Nhytida 0,075 mg/0,030 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

Laboratorios Leon Farma, S.A. C/La Vallina s/n, Pol. Ind. 24008 NAVATEJERA (SPANJE)

ATC-code:

G03AA10

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Gestodene And Ethinylestradiol

Product samenvatting:

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

Autorisatie datum:

1900-01-01

Bijsluiter

LF-GESTEE-NL-NL.H.2961.02.IA.019-D0
B. PACKAGE LEAFLET
LF-GESTEE-NL-NL.H.2961.002.IA.019&II.013-D0
2
PACKAGE LEAFLET: INFORMATION FOR THE USER NHYTIDA 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 lealfet. See section 4. WHAT IS IN THIS LEAFLET
1. What Nhytida is and what it is used for
2. What you need to know before you take Nhytida
3. How to take Nhytida
4. Possible side effects
5. How to store Nhytida
6. Contents of the pack and other information
1.
WHAT NHYTIDA IS AND WHAT IT IS USED FOR
• Nhytida 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 Nhytida that contain two hormones are
called “combination” contraceptives.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NHYTIDA
GENERAL NOTES
Before you start using Nhytida 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
“Bl

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
SPC-GSTDEE-NL-NL.H.2961.002.IA.019 & II.013-D0
1
SPC-GESTEE-NL-NL.H.2961.002.IA.019&II.013-D0
2
1.
NAME OF THE MEDICINAL PRODUCT
NHYTIDA 0,075 MG / 0,030 MG TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white tablet contains 0,075 mg gestodene and 0,030mg
ethinylestradiol
Excipients with known effect:
Each tablet contains 59.12 mg lactose monohydrate. For the full list
of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Nhytida should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Nhytida compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
_How to take Nhytida _
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 Nhytida _
_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,