Marynarka 0,075 mg/0,020 mg tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

ETHINYLESTRADIOL 0,02 mg/stuk ; GESTODEEN 0,075 mg/stuk

Available from:

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

ATC code:

G03AA10

INN (International Name):

ETHINYLESTRADIOL 0,02 mg/stuk ; GESTODEEN 0,075 mg/stuk

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oraal gebruik

Therapeutic area:

Gestodene And Ethinylestradiol

Product summary:

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

Authorization date:

2015-07-08

Patient Information leaflet

B. PACKAGE LEAFLET
1
LF-GSTDEE-NL-NL.H.2962.001.IB.019-D0
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MARYNARKA 0,075 MG/ 0,020 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 Marynarka is and what it is used for
2.
What you need to know before you take Marynarka
3.
How to take Marynarka
4.
Possible side effects
5.
How to store Marynarka
6.
Contents of the pack and other information
1.
WHAT MARYNARKA IS AND WHAT IT IS USED FOR
•
Marynarka 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 Marynarka that contain two hormones are
called “combination”
contraceptives.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARYNARKA
GENERAL NOTES
BEFORE YOU START USING MARYNARKA 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 yo

Summary of Product characteristics

SPC-GSTDEE-NL-NL.H.2962.001.IA.021-D0
1
SUMMARY OF PRODUCT CHARACTERISTICS
SPC-GSTDEE-NL-NL.H.2962.001.IA.021-D0
2
1.
NAME OF THE MEDICINAL PRODUCT
Marynarka 0,075 mg/0,020 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white tablet contains 0,075 mg gestodene and 0,020 mg
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 ‘
_34’ _
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Marynarka should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Marynarka 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 MARYNARKA
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 MARYNARKA
•
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 transderm