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MICROGYNON 30 ED

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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Package booklet: Information for the user

Microgynon® 30 ED
Levonorgestrel
Ethinylestradiol

Packaging Technology Berlin sgqwx
page U 1
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C / Pant yellow C / Pant 166 C / Pant 367 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

Anja
Bernwald

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1.3.2

Digitally signed by Anja
Bernwald
DN: o=Bayer Business Services,
email=anja.bernwald@bayer.c
om, cn=Anja Bernwald
Date: 2017.10.11 15:51:27
+02'00'

10/11/2017 3:45:48 PM

1

Packaging Technology Berlin sgqwx
page U 2
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C / Pant yellow C / Pant 166 C / Pant 367 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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Packaging Technology Berlin sgqwx
page U 3
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C / Pant yellow C / Pant 166 C / Pant 367 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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86007312

Packaging Technology Berlin sgqwx
page U 4
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C / Pant yellow C / Pant 166 C / Pant 367 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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.
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Packaging Technology Berlin sgqwx
page 1
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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 booklet to
make sure Microgynon 30 ED is right for you.
R To prevent pregnancy it is important to take
Microgynon 30 ED as instructed and start each pack on
time. Please make sure that you understand what to do if
you miss a pill or if you think you are pregnant.
Read all of this booklet carefully before you start taking
this medicine.
R Keep this booklet. 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.
[2)
C

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page 2
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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 get severe, or if you notice any
not listed in this booklet, please tell your doctor, family
planning nurse or pharmacist.

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Packaging Technology Berlin sgqwx
page 3
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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In this booklet:

l What Microgynon 30 ED does
m What you need to know before you use
Microgynon 30 ED
n Taking Microgynon 30 ED
3.3 A missed pill

o Possible side effects
p How to store Microgynon 30 ED
q What is in Microgynon 30 ED and who
makes it

5
7
41
46
55
67
69

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Packaging Technology Berlin sgqwx
page 4
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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l

What Microgynon 30 ED does

Microgynon 30 ED is a combined oral contraceptive pill (‘the
Pill’). You take it to stop you getting pregnant.
This contraceptive contains two types of female sex hormones,
oestrogen and progestogen. These hormones stop you getting
pregnant by working in three ways: by preventing an egg being
released from your ovaries; by making the fluid (mucus) in your
cervix thicker, which makes it more difficult for sperm to enter
the womb; and by preventing the lining of your womb
thickening enough for an egg to grow in it.
Microgynon 30 ED is taken every day without a break. You take
an ‘active pill’ each day for 21 days, followed by an ‘inactive pill’
each day for 7 days.
R

1

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page 5
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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.
Microgynon 30 ED will not protect you against sexually
transmitted infections, such as Chlamydia or HIV. Only condoms
can help to do this.
Microgynon 30 ED needs to be taken as directed to prevent
pregnancy.

[6)
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Packaging Technology Berlin sgqwx
page 6
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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m

What you need to know before you use
Microgynon 30 ED

General notes
Before you start using Microgynon 30 ED you should read the
information on blood clots in section 2. It is particularly
important to read the symptoms of a blood clot – see Section
2.3 ‘Blood clots’.
It’s important that you understand the benefits and risks of
taking the Pill before you start taking it, or when deciding
whether to carry on taking it. Although the Pill is suitable for
most healthy women it isn’t suitable for everyone.
J Tell your doctor if you have any of the illnesses or risk
factors mentioned in this booklet.

2

R
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Packaging Technology Berlin sgqwx
page 7
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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.

[8)
I

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page 8
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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.
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 Microgynon 30 ED
You should not use Microgynon 30 ED if you have any of the
conditions listed below. If you do have any of the conditions
listed below, you must tell your doctor. Your doctor will discuss R

2

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page 9
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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with you what other form of birth control would be more
appropriate.
Do not use Microgynon 30 ED:
R If you have (or have ever had) a blood clot in a blood vessel
of your legs (deep vein thrombosis, DVT), your lungs
(pulmonary embolus, PE) or other organs
R If you know you have a disorder affecting your blood
clotting – for instance, protein C deficiency, protein S
deficiency, 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 ‘Blood clots’)
R If you have ever had a heart attack or stroke
[10)

