Cabergoline 1A Farma 1 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

kabergolin

Tillgänglig från:

1A Farma A/S

ATC-kod:

N04BC06

INN (International namn):

cabergoline

Dos:

1 mg

Läkemedelsform:

Tablett

Sammansättning:

laktos (vattenfri) Hjälpämne; kabergolin 1 mg Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Kabergolin

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2010-11-04

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABERGOLINE 1A FARMA 1 MG TABLETS
CABERGOLINE 1A FARMA 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 Cabergoline 1A Farma
is and what it is used for
2. What you need to know before you take Cabergoline 1A Farma
3. How to take Cabergoline 1A Farma
4. Possible side effects
5. How to store Cabergoline 1A Farma
6. Contents of the pack and other information
1. WHAT CABERGOLINE 1A FARMA IS AND WHAT IT IS USED FOR
Cabergoline 1A Farma 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.
Cabergoline 1A Farma 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 CABERGOLINE 1A FARMA
DO NOT TAKE CABERGOLINE 1A FARMA 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 Cabergoline 1A Farma 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 kid

Produktens egenskaper

Produktinformationen för Cabergoline 1A Farma, 1 mg och 2 mg Tablett
MTnr 42525 och 42526, 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
Cabergoline 1A Farma, 1 mg, tablets
Cabergoline 1A Farma, 2 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cabergoline 1A Farma, 1 mg, tablets: Each tablet contains 1 mg
cabergoline.
Cabergoline 1A Farma, 2 mg, tablets: Each tablet contains 2 mg
cabergoline.
Excipient(s):
Cabergoline 1A Farma, 1 mg, tablets: Each tablet contains 75, 4 mg
anhydrous lactose.
Cabergoline 1A Farma, 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
Cabergoline 1A Farma, 1 mg, tablets: White, oval, uncoated, biconvex
tablet, scored and
debossed with “C 1“ on one side.
Cabergoline 1A Farma, 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