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FEMODENE ED TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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1.3.2.1

84327433_03.indd 1

1

13.05.2015 11:56:00

Gestodene
Ethinylestradiol
Important things to know about
! combined hormonal contraceptives
(CHCs):
R They are one of the most reliable reversible
methods of contraception if used correctly.
R 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.
R Please be alert and see your doctor if you
think you may have symptoms of a blood clot
(see section 2.3 ‘Blood clots’).
R The Pill may reduce your risk of cancer of the
ovary and womb if used in the long term.
R The Pill will not protect you against sexually
transmitted diseases.
R This medicine can increase your risk of
problems such as blood clots and breast
cancer.
R 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.
R 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.
R Keep this leaflet. You may need to read it
again.
R If you have any questions or need more
advice, ask your doctor, family planning nurse
or pharmacist.
R This medicine has been prescribed for you. Do
not pass it on to others. It may harm them.
R 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.

Femodene®
ED

Package leaflet: Information for the user

Femodene ED is a combined oral contraceptive pill
(‘the Pill’). You take it to stop you getting
pregnant.
This contraceptive contains two types of female
sex hormones, oestrogen and progestogen. These
hormones stop you getting pregnant by working
in three ways: by preventing an egg being
released from your ovaries; by making the fluid
(mucus) in your cervix thicker, which makes it
more difficult for sperm to enter the womb; and
by preventing the lining of your womb thickening
enough for an egg to grow in it.
Femodene ED is taken every day without a break.
You take an ‘active pill’ each day for 21 days,
followed by an ‘inactive pill’ each day for 7 days.
The benefits of taking the Pill include:
R it is one of the most reliable reversible
methods of contraception if used correctly
R it doesn’t interrupt sex
R it usually makes your periods regular, lighter
and less painful
R it may help with pre-menstrual symptoms.
Femodene ED will not protect you against sexually
transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Femodene ED needs to be taken as directed to
prevent pregnancy.

1. What Femodene ED does

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

2. What you need to know
before you use Femodene ED
General notes
Before you start using Femodene ED you should
read the information on blood clots in section 2. It
is particularly important to read the symptoms of
a blood clot – see Section 2.3 ‘Blood clots’.
It’s important that you understand the benefits
and risks of taking the Pill before you start taking
it, or when deciding whether to carry on taking it.
Although the Pill is suitable for most healthy
women it isn’t suitable for everyone.
M Tell your doctor if you have any of the
illnesses or risk factors mentioned in this
leaflet.
Before you start taking the Pill
R Your doctor will ask about you and your
family’s medical problems and check your
blood pressure and exclude the likelihood of
you being pregnant. You may also need other
checks, such as a breast examination, but
only if these examinations are necessary for
you, or if you have any special concerns.
While you’re on the Pill
R You will need regular check-ups with your
doctor or family planning nurse, usually when
you need another prescription of the Pill.
R You should go for regular cervical smear
tests.
R Check your breasts and nipples every month
for changes – tell your doctor if you can see or
feel anything odd, such as lumps or dimpling
of the skin.
R If you need a blood test tell your doctor that
you are taking the Pill, because the Pill can
affect the results of some tests.
R If you’re going to have an operation, make
sure your doctor knows about it. You may
need to stop taking the Pill about 4–6 weeks
before the operation. This is to reduce the risk
of a blood clot (see section 2.3). Your doctor
will tell you when you can start taking the Pill
again.
2.1 When you should not use Femodene ED
You should not use Femodene ED if you have any
of the conditions listed below. If you do have any
of the conditions listed below, you must tell your
doctor. Your doctor will discuss with you what
other form of birth control would be more
appropriate.
Do not take Femodene ED:
R If you have (or have ever had) a blood clot in a
blood vessel of your legs (deep vein
thrombosis, DVT), your lungs (pulmonary
embolus, PE) or other organs
R If you know you have a disorder affecting
your blood clotting – for instance, protein C
deficiency, protein S deficiency, antithrombinIII deficiency, Factor V Leiden or
antiphospholipid antibodies
R If you need an operation or if you are off your
feet for a long time (see section 2.3 ‘Blood
clots’)
R If you have ever had a heart attack or stroke
R If you have (or have ever had) angina pectoris
(a condition that causes severe chest pain and
may be a first sign of a heart attack) or
transient ischaemic attack (TIA – temporary
stroke symptoms)
R If you have any of the following diseases that
may increase your risk of a clot in the
arteries:
R swelling of one leg or
along a vein in the leg or
foot especially when
accompanied by:
P pain or tenderness in
the leg which may be
felt only when
standing or walking
P increased warmth in
the affected leg
P change in colour of
the skin on the leg e.g.
turning pale, red or
blue
R sudden unexplained
Pulmonary
breathlessness or rapid embolism
breathing
R sudden cough without an
obvious cause, which
may bring up blood
R sharp chest pain which
may increase with deep
breathing
R severe light headedness
or dizziness
R rapid or irregular
heartbeat
R severe pain in your
stomach

