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FEMODENE TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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Package leaflet: Information for the user

Femodene®
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 is right for you.
R To prevent pregnancy it is important to take Femodene 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.
In this leaflet
1. What Femodene does
2. What you need to know before you use Femodene

2.1 When you should not use Femodene
2.2 When to take special care with Femodene
2.3 Blood clots
2.4 The Pill and cancer
2.5 Taking other medicines
2.6 Taking Femodene with food and drink
2.7 Pregnancy and breast-feeding
2.8 Driving and using machines
2.9 Femodene contains lactose and sucrose
3. Taking Femodene

3.1 How to take it
3.2 Starting Femodene
3.3 A missed pill
3.4 A lost pill
3.5 If you are sick or have diarrhoea
3.6 Missed a period – could you be pregnant?
3.7 Taking more than one pill should not cause harm
3.8 When you want to get pregnant
4. Possible side effects
4.1 Serious side effects – see a doctor straight away
4.2 Less serious side effects
4.3 Bleeding between periods should not last long
1.3.2.2
5. How to store Femodene
6. What is in Femodene and who makes it

85182528_03.indd 1

1. What Femodene does
Femodene 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 is a 21-day Pill – you take one each day for 21 days,
followed by 7 days when you take no pills.
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 will not protect you against sexually transmitted
infections, such as Chlamydia or HIV. Only condoms can help to
do this.
Femodene needs to be taken as directed to prevent
pregnancy.

2. What you need to know before you use
Femodene
General notes
Before you start using Femodene 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.
B 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, 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
You should not use Femodene 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:
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,
antithrombin-III 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:
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.
B Tell your doctor or family planning nurse if you have any
medical problems or illnesses

2.2 When to take special care with Femodene
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’.
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 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, 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
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
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)

Are you experiencing any of these signs?

What are
you
possibly
suffering
from?

2.3 Blood clots
Using a combined hormonal contraceptive such as Femodene
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 is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following
signs or symptoms.
Are you experiencing any of these signs?
What are
you
possibly
suffering
from?
R swelling of one leg or along a vein in the leg or Deep vein
foot especially when accompanied by:
thrombosis
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 breathlessness or rapid
Pulmonary
breathing
embolism
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
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:
Retinal vein
thrombosis
(blood clot
in the 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
Heart
attack
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,
Stroke
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.
R swelling and slight blue discolouration of an
extremity

Blood clots
blocking
other blood
vessels

R severe pain in your stomach (acute abdomen)
B See a doctor as soon as possible. Do not take any more
Femodene 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 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 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,
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).

Women who are not using a combined
hormonal pill and are not pregnant
Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate
Women using Femodene

Risk of developing a
blood clot in a year
About 2 out of
10,000 women
About 5-7 out of
10,000 women

About 9-12 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Femodene 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 may need to be stopped
several weeks before surgery or while you are less mobile. If
you need to stop Femodene 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 needs to be stopped.
If any of the above conditions change while you are using
Femodene, 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 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, 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
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, 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 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
B 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.
B 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.

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. 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 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 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 can also affect how well other medicines work.
Your doctor may need to adjust the dose of your other medicine.
In addition, Femodene can also interfere with the results of some
blood tests, so always tell your doctor that you are taking
Femodene if you have a blood test.

2.6 Taking Femodene with food and drink
There are no special instructions about food and drink while on
Femodene.

2.7 Pregnancy and breast-feeding
Do not use Femodene 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.
If you are breast-feeding, your doctor or family planning nurse
may advise you not to take Femodene. They will be able to
suggest alternative contraception. Breast-feeding may not stop
you getting pregnant.

2.8 Driving and using machines
Femodene has no known effect on the ability to drive or use
machines.

2.9 Femodene 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.

Packaging Technology Berlin sgqwx
page 1
Bayer Pharma AG
client: JS86
material-no.: 85182528
PZ: 2709W-3
code-no.: 103
name: LF-INS-Femodene SCT 21 GB
country: GB/-/BPH
colors: Black
version: 19.02.2016/03
approval:
dimension: 266 x 677 mm

This area must be identical on both sides!
3. Taking Femodene
3.1 How to take it
To prevent pregnancy, always take Femodene as described below.
Check with your doctor or family planning nurse if you are not
sure.
Take Femodene every day for 21 days
Femodene comes in strips of 21 pills, each marked with a day of
the week.
R Take your pill at the same time every day.
R Start by taking a pill marked with the correct day of the week.
R Follow the direction of the arrows on the strip. Take one pill
each day, until you have finished all 21 pills.
R Swallow each pill whole, with water if necessary. Do not chew
the pill.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven days
when you take no pills. So, if you take the last pill of one pack on
a Friday, you will take the first pill of your next pack on the
Saturday of the following week.
Within a few days of taking the last pill from the strip, you should
have a withdrawal bleed like a period. This bleed may not have
finished when it is time to start your next strip of pills.
You don’t need to use extra contraception during these seven pillfree days – as long as you have taken your pills correctly and
start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Femodene after the seven pill-free
days – even if you are still bleeding. Always start the new strip on
time.
As long as you take Femodene correctly, you will always start
each new strip on the same day of the week.

