Ditinell 0,060 mg/ 0,015 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk

Available from:

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

ATC code:

G03AA10

INN (International Name):

ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415),

Administration route:

Oraal gebruik

Therapeutic area:

Gestodene And Ethinylestradiol

Product summary:

Hulpstoffen: ALUMINIUMOXIDE 0-WATER; CELLULOSE, MICROKRISTALLIJN (E 460); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLACRILINE KALIUM; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); XANTHAANGOM (E 415);

Authorization date:

1900-01-01

Patient Information leaflet

1/15
PACKAGE LEAFLET: INFORMATION FOR THE USER
DITINELL 0,060 MG/ 0,015 MG FILMOMHULDE 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, ask your doctor 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 combined oral contraceptive tablet. You take it
to stop you getting pregnant.
The yellow tablets contain a small amount of two different female
hormones, 0.060 mg of gestodene,
and 0.015 mg of ethinylestradiol.
Contraceptive tablets that contain two hormones are called
‘combination tablets.’ Due to the small
amount of hormones, is a so-called light tablet.
The white tablets do not contain active substances (only inactive
ingredients or excipients) and are
known as placebo tablets.
Because both hormones in all tablets in the strip are combined in the
same amount, i

Summary of Product characteristics

1/19
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ditinell 0,060 mg/ 0,015 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each yellow active tablet contains 0.060 mg of gestodene and 0.015 mg
of ethinylestradiol.
The white placebo tablet does not contain active ingredients.
_ _
Excipients with known effect
The yellow active tablet contains 57.61 mg of lactose monohydrate and
0,042 mg of lecithin (soya).
The white tablet contains 70.897 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
yellow tablet is round, plain, and film-coated tablet
of 5.5 mm diameter.
The white tablet (placebo) is round and biconvex tablet of 5.5 mm
diameter.
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
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order
shown on the blister pack. Tablet taking is continuous. One tablet is
to be taken daily for 28 consecutive
days. Each subsequent pack is started the day after the last tablet of
the previous pack. Withdrawal
bleeding usually starts on day 2-3 after starting the placebo tablets
(last row) and may not have finished
before the next pack is started.
HOW TO START
2/19
•
No preceding hormonal contraceptive use in the past month
Tablet-taking has to start on day 1 of the women’s natural cycle
(i.e. the first day of her menstrual
bleeding).
•
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring or transdermal patch)
The woman should start with preferably on the day
after the last active ta