Gedarel 20/150 microgram film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethinyloestradiol; Desogestrel

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA09

INN (International Name):

Ethinyloestradiol; Desogestrel

Dosage:

20mcg/150 microgram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; desogestrel and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2009-01-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEDAREL 20/150 MICROGRAMS FILM-COATED TABLETS
ethinylestradiol and desogestrel
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 Gedarel is and what it is used for
2.
What you need to know before you take Gedarel
3.
How to take Gedarel
4.
Possible side effects
5.
How to store Gedarel
6.
Contents of the pack and other information
1.
WHAT GEDAREL IS AND WHAT IT IS USED FOR
Gedarel is a COC, also called the pill. It contains two types of
female hormones: a progestogen,
desogestrel, and an oestrogen, ethinylestradiol in a low dose. These
help to stop you from getting
pregnant, just as your natural hormones would stop you conceiving
again when you are already
pregnant.
The COC pill protects you against getting pregnant in three ways.
These hormones
1.
stop the ovary from releasing an egg each month (ovulation).
2.
also thicken the fluid (at the neck of the womb making it more
difficult for the sperm to reach
the egg.
3.
alter the lining of the womb to make it less likely to accept a
fertilised egg.
GENERAL INFORMATION
If tak

Summary of Product characteristics

Health Products Regulatory Authority
15 February 2023
CRN00CX32
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gedarel 20/150 microgram film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
20 micrograms ethinylestradiol
150 micrograms desogestrel
Excipient with known effect: 64.3 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Slightly yellow, round shaped, biconvex film-coated tablets of about 6
mm diameter, with P9 sign on one side and RG sign on
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Gedarel should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Gedarel
compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE GEDAREL
Tablets must be taken in the order directed on the package every day
at about the same time. One tablet is 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 GEDAREL
_No preceding hormonal contraceptive use [in the past month]_
The tablet intake must be started on day 1 of the normal menstrual
cycle (i.e. on the first day on which the woman has a
menstrual bleeding). Tablet intake is also allowed to start on day
2-5, but during the first cycle concurrent use of a barrier
method for the first 7 days of tablet intake is advisable.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), combined contraceptive vaginal ring or _
_transdermal patch)_
The woman should start taking Gedarel on the day after the last active
tablet (th