FEMODETTE

Active substance: GESTODENE

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Package booklet: Information for the user

Femodette®
Gestodene
Ethinylestradiol

Five important things to know about the Pill.
 The Pill is a reliable contraceptive and 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 booklet to make sure Femodette is right for you.
 To prevent pregnancy it is important to take Femodette 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 booklet carefully before you start taking this medicine.
 Keep this booklet. 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
booklet, please tell your doctor, family planning nurse or pharmacist.
In this booklet:
1.
2.

3.

What Femodette does
Make sure Femodette is OK for you
2.1 The Pill and blood clots
2.2 The Pill and cancer
2.3 Femodette should not be taken by some women
2.4 Femodette can make some illnesses worse
2.5 Taking other medicines
2.6 Taking Femodette with food and drink
2.7 Pregnancy and breast-feeding
2.8 Driving and using machines
2.9 Femodette contains lactose and sucrose
Taking Femodette
3.1 How to take it
3.2 Starting Femodette
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
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4.

5.
6.

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
How to store Femodette
What is in Femodette and who makes it

1.

What Femodette does

Femodette 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.
Femodette 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:
 it is one of the most reliable reversible methods of contraception if used
correctly
 it doesn’t interrupt sex
 it usually makes your periods regular, lighter and less painful
 it may help with pre-menstrual symptoms.
Femodette will not protect you against sexually transmitted infections, such as
Chlamydia or HIV. Only condoms can help to do this.
Femodette needs to be taken as directed to prevent pregnancy.

2.

Make sure Femodette is OK for you

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.

Tell your doctor if you have any of the illnesses or risk factors mentioned in
this booklet.
Before you start taking the Pill
 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.

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While you’re on the Pill
 You will need regular check-ups with your doctor or family planning nurse,
usually when you need another prescription of the Pill.
 You should go for regular cervical smear tests.
 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.
 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.
 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 2.1). Your doctor will tell
you when you can start taking the Pill again.
2.1

The Pill and blood clots

The Pill may slightly increase your risk of having a blood clot (called a
thrombosis), especially in the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always serious.
However, if it moves up the veins and blocks an artery in the lungs, it can cause
chest pain, breathlessness, collapse or even death. This is called a pulmonary
embolism and is very rare.
Your chances of having a blood clot are only increased slightly by taking the
Pill.
 Of 100,000 women who are not on the Pill and not pregnant, about 5 will
have a blood clot in a year.
 Of 100,000 women taking a Pill such as Femodette, about 25 will have a
blood clot in a year.
 Of 100,000 women who are pregnant, around 60 will have a blood clot in a
year.
Very rarely, blood clots can also form in the blood vessels of the heart (causing a
heart attack) or the brain (causing a stroke). In healthy young women the chance of
having a heart attack or stroke is extremely small.
You are more at risk of having a blood clot:











as you get older
if you smoke
if you or any of your close family have had blood clots
if you are seriously overweight
if you have a disorder of blood fat (lipid) metabolism, or some other very
rare blood disorders
if you have high blood pressure
if you suffer from migraines
if you have a heart valve disorder or a particular type of irregular heartbeat
(atrial fibrillation)
if you have recently had a baby
if you have diabetes
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if you have certain rare medical conditions such as systemic lupus
erythematosus, sickle cell disease, Crohn’s disease or ulcerative colitis
if you’re off your feet for a long time because of major surgery, injury or
illness.


Tell your doctor if any of these apply to you. Taking the pill may add to this
risk so Femodette may not be suitable for you.
Signs of a blood clot include:
 a migraine for the first time, a migraine that is worse than normal or unusually
frequent or severe headaches
 any sudden changes to your eyesight (such as loss of vision or blurred
vision)
 any sudden changes to your hearing, speech, sense of smell, taste or
touch
 pain or swelling in your leg
 stabbing pain when you breathe
 coughing for no apparent reason
 pain and tightness in the chest
 sudden weakness or numbness in one side or part of your body
 dizziness or fainting.

See a doctor as soon as possible. Do not take any more Femodette until
your doctor says you can. Use another method of contraception, such as condoms,
in the meantime.
2.2

The Pill and cancer

While high dose Pills reduces your risk of cancer of the ovary and womb if used in
the long term, it is not clear whether lower dose Pills like Femodette 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:
 Of 10,000 women who have never taken the Pill, about 16 will have breast
cancer by the time they are 35 years old.
 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.



Of 10,000 women who have never taken the Pill, about 100 will have breast
cancer by the time they are 45 years old.
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.
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Your risk of breast cancer is higher:
 if you have a close relative (mother, sister or grandmother) who has had
breast cancer
 if you are seriously overweight.

