Pramipexole Hexal 0,52 mg Depottablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

pramipexoldihydrokloridmonohydrat

Prieinama:

Hexal A/S

ATC kodas:

N04BC05

INN (Tarptautinis Pavadinimas):

dihydrochloride monohydrate

Dozė:

0,52 mg

Vaisto forma:

Depottablett

Sudėtis:

pramipexoldihydrokloridmonohydrat 0,75 mg Aktiv substans

Klasė:

Apotek

Recepto tipas:

Receptbelagt

Gydymo sritis:

Pramipexol

Produkto santrauka:

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

Autorizacija statusas:

Avregistrerad

Leidimo data:

2014-11-06

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
Pramipexole Hexal 0.26 mg prolonged-release tablets
Pramipexole Hexal 0.52 mg prolonged-release tablets
Pramipexole Hexal 1.05 mg prolonged-release tablets
Pramipexole Hexal 1.57 mg prolonged-release tablets
Pramipexole Hexal 2.1 mg prolonged-release tablets
Pramipexole Hexal 2.62 mg prolonged-release tablets
Pramipexole Hexal 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 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, or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pramipexole Hexal is and what it is used for
2.
What you need to know before you take Pramipexole Hexal
3.
How to take Pramipexole Hexal
4.
Possible side effects
5.
How to store Pramipexole Hexal
6.
Contents of the pack and other information
1.
WHAT PRAMIPEXOLE HEXAL IS AND WHAT IT IS USED FOR
Pramipexole Hexal 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 Hexal is used in adults 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 HEXAL
DO NOT TAKE PRAMIPEXOLE HEXAL
- 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
Pramipexole Hexal. Tell your doctor
IF YOU

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pramipexole Hexal 0.26 mg prolonged-release tablets
Pramipexole Hexal 0.52 mg prolonged-release tablets
Pramipexole Hexal 1.05 mg prolonged-release tablets
Pramipexole Hexal 1.57 mg prolonged-release tablets
Pramipexole Hexal 2.1 mg prolonged-release tablets
Pramipexole Hexal 2.62 mg prolonged-release tablets
Pramipexole Hexal 3.15 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 0.375 mg pramipexole
dihydrochloride monohydrate equivalent to
0.26 mg pramipexole.
Each prolonged-release tablet contains 0.75 mg pramipexole
dihydrochloride monohydrate equivalent to
0.52 mg pramipexole.
Each prolonged-release tablet contains 1.5 mg pramipexole
dihydrochloride monohydrate equivalent to 1.05
mg pramipexole.
Each prolonged-release tablet contains 2.25 mg pramipexole
dihydrochloride monohydrate equivalent to
1.57 mg pramipexole.
Each prolonged-release tablet contains 3 mg pramipexole
dihydrochloride monohydrate equivalent to 2.1 mg
pramipexole.
Each prolonged-release tablet contains 3.75 mg pramipexole
dihydrochloride monohydrate equivalent to
2.62 mg pramipexole.
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.
Pramipexole Hexal 0.26 mg prolonged-release tablets: The tablets of 9
mm are white or nearly white,
cylindrical, plans, with beveled edges and marked with 026 on one side
Pramipexole Hexal 0.52 mg prolonged-release tablets: The tablets of 10
mm are white or nearly white,
cylindrical, biconvex and marked with 052 on one side
Pramipexole Hexal 1.05 mg prolonged-release tablets: The tablets of 10
mm are white or nearly white,
cylin