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FEMODETTE

Active substance(s): ETHINYLOESTRADIOL / GESTODENE / ETHINYLOESTRADIOL / GESTODENE / ETHINYLOESTRADIOL / GESTODENE

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k/

4

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m
T 21

421

Gestodene
Ethinylestradiol

D

Package booklet: Information for the user

PH

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85688421

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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.

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R They are one of the most reliable reversible methods of contraception if
used correctly.

Important things to know about combined hormonal
contraceptives (CHCs):

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R This medicine can increase your risk of problems such as blood clots and
breast cancer.

R The Pill will not protect you against sexually transmitted diseases.

R The Pill may reduce your risk of cancer of the ovary and womb if used in
the long term.

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').

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R 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.

R 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.

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R 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.

R This medicine has been prescribed for you. Do not pass it on to others. It
may harm them.

R If you have any questions or need more advice, ask your doctor, family
planning nurse or pharmacist.

R Keep this booklet. You may need to read it again.

Read all of this booklet carefully before you start taking this medicine.

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2.1 When you should not use Femodette
2.2 When to take special care with Femodette
2.3 Blood clots

l What Femodette does
m What you need to know before you use Femodette

In this booklet:
1

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5
9
15
22

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2.4 The Pill and cancer
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

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47
52
56
57
58
58

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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?

n Taking Femodette

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59
59
62
66
70
72
73

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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

o Possible side effects

3.7 Taking more than one pill should not cause harm
3.8 When you want to get pregnant

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77
79
84
91

74
75

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97

What is in Femodette and who makes it

q

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95

How to store Femodette

p

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l What Femodette does

1

b
(1]

R

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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

Femodette is a combined oral contraceptive pill (‘the Pill’). You take it to
stop you getting pregnant.

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C
[2)

R it doesn’t interrupt sex

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R it is one of the most reliable reversible methods of contraception if used
correctly

The benefits of taking the Pill include:

Femodette is a 21-day Pill – you take one each day for 21 days, followed by
7 days when you take no pills.

difficult for sperm to enter the womb; and by preventing the lining of your
womb thickening enough for an egg to grow in it.

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1

Femodette needs to be taken as directed to prevent pregnancy.

d
(3]

R

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Femodette will not protect you against sexually transmitted infections, such
as Chlamydia or HIV. Only condoms can help to do this.

R it may help with pre-menstrual symptoms.

R it usually makes your periods regular, lighter and less painful

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E
[4)

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m What you need to know before you use Femodette

2

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.

f
(5]

R

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Before you start using Femodette 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'.

General notes

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G
[6)

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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,

Before you start taking the Pill

B Tell your doctor if you have any of the illnesses or risk factors
mentioned in this booklet.

Although the Pill is suitable for most healthy women it isn’t suitable for
everyone.

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2

R You should go for regular cervical smear tests.

R You will need regular check-ups with your doctor or family planning
nurse, usually when you need another prescription of the Pill.

While you’re on the Pill

h
(7]

R

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but only if these examinations are necessary for you, or if you have any
special concerns.

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I
[8)

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

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.

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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.

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2

j
(9]

R

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You should not use Femodette 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.

2.1 When you should not use Femodette

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.

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[10)

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

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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

Do not use Femodette:

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2

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(11]

R If you have any of the following diseases that may increase your risk of a
clot in the arteries:
R

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 ever had a heart attack or stroke

R If you need an operation or if you are off your feet for a long time (see
section ‘Blood clots’)

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[12)

R If you have or have ever had breast cancer

R If you have (or have ever had) a type of migraine called ‘migraine with
aura’

P a condition known as hyperhomocysteinaemia

P a very high level of fat in the blood (cholesterol or triglycerides)

P very high blood pressure

P severe diabetes with blood vessel damage

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2

R
(13]

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Do not use Femodette if you have hepatitis C and are taking the medicinal
products containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see
also in section ‘Taking other medicines’).

R If you are allergic (hypersensitive) to any of the ingredients in Femodette.

R If you have ever had liver tumours

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

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[14)

B Tell your doctor or family planning nurse if you have any medical
problems or illnesses.

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2

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).

2.2 When to take special care with Femodette

R

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(15]

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[16)

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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.

For a description of the symptoms of these serious side effects please go to
'How to recognise a blood clot'.

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2

R
(17]

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R If you have systemic lupus erythematosus (SLE – a disease affecting your
natural defence system)

R If you have Crohn’s disease or ulcerative colitis (chronic inflammatory
bowel disease)

If the condition develops, or gets worse while you are using Femodette, you
should also tell your doctor.

Tell your doctor if any of the following conditions apply to you.

