Gedarel extra 30/150 micrograms Film Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethinylestradiol; Desogestrel

Available from:

Gedeon Richter Plc

ATC code:

G03AA; G03AA09

INN (International Name):

Ethinylestradiol; Desogestrel

Dosage:

30mcg/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 EXTRA 30/150 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 extra is and what it is used for
2.
What you need to know before you take Gedarel extra
3.
How to take Gedarel extra
4.
Possible side effects
5.
How to store Gedarel extra
6.
Contents of the pack and other information
1.
WHAT GEDAREL EXTRA IS AND WHAT IT IS USED FOR
Gedarel extra is a combined oral contraceptive, 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

Summary of Product characteristics

Health Products Regulatory Authority
09 February 2023
CRN00CX29
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gedarel extra 30/150 micrograms Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
30 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
White, or almost white, round shaped, biconvex film-coated tablets of
6mm diameter, with P8 sign on one side and RG sign on
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Gedarel extra 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 extra compares with other combined
hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 take Gedarel extra_
Tablets must be taken in the order directed on the package every day
at about the same time.
HOW TO START GEDAREL EXTRA
_No preceding hormonal contraceptive use[in the past month]_
The tablet intake must be started on the first day of the woman's
natural cycle (i.e. on the first day 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 Gedare