Freedo 0.03mg/3mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Rowex Ltd

ATC code:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

0.03 mg/3 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Authorization status:

Marketed

Authorization date:

2009-10-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FREEDO 0.03 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 Freedo is and what it is used for
2.
What you need to know before you take Freedo
3.
How to take Freedo
4.
Possible side effects
5.
How to store Freedo
6.
Contents of the pack and other information
1.
WHAT FREEDO IS AND WHAT IT IS USED FOR
Freedo 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 FREEDO
GENERAL NOTES
Before you start using Freedo 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 you can begin taking Freedo, your doctor will ask you some
questions about your personal
health his

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2023
CRN00DCYG
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Freedo 0.03mg/3mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone.
Excipient with known effect
Each tablet contains 58.90 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, round.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Freedo should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Freedo
compares with other CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
HOW TO TAKE FREEDO
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 FREEDO

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 Freedopreferably 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 Freedo _ _preferably on
the day of removal, but at t