MEMANTINE TEVA 10 Milligram Film Coated Tablet

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

MEMANTINE HYDROCHLORIDE

Tilgængelig fra:

Teva Pharma B.V.

ATC-kode:

N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE

Dosering:

10 Milligram

Lægemiddelform:

Film Coated Tablet

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Other anti-dementia drugs

Autorisation status:

Authorised

Autorisation dato:

2014-03-07

Indlægsseddel

PRODUCT
:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT
 Harlow
Signed
Signed
32540
MEMANTINE T
EVA 10MG FC T
ABS 
ALL TEI (TPW)
31-1-14
160 x 380mm
1
31-1-14
WA
WA
Leafl
 et
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
INDESIGN CS6
Last amend:
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Artwork, text and content must NOT be altered. The only exceptions to
this are: bleeds, 
chokes, spreads or other adjustments required for print reproduction
purposes only
. If you have any diffi
 culties 
please contact the T
eva Artwork T
eam. W
e
 must receive a copy of the 3rd Party V
endors Proof before fi
 nal 
approval can be made. 
Body: Univers 55 Roman/

65 Bold/ 55 Oblique 9pts
Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 13pts
MEMANTINE TEVA 10 MG 
FILM-COATED TABLETS
MEMANTINE HYDROCHLORIDE
PACKAGE LEAFLET: INFORMATION FOR 
THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. You may need to read it 
again.
•  If you have any further questions, ask 
your doctor or pharmacist.
•  This medicine has been prescribed for you 
only. Do not pass it on to others. It may 
harm them, even if their signs of illness 
are the same as yours.
•  If you get any side effects, talk to your 
doctor or pharmacist. This includes any 
possible side effects not listed in this 
leafl et. See section 4. 
WHAT IS IN THIS LEAFLET: 
1.  WHAT MEMANTINE TEVA IS AND WHAT IT IS 
USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
MEMANTINE TEVA
3.  HOW TO TAKE MEMANTINE TEVA
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE MEMANTINE TEVA
6.  CONTENTS OF THE PACK AND OTHER 
INFORMATION
   WHAT MEMANTINE TEVA IS 
AND WHAT IT IS USED FOR
HOW DOES MEMANTINE TEVA WORK
Memantine Teva belongs to a group of 
medicines known as anti-dementia 
medicines.
Memory loss in Alzheimer’s disease is due to 
a disturbance of message signals in the 
brai

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Teva 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
The 10 mg film-coated tablets are white to off-white, oval shaped film coated tablets, approximately 9.1 mm x 4.6 mm.
On one side debossed with "M" on either side of the score, and on the other side with "1" on the left side of the score
and with “0” on the right.
The tablet can be divided into equal doses.
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.
Posology
Adults:
Dose titration
The maximum daily