EBIXA TABLET 10 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MEMANTINE HCl

Available from:

LUNDBECK SINGAPORE PTE. LTD.

ATC code:

N06DX01

Dosage:

10 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

MEMANTINE HCl 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ROTTENDORF PHARMA GMBH

Authorization status:

ACTIVE

Authorization date:

2003-06-11

Patient Information leaflet

EBIXA 10 MG FILM-COATED TABLETS 

Memantine hydrochloride   
1. NAME OF THE MEDICINAL PRODUCT 

Ebixa 10 mg film-coated tablets.   
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg 
memantine.  

For a full list of excipients, see section 6.1.   
3. PHARMACEUTICAL FORM 

Film-coated tablets.   

Pale yellow to yellow, oval shaped film-coated tablet with breaking
line and engravings “1 0” on one 
side and “M M” on the other side. 

The tablet can be divided into equal halves. 
4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Treatment of patients with moderate to severe Alzheimer’s
disease.   

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Treatment should be initiated and supervised by a
physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia. Therapy should only be started if
a caregiver is available who 
will regularly monitor the intake of the medicinal product by the
patient. Diagnosis should be made 
according to current guidelines. 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 should be administered once a day and should be taken at the
same time every day. The 
film-coated tablets can be taken with or without food.   

_Adults:_

Dose titra

Summary of Product characteristics

EBIXA 10 MG FILM-COATED TABLETS
Memantine hydrochloride
1. NAME OF THE MEDICINAL PRODUCT
Ebixa 10 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Pale yellow to yellow, oval shaped film-coated tablet with breaking
line and engravings “1 0” on one
side and “M M” on the other side.
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer’s disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of Alzheimer’s dementia. Therapy should only be started if
a caregiver is available who
will regularly monitor the intake of the medicinal product by the
patient. Diagnosis should be made
according to current guidelines. 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 should be administered once a day and should be taken at the
same time every day. The
film-coated tablets can be taken with or without food.
_Adults:_
Dose titration
The maximum daily dose is 20 mg per day. In order to reduce the risk
of undesirable effects the
maintenance dose is achieved by upward titration of 5 mg per week over
the first 3 weeks as
follows.
Week 1 (day 1-7):
The patient should tak