Ebixa Tablet 20mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Memantine 16.62mg eqv Memantine hydrochloride

Available from:

LUNDBECK SINGAPORE PTE. LTD.

ATC code:

N06DX01

Dosage:

20mg/ tablet

Pharmaceutical form:

TABLET, FILM COATED

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Rottendorf Pharma GmbH & Co. KGaA

Authorization date:

2011-12-28

Patient Information leaflet

EBIXA 20 MG FILM-COATED TABLETS 

Memantine hydrochloride   
1. NAME OF THE MEDICINAL PRODUCT 

Ebixa 20 mg film-coated tablets.   
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 20 mg
of memantine hydrochloride equivalent to 16.62 mg memantine.   

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

Film-coated tablets.   
Pink coloured, oval shape film-coated tablet with engravings
“20” and “MEM” on both sides. 
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 maint