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 noncancer 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.

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 Femodette.
2.3

Femodette should not be taken by some women


Tell your doctor or family planning nurse if you have any medical problems
or illnesses.
Do not take Femodette if any of the following apply to you. Taking Femodette
would put your health at risk.
 If you have or have ever had breast cancer
 If you have ever had a problem with your blood circulation. This includes a
blood clot (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary
embolism), heart (heart attack), brain (stroke) or any other parts of the body
 If you have any condition which makes you more at risk of a blood clot
(thrombosis – see section 2.1, The Pill and blood clots)
 If you have very high or uncontrolled blood pressure
 If you have any symptoms of a blood clot, such as chest pain (angina
pectoris) or ‘mini-stroke’ (transient ischaemic attack)
 If you have ever suffered from migraine with visual disturbances
 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
 If you have ever had liver tumours
 If you have severe diabetes affecting your blood vessels
 If you are allergic (hypersensitive) to any of the ingredients in Femodette.

If you suffer from any of these, or get them for the first time while taking
Femodette, contact your doctor as soon as possible. Do not take Femodette.
2.4

Femodette can make some illnesses worse

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 Femodette but you
need to take special care and have check-ups more often.


If you have diabetes
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If you or your close family have ever had problems with your heart, or
circulation such as high blood pressure
If you or your close family have ever had problems with blood clotting
If you have the inherited disease called porphyria
If you are overweight (obese)
If you have migraines
If you have inflammation of the pancreas (pancreatitis) or a history or family
history of high levels of fat in your blood (hypertriglyceridemia), as you may
be at risk of developing pancreatitis
If you have any illness that worsened during pregnancy or previous use
of the Pill (see section 4.2)


Tell your doctor or family planning nurse if any apply to you. Also tell
them if you get any of these for the first time while taking the Pill, or if any get worse
or come back, because you may need to stop taking Femodette.
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 Femodette. Also
check the booklets that come with all your medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Femodette from working properly – for example:
 some medicines used to treat epilepsy
 some medicines used to treat HIV
 griseofulvin (an anti-fungal medicine)
 certain antibiotics
 certain sedatives (called barbiturates)
 St. John’s Wort (a herbal remedy).
If you do need to take one of these medicines, Femodette 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.
Femodette can also affect how well other medicines work. Your doctor may
need to adjust the dose of your other medicine.
In addition, Femodette can also interfere with the results of some blood tests, so
always tell your doctor that you are taking Femodette if you have a blood test.

2.6

Taking Femodette with food and drink

There are no special instructions about food and drink while on Femodette.
2.7

Pregnancy and breast-feeding

Do not use Femodette if you are pregnant. If you think you might be pregnant, do a
pregnancy test to confirm that you are before you stop taking Femodette.
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If you are breast-feeding, your doctor or family planning nurse may advise you not
to take Femodette. They will be able to suggest alternative contraception. Breastfeeding may not stop you getting pregnant.
2.8

Driving and using machines

Femodette has no known effect on the ability to drive or use machines.
2.9

Femodette contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars,
contact your doctor before using Femodette.

3.

Taking Femodette

3.1

How to take it

To prevent pregnancy, always take Femodette as described below. Check with your
doctor or family planning nurse if you are not sure.
Take Femodette every day for 21 days
Femodette comes in strips of 21 pills, each marked with a day of the week.
 Take your pill at the same time every day.
 Start by taking a pill marked with the correct day of the week.
 Follow the direction of the arrows on the strip. Take one pill each day, until
you have finished all 21 pills.
 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 Femodette after the seven pill-free days – even if you
are still bleeding. Always start the new strip on time.
As long as you take Femodette correctly, you will always start each new strip on the
same day of the week.
3.2

Starting Femodette

As a new user or starting the Pill again after a break
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It is best to take your first Femodette 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 Femodette from another contraceptive Pill
 If you are currently taking a 21-day Pill: start Femodette 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 Femodette.
 If you are taking a 28-day Pill: start taking Femodette 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 Femodette.
 Or, if you are taking a progestogen-only Pill (POP or ‘mini Pill’): start
Femodette 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 Femodette 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 Femodette 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 Femodette 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 Femodette 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.
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.






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.
Continue to take a pill every day for the next seven days at your usual
time.
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.
Use extra contraception for seven days after missing a pill, such as
condoms.
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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 Femodette, 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 Femodette,
see section 3.3, A missed pill.

