Nobabelle Cala 0.075 mg/0.030 mg tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

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

Available from:

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

ATC code:

G03AA10

INN (International Name):

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

Pharmaceutical form:

Tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLACRILINE KALIUM ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Gestodene And Ethinylestradiol

Product summary:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLACRILINE KALIUM; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Authorization date:

2015-07-08

Patient Information leaflet

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOBABELLE CALA 0.075 MG / 0.030 MG TABLETTEN
(21 ACTIVE PLUS 7 PLACEBO TABLETS)
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 blo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nobabelle Cala 0.075 mg / 0.030 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Each active white tablet contains 0.075 mg gestodene and 0.030 mg
ethinylestradiol.
Excipient with known effect
Each active white tablet contains 59.12 mg lactose monohydrate.
Each placebo green tablet contains 55.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
Active tablets: 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.
Placebo tablets: Round, green film-coated tablets, with a diameter of
5 mm approximately.
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 white active tablet per day
should be taken for 21 days and then a
green placebo tablet for the last 7 days. You must then start a new
pack straightaway (21 white and then 7
green tablets). There is therefore no gap between packs. A withdrawal
bleeding will occur usually on the 2
nd
or 3
rd
day taking the placebo green tablets, 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
recommen