Pipexus 3,15 mg Depottablett

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

pramipexoldihydrokloridmonohydrat

Commercializzato da:

Ethypharm SA

Codice ATC:

N04BC05

INN (Nome Internazionale):

dihydrochloride monohydrate

Dosaggio:

3,15 mg

Forma farmaceutica:

Depottablett

Composizione:

pramipexoldihydrokloridmonohydrat 4,5 mg Aktiv substans

Tipo di ricetta:

Receptbelagt

Dettagli prodotto:

Förpacknings: Blister, 10 tabletter; Blister, 30 tabletter; Blister, 100 tabletter

Stato dell'autorizzazione:

Avregistrerad

Data dell'autorizzazione:

2016-09-08

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
Pipexus 0.26 mg prolonged-release tablets
Pipexus 0.52 mg prolonged-release tablets
Pipexus 1.05 mg prolonged-release tablets
Pipexus 1.57 mg prolonged-release tablets
Pipexus 2.1 mg prolonged-release tablets
Pipexus 2.62 mg prolonged-release tablets
Pipexus 3.15 mg prolonged-release 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, pharmacist or
nurse .
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Pipexus is and what it is used for
2.
What you need to know before you take Pipexus
3.
How to take Pipexus
4.
Possible side effects
5.
How to store Pipexus
6.
Contents of the pack and other information
1.
WHAT PIPEXUS
IS AND WHAT IT IS USED FOR
Pipexus 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.
Pipexus 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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIPEXUS
DO NOT TAKE PIPEXUS
-
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 Pipexus. Tell your doctor if you
have (had) or develop any medical
conditions or symptoms, especially any of the following:
-
Kidney disease.
-
Hallucinations (seeing, he

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pipexus 0.26 mg prolonged-release tablets
Pipexus 0.52 mg prolonged-release tablets
Pipexus 1.05 mg prolonged-release tablets
Pipexus 1.57 mg prolonged-release tablets
Pipexus 2.1 mg prolonged-release tablets
Pipexus 2.62 mg prolonged-release tablets
Pipexus 3.15 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pipexus 0.26 mg prolonged-release tablets
Each prolonged-release tablet contains 0.375 mg pramipexole
dihydrochloride monohydrate equivalent to
0.26 mg pramipexole.
Pipexus 0.52 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg pramipexole
dihydrochloride monohydrate equivalent to
0.52 mg pramipexole.
Pipexus 1.05 mg prolonged-release tablets
Each prolonged-release tablet contains 1.5 mg pramipexole
dihydrochloride monohydrate equivalent to 1.05
mg pramipexole.
Pipexus 1.57 mg prolonged-release tablets
Each prolonged-release tablet contains 2.25 mg pramipexole
dihydrochloride monohydrate equivalent to
1.57 mg pramipexole.
Pipexus 2.10 mg prolonged-release tablets
Each prolonged-release tablet contains 3 mg pramipexole
dihydrochloride monohydrate equivalent to 2.1 mg
pramipexole.
Pipexus 2.62 mg prolonged-release tablets
Each prolonged-release tablet contains 3.75 mg pramipexole
dihydrochloride monohydrate equivalent to
2.62 mg pramipexole.
Pipexus 3.15 mg prolonged-release tablets
Each prolonged-release tablet contains 4.5 mg pramipexole
dihydrochloride monohydrate equivalent to 3.15
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).
2
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Pipexus 0.26 mg prolonged-release tablets
The round tablets of 9 mm diameter are white or nearly white, have a
flat surface with bevelled edges and
are marked with 026 on one side
Pipexus 0.52 mg prolonge