Gedarel 30microgram/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 ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5391512451189

Patient Information leaflet

BLOOD CLOTS IN A VEIN
WHAT CAN HAPPEN IF A BLOOD CLOT FORMS IN A VEIN?
• The use of combined hormonal contraceptives has been connected
with an increase in the risk of blood clots in the vein (venous
thrombosis). However, these side effects are rare. Most frequently,
they occur in the first year of use of a combined hormonal
contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a
deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the
eye (retinal vein thrombosis).
WHEN IS THE RISK OF DEVELOPING A BLOOD CLOT IN A VEIN HIGHEST?
The risk of developing a blood clot in a vein is highest during the
first year of taking a combined hormonal contraceptive for the
first time. The risk may also be higher if you restart taking a
combined hormonal contraceptive (the same product or a different
product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly
higher than if you were not using a combined hormonal
contraceptive.
When you stop Gedarel your risk of a blood clot returns to normal
within a few weeks.
WHAT IS THE RISK OF DEVELOPING A BLOOD CLOT?
The risk depends on your natural risk of VTE and the type of combined
hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with
Gedarel is small.
• Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a
blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone, or
norgestimate about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains desogestrel, such as Gedarel between
about 9 and 12 women will develop a blood clot in a year.
• The risk of having a blood clot will vary according to your
perso

Summary of Product characteristics

OBJECT 1
GEDAREL 30/150 MICROGRAM FILM-COATED TABLETS
Summary of Product Characteristics Updated 02-Oct-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Gedarel 30/150 microgram film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 30 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
White, or almost white, round shaped, biconvex film-coated tablets of
6 mm 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 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
The tablets must be taken in the order directed on the package every
day at about the same time of the
day. 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 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 should 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 oral contraceptive (COC), combined
contraceptive vaginal ring or _
_transdermal patch_
The woman should start taking Gedarel on the day after the last active
tab