What are you
possibly
suffering
from?
Deep vein
thrombosis

Are you experiencing any
of these signs?

Some of the conditions listed below can be made
worse by taking the Pill. Or they may mean it is
less suitable for you. You may still be able to take
Femodene ED but you need to take special care
and have check-ups more often.
Tell your doctor if any of the following
conditions apply to you.
If the condition develops, or gets worse while you
are using Femodene ED, you should also tell your
doctor.
R If you have Crohn’s disease or ulcerative
colitis (chronic inflammatory bowel disease)
R If you have systemic lupus erythematosus
(SLE – a disease affecting your natural
defence system)
R If you have haemolytic uraemic syndrome
(HUS – a disorder of blood clotting causing
failure of the kidneys)
R If you have sickle cell anaemia (an inherited
disease of the red blood cells)
R If you have inflammation of the pancreas
(pancreatitis)
R If you have elevated levels of fat in the blood
(hypertriglyceridaemia) or a positive family
history for this condition.
Hypertriglyceridaemia has been associated
with an increased risk of developing
pancreatitis (inflammation of the pancreas)
R If you need an operation, or you are off your
feet for a long time (see in section 2.3 ‘Blood
clots’)
R If you have just given birth you are at an
increased risk of blood clots. You should ask
your doctor how soon after delivery you can
start taking Femodene ED
R If you have an inflammation in the veins
under the skin (superficial thrombophlebitis)
R If you have varicose veins
R If you have diabetes

When should you contact your doctor?
Seek urgent medical attention
R if you notice possible signs of a blood clot
that may mean you are suffering from a
blood clot in the leg (i.e. deep vein
thrombosis), a blood clot in the lung (i.e.
pulmonary embolism), a heart attack or a
stroke (see ‘Blood clots’ section below).
For a description of the symptoms of these
serious side effects please go to ‘How to
recognise a blood clot’.

R If you or your close family have ever had
problems with your heart, or circulation such
as high blood pressure
R If you or your close family have ever had
problems with blood clotting
R If you have the inherited disease called
porphyria
R If you are overweight (obese)
R If you have migraines
R If you have any illness that worsened during
pregnancy or previous use of the Pill (see
section 4.2)
2.3 Blood clots
Using a combined hormonal contraceptive such
as Femodene ED increases your risk of developing
a blood clot compared with not using one. In rare
cases a blood clot can block vessels and cause
serious problems.
Blood clots can develop:
R in veins (referred to as a ‘venous thrombosis’,
‘venous thromboembolism’ or VTE);
R in the arteries (referred to as an ‘arterial
thrombosis’, ‘arterial thromboembolism’ or
ATE).
Recovery from blood clots is not always complete.
Rarely, there may be serious lasting effects or,
very rarely, they may be fatal.
It is important to remember that the overall
risk of having a harmful blood clot due to
Femodene ED is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of
the following signs or symptoms.

