Cabarsuss 1 mg Tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

kabergolin

Available from:

Hexal A/S

ATC code:

N04BC06

INN (International Name):

cabergoline

Dosage:

1 mg

Pharmaceutical form:

Tablett

Composition:

laktos (vattenfri) Hjälpämne; kabergolin 1 mg Aktiv substans

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Kabergolin

Authorization status:

Avregistrerad

Authorization date:

2010-11-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABARSUSS 1 MG TABLETS
CABARSUSS 2 MG TABLETS
cabergoline
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
CABARSUSS
is and what it is used for
2. What you need to know before you take
CABARSUSS
3. How to take
CABARSUSS
4. Possible side effects
5. How to store
CABARSUSS
6. Contents of the pack and other information
1. WHAT CABARSUSS IS AND WHAT IT IS USED FOR
CABARSUSS
belongs to a group of medicines known as dopamine agonists. It
acts in a similar
way to a chemical present in the nervous system called dopamine.
Patients with Parkinson’s
disease do not have enough of this important chemical in their body.
CABARSUSS
is used to treat Parkinson’s disease. It can be used either taken
alone or in
combination with levodopa, as second choice following non-ergot
derived therapies.
Treatment by a specialist is required with regular checks.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABARSUSS
DO NOT TAKE CABARSUSS IF YOU:

are allergic to cabergoline or other ergot alkaloid medicines (e.g.
bromocriptine) or any of
the other ingredients of this medicine (
_see Section 6 and end of Section 2_
)

will be treated with
CABARSUSS
for a long period and
_have_
or had fibrotic reactions (scar
tissue) affecting your heart

have ever been diagnosed in the past with a problem known as fibrosis
affecting the lungs,
lower back and kidneys or heart.
Before you are given
CABARSUSS
your doctor will arrange for you to have tests to assess the
condition of your heart.

Summary of Product characteristics

Produktinformationen för Cabarsuss, 1 mg och 2 mg Tablett, MTnr 42522
och 42523, 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.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cabarsuss, 1 mg, tablets
Cabarsuss, 2 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cabarsuss, 1 mg, tablets: Each tablet contains 1 mg cabergoline.
Cabarsuss, 2 mg, tablets: Each tablet contains 2 mg cabergoline.
Excipient(s):
Cabarsuss, 1 mg, tablets: Each tablet contains 75, 4 mg anhydrous
lactose.
Cabarsuss, 2 mg, tablets: Each tablet contains 150, 8 mg anhydrous
lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Cabarsuss, 1 mg, tablets: White, oval, uncoated, biconvex tablet,
scored and debossed with “C
1“ on one side.
Cabarsuss, 2 mg, tablets: White, oval, uncoated, biconvex tablet,
scored and debossed with “C
2“ on one side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Parkinson's disease.
If treatment with a dopamine agonist is being considered, cabergoline
is indicated as second
line therapy in patients who are intolerant or fail treatment with a
non-ergot compound, as
monotherapy, or as adjunctive treatment to levodopa plus
dopa-decarboxylase inhibitor, in the
management of the signs and symptoms of Parkinson's disease.
Treatment should be initiated under specialist supervision. The
benefit of continued treatment
should be regularly reassessed taking into account the risk of
fibrotic reactions and
valvulopathy (see sections 4.3, 4.4 and 4.8).
4.2
POSOLOGY AND