CLEOSENSA 0.03/3 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DROSPIRENONE, ETHINYL ESTRADIOL

Available from:

Actavis Group PTC ehf

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE, ETHINYL ESTRADIOL

Dosage:

0.03/3 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations

Authorization status:

Authorised

Authorization date:

2014-01-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEOSENSA 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.
-
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 Cleosensa is and what it is used for
2.
What you need to know before you take Cleosensa
3.
How to take Cleosensa
4.
Possible side effects
5.
How to store Cleosensa
6.
Contents of the pack and other information
1.
WHAT CLEOSENSA IS AND WHAT IT IS USED FOR
Cleosensa 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEOSENSA
GENERAL NOTES
Before you start using Cleosensa 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”). Your
doctor will ask you some questions about your personal health history
and that of your close
relatives. The doctor will also measure

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cleosensa 0.03 mg/3 mg film
-
coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
Excipient with known effect:
Each film
-
coated tablet contains 62 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film
-
coated tablet.
Yellow, round, plain, 5.7x3.5 mm, film
-
coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Cleosensa should take into consideration the
individual woman’s current risk factors,
particularly those for venous thromboembolism (VTE), and how the risk
of VTE with Cleosensa 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. 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 Cleosensa_
-
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 Cleosensa 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
Cleosensa preferably on the day of removal, but at the latest when the
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