Cabarsuss 0,5 mg Tablett

Țară: Suedia

Limbă: suedeză

Sursă: Läkemedelsverket (Medical Products Agency)

Ingredient activ:

kabergolin

Disponibil de la:

Hexal A/S

Codul ATC:

G02CB03

INN (nume internaţional):

cabergoline

Dozare:

0,5 mg

Forma farmaceutică:

Tablett

Compoziție:

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

Clasă:

Apotek

Tip de prescriptie medicala:

Receptbelagt

Zonă Terapeutică:

Kabergolin

Statutul autorizaţiei:

Avregistrerad

Data de autorizare:

2010-11-04

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABARSUSS 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 Cabarsuss
is and what it is used for
2. What you need to know before you take Cabarsuss
3. How to take Cabarsuss
4. Possible side effects
5. How to store Cabarsuss
6. Contents of the pack and other information
1. WHAT CABARSUSS IS AND WHAT IT IS USED FOR
Cabarsuss
belongs to a group of medicines known as prolactin inhibitors.
Cabarsuss
prevents lactation (production of milk) by decreasing levels of a
hormone known as
prolactin.
Cabarsuss
can also be used to reduce abnormal quantities of the hormone
prolactin in the
blood.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABARSUSS
DO NOT TAKE CABARSUSS 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 Cabarsuss 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 CABARSUSS
If you have any of the following health problems you must inform your
doctor
BEFORE
taking
Cabarsuss
as this medicine may be unsuitable for you:

cardiovascular disease

stomach ulcer or bleeding in the gastrointestinal tract (this
condition can

Caracteristicilor produsului

Produktinformationen för Cabarsuss, 0,5 mg Tablett, MTnr 42521,
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
Cabarsuss, 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 is usually 1
mg caberg