P severe diabetes with blood vessel damage
P very high blood pressure
P a very high level of fat in the blood
(cholesterol or triglycerides)
P a condition known as
hyperhomocysteinaemia
R If you have (or have ever had) a type of
migraine called ‘migraine with aura’
R If you have or have ever had breast cancer
R If you have ever had a severe liver disease,
and you have been told by your doctor that
your liver function test results are not yet
back to normal
R If you have ever had liver tumours
R If you are allergic (hypersensitive) to any of
the ingredients in Femodene ED.
M Tell your doctor or family planning nurse if
you have any medical problems or illnesses.
2.2 When to take special care with Femodene
ED
If you are unsure, talk to a
doctor as some of these
symptoms such as coughing
or being short of breath may
be mistaken for a milder
condition such as a
respiratory tract infection
(e.g. a ‘common cold’).
Symptoms most commonly
occur in one eye:
R immediate loss of vision
or
R painless blurring of
vision which can
progress to loss of vision
R chest pain, discomfort,
pressure, heaviness
R sensation of squeezing
or fullness in the chest,
arm or below the
breastbone
R fullness, indigestion or
choking feeling
R upper body discomfort
radiating to the back,
jaw, throat, arm and
stomach
R sweating, nausea,
vomiting or dizziness
R extreme weakness,
anxiety, or shortness of
breath
R rapid or irregular
heartbeats
R sudden weakness or
numbness of the face,
arm or leg, especially on
one side of the body
R sudden confusion,
trouble speaking or
understanding
R sudden trouble seeing in
one or both eyes
R sudden trouble walking,
dizziness, loss of balance
or coordination
R sudden, severe or
prolonged headache with
no known cause
R loss of consciousness or
fainting with or without
seizure
Sometimes the symptoms of
stroke can be brief with an
almost immediate and full
recovery, but you should still
seek urgent medical
attention as you may be at
risk of another stroke.

Are you experiencing any
of these signs?

Stroke

Heart attack

Retinal vein
thrombosis
(blood clot in
the eye)

What are you
possibly
suffering
from?

What are you
possibly
suffering
from?
Blood clots
blocking other
blood vessels

M See a doctor as soon as possible. Do not
take any more Femodene ED until your
doctor says you can. Use another method of
contraception, such as condoms, in the
meantime.
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a
vein?
R 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.
R If a blood clot forms in a vein in the leg or
foot it can cause a deep vein thrombosis
(DVT).
R If a blood clot travels from the leg and lodges
in the lung it can cause a pulmonary
embolism.
R 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 Femodene ED 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 Femodene ED is small.
R 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.
R 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.
R Out of 10,000 women who are using a
combined hormonal contraceptive that
contains gestodene such as Femodene ED,
between about 9 and 12 women will develop
a blood clot in a year.
R The risk of having a blood clot will vary
according to your personal medical history
(see ‘Factors that increase your risk of a blood
clot in a vein’ below).

R swelling and slight blue
discolouration of an
extremity
R severe pain in your
stomach (acute
abdomen)

Are you experiencing any
of these signs?

Factors that increase your risk of a blood clot
in a vein
The risk of a blood clot with Femodene ED is small
but some conditions will increase the risk. Your
risk is higher:
R if you are very overweight (body mass index
or BMI over 30kg/m2)
R if one of your immediate family has had a
blood clot in the leg, lung or other organ at a
young age (e.g. below the age of about 50). In
this case you could have a hereditary blood
clotting disorder
R if you need to have an operation, or if you are
off your feet for a long time because of an
injury or illness, or you have your leg in a
cast. The use of Femodene ED may need to be
stopped several weeks before surgery or
while you are less mobile. If you need to stop
Femodene ED ask your doctor when you can
start using it again.
R as you get older (particularly above about 35
years)
R if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the
more conditions you have.
Air travel (>4 hours) may temporarily increase
your risk of a blood clot, particularly if you have
some of the other factors listed.
It is important to tell your doctor if any of these
conditions apply to you, even if you are unsure.
Your doctor may decide that Femodene ED needs
to be stopped.
If any of the above conditions change while you
are using Femodene ED, for example a close
family member experiences a thrombosis for no
known reason, or you gain a lot of weight, tell
your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an
artery?
Like a blood clot in a vein, a clot in an artery can
cause serious problems. For example, it can cause
a heart attack or a stroke.
Factors that increase your risk of a blood clot
in an artery
It is important to note that the risk of a heart
attack or stroke from using Femodene ED is very
small but can increase:
R with increasing age (beyond about 35 years)
R if you smoke. When using a combined
hormonal contraceptive like Femodene ED,
you are advised to stop smoking. If you are
unable to stop smoking and are older than 35
your doctor may advise you to use a different
type of contraceptive
R if you are overweight
R if you have high blood pressure

Risk of
developing a
blood clot in
a year
Women who are not using a
About 2 out
combined hormonal pill and are of 10,000
not pregnant
women
Women using a combined
About 5-7 out
hormonal contraceptive pill
of 10,000
containing levonorgestrel,
women
norethisterone or
norgestimate
Women using Femodene ED
About 9-12
out of 10,000
women

