Rivastigmine Teva
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
27-09-2012
Produktets egenskaber
(SPC)
27-09-2012
Offentlige vurderingsrapport
(PAR)
27-09-2012
Aktiv bestanddel:
rivastigmine
Tilgængelig fra:
Teva Pharma B.V.
ATC-kode:
N06DA03
INN (International Name):
rivastigmine
Terapeutisk gruppe:
Anticholinesterases
Terapeutisk område:
Dementia; Alzheimer Disease; Parkinson Disease
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 4
Autorisation status:
Withdrawn
Autorisation dato:
2009-04-17
Indlægsseddel
B. PACKAGE LEAFLET
78
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVASTIGMINE TEVA 1.5 MG HARD CAPSULES
RIVASTIGMINE TEVA 3 MG HARD CAPSULES
RIVASTIGMINE TEVA 4.5 MG HARD CAPSULES
RIVASTIGMINE TEVA 6 MG HARD CAPSULES
Rivastigmine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Rivastigmine Teva is and what it is used for
2.
Before you take Rivastigmine Teva
3.
How to take Rivastigmine Teva
4.
Possible side effects
5.
How to store Rivastigmine Teva
6.
Further information
1.
WHAT RIVASTIGMINE TEVA IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine Teva is rivastigmine
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors.
Rivastigmine Teva is used for the treatment of memory disorders in
patients with Alzheimer’s disease.
It is also used for the treatment of dementia in patients with
Parkinson’s disease.
2.
BEFORE YOU TAKE RIVASTIGMINE TEVA
DO NOT TAKE RIVASTIGMINE TEVA
-
If you are allergic (hypersensitive) to rivastigmine (the active
substance in Rivastigmine Teva)
or to any of the other ingredients of Rivastigmine Teva listed in
section 6 of this leaflet
-
If this applies to you, tell your doctor and do not take Rivastigmine
Teva.
TAKE SPECIAL CARE WITH RIVASTIGMINE TEVA
-
if you have, or have ever had, irregular heartbeat.
-
if you have, or have ever had, an active stomach ulcer.
-
if you have, or have ever had, difficulties in passing urine.
-
if you have, or have ever had, seizures.
-
if you have, or have ever had, asthma or severe respiratory disease.
-
if you have, or have ever had,
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Produktets egenskaber
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Teva 1.5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate corresponding to
rivastigmine 1.5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
White cap imprinted with “R” & white body imprinted with “1.5”
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.
Rivastigmine should be administered twice a day, with morning and
evening meals. The capsules
should be swallowed whole.
Initial dose:
1.5 mg twice a day.
Dose titration
The starting dose is 1.5 mg twice a day. If the dose is well tolerated
after a minimum of two weeks of
treatment, the dose may be increased to 3 mg twice a day. Subsequent
increases to 4.5 mg and then
6 mg twice a day should also be based on good tolerability of the
current dose and may be considered
after a minimum of two weeks of treatment at that dose level.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of
appetite), weight decrease or
worsening of extrapyramidal symptoms (e.g. tremor) in patients with
dementia associated with
Parkinson’s disease are observed during treatment, these may respond
to omitting one or more doses.
If adverse reactions persist, the daily dose should be temporarily
reduced to the previous well-tol
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