Cabergoline 1A Farma 3 mg Tablett

国家: 瑞典

语言: 瑞典文

来源: Läkemedelsverket (Medical Products Agency)

有效成分:

kabergolin

可用日期:

1A Farma A/S

ATC代码:

N04BC06

INN（国际名称）:

cabergoline

剂量:

3 mg

药物剂型:

Tablett

组成:

laktos (vattenfri) Hjälpämne; kabergolin 3 mg Aktiv substans

类:

Apotek

处方类型:

Receptbelagt

治疗领域:

Kabergolin

授权状态:

Avregistrerad

授权日期:

2012-04-19

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABERGOLINE 1A FARMA 3 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 kidneys or heart.
Before you are give

产品特点

Produktinformationen för Cabergoline 1A Farma 3 mg tablett, MTnr
45933, 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, 3 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cabergoline 1A Farma, 3 mg, tablets: Each tablet contains 3 mg
cabergoline.
Excipient(s):
Cabergoline 1A Farma, 3 mg, tablets: Each tablet contains 226.2 mg
anhydrous lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Cabergoline 1A Farma, 3 mg, tablets:
White, round biconvex uncoated tablet with
tripartite score line on both sides.
Diameter 8.6 – 9.1 mm
.
The tablet can be divided into three equal parts.
_ _
See section 4.2 for detailed
information.
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
cabergo