Packaging Technology Berlin sgqwx
page 10
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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R If you have (or have ever had) angina pectoris (a condition
that causes severe chest pain and may be a first sign of a
heart attack) or transient ischaemic attack (TIA – temporary
stroke symptoms)
R If you have any of the following diseases that may increase
your risk of a clot in the arteries:
R severe diabetes with blood vessel damage
R very high blood pressure
R a very high level of fat in the blood (cholesterol or
triglycerides)
R 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

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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
Microgynon 30 ED.
Do not use Microgynon 30 ED if you have hepatitis C and are
taking the medicinal products containing ombitasvir/
paritaprevir/ritonavir and dasabuvir (see also in section “Taking
other medicines”).
J Tell your doctor or family planning nurse if you have any
medical problems or illnesses.

[12)

Packaging Technology Berlin sgqwx
page 12
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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2.2 When to take special care with Microgynon 30 ED
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
R

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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may still be able to take Microgynon 30 ED but you need to take
special care and have check-ups more often.
Tell your doctor if any of the following conditions apply to
you.
If the condition develops, or gets worse while you are using
Microgynon 30 ED, you should also tell your doctor.
R If you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease)
R If you have systemic lupus erythematosus (SLE – a disease
affecting your natural defence system)
R If you have haemolytic uraemic syndrome (HUS – a disorder
of blood clotting causing failure of the kidneys)
R If you have sickle cell anaemia (an inherited disease of the
red blood cells)
[14)

Packaging Technology Berlin sgqwx
page 14
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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 Microgynon 30 ED
R If you have an inflammation in the veins under the skin
(superficial thrombophlebitis)
R If you have varicose veins
R

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page 15
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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)

[16)

Packaging Technology Berlin sgqwx
page 16
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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2.3 Blood clots
Using a combined hormonal contraceptive such as
Microgynon 30 ED increases your risk of developing a blood clot
compared with not using one. In rare cases a blood clot can
block vessels and cause serious problems.
Blood clots can develop:
R in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE);
R in the arteries (referred to as an ‘arterial thrombosis’,
‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there
may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of having a
harmful blood clot due to Microgynon 30 ED is small.
R

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Packaging Technology Berlin sgqwx
page 17
Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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 Deep vein
leg or foot especially when accompanied thrombosis
by:
R pain or tenderness in the leg which
may be felt only when standing or
walking
R increased warmth in the affected leg

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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R
R
R
R
R
R

R change in colour of the skin on the
leg e.g. turning pale, red or blue
sudden unexplained breathlessness or
Pulmonary
rapid breathing
embolism
sudden cough without an obvious cause,
which may bring up blood
sharp chest pain which may increase
with deep breathing
severe light headedness or dizziness
rapid or irregular heartbeat
severe pain in your stomach
R

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for a
milder condition such as a respiratory tract
infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one
eye:
R immediate loss of vision or
R painless blurring of vision which can
progress to loss of vision
R chest pain, discomfort, pressure,
heaviness

Retinal vein
thrombosis
(blood clot in
the eye)
Heart attack

[20)

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
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dimension: 85 x 60 mm

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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
Stroke
R sudden weakness or numbness of the
face, arm or leg, especially on one side
of the body
R

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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

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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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
R severe pain in your stomach (acute
abdomen)

Blood clots
blocking other
blood vessels

J See a doctor as soon as possible. Do not take any more
Microgynon 30 ED until your doctor says you can. Use
another method of contraception, such as condoms, in the
meantime.
R

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Packaging Technology Berlin sgqwx
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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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).
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Packaging Technology Berlin sgqwx
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Bayer AG
client: 0021
item-no.: 86007312
PZ: 2537A-4C
code-no.: 298
name: LF-BRO-Microgynon 30 ED SCT 28
country: GB/-/BAG
colors: Black / Pant 368 C
version: 11.10.2017/02
Restricted Document
dimension: 85 x 60 mm

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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 Microgynon 30 ED your risk of a blood clot
returns to normal within a few weeks.

R

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country: GB/-/BAG
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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 Microgynon 30 ED is small.
R Out of 10,000 women who are not using any combined
hormonal contraceptive and are not pregnant, about 2 will
develop a blood clot in a year.
R Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, such as
Microgynon 30 ED, about 5-7 will develop a blood clot in a
year.

