Memantine ratiopharm
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-06-2022
Charakterystyka produktu
(SPC)
30-06-2022
Sprawozdanie z oceny publicznego
(PAR)
20-06-2013
Składnik aktywny:
memantine hydrochloride
Dostępny od:
Ratiopharm GmbH
Kod ATC:
N06DX01
INN (International Nazwa):
memantine
Grupa terapeutyczna:
Psychoanaleptics,
Dziedzina terapeutyczna:
Alzheimer Disease
Wskazania:
Treatment of patients with moderate to severe Alzheimer’s disease
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Authorised
Data autoryzacji:
2013-06-12
Ulotka dla pacjenta
56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE RATIOPHARM 10 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 Memantine ratiopharm is and what it is used for
2.
What you need to know before you take Memantine ratiopharm
3.
How to take Memantine ratiopharm
4.
Possible side effects
5.
How to store Memantine ratiopharm
6.
Contents of the pack and other information
1.
WHAT MEMANTINE RATIOPHARM IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE RATIOPHARM WORK
Memantine ratiopharm contains the active substance memantine
hydrochloride. It 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. Memantine ratiopharm belongs
to a group of medicines
called NMDA-receptor antagonists. Memantine ratiopharm acts on these
NMDA-receptors improving
the transmission of nerve signals and the memory.
WHAT IS MEMANTINE RATIOPHARM USED FOR
Memantine ratiopharm is used for the treatment of patients with
moderate to severe Alzheimer’s
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE RATIOPHARM
DO NOT TAKE MEMANTINE RATIOPHARM
●
if you are allergic to memantine hydrochloride, peanut or soya or any
of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTION
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Memantine ratiopharm 10 mg film-coated tablets
Memantine ratiopharm 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Memantine ratiopharm 10 mg
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
Memantine ratiopharm 20 mg
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg
memantine.
Excipients with known effect:
Memantine ratiopharm 10 mg
Lactose (80 mg/film-coated tablet) and soya lecithin (0.13
mg/film-coated tablet).
Memantine ratiopharm 20 mg
Lactose (160 mg/film-coated tablet) and soya lecithin (0.26
mg/film-coated tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Memantine ratiopharm 10 mg
White to off-white, capsule shaped, biconvex tablets with a break
score on one side and debossed with
“10” on the other side. The tablet can be divided into equal
doses.
Memantine ratiopharm 20 mg
White to off-white, capsule shaped, biconvex tablets with a break
score on one side and debossed with
“20” on the other side. The tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult 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.
3
Posology
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.
Maintenanc
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