Cabergoline Teva Pharma 1 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

kabergolin

Tillgänglig från:

Teva Pharma BV

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:

2006-06-16

Bipacksedel

1
PACKAGE LEAFLET: Information for the user
CABERGOLINE TEVA PHARMA 1 MG AND 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 Teva Pharma is and what it is used for
2.
What you need to know before you take Cabergoline Teva Pharma
3.
How to take Cabergoline Teva Pharma
4.
Possible side effects
5.
How to store Cabergoline Teva Pharma
6.
Contents of the pack and other information
1.
WHAT CABERGOLINE TEVA PHARMA IS AND WHAT IT IS USED FOR
Cabergoline Teva Pharma belongs to a group of medicines known as
dopamine agonists. Cabergoline
Teva Pharma 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.
Cabergoline Teva Pharma 1 mg and 2 mg is used to treat Parkinson’s
disease. It can be either taken alone
or in combination with levodopa plus decarboxylase inhibitor, as
second choice following non-ergot
derived therapies.
Treatment under a specialist is required.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE TEVA PHARMA
DO NOT TAKE CABERGOLINE TEVA PHARMA 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 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 Teva Pharma for a long period and
have or had fibrotic re

Produktens egenskaper

1
Produktinformationen för Cabergoline Teva Pharma, 1 mg tablett, MTnr
23671, 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 00200872, Version 3.3, Namn Cabergoline Teva
Pharma 1 mg tablet SmPC
2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabergoline CT 1 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg cabergoline.
Excipient: lactose 75.3 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
The tablet can be divided into equal halves.
White, oval, flat tablets with scores on both sides and bevelled
edges. One side is debossed with
‘CBG’ and ‘1’ on either side of the score.
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 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.
_ADUL