Pramipexole Orion 1,57 mg Depottablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

pramipexoldihydrokloridmonohydrat

Available from:

Orion Corporation

ATC code:

N04BC05

INN (International Name):

dihydrochloride monohydrate

Dosage:

1,57 mg

Pharmaceutical form:

Depottablett

Composition:

pramipexoldihydrokloridmonohydrat 2,25 mg Aktiv substans

Prescription type:

Receptbelagt

Product summary:

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

Authorization status:

Avregistrerad

Authorization date:

2018-02-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAMIPEXOLE ORION 0.26 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 0.52 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 1.05 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 1.57 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 2.1 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 2.62 MG PROLONGED-RELEASE TABLETS
PRAMIPEXOLE ORION 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 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 Pramipexole Orion is and what it is used for
2.
What you need to know before you take Pramipexole Orion
3.
How to take Pramipexole Orion
4.
Possible side effects
5.
How to store Pramipexole Orion
6.
Contents of the pack and other information
1.
WHAT PRAMIPEXOLE ORION IS AND WHAT IT IS USED FOR
Pramipexole Orion 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.
Pramipexole Orion 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 PRAMIPEXOLE ORION
DO NOT TAKE PRAMIPEXOLE ORION:
-
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 Pramipexole Orion. Te

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pramipexole Orion 0.26 mg prolonged-release tablets
Pramipexole Orion 0.52 mg prolonged-release tablets
Pramipexole Orion 1.05 mg prolonged-release tablets
Pramipexole Orion 1.57 mg prolonged-release tablets
Pramipexole Orion 2.1 mg prolonged-release tablets
Pramipexole Orion 2.62 mg prolonged-release tablets
Pramipexole Orion 3.15 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pramipexole Orion 0.26 mg prolonged-release tablets
Each prolonged-release tablet contains 0.375 mg pramipexole
dihydrochloride monohydrate
equivalent to 0.26 mg pramipexole.
Pramipexole Orion 0.52 mg prolonged-release tablets
Each prolonged-release tablet contains 0.75 mg pramipexole
dihydrochloride monohydrate equivalent
to 0.52 mg pramipexole.
Pramipexole Orion 1.05 mg prolonged-release tablets
Each prolonged-release tablet contains 1.5 mg pramipexole
dihydrochloride monohydrate equivalent
to 1.05 mg pramipexole.
Pramipexole Orion 1.57 mg prolonged-release tablets
Each prolonged-release tablet contains 2.25 mg pramipexole
dihydrochloride monohydrate equivalent
to 1.57 mg pramipexole.
Pramipexole Orion 2.1 mg prolonged-release tablets
Each prolonged-release tablet contains 3 mg pramipexole
dihydrochloride monohydrate equivalent to
2.1 mg pramipexole.
Pramipexole Orion 2.62 mg prolonged-release tablets
Each prolonged-release tablet contains 3.75 mg pramipexole
dihydrochloride monohydrate equivalent
to 2.62 mg pramipexole.
Pramipexole Orion 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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
2
Pramipexole Orion 0.26 mg prolonged-release tablets
White or near