Gedarel 20microgram/150microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desogestrel; Ethinylestradiol

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G03AA09

INN (International Name):

Desogestrel; Ethinylestradiol

Dosage:

150microgram ; 20microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5391512451172

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GEDAREL® 20/150
MICROGRAM 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”).
WHAT IS IN THIS LEAFLET
The name of your medicine is ‘Gedarel 20/150 microgram film-coated
tablets’, but will be referred to as ‘Gedarel’ throughout the
remainder of 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 taken correctly, the pill is an effective reversible form of
contraception. However, in certain circumstances the effectiveness
of the pill may reduce or you should stop taking the pill (see later).
In these cases either do not have sex, or use extra
contraceptive precautions (such as condoms or spermicides) during
intercourse t

Summary of Product characteristics

OBJECT 1
GEDAREL 20/150 MICROGRAM FILM-COATED TABLETS
Summary of Product Characteristics Updated 29-Sep-2017 | Consilient
Health Ltd
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 and
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 day 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 a