Dretinelle 0.02 mg/3 mg Film-coated Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ethinylestradiol; Drospirenone

Pieejams no:

Theramex Ireland Limited

ATĶ kods:

G03FA; G03FA17

SNN (starptautisko nepatentēto nosaukumu):

Ethinylestradiol; Drospirenone

Deva:

0.02 mg / 3 milligram(s)

Zāļu forma:

Film-coated tablet

Ārstniecības joma:

Progestogens and estrogens, fixed combinations; drospirenone and estrogen

Autorizācija statuss:

Not marketed

Autorizācija datums:

2009-10-09

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_DRETINELLE 0.02 MG/3 MG FILM-COATED TABLETS _
ETHINYLESTRADIOL/DROSPIRENONE
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,
even if their signs of illness are the same as yours.
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.
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”).
WHAT IS IN THIS LEAFLET
1.
WHAT DRETINELLE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRETINELLE
3.
HOW TO TAKE DRETINELLE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DRETINELLE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DRETINELLE IS AND WHAT IT IS USED FOR
Dretinelle is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones,
namely drospirenone and
ethinylestradiol.
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRETINELLE
GENERAL NOTES
Before you start using Dretinelle 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”.
2
Before you can begin taking Dretinelle, your doctor will ask

Produkta apraksts

Health Products Regulatory Authority
21 November 2022
CRN00D6KJ
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dretinelle 0.02 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient(s) with known effect:
Lactose monohydrate 44 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Dretinelle should take into consideration
the individual woman's current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with
Dretinelle compares with other combined hormonal
contraceptives CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE DRETINELLE 0.02 MG/3 MG FILM-COATED TABLETS
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. One tablet is to be taken daily for 21 consecutive days. Each
subsequent pack is started after a 7-day tablet-free interval,
during which time a withdrawal bleed usually occurs. This usually
starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
HOW TO START DRETINELLE 0.02 MG/3 MG FILM-COATED TABLETS

No preceding hormonal contraceptive use (in the past
month)Tablet-taking has to start on day 1 of the woman'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 Dretinelle 0.02 mg/3 mg
Film-coated Tablets preferably on the
day after the last active tablet (the last tablet containing the
active substances) of her previous COC, but at the
latest on the day following the usual tablet-free or placebo tablet
interval of her previous