Nemdatine
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-01-2024
Charakterystyka produktu
(SPC)
17-01-2024
Sprawozdanie z oceny publicznego
(PAR)
30-04-2013
Składnik aktywny:
memantine
Dostępny od:
Actavis Group PTC ehf.
Kod ATC:
N06DX01
INN (International Nazwa):
memantine
Grupa terapeutyczna:
Psychoanaleptics, , Other anti-dementia drugs
Dziedzina terapeutyczna:
Alzheimer Disease
Wskazania:
Treatment of patients with moderate to severe Alzheimer’s disease.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Authorised
Data autoryzacji:
2013-04-22
Ulotka dla pacjenta
70
B. PACKAGE LEAFLET
71
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEMDATINE 5 MG FILM-COATED TABLETS
memantine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. 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 leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nemdatine is and what it is used for
2.
What you need to know before you take Nemdatine
3.
How to take Nemdatine
4.
Possible side effects
5.
How to store Nemdatine
6.
Contents of the pack and other information
1.
WHAT NEMDATINE IS AND WHAT IT IS USED FOR
HOW DOES NEMDATINE WORK
Nemdatine contains the active substance memantine hydrochloride.
Nemdatine 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 brain. The brain
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are
involved in transmitting nerve
signals important in learning and memory. Nemdatine belongs to a group
of medicines called NMDA-
receptor antagonists. Nemdatine acts on these NMDA-receptors improving
the transmission of nerve
signals and the memory.
WHAT IS NEMDATINE USED FOR
Nemdatine is used for the treatment of adult patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEMDATINE
DO NOT TAKE NEMDATINE
-
if you are allergic to memantine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nemdatine
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infar
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg film-coated tablets
Nemdatine 10 mg film-coated tablets
Nemdatine 15 mg film-coated tablets
Nemdatine 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nemdatine 5 mg
Each film-coated tablet contains 5 mg of memantine hydrochloride
equivalent to 4.15 mg memantine.
Nemdatine 10 mg
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
Nemdatine 15 mg
Each film-coated tablet contains 15 mg of memantine hydrochloride
equivalent to 12.46 mg
memantine.
Nemdatine 20 mg
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg
memantine.
Excipient(s) with known effect:
Nemdatine 5 mg film-coated tablets
Each film-coated tablet contains 0.47 mg lactose monohydrate.
Nemdatine 10 mg film-coated tablets
Each film-coated tablet contains 0.95 mg lactose monohydrate.
Nemdatine 15 mg film-coated tablets
Each film-coated tablet contains 1.42 mg lactose monohydrate.
Nemdatine 20 mg film-coated tablets
Each film-coated tablet contains 1.89 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Nemdatine 5 mg film-coated tablets
White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in
size, with the marking “M5”
3
engraved on one side.
Nemdatine 10 mg film-coated tablets
White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in
size, with score line and the
marking “M 10” engraved on the scored side.
The tablet can be divided into equal doses.
Nemdatine 15 mg film-coated tablets
Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in
size, with the marking “M15”
engraved on one side.
Nemdatine 20 mg film-coated tablets
Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in
size, with the marking
“M20” engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with mo
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