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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).
Risk of developing a
blood clot in a year
Women who are not using a combined About 2 out of
hormonal pill and are not pregnant
10,000 women
About 5-7 out of
Women using a combined hormonal
10,000 women
contraceptive pill containing
levonorgestrel
Women using Microgynon 30 ED
About 5-7 out of
10,000 women
R

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Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Microgynon 30 ED is small but
some conditions will increase the risk. Your risk is higher:
R if you are very overweight (body mass index or BMI over
30kg/m2)
R if one of your immediate family has had a blood clot in the
leg, lung or other organ at a young age (e.g. below the age
of about 50). In this case you could have a hereditary blood
clotting disorder
R if you need to have an operation, or if you are off your feet
for a long time because of an injury or illness, or you have
your leg in a cast. The use of Microgynon 30 ED may need to
be stopped several weeks before surgery or while you are

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less mobile. If you need to stop Microgynon 30 ED ask your
doctor when you can start using it again.
R as you get older (particularly above about 35 years)
R if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more
conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a
blood clot, particularly if you have some of the other factors
listed.
It is important to tell your doctor if any of these conditions
apply to you, even if you are unsure. Your doctor may decide
that Microgynon 30 ED needs to be stopped.
If any of the above conditions change while you are using
Microgynon 30 ED, for example a close family member
R

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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 Microgynon 30 ED is very small but can increase:
R with increasing age (beyond about 35 years)
R if you smoke. When using a combined hormonal
contraceptive like Microgynon 30 ED, you are advised to stop
smoking. If you are unable to stop smoking and are older
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R
R
R

R
R
R
R

than 35 your doctor may advise you to use a different type
of contraceptive
if you are overweight
if you have high blood pressure
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
if you, or someone in your immediate family, have a high
level of fat in the blood (cholesterol or triglycerides)
if you get migraines, especially migraines with aura
if you have a problem with your heart (valve disorder,
disturbance of the rhythm called atrial fibrillation)
if you have diabetes.
R

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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
Microgynon 30 ED, for example you start smoking, a close
family member experiences a thrombosis for no known reason,
or you gain a lot of weight, tell your doctor.

2.4 The Pill and cancer
While high dose Pills reduce your risk of cancer of the ovary and
womb if used in the long term, it is not clear whether lower
dose Pills like Microgynon 30 ED also provide the same
protective effects. However, it also seems that taking the Pill
slightly increases your risk of cancer of the cervix – although
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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

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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
J 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
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rarely, the Pill has also been linked with some forms of liver
cancer in women who have taken it for a long time.
J 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 Microgynon 30 ED.

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 Microgynon 30 ED. Also check the leaflets
that come with all your medicines to see if they can be taken
with hormonal contraceptives.
Some medicines can have an influence on the blood levels of
Microgynon 30 ED and can stop it from working properly – for
R
example:

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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).

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If you do need to take one of these medicines,
Microgynon 30 ED may not be suitable for you or you may need
to use extra contraception for a while. Your doctor, pharmacist
or dentist can tell you if this is necessary and for how long.
Microgynon 30 ED can also affect how well other medicines
work. Your doctor may need to adjust the dose of your other
medicine.
In addition, Microgynon 30 ED can also interfere with the
results of some blood tests, so always tell your doctor that you
are taking Microgynon 30 ED if you have a blood test.
Do not use Microgynon 30 ED 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 liver enzyme).
R

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Your doctor will prescribe another type of contraceptive prior to
start of the treatment with these medicinal products.
Microgynon 30 ED can be restarted approximately 2 weeks after
completion of this treatment. See section “Do not use
Microgynon 30 ED”.

2.6 Taking Microgynon 30 ED with food and drink
There are no special instructions about food and drink while on
Microgynon 30 ED.

2.7 Pregnancy and breast-feeding
Do not use Microgynon 30 ED if you are pregnant. If you think
you might be pregnant, do a pregnancy test to confirm that you
are before you stop taking Microgynon 30 ED.
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If you are breast-feeding, your doctor or family planning
nurse may advise you not to take Microgynon 30 ED. They will
be able to suggest alternative contraception. Breast-feeding
may not stop you getting pregnant.

