Femodene ED tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Bayer Plc

ATC code:

G03AA10

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07030100; GTIN: 5016703002994

Patient Information leaflet

Page 1 of 19
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PACKAGE LEAFLET: Information for the user

Femodene
®
ED
Gestodene
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 2.3 ‘Blood clots’).

The Pill may reduce your risk of cancer of the ovary and womb if used
in the
long term.

The Pill will not protect you against sexually transmitted diseases.

This medicine can increase your risk of problems such as blood clots
and
breast cancer.

Some women should not take the Pill because of current medical
problems or
illnesses. Please read this leaflet to make sure Femodene ED is right
for you.

To prevent pregnancy it is important to take Femodene ED as instructed
and
start each pack on time. Please make sure that you understand what to
do if
you miss a pill or if you think you are pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any questions or need more advice, ask your doctor, family
planning nurse or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them.

IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not
listed in this
leaflet, please tell your doctor, family planning nurse or pharmacist.
IN THIS LEAFLET:
1.
WHAT FEMODENE ED DOES
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FEMODENE ED
3.
TAKING FEMODENE ED
3.3
A missed pill
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FEMODENE ED
6.
WHAT IS IN FEMODENE ED AND WHO MAKES IT
Page 2 of 19
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1.
WHAT FEMODENE ED DOES
Femodene ED is a combined oral contraceptive pill (‘the Pill�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Femodene ® ED
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active tablet contains 75 micrograms gestodene and 30 micrograms
ethinylestradiol.
Each pack also contains seven placebo tablets which are larger.
Excipients with known effect:
Active Tablet
Lactose
37.43 mg
Sucrose
19.660 mg
Placebo Tablet
Lactose
48.25 mg
Sucrose
33.98 mg
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sugar-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception and the recognised gynaecological indications for
such oestrogen
progestogen combinations.
The decision to prescribe Femodene ED should take into consideration
the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Femodene ED compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_First treatment cycle: _1 tablet daily for 28 days, starting on the
first day of the
menstrual cycle. 21 (small) active tablets are taken followed by 7
(larger)
placebo tablets. Contraceptive protection begins immediately_. _
_Subsequent cycles:_ Tablet-taking is continuous, which means that the
next
pack of Femodene ED follows immediately without a break. A withdrawal
bleed usually occurs when the placebo tablets are being taken.
_Changing from 21-day combined oral contraceptives:_ The first tablet
of
Femodene ED should be taken on the first day immediately after the end
of the
previous oral contraceptive course. Additional contraceptive
precautions are
not required.
_Changing from a combined Every Day pill (28 -day pill):_ Femodene ED
should be started after taking the last active tablet from the
previous Every
Day
pill
pack.
The
first
Femodene
ED
tablet
is
taken
the
next
day.
Additional contraceptive precautions are not then required.
_Changing from a progestogen-only pill (POP):_
The first tablet of Femodene ED should be taken on th