Cabergoline ratiopharm 0,5 mg Tablett

Ország: Svédország

Nyelv: svéd

Forrás: Läkemedelsverket (Medical Products Agency)

Aktív összetevők:

kabergolin

Beszerezhető a:

ratiopharm GmbH

ATC-kód:

G02CB03

INN (nemzetközi neve):

cabergoline

Adagolás:

0,5 mg

Gyógyszerészeti forma:

Tablett

Összetétel:

laktos (vattenfri) Hjälpämne; kabergolin 0,5 mg Aktiv substans

Osztály:

Apotek

Recept típusa:

Receptbelagt

Terápiás terület:

Kabergolin

Termék összefoglaló:

Förpacknings: Burk, 15 tabletter; Burk, 16 tabletter; Burk, 20 tabletter; Burk, 96 tabletter; Burk, 32 tabletter; Burk, 14 tabletter; Burk, 30 tabletter; Burk, 28 tabletter; Burk, 40 tabletter; Burk, 48 tabletter; Burk, 50 tabletter; Burk, 100 tabletter; Burk, 2 tabletter; Burk, 90 tabletter; Burk, 60 tabletter; Burk, 8 tabletter

Engedélyezési státusz:

Godkänd

Engedély dátuma:

2006-06-16

Betegtájékoztató

1
PACKAGE LEAFLET: Information for the user
CABERGOLINE RATIOPHARM 0.5 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 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 ratiopharm is and what it is used for
2.
What you need to know before you take Cabergoline ratiopharm
3.
How to take Cabergoline ratiopharm
4.
Possible side effects
5.
How to store Cabergoline ratiopharm
6.
Contents of the pack and other information
1.
WHAT CABERGOLINE RATIOPHARM IS AND WHAT IT IS USED FOR
Cabergoline ratiopharm belongs to a group of medicines known as
prolactin inhibitors. Cabergoline
ratiopharm prevents lactation (production of milk) by decreasing
levels of a hormone known as prolactin.
Cabergoline ratiopharm can also be used to reduce abnormal quantities
of the hormone prolactin in the
blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE RATIOPHARM
DO NOT TAKE CABERGOLINE RATIOPHARM IF YOU

are allergic to cabergoline or other ergot alkaloids (e.g.
bromocriptine), or to any of the other
ingredients of this medicine (listed in section 6)

have (or have had in the past) psychosis or you are at risk of
psychosis after childbirth

have ever been diagnosed in the past with problems described as
fibrotic reactions affecting the lungs,
back of the abdomen and kidneys or heart

will be treated with Cabergoline ratiopharm for a long period and have
or had fibrotic reactions (scar
tissue) affecting your heart.
WARNINGS AND PRECAUTIONS
If you have any of the following health problems you must inform your
doctor before ta

Termékjellemzők

Pre-existing information not covered by the CSP is highlighted in
yellow
1
Produktinformationen för Cabergoline ratiopharm 0,5 mg tablett, MTnr
23663, 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.
Pre-existing information not covered by the CSP is highlighted in
yellow
2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabergoline ratiopharm 0.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg cabergoline.
Excipient: lactose 75.8 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, oval, flat tablets with bevelled edges. One side is smooth and
the other side has a dividing score line and
is debossed with ‘CBG’ and ‘0.5’ on either side of the score.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Inhibition of lactation for medical reasons.
Hyperprolactimaemic disorders
Prolactin secreting pituitary adenomas
Idiopathic hyperprolactinaemia
It is recommended that the medicinal product is initially prescribed
by an appropriate specialist or after
consulting a specialist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cabergoline is to be administered by the oral route.
In order to reduce the risk of gastrointestinal undesirable effects it
is recommended that cabergoline is taken with
meals for all therapeutic indications.
ADULTS
:
Treatment of hyperprolactinaemic disorders:
The recommended initial dosage is 0.5 mg cabergoline per week given in
one or two doses (e.g. on Monday and
Thursday) per week. The weekly dose should be increased gradually,
pr