DRETINE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DROSPIRENONE ; ETHINYLESTRADIOL

Available from:

Teva Pharma B.V.

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE ; ETHINYLESTRADIOL

Dosage:

0.03 / 3 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

drospirenone and ethinylestradiol

Authorization status:

Not Marketed

Authorization date:

2009-10-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_DRETINE 0.03 MG/3 MG FILM-COATED TABLETS _
_ _
ETHINYLESTRADIOL/DROSPIRENONE
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,
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.
WHAT IS IN THIS LEAFLET
1.
What Dretine is and what it is used for
2.
What you need to know before you take Dretine
3.
How to take Dretine
4.
Possible side effects
5.
How to store Dretine
6.
Contents of the pack and other information
1.
WHAT DRETINE IS AND WHAT IT IS USED FOR
Dretine 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 DRETINE
GENERAL NOTES
Before you start using Dretine 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 Dretine, your doctor will ask you some
questions about

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dretine 0.03 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient(s) with known effect:
Lactose monohydrate 62 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Dretine should take into consideration the
individual woman’s current risk factors,
particularly those for venous thromboembolism (VTE), and how the risk
of VTE with Dretine compares with other
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 COC.
In case a vaginal ring or transdermal patch has been
used, the woman should start using Dretinelle 0.02 mg/