Norprolac 75 mikrogram Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

kinagolidhydroklorid

Tillgänglig från:

Orifarm AB

ATC-kod:

G02CB04

INN (International namn):

kinagolidhydroklorid

Dos:

75 mikrogram

Läkemedelsform:

Tablett

Sammansättning:

kinagolidhydroklorid 82 mikrog Aktiv substans; laktosmonohydrat Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 30 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2017-08-30

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORPROLAC 25 MICROGRAM + 50 MICROGRAM TABLETS
NORPROLAC 75 MICROGRAM TABLETS
NORPROLAC 150 MICROGRAM TABLETS
Quinagolide
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 Norprolac is and what it is used for
2. What you need to know before you take Norprolac
3. How to take Norprolac
4. Possible side effects
5. How to store Norprolac
6. Contents of the pack and other information
1. WHAT NORPROLAC IS AND WHAT IT IS USED FOR
Norprolac contains quinagolide which belongs to a group of medicines
known as prolactin inhibitors.
Quinagolide reduces the secretion of the hormone prolactin.
Norprolac is used to treat elevated levels of prolactin caused by
prolactin-secreting tumours of the pituitary
gland or by unknown causes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORPROLAC
DO NOT TAKE NORPROLAC:
- if you are allergic to quinagolide or any of the other ingredients
of this medicine (listed in section 6).
- if you have severely impaired kidney or liver function.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Norprolac
- if you have a prolactin-related fertility disorder, as fertility may
be restored by treatment with Norprolac.
Women of child-bearing age who do not wish to become pregnant should
use a reliable method of
contraception during treatment with Norprolac. (See also section
“Pregnancy, breast-feeding and fertility”.)
- if you have any of the following diseases: psychiatric disorders or
impaired liver or kidney function.
- if yo

Produktens egenskaper

1.
NAME OF THE MEDICINAL PRODUCT
NORPROLAC 25 microgram + 50 microgram tablets
NORPROLAC 75 microgram tablets
NORPROLAC 150 microgram tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet 25 microgram contains: 25 microgram of quinagolide as
quinagolide hydrochloride.
1 tablet 50 microgram contains: 50 microgram of quinagolide as
quinagolide hydrochloride.
1 tablet 75 microgram contains: 75 microgram of quinagolide as
quinagolide hydrochloride.
1 tablet 150 microgram contains:150 microgram of quinagolide as
quinagolide hydrochloride.
Excipient(s) with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
25 microgram:
Light pink with isolated pigment spots, circular, flat, bevelled edge,
7 mm in
diameter. Inscriptions: “NORPROLAC” circular on one side and
“25” linear on the
other side.
50 microgram:
Light blue with isolated pigment spots, circular, flat, bevelled edge,
7 mm in
diameter. Inscriptions: “NORPROLAC” circular on one side and
“50” linear on the
other side.
75 microgram:
White, circular, flat, bevelled edge, 7 mm in diameter.
Inscriptions:
“NORPROLAC” circular on one side and “75” linear on the other
side.
150 microgram:
White, circular, flat, bevelled edge, 9 mm in diameter.
Inscriptions:
“NORPROLAC” circular on one side and “150” linear on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hyperprolactinaemia (idiopathic or originating from a
prolactin-secreting pituitary microadenoma or
macroadenoma).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Since dopaminergic stimulation may lead to symptoms of orthostatic
hypotension, the dosage of
NORPROLAC should be initiated gradually with the aid of the titration
pack, and given once daily in the
evening with food. The optimal dose must be titrated individually on
the basis of the prolactin-lowering
effect and tolerability.
_Adults_
With the titration pack treatment begins with 25 micrograms/day for
the first 3 days, followed by 50
micro