DOSTINEX

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

CABERGOLINE

Saadav alates:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC kood:

N04BC06

Ravimvorm:

TABLETS

Koostis:

CABERGOLINE 0.5 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

PFIZER ITALIA S.R.L, ITALY

Terapeutiline rühm:

CABERGOLINE

Terapeutiline ala:

CABERGOLINE

Näidustused:

Treatment of hyperprolactinemic disorders.Dostinex is indicated for the treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea. Dostinex is indicated in patients with prolactin-secreting pituitary adenomas (micro-and macroprolactinomas), idiopathic hyperprolactinemia, or empty sella syndrome with associated hyperprolactinemia. Inhibition and supression of lactation .

Loa andmise kuupäev:

2023-08-31

Infovoldik

Dostinex PIL CC 240621
2021-0070329
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
DOSTINEX
®
TABLETS
EACH TABLET CONTAINS:
CABERGOLINE 0.5 MG
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this medicine’s
ingredients’ and section 6 ‘Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
The medicine supresses production of prolactin and is indicated for
the treatment of
hyperprolactinemia and to prevent/stop breast milk production.
THERAPEUTIC GROUP:
Dopamine receptor agonist.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to cabergoline, other medicines called
ergot alkaloids (e.g. pergolide,
bromocriptine, lisuride, ergotamine or ergometrine) or to any of the
other ingredients of this medicine
(listed in section 6).
•
you have severe liver disease.
•
you have high blood pressure in pregnancy associated with swelling and
protein in the urine (toxaemia of
pregnancy).
•
you are being treated with anti-psychotics or have a history of mental
illness associated with child-birth
(puerperal psychosis).
•
you are pregnant or breastfeeding.
•
you will be treated with Dostinex
®
for a long period and have stiff and inflamed heart valves (cardiac
valvulopathy).
•
you have had fibrotic reactions (scar tissue) affecting your abdomen,
heart or lungs.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DOSTINEX
®
, TELL YOUR DOCTOR IF YOU HAVE OR HAD ANY OF THE FOLLOWING CONDITIONS:
•
Disease that involves the heart and blood vessels (ca

Toote omadused

Dostinex LPD CC 311220
Page 1 of 11
2013-0003257, 2016-0018531, 2019-0056084
DOSTINEX
®
1.
NAME OF THE MEDICINAL PRODUCT
Dostinex
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One Dostinex
®
tablet contains 0.5 mg cabergoline.
Excipients with known effect:
Each tablet contains 75.90 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, flat, oblong, white engraving "PU" divided by a score on one
side; engraving "700"
and light score above and below the central "0" on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of hyperprolactinemic disorders.
Dostinex
®
is indicated for the treatment of dysfunctions associated with
hyperprolactinemia,
including amenorrhea, oligomenorrhea, anovulation and galactorrhea.
Dostinex
®
is indicated in patients with prolactin-secreting pituitary adenomas
(micro-and
macroprolactinomas), idiopathic hyperprolactinemia, or empty sella
syndrome with associated
hyperprolactinemia. Inhibition and suppression of lactation.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dostinex
®
is to be administered by the oral route. Since the tolerability of
this class of
compounds is improved with food, it is recommended that Dostinex
®
be preferably taken with
meals for all the therapeutic indications.
In patients known to be intolerant to dopaminergic drugs, the
likelihood of adverse events
may be lessened by starting therapy with Dostinex
®
at reduced doses (e.g., 0.25 mg once a
week) with subsequent gradual increase until the therapeutic dosage is
reached. If persistent
or severe adverse events occur, temporary reduction of dosage followed
by a more gradual
increase (e.g., increments of 0.25 mg per week every two weeks) may
increase tolerability.
Inhibition/suppression of physiological lactation
For inhibition of lactation Dostinex
®
should be administered during the first day post-partum.
The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as
a single dose.
For suppression of established lacta