pack, 14 tablets

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Lundbeck Pharmaceuticals Italy SpA

치료 징후:

Treatment of patients with moderate to severe Alzheimer's disease

제품 요약:

Package - Contents - Shelf Life: Blister pack, PP/Al, Starter pack - 14 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, PP/Al - 30 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, PP/Al - 50 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, PP/Al - 56 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, PP/Al - 100 tablets - 4 years from date of manufacture stored at or below 30°C

승인 날짜:

2002-06-12

환자 정보 전단

EBIXA
1
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 exp

제품 특성 요약

NEW ZEALAND DATA SHEET
Ebixa v 2.0 June 2020
REG_00033706
Page
1
of
14
v. 4.0
1
NAME OF THE MEDICINE
Ebixa
®
10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Memantine Hydrochloride 10 mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ebixa 10 mg tablets are pale yellow scored oblong biconvex film-coated
tablets with a single score on
both sides. The tablets are marked ‘M’ both right and left of the
score line and on the other side, ‘1’ left
and ‘0’ right of the score line.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IN ADULTS:
Treatment of the symptoms of moderate to severe Alzheimer's disease
(see Sections 4.4 Special warnings
and precautions for use and 5.1 Pharmacodynamic properties).
4.2
DOSE AND METHOD OF ADMINISTRATION
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.
ADULTS
The recommended maintenance dose is 20 mg (2 x 10 mg tablets) once a
day, at the same time every
day. This is achieved by upward titration as follows:
Treatment should be started with 5 mg (half a tablet) daily during the
1
st
week. In the 2
nd
week the dose
is 10 mg daily (one tablet) and in the 3
rd
week 15 mg/day (one and a half tablets per day) is recommended.
From the 4
th
week on, treatment is usually continued with the maintenance dose of
20 mg/day (two tablets
per day).
Tablets should be swallowed with a little liquid. They can be taken
with or without food.