Please turn over J

2.5 Taking other medicines
If you ever need to take another medicine at the
same time as being on the Pill, always tell your
doctor, pharmacist or dentist that you’re taking
Femodene ED. Also check the leaflets that come
with all your medicines to see if they can be taken
with hormonal contraceptives.
Some medicines can have an influence on the
blood levels of Femodene ED and can stop it from
working properly – for example:
R some medicines used to treat epilepsy
R some medicines used to treat HIV and
Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside
reverse transcriptase inhibitors)
R griseofulvin (an anti-fungal medicine)
R certain antibiotics
R certain sedatives (called barbiturates)
R St. John’s Wort (a herbal remedy).
If you do need to take one of these medicines,
Femodene ED may not be suitable for you or you
may need to use extra contraception for a while.
Your doctor, pharmacist or dentist can tell you if
this is necessary and for how long.
Femodene ED can also affect how well other
medicines work. Your doctor may need to adjust
the dose of your other medicine.
In addition, Femodene ED can also interfere with
the results of some blood tests, so always tell
your doctor that you are taking Femodene ED if
you have a blood test.
2.6 Taking Femodene ED with food and drink
There are no special instructions about food and
drink while on Femodene ED.
2.7 Pregnancy and breast-feeding
Do not use Femodene ED if you are pregnant. If
you think you might be pregnant, do a pregnancy
test to confirm that you are before you stop
taking Femodene ED.
If you are breast-feeding, your doctor or family
planning nurse may advise you not to take
Femodene ED. They will be able to suggest
alternative contraception. Breast-feeding may
not stop you getting pregnant.
2.8 Driving and using machines
Femodene ED has no known effect on the ability
to drive or use machines.
2.9 Femodene ED contains lactose and sucrose
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before using Femodene ED.

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
item-no.: 84327433
PZ: 2688A-3
code-no.: 179
name: LF-OUTS-Femodene ED SCT 28
country: GB/-/BPH
colors: Black
version: 13.05.2015/03
approval:
dimension: 355 x 594 mm

R if a member of your immediate family has
had a heart attack or stroke at a young age
(less than about 50). In this case you could
also have a higher risk of having a heart
attack or stroke
R if you, or someone in your immediate family,
have a high level of fat in the blood
(cholesterol or triglycerides)
R if you get migraines, especially migraines
with aura
R if you have a problem with your heart (valve
disorder, disturbance of the rhythm called
atrial fibrillation)
R if you have diabetes.
If you have more than one of these conditions or
if any of them are particularly severe the risk of
developing a blood clot may be increased even
more.
If any of the above conditions change while you
are using Femodene ED, for example you start
smoking, a close family member experiences a
thrombosis for no known reason, or you gain a lot
of weight, tell your doctor.
2.4 The Pill and cancer
While high dose Pills reduce your risk of cancer of
the ovary and womb if used in the long term, it is
not clear whether lower dose Pills like Femodene
ED also provide the same protective effects.
However, it also seems that taking the Pill slightly
increases your risk of cancer of the cervix –
although this may be due to having sex without a
condom, rather than the Pill. All women should
have regular smear tests.
If you have breast cancer, or have had it in the
past, you should not take the Pill. The Pill slightly
increases your risk of breast cancer. This risk goes
up the longer you’re on the Pill, but returns to
normal within about 10 years of stopping it.
Because breast cancer is rare in women under the
age of 40, the extra cases of breast cancer in
current and recent Pill users is small. For
example:
R Of 10,000 women who have never taken the
Pill, about 16 will have breast cancer by the
time they are 35 years old.
R Of 10,000 women who take the Pill for 5
years in their early twenties, about 17–18
will have breast cancer by the time they are
35 years old.
R Of 10,000 women who have never taken the
Pill, about 100 will have breast cancer by the
time they are 45 years old.
R Of 10,000 women who take the Pill for 5
years in their early thirties, about 110 will
have breast cancer by the time they are 45
years old.
Your risk of breast cancer is higher:
R if you have a close relative (mother, sister or
grandmother) who has had breast cancer
R if you are seriously overweight
M See a doctor as soon as possible if you
notice any changes in your breasts, such as
dimpling of the skin, changes in the nipple or
any lumps you can see or feel.
Taking the Pill has also been linked to liver
diseases, such as jaundice and non-cancer liver
tumours, but this is rare. Very rarely, the Pill has
also been linked with some forms of liver cancer
in women who have taken it for a long time.
M See a doctor as soon as possible if you get
severe pain in your stomach, or yellow
skin or eyes (jaundice). You may need to stop
taking Femodene ED.

