Nobabelle 0.075 mg/0.030 mg tabletten

Nazione: Paesi Bassi

Lingua: olandese

Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Principio attivo:

ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk

Commercializzato da:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

Codice ATC:

G03AA10

INN (Nome Internazionale):

ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk

Forma farmaceutica:

Tablet

Composizione:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201), CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201),

Via di somministrazione:

Oraal gebruik

Area terapeutica:

Gestodene And Ethinylestradiol

Dettagli prodotto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLACRILINE KALIUM; POVIDON K 30 (E 1201);

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOBABELLE 0.075 MG / 0.030 MG TABLETTEN
Gestodene / Ethinylestradiol
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the first
year or when restarting a combined hormonal contraceptive following a
break of 4 or more weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see section 2
“Blood clots”).
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 or need more advice, ask your
doctor, family planning nurse, or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them.
-
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a contraceptive tablet and is used to prevent
pregnancy.
Each tablet contains a small amount of two different female hormones,
namely ethinylestradiol and
gestodene.
Contraceptive tablets as that contain two hormones are
called “combination”
contraceptives.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GENERAL NOTES
Before you start using you should read the information
on blood clots in section 2. It is
particularly important to read the symptoms of a blood clot – see
Section 2 “Blood clots”.
Before you can b

Scheda tecnica

2
1.
NAME OF THE MEDICINAL PRODUCT
Nobabelle 0.075 mg / 0.030 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white tablet contains 0.075 mg gestodene and 0.030 mg
ethinylestradiol.
Excipient with known effect
Each tablet contains 59.12 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Round, white tablets, with a diameter of 5.7 mm approximately. The
white tablet is debossed with a ‘
_C’_
on
one side and ‘
_33’_
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe should take into
consideration the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_How to take _
The tablets must be taken every day at approximately the same time, if
necessary with a little liquid, in the
order indicated on the blister pack. One tablet per day should be
taken for 21 days. Each subsequent pack
should be started after a 7-day tablet-free interval during which time
a withdrawal bleeding will occur. This
bleeding usually starts on the 2
nd
or 3
rd
day after taking the last tablet, and may not stop until the next pack
is
started.
_How to start taking _
_If no preceding hormonal contraceptive use in the past month _
Taking of the tablets should begin on the first day of the woman’s
natural cycle (i.e. on the first day of the
woman’s menstrual bleeding). One may begin taking the pills on day
2-5, but in these cases, it is
recommended that a barrier method also be used for the first 7 days on
which pills are taken during the first
cycle.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring, or _
_transdermal patch _
The woman should start taking on the next day after
taking the last active tablet in