SIFROL ER 0.375 mg

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Beschikbaar vanaf:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC-code:

N04BC05

farmaceutische vorm:

TABLETS EXTENDED RELEASE

Samenstelling:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.375 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Therapeutische categorie:

PRAMIPEXOLE

Therapeutisch gebied:

PRAMIPEXOLE

therapeutische indicaties:

Treatment of signs and symptoms of idiopathic Parkinson's disease, as monotherapy or in combination with levodopa.

Autorisatie datum:

2015-11-30

Bijsluiter

Sifrol ER
Updated Patient Information Leaflet
0.375,0.75,1.5 mg
April 2020
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied upon physician’s prescription only
SIFROL
® ER 0.375
SIFROL
® ER 0.75
SIFROL
® ER 1.5
EXTENDED-RELEASE TABLETS
Each tablet of Sifrol ER 0.375 contains pramipexole dihydrochloride
monohydrate 0.375 mg
Each tablet of Sifrol ER 0.75 contains pramipexole dihydrochloride
monohydrate 0.75 mg
Each tablet of Sifrol ER 1.5 contains pramipexole dihydrochloride
monohydrate 1.5 mg
*For the list of inactive ingredients and allergens in the medicine -
see section 6, "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains essential information about
this medicine. If you have any further questions, refer to the
physician or the pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may harm them, even if it
seems to you that their medical condition is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is indicated for the treatment of the signs and symptoms
of Parkinson's disease (alone or
in
combination with levodopa).
THERAPEUTIC GROUP: medicines that activate the dopamine receptor
(dopaminergic medicines).
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients that this medicine
contains (for the list of inactive ingredients, see section 6).
•
You are breastfeeding.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE TAKING SIFROL ER, TELL YOUR PHYSICIAN IF you have (had) or if
you develop any symptoms or medical
conditions, especially any of the following:
•
Kidney disease.
•
Hallucinations (seeing, hearing or feeling things that are not there).
Most hallucinations are visual.
•
You suffer from dyskinesia (e.g. abnormal, uncontrolled movements of
the limbs). If you have advanced
Parkinson’s disease and are taking

Productkenmerken

Sifrol ER
Updated Prescribing Information
0.375,0.75,1.5 mg
April 2020
1
PRODUCT INFORMATION
SIFROL ER
PRAMIPEXOLE
EXTENDED-RELEASE TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
SIFROL ER 0.375 MG EXTENDED-RELEASE TABLETS
SIFROL ER 0.75 MG EXTENDED-RELEASE TABLETS
SIFROL ER 1.5 MG EXTENDED-RELEASE TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sifrol ER 0.375 extended-release tablet contains 0.375 mg
pramipexole dihydrochloride
monohydrate equivalent to 0.26 mg pramipexole.
Each Sifrol ER 0.75 extended-release tablet contains 0.75 mg
pramipexole dihydrochloride
monohydrate equivalent to 0.52 mg pramipexole.
Each Sifrol ER 1.5 extended-release tablet contains 1.5 mg pramipexole
dihydrochloride monohydrate
equivalent to 1.05 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
EXTENDED-RELEASE TABLETS.
The tablets are white to off-white and have a code embossed.
STRENGTH (MG SALT)
APPEARANCE
Sifrol ER 0.375
round, with bevelled edges, code embossed (one side with code P1 and
one
side with the Boehringer Ingelheim company symbol).
Sifrol ER 0.75
round, with bevelled edges, code embossed (one side with code P2 and
one
side with the Boehringer Ingelheim company symbol).
Sifrol ER 1.5
oval, code embossed (one side with code P3 and one side with the
Boehringer
Ingelheim company symbol).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SIFROL is indicated for treatment of signs and symptoms of idiopathic
Parkinson’s disease, as
monotherapy or in combination with levodopa.
Sifrol ER
Updated Prescribing Information
0.375,0.75,1.5 mg
April 2020
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
SIFROL extended-release tablets are a once-a-day oral formulation of
pramipexole.
Initial treatment
Doses should be increased gradually from a starting dose of 0.375 mg
of salt (0.26 mg of base)