Rivastigmine Sandoz
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-09-2023
Charakterystyka produktu
(SPC)
25-09-2023
Sprawozdanie z oceny publicznego
(PAR)
06-02-2013
Składnik aktywny:
rivastigmine
Dostępny od:
Sandoz GmbH
Kod ATC:
N06DA03
INN (International Nazwa):
rivastigmine
Grupa terapeutyczna:
Psychoanaleptics,
Dziedzina terapeutyczna:
Dementia; Alzheimer Disease; Parkinson Disease
Wskazania:
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2009-12-10
Ulotka dla pacjenta
53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVASTIGMINE SANDOZ 1.5 MG HARD CAPSULES
RIVASTIGMINE SANDOZ 3 MG HARD CAPSULES
RIVASTIGMINE SANDOZ 4.5 MG HARD CAPSULES
RIVASTIGMINE SANDOZ 6 MG HARD CAPSULES
rivastigmine
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 Rivastigmine Sandoz is and what it is used for
2.
What you need to know before you take Rivastigmine Sandoz
3.
How to take Rivastigmine Sandoz
4.
Possible side effects
5.
How to store Rivastigmine Sandoz
6.
Contents of the pack and other information
1.
WHAT RIVASTIGMINE SANDOZ IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine Sandoz is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. In patients with
Alzheimer’s dementia or dementia due to Parkinson’s disease,
certain nerve cells die in the brain,
resulting in low levels of the neurotransmitter acetylcholine (a
substance that allows nerve cells to
communicate with each other). Rivastigmine works by blocking the
enzymes that break down
acetylcholine: acetylcholinesterase and butyrylcholinesterase. By
blocking these enzymes,
Rivastigmine Sandoz allows levels of acetylcholine to be increased in
the brain, helping to reduce the
symptoms of Alzheimer’s disease and dementia associated with
Parkinson’s disease.
Rivastigmine Sandoz is used for the treatment of adult patients with
mild to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affects memory, intellectual a
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Sandoz 1.5 mg hard capsules
Rivastigmine Sandoz 3 mg hard capsules
Rivastigmine Sandoz 4.5 mg hard capsules
Rivastigmine Sandoz 6 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6 mg rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Off-white to slightly yellow powder in a capsule with yellow cap and
yellow body, with red imprint
“RIV 1.5 mg” on the body.
Off-white to slightly yellow powder in a capsule with orange cap and
orange body, with red imprint
“RIV 3 mg” on the body.
Off-white to slightly yellow powder in a capsule with red cap and red
body, with white imprint
“RIV 4.5 mg” on the body.
Off-white to slightly yellow powder in a capsule with red cap and
orange body, with red imprint
“RIV 6 mg” on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderately severe Alzheimer’s
dementia.
Symptomatic treatment of mild to moderately severe dementia in
patients with idiopathic Parkinson’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 or dementia associated with
Parkinson’s disease. Diagnosis should
be made according to current guidelines. Therapy with rivastigmine
should only be started if a
caregiver is available who will regularly monitor intake of the
medicinal product by the patient.
Posology
Rivastigmine should be administered twice a day, with morning and
evening meals. The capsules
should be swallowed whole.
Initial dose
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