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[18)

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R If you have elevated levels of fat in the blood (hypertriglyceridaemia) or
a positive family history for this condition. Hypertriglyceridaemia has

R If you have inflammation of the pancreas (pancreatitis)

R If you have sickle cell anaemia (an inherited disease of the red blood
cells)

R If you have haemolytic uraemic syndrome (HUS – a disorder of blood
clotting causing failure of the kidneys)

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2

R
(19]

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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
Femodette

R If you need an operation, or you are off your feet for a long time (see in
section 2.3 ‘Blood clots’)

been associated with an increased risk of developing pancreatitis
(inflammation of the pancreas)

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[20)

R If you or your close family have ever had problems with blood clotting

R If you or your close family have ever had problems with your heart, or
circulation such as high blood pressure

R If you have diabetes

R If you have varicose veins

R If you have an inflammation in the veins under the skin (superficial
thrombophlebitis)

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2

R
(21]

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R If you have any illness that worsened during pregnancy or previous use
of the Pill (see section 4.2)

R If you have migraines

R If you are overweight (obese)

R If you have the inherited disease called porphyria

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[22)

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R in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’
or VTE);

Blood clots can develop:

Using a combined hormonal contraceptive such as Femodette 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.

2.3 Blood clots

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2

It is important to remember that the overall risk of having a harmful
blood clot due to Femodette is small.

Recovery from blood clots is not always complete. Rarely, there may be
serious lasting effects or, very rarely, they may be fatal.

R in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).

R

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(23]

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[24)

R swelling of one leg or along a vein in the leg
or foot especially when accompanied by:

Are you experiencing any of these signs?

What are you possibly
suffering from?
Deep vein thrombosis

Seek urgent medical attention if you notice any of the following signs or
symptoms.

HOW TO RECOGNISE A BLOOD CLOT

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2

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
breathing
Pulmonary embolism

R

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(25]

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26)

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

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2

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(27]

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

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[28)

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

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2

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

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(29]

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[30)

R sudden trouble walking, dizziness, loss of
balance or coordination

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

Stroke

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2

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

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(31]

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[32)

B 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.

R swelling and slight blue discolouration of an Blood clots blocking
extremity
other blood vessels
R severe pain in your stomach (acute abdomen)

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2

R
(33]

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R If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).

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.

What can happen if a blood clot forms in a vein?

BLOOD CLOTS IN A VEIN

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[34)

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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

When is the risk of developing a blood clot in a vein highest?

R Very rarely a clot may form in a vein in another organ such as the eye
(retinal vein thrombosis).

R If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.

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2

R
(35]

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When you stop Femodette your risk of a blood clot returns to normal within
a few weeks.

After the first year, the risk gets smaller but is always slightly higher than if
you were not using a combined hormonal contraceptive.

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.

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[36)

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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.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Femodette
is small.

The risk depends on your natural risk of VTE and the type of combined
hormonal contraceptive you are taking.

What is the risk of developing a blood clot?

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2

R
(37]

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R Out of 10,000 women who are using a combined hormonal contraceptive
that contains gestodene such as Femodette, between about 9 and 12
women 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.

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[38)

Women who are not using a combined
hormonal pill and are not pregnant

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

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).

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2

Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate
Women using Femodette

R
(39]

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About 9-12 out of 10,000
women

About 5-7 out of 10,000
women

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[40)

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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 are very overweight (body mass index or BMI over 30kg/m2)

The risk of a blood clot with Femodette is small but some conditions will
increase the risk. Your risk is higher:

Factors that increase your risk of a blood clot in a vein

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2

R
(41]

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The risk of developing a blood clot increases the more conditions you have.

R if you gave birth less than a few weeks ago.

R as you get older (particularly above about 35 years)

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 Femodette may need to be stopped several weeks before surgery
or while you are less mobile. If you need to stop Femodette ask your
doctor when you can start using it again.

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[42)

If any of the above conditions change while you are using Femodette, for
example a close family member experiences a thrombosis for no known
reason, or you gain a lot of weight, tell your doctor.

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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 Femodette needs to be
stopped.

Air travel (>4 hours) may temporarily increase your risk of a blood clot,
particularly if you have some of the other factors listed.

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2

R
(43]

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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.

What can happen if a blood clot forms in an artery?

BLOOD CLOTS IN AN ARTERY

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[44)

R if you smoke. When using a combined hormonal contraceptive like
Femodette, 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 with increasing age (beyond about 35 years)

It is important to note that the risk of a heart attack or stroke from using
Femodette is very small but can increase:

Factors that increase your risk of a blood clot in an artery

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2

R if you get migraines, especially migraines with aura

R
(45]

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R if you, or someone in your immediate family, have a high level of fat in
the blood (cholesterol or triglycerides)

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 have high blood pressure

R if you are overweight

21_03.indd 46

[46)

If any of the above conditions change while you are using Femodette, for
example you start smoking, a close family member experiences a

7/27/2017 1:44:45 PM

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.