Femodene® ED

84327433_03.indd 2

3.1 How to take it
To prevent pregnancy, always take Femodene ED as
described below. Check with your doctor or family
planning nurse if you are not sure.
This pack is designed to help you remember to take your
pills. Your pack contains 3 foil memo strips with 3 sets
of 7 self-adhesive strips showing the days of the week.
Each foil memo strip contains 28 tablets: 21 small
active tablets in 3 rows and 7 larger inactive tablets in
the last row.
Take Femodene ED every day for 28 days
R Find the set of self-adhesive strips. Each strip
starts with a different day of the week. Peel off a
strip that starts with your starting day.
R For instance, if you start the tablets on a
Wednesday, use a strip that starts with ‘Wed’.
R Stick the strip along the top of the foil memo-strip
so that the first day is above the pill marked ‘start’.
R You can now see on which day you have to take
each tablet.
R Take your pill at the same time every day.
R Follow the direction of the arrows on the strip. Take
one pill each day, until you have finished all 28 pills.
R Swallow each pill whole, with water if necessary. Do
not chew the pill.
Then start your next strip
Start taking your next strip of Femodene ED the next
day. Do not leave a gap between packs.
As long as you take Femodene ED correctly, you will
always start each new strip on the same day of the
week.
3.2 Starting Femodene ED
As a new user or starting the Pill again after a break
It is best to take your first Femodene ED pill on the first
day of your next period. By starting in this way, you will
have contraceptive protection with your first pill.
Changing to Femodene ED from another
contraceptive Pill
R If you are currently taking a 21-day Pill: start
Femodene ED the next day after the end of the
previous strip. You will have contraceptive
protection with your first pill. You will not have a
bleed until after your first strip of Femodene ED.
R If you are taking a 28-day Pill: start taking
Femodene ED the day after your last active pill. You
will have contraceptive protection with your first
pill. You will not have a bleed until after your first
strip of Femodene ED.

3. Taking Femodene ED

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R Or, if you are taking a progestogen-only Pill
(POP or ‘mini Pill’): start Femodene ED on the first
day of bleeding, even if you have already taken the
progestogen-only Pill for that day. You will have
contraceptive cover straight away.
Starting Femodene ED after a miscarriage or
abortion
If you have had a miscarriage or an abortion during the
first three months of pregnancy, your doctor may tell
you to start taking Femodene ED straight away. This
means that you will have contraceptive protection with
your first pill.
If you have had a miscarriage or an abortion after the
third month of pregnancy, ask your doctor for advice.
You may need to use extra contraception, such as
condoms, for a short time.
Contraception after having a baby
If you have just had a baby, your doctor may advise you
that Femodene ED should be started 21 days after
delivery provided that you are fully mobile. You do not
have to wait for a period. You will need to use another
method of contraception, such as a condom, until you
start Femodene ED and for the first 7 days of pill taking.
Active (small)

 You may see some bleeding on the days you take the active

 If you have missed one or more pills

from the first week of your strip
(days 1 to 7), and you had sex in that
week, you could become pregnant.
Contact your doctor, family planning
nurse or pharmacist for advice as
soon as possible. They may
recommend you use emergency
contraception.

your strip (days 1 to 7), and you had sex in that week, you
could become pregnant. Contact your doctor, family
planning nurse or pharmacist for advice as soon as possible.

 If you have missed one or more pills from the first week of

talk to your doctor before you start the next pack.

 If you do not have a period after the second pack, you must

pills, but do not worry.

inactive tablets and start the next strip the next day.

 When you finish the active pills, throw away the large

 Complete your pack as usual

before starting the next one

Fewer than 7 active pills left

7 or more active pills left

 Don’t worry, your contraceptive

protection should not be reduced.

after the most recently missed pill.

 Check how many active pills are left in the strip

the next 7 days.

two pills in one day.

further pills as usual. This may mean
taking two pills in one day.

 Take the delayed pill straight away and

 Use extra precautions (condoms for instance) for

Less than 12 hours ago

Inactive (large)

 Take the most recently missed pill straight away.
 Leave any earlier missed pills in the strip.
 Take your further pills as usual. This may mean taking

More than 12 hours ago,
or you have missed
more than one pill.

When were you due to take the missed pill?

