Cabergoline 1A Farma 0,5 mg Tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

kabergolin

Dostopno od:

1A Farma A/S

Koda artikla:

G02CB03

INN (mednarodno ime):

cabergoline

Odmerek:

0,5 mg

Farmacevtska oblika:

Tablett

Sestava:

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

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Kabergolin

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2010-11-04

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABERGOLINE 1A FARMA 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 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
prolactin inhibitors.
Cabergoline 1A Farma prevents lactation (production of milk) by
decreasing levels of a hormone
known as prolactin.
CABERGOLINE 1A FARMA
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 1A FARMA
DO NOT TAKE CABERGOLINE 1A FARMA IF YOU:

are allergic to cabergoline or any of the other ingredients of this
medicine
(listed in section 6)

have psychosis, or a history of psychosis, or you are at risk of
psychosis after childbirth

will be treated with Cabergoline 1A Farma for a long period and
_have_
stiff and inflamed heart
valves (cardiac valvulopathy)

have ever been diagnosed in the past with a problem known as fibrosis
affecting the lungs, lower
back and kidneys or heart.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING CABERGOLINE 1A FARMA
If you have any of the following health problems you must inform your
doctor
BEFORE
taking
Cabergoline 1A Fa

Lastnosti izdelka

Produktinformationen för Cabergoline 1A Farma, 0,5 mg Tablett MTnr
42524, 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, 0,5 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0,5 mg cabergoline.
Excipient(s):
Each tablet contains 75, 9 mg anhydrous lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, oval, uncoated, biconvex tablet, scored and debossed with “C
1/2“ on one side
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.
The maximum dose is 3 mg cabergoline per day.
Treatment of hyperprolactinaemic disorders.
The recommended initial dosage of cabergoline is 0.5 mg per week given
in one (single 0.5
mg) or two (separate 0.25 mg) doses (e.g. on Monday and Thursday) per
week. The weekly
dose should be increased gradually, preferably by adding 0.5 mg per
week at monthly
intervals until an optimal therapeutic response is achieved. The
therapeutic dosage i