R if you have diabetes.

R if you have a problem with your heart (valve disorder, disturbance of the
rhythm called atrial fibrillation)

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2

R
(47]

7/27/2017 1:44:45 PM

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 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

2.4 The Pill and cancer

thrombosis for no known reason, or you gain a lot of weight, tell your
doctor.

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[48)

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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:

may be due to having sex without a condom, rather than the Pill. All women
should have regular smear tests.

21_03.indd 49

2

R
(49]

7/27/2017 1:44:45 PM

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.

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 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 16 will have
breast cancer by the time they are 35 years old.

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[50)

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.

R if you are seriously overweight.

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R if you have a close relative (mother, sister or grandmother) who has had
breast cancer

Your risk of breast cancer is higher:

21_03.indd 51

2

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 Femodette.

R
(51]

7/27/2017 1:44:45 PM

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.

21_03.indd 52

[52)

R some medicines used to treat epilepsy

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Some medicines can have an influence on the blood levels of Femodette and
can stop it from working properly – for example:

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.

2.5 Taking other medicines

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2

R St. John’s Wort (a herbal remedy).

R certain sedatives (called barbiturates)

R certain antibiotics

R griseofulvin (an anti-fungal medicine)

R
(53]

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R some medicines used to treat HIV and Hepatitis C Virus infections
(so-called protease inhibitors and non-nucleoside reverse transcriptase
inhibitors)

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[54)

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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.

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2

R
(55]

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Do not use Femodette if you have hepatitis C and are taking the medicinal
products containing ombitasvir / paritaprevir / ritonavir and dasabuvir as
this may cause increases in liver function blood test results (increase in ALT

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.

Femodette can also affect how well other medicines work. Your doctor
may need to adjust the dose of your other medicine.

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[56)

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

2.6 Taking Femodette with food and drink

liver enzyme). Your doctor will prescribe another type of contraceptive prior
to start of the treatment with these medicinal products. Femodette can be
restarted approximately 2 weeks after completion of treatment. See section
‘Do not use Femodette’).

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2

R
(57]

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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. Breast-feeding may not stop you getting pregnant.

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.

2.7 Pregnancy and breast-feeding

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[58)

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

2.9 Femodette contains lactose and sucrose

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

2.8 Driving and using machines

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n Taking Femodette

3

R Take your pill at the same time every day.

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(59]

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Femodette comes in strips of 21 pills, each marked with a day of the week.

Take Femodette every day for 21 days

To prevent pregnancy, always take Femodette as described below. Check
with your doctor or family planning nurse if you are not sure.

3.1 How to take it

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[60)

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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.

Then have seven pill-free days

R Swallow each pill whole, with water if necessary. Do not chew the pill.

R Follow the direction of the arrows on the strip. Take one pill each day,
until you have finished all 21 pills.

R Start by taking a pill marked with the correct day of the week.

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3

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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.

Then start your next strip

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 pill-free days – as long as you have taken
your pills correctly and start the next strip of pills on time.

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[62)

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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.

As a new user or starting the Pill again after a break

3.2 Starting Femodette

As long as you take Femodette correctly, you will always start each new strip
on the same day of the week.

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3

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R 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.

R 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.

Changing to Femodette from another contraceptive Pill

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[64)

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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

Starting Femodette after a miscarriage or abortion

R 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.

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3

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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.

Contraception after having a baby

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.

away. This means that you will have contraceptive protection with your first
pill.

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[66)

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.

3.3 A missed pill

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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.

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3

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(67]

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
R

R Continue to take a pill every day for the next seven days at your
usual time.

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.

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.

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[68)

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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

R Use extra contraception for seven days after missing a pill, such as
condoms.

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.

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3

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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

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.

soon as possible. They may recommend you use emergency
contraception.

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[70)

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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

If you lose a pill,

3.4 A lost pill

for advice. You may need to consider emergency contraception. You should
also use extra contraception, such as a condom, for seven days.

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3

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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.

seven pill-free days you will have a new starting day, one day earlier than
before.

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[72)

If you are still sick or have diarrhoea more than 12 hours after taking
Femodette, see section 3.3, A missed pill.

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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.

3.5 If you are sick or have diarrhoea

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3

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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

3.6 Missed a period – could you be pregnant?

B Talk to your doctor if your stomach upset carries on or gets worse.
He or she may recommend another form of contraception.

