Calmolan 0,26 mg Depottablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

pramipexoldihydrokloridmonohydrat

Available from:

G.L. Pharma GmbH

ATC code:

N04BC05

INN (International Name):

dihydrochloride monohydrate

Dosage:

0,26 mg

Pharmaceutical form:

Depottablett

Composition:

pramipexoldihydrokloridmonohydrat 0,375 mg Aktiv substans

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Pramipexol

Product summary:

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

Authorization status:

Godkänd

Authorization date:

2014-01-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Calmolan 0.26 mg prolonged-release tablets
Calmolan 0.52 mg prolonged-release tablets
Calmolan 1.05 mg prolonged-release tablets
Calmolan 1.57 mg prolonged-release tablets
Calmolan 2.1 mg prolonged-release tablets
Calmolan 2.62 mg prolonged-release tablets
Calmolan 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 Calmolan is and what it is used for
2.
What you need to know before you take Calmolan
3.
How to take Calmolan
4.
Possible side effects
5.
How to store Calmolan
6.
Contents of the pack and other information
1.
WHAT CALMOLAN IS AND WHAT IT IS USED FOR
Calmolan 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.
Calmolan 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 CALMOLAN
DO NOT TAKE CALMOLAN
- 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 Calmolan. Tell your doctor if you
have (had) or develop any medical
conditions or symptoms, especially any of the following:
- Kidney disease.
- Hallucinations (seeing, he

Summary of Product characteristics

Page 1 of 13
Produktinformationen för Calmolan 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg,
2,1 mg, 2,62 mg, 3,15 mg
depottablett, MTnr 48395, 48396, 48397, 48398, 48399, 48400, 48401,
gäller vid det tillfälle då läkemedlet
godkändes. Informationen kommer inte att uppdateras eftersom
läkemedlet inte marknadsförs i Sverige. Av
samma anledning finns inte någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige är
referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror det på
att läkemedlet i Sverige är godkänt under ett annat namn.
PDF rendering: Titel 00848887, Version 0.2, Namn Calmolan
prolonged-release tablet SmPC
Page 2 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calmolan 0.26 mg prolonged-release tablets
Calmolan 0.52 mg prolonged-release tablets
Calmolan 1.05 mg prolonged-release tablets
Calmolan 1.57 mg prolonged-release tablets
Calmolan 2.1 mg prolonged-release tablets
Calmolan 2.62 mg prolonged-release tablets
Calmolan 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:_
Prami