Leonore 100 micrograms/20 micrograms coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol

Available from:

Rowex Ltd

ATC code:

G03AA; G03AA07

INN (International Name):

Levonorgestrel; Ethinylestradiol

Dosage:

100 microg/20 microgram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Authorization status:

Marketed

Authorization date:

2008-02-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEONORE 100 MICROGRAMS/20 MICROGRAMS COATED TABLETS
levonorgestrel/ethinylestradiol
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 Leonore is and what it is used for
2.
What you need to know before you take Leonore
3.
How to take Leonore
4.
Possible side effects
5.
How to store Leonore
6.
Contents of the pack and other information
1. WHAT LEONORE IS AND WHAT IT IS USED FOR
Levonorgestrel/Ethinylestradiol is used
•
for
PREVENTION OF PREGNANCY
(contraception).
-
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEONORE
GENERAL NOTES
Before you start using Leonore 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 start taking Leonore, your doctor will ask you some
questions about your personal health history

Summary of Product characteristics

Health Products Regulatory Authority
22 December 2022
CRN00D7K2
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Leonore 100 micrograms/20 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 100 micrograms of levonorgestrel and 20
micrograms of ethinylestradiol.
Excipient(s) with known effect
Each coated tablet contains 30.17 mg of lactose (as monohydrate) and
19.66 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
White, round, biconvex, coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Leonore should take into consideration the
individual woman’s current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Leonore
compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tablets must be taken each day at about the same time, if
necessary with some liquid, in the order indicated on the blister
pack. One tablet must be taken daily for 21 consecutive days. Taking
the tablets from the next blister pack begins after a 7-day
break in which a withdrawal bleeding usually occurs. This generally
begins 2-3 days after taking the last tablet and may still be
ongoing when use of the next blister pack is started.
Starting to take Leonore
_No previous intake of hormonal contraceptives in the last month_
The first tablet should be taken on the first day of the cycle (on the
first day of the menstrual period). If administration is
started between day 2 and 5, a non-hormonal method should be used
during the first 7 days of tablet intake.
_Change from another combined hormonal contraceptive (combined oral
contraceptive, vaginal ring, transdermal patch) _
The use of Leonore is started on the day following the usual
tablet-free (ring-free, patch-free) break or the last placebo tablet
of the previous hormonal contracep