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[74)

It is unlikely that taking more than one pill will do you any harm, but you
may feel sick, vomit or bleed from the vagina. Even girls who have not yet
started to menstruate but have accidentally taken this medicine may

3.7 Taking more than one pill should not cause harm

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.

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3

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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.

3.8 When you want to get pregnant

experience such bleeding. Talk to your doctor if you have any of these
symptoms.

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[76)

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o Possible side effects

4

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

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(77]

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Like all medicines, Femodette 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 Femodette,
please talk to your doctor.

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[78)

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

detailed information on the different risks from taking combined hormonal
contraceptives please see section 2 “What you need to know before you use
Femodette”.

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P stroke

P heart attack

P in a lung (i.e. PE)

P in a leg or foot (i.e. DVT)

4

R harmful blood clots in a vein or artery for example:

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Rare side effects (between 1 and 10 in every 10,000 users may be affected)

4.1 Serious side effects – see a doctor straight away

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[80)

Signs of a blood clot (see section 2.3 'Blood clots')

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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).

P blood clots in the liver, stomach/intestine, kidneys or eye.

P mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)

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R dimpling of the skin

Signs of breast cancer include:

R a red bumpy rash (hives) and itching.

4

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(81]

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R swelling of the hands, face, lips, mouth, tongue or throat. A swollen
tongue/throat may lead to difficulty swallowing and breathing

Signs of a severe allergic reaction or worsening of hereditary
angioedema:

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[82)

R painful sex.

R pelvic pain

R unusual vaginal bleeding

R vaginal discharge that smells and/or contains blood

Signs of cancer of the cervix include:

R any lumps you can see or feel.

R changes in the nipple

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Signs of severe liver problems include:

4

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

R your whole body starts itching.

R inflammation of the liver (hepatitis)

R yellow skin or eyes (jaundice)

R severe pain in your upper abdomen

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[84)

R headaches

R putting on weight

R stomach ache

R feeling sick

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Common side effects (between 100 and 1000 in every 10,000 users may be
affected)

4.2 Less serious side effects

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R migraine

R fluid retention

R being sick and stomach upsets

4

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Uncommon side effects (between 10 and 100 in every 10,000 users may be
affected)

R sore or painful breasts

R depressive moods or mood swings

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[86)

R increase of interest in sex

R losing weight

R poor tolerance of contact lenses

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Rare side effects (between 1 and 10 in every 10,000 users may be affected)

R skin rash, which may be itchy

R breast enlargement

R loss of interest in sex

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4

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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 Femodette. If it continues, becomes heavy or starts again, contact
your doctor (see section 4.3).

Other side effects reported

R vaginal or breast discharge

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[88)

P kidney or liver problems

P persistent itching (pruritus)

P yellowing of the skin (jaundice)

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R Conditions that may worsen during pregnancy or previous use of the
Pill:

R 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

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P Crohn’s disease

4

P an inherited form of deafness (otosclerosis)

P blister-like rash (herpes gestationis) whilst pregnant

P occurrence or deterioration of the movement disorder chorea

P certain rare medical conditions such as systemic lupus
erythematosus

P gall stones

R

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(89]

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[90)

P ulcerative colitis

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

P cancer of the cervix

P an inherited disease called porphyria

P swelling of body parts (hereditary angioedema)

P a personal or family history of a form of sickle cell disease

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4

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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.

4.3 Bleeding between periods should not last long

Also tell them if any existing conditions get worse while you are taking
Femodette.

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[92)

R carries on even after you’ve stopped taking Femodette.

R starts after you’ve been taking Femodette for a while

R carries on for more than the first few months

B Make an appointment to see your doctor if you get breakthrough
bleeding or spotting that:

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.

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4

By reporting side effects you can help provide more information on the
safety of this medicine.

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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.

Reporting of side effects

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p How to store Femodette

5

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(95]

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.
R

Do not store above 25°C and protect from light.

Do not use Femodette after the expiry date shown on the strip.

Keep all medicines out of the sight and reach of children.

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q What is in Femodette and who makes it

6

lactose, maize starch, povidone, magnesium stearate (E572), sucrose,

Femodette also contains the inactive ingredients:

Each box of Femodette contains 21 white sugar-coated tablets containing
75 micrograms of the progestogen gestodene, and 20 micrograms of the
oestrogen ethinylestradiol.

What is in Femodette

R

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(97]

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[98)

Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA.

The company that holds the product licence for Femodette is:

montan glycol wax.

macrogol 6000, calcium carbonate (E170), talc,

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This booklet was last updated in July 2017.

Bayer AG, Mullerstrasse 178
13353 Berlin, Germany
or
Delpharm Lille SAS, Lys-Lez-Lannoy, France.

Femodette is made by:

6

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[100)

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(101]

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85688421

Expand Transcript

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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