ERLIDONA 0.1/0.02 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVONORGESTREL, ETHINYLESTRADIOL

Available from:

Actavis Group PTC ehf

ATC code:

G03AA07

INN (International Name):

LEVONORGESTREL, ETHINYLESTRADIOL

Dosage:

0.1/0.02 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

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLIDONA 0.10 MG/0.02 MG FILM-COATED TABLET
Levonorgestrel / Ethinylestradiol
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 further questions, please 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Erlidona is and what it is used for
2.
What you need to know before you take Erlidona
3.
How to take Erlidona
4.
Possible side effects
5.
How to store Erlidona
6.
Contents of the pack and other information
1.
WHAT ERLIDONA IS AND WHAT IT IS USED FOR
Erlidona is a contraceptive pill and it is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones,
namely levonorgestrel and
ethinylestradiol.
Contraceptive pills that contain two hormones are called
‘combination pills.’ Erlidona is called a “low-
dose” contraceptive pill because it contains only a small amount of
hormones.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLIDONA
GENERAL NOTES
Before you can begin taking Erlidona, your doctor will ask you some
questions about your
personal health history and that of your close relatives. The doctor
will also measure your blood
pressure, and, depending upon your personal situation, may also carry
out some other tests.
In this leaflet, several situations are described where you should
stop using Erlidona, or where the
reliability of Erlidona may be decreased. In such situations you
should either not have sex or you
should take extra non-hormonal contraceptive precautions, e.g. use a
condom or another barrier
method. Do not use rhythm or temperature methods. These methods can be
unreliable because
Erlidona alters the monthly changes of bo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erlidona 0.10mg/0.02mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.10 mg levonorgestrel and 0.02 mg
ethinylestradiol
Excipients with known effect:
Each tablet contains 89.38 mg of lactose anhydrous.
Red aluminium lake (E129)
and soya lecithin are present in the film-coating.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are pink and rounded with a diameter of 6 mm approx.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
How to use Erlidona 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 Erlidona 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).
Starting on days 2-5 is allowed but in that case an additional barrier
method is recommended for the first 7 days of the
first cycle.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring, or_
_transdermal patch)_
The woman should start with Erlidona 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
Erlidonapreferably on the day of removal, but at the latest when the
next application would have been due.
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