What kind of pill did you miss?

3.3 A missed pill
If you miss a pill, follow these instructions:
If you have missed any of the pills in a strip, and you
do not bleed while taking the large inactive pills,
you may be pregnant. Contact your doctor or family
planning clinic, or do a pregnancy test yourself.
If you start a new strip of pills late, you may not be
protected from pregnancy. If you had sex in the last
seven days, ask your doctor, family planning nurse or
pharmacist for advice. You may need to consider
emergency contraception. You should also use extra
contraception, such as condoms, for seven days.
3.4 A lost pill
If you lose an active pill,
Either take the last active pill of the strip in place of the
lost pill. Then take all the other pills on their proper
days. Your cycle will be one day shorter than normal,
but your contraceptive protection won’t be affected.
After taking the large white inactive pills you will have a
new starting day, one day earlier than before.
Or if you do not want to change the starting day of your
cycle, take a pill from a spare strip. Then take all the
other pills from your current strip as usual. You can
then keep the opened spare strip in case you lose any
more pills.
If you lose an inactive pill, don’t worry, just continue
taking the remaining tablets at the correct time. Your
contraceptive protection won’t be affected.
3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea within
4 hours of taking the Pill, your body may not get its
usual dose of hormones from that pill. If you are better
within 12 hours of taking Femodene ED, follow the
instructions in section 3.4 A lost pill.
If you are still sick or have diarrhoea more than 12
hours after taking Femodene ED, see section 3.3, A
missed pill.
M Talk to your doctor if your stomach upset
carries on or gets worse. He or she may
recommend another form of contraception.
3.6 Missed a period – could you be pregnant?
Occasionally, you may miss a withdrawal bleed. This
could mean that you are pregnant, but that is very
unlikely if you have taken your pills correctly. Start your
next strip at the normal time. If you think that you
might have put yourself at risk of pregnancy (for
example, by missing pills or taking other medicines), or
if you miss a second bleed, you should do a pregnancy
test. You can buy these from the chemist or get a free
test at your family planning clinic or doctors surgery. If
you are pregnant, stop taking Femodene ED and see
your doctor.

Like all medicines, Femodene ED can cause side effects,
although not everybody gets them. If you get any side
effect, particularly if severe and persistent, or have any
change to your health that you think may be due to
Femodene ED, please talk to your doctor.
An increased risk of blood clots in the veins (venous
thromboembolism (VTE)) or blood clots in the arteries
(arterial thromboembolism (ATE)) is present for all
women using combined hormonal contraceptives. For
more detailed information on the different risks from
taking combined hormonal contraceptives please see
section 2 “What you need to know before you use
Femodene ED”.
M Tell your doctor, pharmacist or family planning
nurse if you are worried about any side effects
which you think may be due to Femodene ED.
4.1 Serious side effects – see a doctor straight away
Rare side effects (between 1 and 10 in every 10,000
users may be affected)
R harmful blood clots in a vein or artery for example:
P in a leg or foot (i.e. DVT)
P in a lung (i.e. PE)
P heart attack
P stroke
P mini-stroke or temporary stroke-like symptoms,
known as a transient ischaemic attack (TIA)
P blood clots in the liver, stomach/intestine,
kidneys or eye.
The chance of having a blood clot may be higher if you
have any other conditions that increase this risk (see
section 2 for more information on the conditions that
increase risk for blood clots and the symptoms of a
blood clot).

4. Possible side effects

3.7 Taking more than one pill should not cause
harm
It is unlikely that taking more than one pill will do you
any harm, but you may feel sick, vomit or have some
vaginal bleeding. Talk to your doctor if you have any of
these symptoms.
3.8 When you want to get pregnant
If you are planning a baby, it’s best to use another
method of contraception after stopping Femodene ED
until you have had a proper period. Your doctor or
midwife relies on the date of your last natural period to
tell you when your baby is due. However, it will not
cause you or the baby any harm if you get pregnant
straight away.

