Enador & Placebo 0.02mg/3mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

0.02 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:

Not marketed

Authorization date:

2011-06-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Enador & Placebo 0.02mg/3mg 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 Enador & Placebo 0.02mg/3mg film-coated tablets is and what it is
used for
2.
What you need to know before you use Enador & Placebo 0.02mg/3mg
film-coated tablets
3.
How to take Enador & Placebo 0.02mg/3mg film-coated tablets
4.
Possible side effects
5.
How to store Enador & Placebo 0.02mg/3mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT ENADOR & PLACEBO 0.02MG/3MG FILM-COATED TABLETS IS AND WHAT IT IS
USED FOR
-
Enador & Placebo 0.02mg/3mg film-coated tablets is a contraceptive
pill and is used to prevent
pregnancy.
-
Each of the 21 white active tablet contains a small amount of
different female hormones,
namely drospirenone and ethinylestradiol.
-
The 7 green tablets contain no active substances and are also called
placebo tablets.
-
Contraceptive pills that contain two hormones are called combination
pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ENADOR & PLACEBO 0

Summary of Product characteristics

Health Products Regulatory Authority
08 March 2023
CRN00D7P9
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enador & Placebo 0.02mg/3mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
21 white or almost white _(active)_ film-coated tablets:
Each film-coated tablet contains 3 mg drospirenone and 0.02 mg
ethinylestradiol.
Excipients with known effect:
Each film-coated tablet contains 48.53 mg of lactose monohydrate and
0.070 mg of soya lecithin.
7 green placebo (inactive) film-coated tablets:
The tablet does not contain active substances.
Excipients with known effect:
Each film-coated tablet contains 37.26 mg of lactose and 0.003 mg of
sunset yellow FCF (E110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
The active tablet is white or almost white, round, biconvex
film-coated tablet, diameter about 6 mm. Engraving on one side:
“G73”, the other side is without engraving.
The placebo tablet is green, round, biconvex film-coated tablet,
diameter about 6 mm, without engraving.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Enador&Placebo 0.02mg/3mg film-coated
tablets should take into consideration the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and how the risk of VTE with
Enador&Placebo 0.02mg/3mg film-coated tablets compares with other
combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Route of administration: oral use
Posology
HOW TO TAKE ENADOR&PLACEBO 0.02MG/3MG 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. Tablet taking is continuous. One tablet is to be taken daily for
28 consecutive days. Each subsequent pack is started on
the day after the last tablet of the previous pack. Withdrawal
bleeding usually starts on day 2-3 afte