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 Femodette and see your doctor.
3.7

Taking more than one pill should not cause harm
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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 Femodette 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.

4.

Possible side effects

Like all medicines, Femodette can cause side effects, although not everybody gets
them.

Tell your doctor, pharmacist or family planning nurse if you are worried
about any side effects which you think may be due to Femodette.
4.1

Serious side effects – see a doctor straight away

Signs of a blood clot:
 a migraine for the first time, a migraine that is worse than normal, or
unusually frequent or severe headaches
 any sudden changes to your eyesight (such as loss of vision or blurred
vision)
 any sudden changes to your hearing, speech, sense of smell, taste or
touch
 pain or swelling in your leg
 stabbing pain when you breathe
 coughing for no apparent reason
 pain and tightness in the chest
 sudden weakness or numbness in one side or part of your body
 dizziness or fainting.
Signs of a severe allergic reaction or worsening of hereditary angioedema:
 swelling of the hands, face, lips, mouth, tongue or throat. A swollen
tongue/throat may lead to difficulty swallowing and breathing
 a red bumpy rash (hives) and itching.
Signs of breast cancer include:
 dimpling of the skin
 changes in the nipple
 any lumps you can see or feel.
Signs of cancer of the cervix include:
 vaginal discharge that smells and/or contains blood
 unusual vaginal bleeding
 pelvic pain
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painful sex.

Signs of severe liver problems include:
 severe pain in your upper abdomen
 yellow skin or eyes (jaundice)
 inflammation of the liver (hepatitis)
 your whole body starts itching.

If you think you may have any of these, see a doctor straight away. You
may need to stop taking Femodette.
4.2

Less serious side effects

Common side effects (between 100 and 1000 in every 10,000 users may be
affected)
 feeling sick
 stomach ache
 putting on weight
 headaches
 depressive moods or mood swings
 sore or painful breasts
Uncommon side effects (between 10 and 100 in every 10,000 users may be
affected)
 being sick and stomach upsets
 fluid retention
 migraine
 loss of interest in sex
 breast enlargement
 skin rash, which may be itchy
Rare side effects (between 1 and 10 in every 10,000 users may be affected)
 poor tolerance of contact lenses
 losing weight
 increase of interest in sex
 vaginal or breast discharge
Other side effects reported
 Bleeding and spotting between your periods can sometimes occur for the
first few months but this usually stops once your body has adjusted to
Femodette. If it continues, becomes heavy or starts again, contact your
doctor (see section 4.3).
 Chloasma (yellow brown patches on the skin). This may happen even if you
have been using Femodette for a number of months. Chloasma may be
reduced by avoiding too much sunlight and/or UV lamps
 Conditions that may worsen during pregnancy or previous use of the
Pill:
- yellowing of the skin (jaundice)
- persistent itching (pruritus)
- kidney or liver problems
- gall stones
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-

certain rare medical conditions such as systemic lupus
erythematosus
occurrence or deterioration of the movement disorder chorea
blister-like rash (herpes gestationis) whilst pregnant
an inherited form of deafness (otosclerosis)
Crohn’s disease
ulcerative colitis
a personal or family history of a form of sickle cell disease
swelling of body parts (hereditary angioedema)
an inherited disease called porphyria
cancer of the cervix


Tell your doctor, pharmacist or family planning nurse if you are worried
about any side effects which you think may be due to Femodette. Also tell them if
any existing conditions get worse while you are taking Femodette.
4.3

Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking
Femodette, especially during the first few months. Normally, this bleeding is nothing
to worry about and will stop after a day or two. Keep taking Femodette 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.

Make an appointment to see your doctor if you get breakthrough bleeding
or spotting that:
 carries on for more than the first few months
 starts after you’ve been taking Femodette for a while
 carries on even after you’ve stopped taking Femodette.

5.

How to store Femodette

Keep all medicines out of the reach and sight of children.
Do not use Femodette 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.

6.

What is in Femodette and who makes it

What is in Femodette
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Each box of Femodette contains 21 white sugar-coated tablets containing 75
micrograms of the progestogen gestodene, and 20 micrograms of the oestrogen
ethinylestradiol.
Femodette also contains the inactive ingredients:
lactose, maize starch, povidone, magnesium stearate (E572), sucrose,
macrogol 6000, calcium carbonate (E170), talc,
montan glycol wax.
The company that holds the product licence for Femodette is:
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA.
Femodette is made by:
Bayer Pharma AG, Berlin, Germany
or
Delpharm Lille SAS, Lys-Lez-Lannoy, France.
This booklet was last updated in January 2013.

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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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