Signs of a blood clot (see section 2.3 'Blood clots')
Signs of a severe allergic reaction or worsening of
hereditary angioedema:
R swelling of the hands, face, lips, mouth, tongue
or throat. A swollen tongue/throat may lead to
difficulty swallowing and breathing
R a red bumpy rash (hives) and itching.
Signs of breast cancer include:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or feel.
Signs of cancer of the cervix include:
R vaginal discharge that smells and/or contains
blood
R unusual vaginal bleeding
R pelvic pain
R painful sex.
Signs of severe liver problems include:
R severe pain in your upper abdomen
R yellow skin or eyes (jaundice)
R inflammation of the liver (hepatitis)
R your whole body starts itching.
M If you think you may have any of these, see a
doctor straight away. You may need to stop taking
Femodene ED.
4.2 Less serious side effects
Common side effects (between 100 and 1000 in every
10,000 users may be affected)
R feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood swings
R sore or painful breasts
Uncommon side effects (between 10 and 100 in every
10,000 users may be affected)
R being sick and stomach upsets
R fluid retention
R migraine
R loss of interest in sex
R breast enlargement
R skin rash, which may be itchy
Rare side effects (between 1 and 10 in every 10,000
users may be affected)
R poor tolerance of contact lenses
R losing weight
R increase of interest in sex

What is in Femodene ED
Each box of Femodene ED contains three strips of 28
tablets with three sets of 7 self-adhesive strips showing
the days of the week.
Each strip of Femodene ED contains 21 white sugarcoated tablets containing 75 micrograms of the
progestogen gestodene and 30 micrograms of the
oestrogen ethinylestradiol and 7 larger, white, inactive
tablets.
Femodene ED also contains the inactive ingredients:
Lactose, maize starch, povidone, sodium calcium
edetate, magnesium stearate (E572), sucrose, macrogol
6000, calcium carbonate (E170), talc, montan glycol
wax.
The company that holds the product licence for
Femodene ED is:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire, RG14 1JA.
Femodene ED is made by:
Bayer Weimar GmbH & Co KG, Weimar, Germany
or Delpharm Lille SAS, Lys-Lez-Lannoy, France.
This leaflet was last updated in May 2015.

6. What is in Femodene ED and
who makes it

Keep all medicines out of the sight and reach of
children.
Do not use Femodene ED after the expiry date shown on
the strip.
Do not store above 25°C and protect from light.
Do not throw away any medicines down a drain or into
a bin. Ask your pharmacist what to do with any
medicines you do not want. This will help to protect the
environment.

5. How to store Femodene ED

R carries on for more than the first few months
R starts after you’ve been taking Femodene ED for a
while
R carries on even after you’ve stopped taking
Femodene ED.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
item-no.: 84327433
PZ: 2688A-3
code-no.: 179
name: LF-OUTS-Femodene ED SCT 28
country: GB/-/BPH
colors: Black
version: 13.05.2015/03
approval:
dimension: 355 x 594 mm

R vaginal or breast discharge
Other side effects reported
R Bleeding and spotting between your periods can
sometimes occur for the first few months but this
usually stops once your body has adjusted to
Femodene ED. If it continues, becomes heavy or
starts again, contact your doctor (see section 4.3).
R Chloasma (yellow brown patches on the skin). This
may happen even if you have been using Femodene
ED for a number of months. Chloasma may be
reduced by avoiding too much sunlight and/or UV
lamps
R Occurrence or deterioration of the movement
disorder chorea
R Ulcerative colitis
R Conditions that may worsen during pregnancy
or previous use of the Pill:
P yellowing of the skin (jaundice)
P persistent itching (pruritus)
P kidney or liver problems
P gall stones
P certain rare medical conditions such as
systemic lupus erythematosus
P blister-like rash (herpes gestationis) whilst
pregnant
P an inherited form of deafness (otosclerosis)
P Crohn’s disease
P a personal or family history of a form of sickle
cell disease
P swelling of body parts (hereditary angioedema)
P an inherited disease called porphyria
P cancer of the cervix
M Tell your doctor, pharmacist or family planning
nurse if you are worried about any side effects
which you think may be due to Femodene ED. Also
tell them if any existing conditions get worse while
you are taking Femodene ED.
4.3 Bleeding between periods should not last long
A few women have a little unexpected bleeding or
spotting while they are taking Femodene ED, especially
during the first few months. Normally, this bleeding is
nothing to worry about and will stop after a day or two.
Keep taking Femodene ED as usual. The problem should
disappear after the first few strips.
You may also have unexpected bleeding if you are not
taking your pills regularly, so try to take your pill at the
same time every day. Also, unexpected bleeding can
sometimes be caused by other medicines.
M Make an appointment to see your doctor if you
get breakthrough bleeding or spotting that:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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