3.2 Starting Femodene
As a new user or starting the Pill again after a break
It is best to take your first Femodene 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 from another contraceptive Pill
R If you are currently on a 21-day Pill: start Femodene 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.
R If you are currently on a 28-day Pill: start taking Femodene
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.
R Or, if you are taking a progestogen-only Pill (POP or ‘mini
Pill’): start Femodene 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 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 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 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 and for the first 7 days of pill
taking.

3.3 A missed pill
If you are less than 12 hours late with a pill, take it straight
away. Keep taking your pills at the usual time. This may mean
taking two pills in one day. Don’t worry – your contraceptive
protection should not be reduced.

19.02.2016 10:31:32

1

19.02.2016 10:32:01

2

If you are more than 12 hours late with a pill, or you have
missed more than one pill, your contraceptive protection may be
reduced.
R Take the most recently missed pill as soon as you
remember, even if it means taking two at once. Leave any
earlier missed pills in the pack.
R Continue to take a pill every day for the next seven days at
your usual time.
R If you come to the end of a strip of pills during these seven
days, start the next strip without taking the usual seven day
break. You probably won’t have a bleed until after you finish
the second strip of pills, but don’t worry. If you finish the
second strip of pills and don’t have a bleed, do a pregnancy
test before starting another strip.
R Use extra contraception for seven days after missing a pill,
such as condoms.
R 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.
If you have missed any of the pills in a strip, and you do not
bleed in the first pill-free break, 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, or make your ‘week off’
longer than seven days, 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 a condom, for seven days.

3.4 A lost pill
If you lose a pill,
Either take the last 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 your seven pill-free days 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 if you have one. 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.

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, follow the instructions in section 3.4 A lost pill,
which describes how to take another pill.
If you are still sick or have diarrhoea more than 12 hours after
taking Femodene, see section 3.3, A missed pill.
B Talk to your doctor if your stomach upset carries on or
gets worse. He or she may recommend another form of
contraception.
Packaging Technology Berlin sgqwx
page 2
Bayer Pharma AG
client: JS86
material-no.: 85182528
PZ: 2709W-3
code-no.: 103
name: LF-INS-Femodene SCT 21 GB
country: GB/-/BPH
colors: Black
version: 19.02.2016/03
approval:
dimension: 266 x 677 mm

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 and see your doctor.

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 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

This area must be identical on both sides!
will not cause you or the baby any harm if you get pregnant
straight away.

4. Possible side effects
Like all medicines, Femodene 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, 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”.
B Tell your doctor, pharmacist or family planning nurse if
you are worried about any side effects which you think may be
due to Femodene.

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).
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.
B If you think you may have any of these, see a doctor
straight away. You may need to stop taking Femodene.

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
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. 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 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
B Tell your doctor, pharmacist or family planning nurse if
you are worried about any side effects which you think may be
due to Femodene. Also tell them if any existing conditions get
worse while you are taking Femodene.

85182528_03.indd 2

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.

6. What is in Femodene and who makes it

1.3.2.2

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Gestodene, Ethinylestradiol

Femodene®

What is in Femodene
Each box of Femodene contains three strips of 21 white tablets
containing 75 micrograms of the progestogen gestodene, and
30 micrograms of the oestrogen ethinylestradiol.
Femodene also contains the inactive ingredients:
Lactose, maize starch, povidone, magnesium stearate (E572),
sodium calcium edetate, sucrose, macrogol 6000, calcium
carbonate (E170), talc, montan glycol wax.
The company that holds the product licence for Femodene is:
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14
1JA.
Femodene is made by:
Bayer Weimar GmbH & Co KG, Weimar, Germany
or Delpharm Lille SAS, Lys-Lez-Lannoy, France.
This leaflet was last updated in February 2016.

4.3 Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting while
they are taking Femodene, 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 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.
B Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
R carries on for more than the first few months
R starts after you’ve been taking Femodene for a while
R carries on even after you’ve stopped taking Femodene.
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.

5. How to store Femodene
Keep all medicines out of the sight and reach of children.
Do not use Femodene after the expiry date shown on the strip.
Do not store above 25°C and protect from light.
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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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