Sifrol
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
23-01-2024
Fachinformation
(SPC)
23-01-2024
Öffentlichen Beurteilungsberichts
(PAR)
05-01-2011
Wirkstoff:
pramipexole dihydrochloride monohydrate
Verfügbar ab:
Boehringer Ingelheim International GmbH
ATC-Code:
N04BC05
INN (Internationale Bezeichnung):
pramipexole
Therapiegruppe:
Anti-Parkinson drugs
Therapiebereich:
Restless Legs Syndrome; Parkinson Disease
Anwendungsgebiete:
Sifrol is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Produktbesonderheiten:
Revision: 37
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1997-10-13
Gebrauchsinformation
67
B. PACKAGE LEAFLET
68
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIFROL 0.088 MG TABLETS
SIFROL 0.18 MG TABLETS
SIFROL 0.35 MG TABLETS
SIFROL 0.7 MG TABLETS
pramipexole
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 of the 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 SIFROL is and what it is used for
2.
What you need to know before you take SIFROL
3.
How to take SIFROL
4.
Possible side effects
5.
How to store SIFROL
6.
Contents of the pack and other information
1.
WHAT SIFROL IS AND WHAT IT IS USED FOR
SIFROL contains the active substance pramipexole and belongs to a
group of medicines known as
dopamine agonists, which stimulate dopamine receptors in the brain.
Stimulation of the dopamine
receptors triggers nerve impulses in the brain that help to control
body movements.
SIFROL IS USED TO:
-
treat the symptoms of primary Parkinson’s disease in adults. It can
be used alone or in
combination with levodopa (another medicine for Parkinson’s
disease).
-
treat the symptoms of moderate to severe primary Restless Legs
Syndrome in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIFROL
DO NOT TAKE SIFROL
-
if you are allergic to pramipexole or to any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking SIFROL. Tell your doctor if you have
(had) or develop any medical
conditions or symptoms, especially any of the following:
-
Kidney disease.
-
Hallucinations (seeing, hearing or feeling things that are not there).
Most hallucinations are visual.
-
Dyskinesia (e.g. abnormal
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
SIFROL 0.088 mg tablets
SIFROL 0.18 mg tablets
SIFROL 0.35 mg tablets
SIFROL 0.7 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIFROL 0.088 mg tablets
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate
equivalent to 0.088 mg
pramipexole.
SIFROL 0.18 mg tablets
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate
equivalent to 0.18 mg
pramipexole.
SIFROL 0.35 mg tablets
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate
equivalent to 0.35 mg
pramipexole.
SIFROL 0.7 mg tablets
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate
equivalent to 0.7 mg
pramipexole.
_Please note:_
Pramipexole doses as published in the literature refer to the salt
form.
Therefore, doses will be expressed in terms of both pramipexole base
and pramipexole salt (in
brackets).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
SIFROL 0.088 mg tablets
The tablets are white, flat, of round shape, and have a code embossed
(one side with the code P6, and
one side with the Boehringer Ingelheim company symbol).
SIFROL 0.18 mg tablets
The tablets are white, flat, of oval shape, scored on both sides, and
have a code embossed (one side
with the code P7, and one side with the Boehringer Ingelheim company
symbol).
Tablets can be divided into equal halves.
SIFROL 0.35 mg tablets
The tablets are white, flat, of oval shape, scored on both sides, and
have a code embossed (one side
with the code P8, and one side with the Boehringer Ingelheim company
symbol).
Tablets can be divided into equal halves.
SIFROL 0.7 mg tablets
The tablets are white, flat, of round shape, scored on both sides, and
have a code embossed (one side
with the code P9, and one side with the Boehringer Ingelheim company
symbol).
Tablets can be divided into equal halves.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SIFROL is indicated in adults for treatment of the signs and symptoms
of idiopathic
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