NORPROLAC 0.075 MG TABLETS

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

QUINAGOLIDE AS HYDROCHLORIDE

Tillgänglig från:

FERRING PHARMACEUTICALS LTD

ATC-kod:

G02CB04

Läkemedelsform:

TABLETS

Sammansättning:

QUINAGOLIDE AS HYDROCHLORIDE 0.075 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

FERRING GmbH ,GERMANY

Terapeutisk grupp:

QUINAGOLIDE

Terapiområde:

QUINAGOLIDE

Terapeutiska indikationer:

Second line treatment of hyperprolactinaemia (idiopathic or due to prolactin secreting micro- or macroadenoma) and its clinical manifestation (galactorrhoea, oligomenorrhea, infertility, reduced libido).

Tillstånd datum:

2010-09-30

Bipacksedel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
NORPROLAC
®
NORPROLAC
®
25 MCG
50 MCG
TABLETS
TABLETS
COMPOSITION:
COMPOSITION:
Each tablet contains:
Each tablet contains:
Quinagolide 25 mcg
Quinagolide 50 mcg
Lactose 90 mg
Lactose 90 mg
NORPROLAC
®
NORPROLAC
®
75 MCG
150 MCG
TABLETS
TABLETS
COMPOSITION:
COMPOSITION:
Each tablet contains:
Each tablet contains:
Quinagolide 75 mcg
Quinagolide 150 mcg
Lactose 87 mg
Lactose 174 mg
INACTIVE INGREDIENTS – see section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do
not pass it on to others. It may harm them, even if it seems to you
that their
ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine inhibits prolactin secretion.
THERAPEUTIC GROUP: Dopamine D
2
-receptor agonist.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
- Do not breastfeed while taking the medicine.
- Do not use this medicine if there is a known sensitivity to any of
the
medicine’s ingredients.
- Do not use this medicine in cases of impaired liver or kidney
function.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
- Consult with the doctor before beginning treatment if you are
pregnant.
- Consult with the doctor before beginning treatment if you suffer or
have
suffered in the past from: low blood pressure, psychotic disturbances.
- During treatment with this medicine, blood pressure tests should be
performed.
- If you are sensitive to any type of food, inform your doctor before
taking the
medicine.
- Inform your doctor if you or any of your family members notice that
you are
developing urges or cravings to behave in ways that are unusual for
you, or
if you cannot resist the impulse or temptation to carry out cert

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
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 micrograms contains: 25 micrograms of quinagolide as
quinagolide hydrochloride.
1 tablet 50 micrograms contains: 50 micrograms of quinagolide as
quinagolide hydrochloride.
1 tablet 75 micrograms contains: 75 micrograms of quinagolide as
quinagolide hydrochloride.
1 tablet 150 micrograms contains: 150 micrograms of quinagolide as
quinagolide hydrochloride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet 25 micrograms: 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.
Tablet 50 micrograms: 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.
Tablet 75 micrograms: White, circular, flat, bevelled edge, 7 mm in
diameter.
Inscriptions: “NORPROLAC” circular on one side and “75” linear
on
the other side.
Tablet 150 micrograms: 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
Second line treatment of hyperprolactinaemia (idiopathic or due to
prolactin-secreting micro- or macroadenoma) and its clinical
manifestation
(galactorrhoea, oligomenorrhoea, infertility, reduced libido).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 b