Oprymea
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
31-07-2023
Karatteristiċi tal-prodott
(SPC)
31-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
20-03-2018
Ingredjent attiv:
pramipexole dihydrochloride monohydrate
Disponibbli minn:
Krka, d.d., Novo mesto
Kodiċi ATC:
N04BC05
INN (Isem Internazzjonali):
pramipexole
Grupp terapewtiku:
Anti-Parkinson drugs
Żona terapewtika:
Parkinson Disease
Indikazzjonijiet terapewtiċi:
Oprymea 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, through 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).Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Sommarju tal-prodott:
Revision: 22
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2008-09-12
Fuljett ta 'informazzjoni
92
B. PACKAGE LEAFLET
93
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPRYMEA 0.088 MG TABLETS
OPRYMEA 0.18 MG TABLETS
OPRYMEA 0.35 MG TABLETS
OPRYMEA 0.7 MG TABLETS
OPRYMEA 1.1 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 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 Oprymea is and what it is used for
2.
What you need to know before you take Oprymea
3.
How to take Oprymea
4.
Possible side effects
5.
How to store Oprymea
6.
Contents of the pack and other information
1.
WHAT OPRYMEA IS AND WHAT IT IS USED FOR
Oprymea 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.
Oprymea 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 OPRYMEA
DO NOT TAKE OPRYMEA
-
if you are allergic to pramipexole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Oprymea. Tell your doctor if you
have or 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
visu
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Oprymea 0.088 mg tablets
Oprymea 0.18 mg tablets
Oprymea 0.35 mg tablets
Oprymea 0.7 mg tablets
Oprymea 1.1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oprymea 0.088 mg tablets
Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole
dihydrochloride monohydrate).
Oprymea 0.18 mg tablets
Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole
dihydrochloride monohydrate).
Oprymea 0.35 mg tablets
Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole
dihydrochloride monohydrate).
Oprymea 0.7 mg tablets
Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole
dihydrochloride monohydrate).
Oprymea 1.1 mg tablets
Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole
dihydrochloride monohydrate).
_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
Oprymea 0.088 mg tablets
White, round, with bevelled edges and imprint "P6" on one side of the
tablet.
Oprymea 0.18 mg tablets
White, oval, with bevelled edges, both sides scored, with imprint "P7"
on both halves of one side of
the tablet. The tablet can be divided into equal doses.
Oprymea 0.35 mg tablets
White, oval, with bevelled edges, both sides scored, with imprint "P8"
on both halves of one side of
the tablet. The tablet can be divided into equal doses.
Oprymea 0.7 mg tablets
White, round, with bevelled edges, both sides scored, with imprint
"P9" on both halves of one side of
the tablet. The tablet can be divided into equal doses.
Oprymea 1.1 mg tablets
White, round, with bevelled edges, both sides scored. The tablet can
be divided into equal doses.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oprymea is indicated in adults for treatment of the signs and symptoms
of idiopathic Parkinson's
disease, alone (without l
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