2.8 Driving and using machines
Microgynon 30 ED has no known effect on the ability to drive or
use machines.

2.9 Microgynon 30 ED contains lactose and sucrose
If you have been told by your doctor that you have intolerance
to some sugars, contact your doctor before using
Microgynon 30 ED.
R

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n

Taking Microgynon 30 ED

3.1 How to take it
To prevent pregnancy, always take Microgynon 30 ED as
described below. Check with your doctor or family planning
nurse if you are not sure.
This pack is designed to help you remember to take your pills.
Your pack contains 3 foil memo strips with 3 sets of 7 selfadhesive strips showing the days of the week. Each foil memo
strip contains 28 tablets: 21 small active tablets in 3 rows and
7 larger inactive tablets in the last row.

R

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Take Microgynon 30 ED every day for 28 days
R Find the set of self-adhesive strips. Each strip starts with a
different day of the week. Peel off a strip that starts with
your starting day.
R For instance, if you start the tablets on a Wednesday, use a
strip that starts with ‘Wed’.
R Stick the strip along the top of the foil memo-strip so that
the first day is above the pill marked ‘start’.
R You can now see on which day you have to take each tablet.
R Take your pill at the same time every day.
R Follow the direction of the arrows on the strip. Take one pill
each day, until you have finished all 28 pills.
R Swallow each pill whole, with water if necessary. Do not
chew the pill.
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Then start your next strip
Start taking your next strip of Microgynon 30 ED the next day.
Do not leave a gap between packs.
As long as you take Microgynon 30 ED correctly, you will always
start each new strip on the same day of the week.

3.2 Starting Microgynon 30 ED
As a new user or starting the Pill again after a break
It is best to take your first Microgynon 30 ED pill on the first day
of your next period. By starting in this way, you will have
contraceptive protection with your first pill.

R

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Changing to Microgynon 30 ED from another contraceptive
Pill
If you are currently taking a 21-day Pill: start
Microgynon 30 ED the next day after the end of the previous
strip. You will have contraceptive protection with your first pill.
You will not have a bleed until after your first strip of
Microgynon 30 ED.
If you are taking a 28-day Pill: start taking Microgynon 30 ED
the day after your last active pill. You will have contraceptive
protection with your first pill. You will not have a bleed until
after your first strip of Microgynon 30 ED.
Or, if you are taking a progestogen-only Pill (POP or ‘mini
Pill’): start Microgynon 30 ED on the first day of bleeding, even

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if you have already taken the progestogen-only Pill for that day.
You will have contraceptive cover straight away.
Starting Microgynon 30 ED after a miscarriage or abortion
If you have had a miscarriage or an abortion during the first
three months of pregnancy, your doctor may tell you to start
taking Microgynon 30 ED straight away. This means that you
will have contraceptive protection with your first pill.
If you have had a miscarriage or an abortion after the third
month of pregnancy, ask your doctor for advice. You may need
to use extra contraception, such as condoms, for a short time.
Contraception after having a baby
If you have just had a baby, your doctor may advise you that
Microgynon 30 ED should be started 21 days after delivery
provided that you are fully mobile. You do not have to wait for aR

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period. You will need to use another method of contraception,
such as a condom, until you start Microgynon 30 ED and for the
first 7 days of pill taking.

3.3 A missed pill
If you are less than 12 hours late with an active 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 an active pill, or you
have missed more than one active 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.
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R Continue to take a pill every day for the next seven days
at your usual time.
R If these 7 days run beyond the last active (small) tablet,
finish taking the small active tablets, throw away the large
white inactive tablets and start a new pack of
Microgynon 30 ED the next day. Start with the tablet marked
‘start’ and use the self-adhesive strips to help you to see on
which day you have to take each tablet (see section 3.1, How
to take it). If you have to miss the large white inactive tablets
you may see some bleeding on the days you take the active
pills, but do not worry. If you do not have a period after the
second pack, you must talk to your doctor before you start
the next pack.
R Use extra contraception for the next seven days, such as
R
condoms.

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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 soon as possible.
They may recommend you use emergency contraception.
If you forget to take one of the large white inactive pills,
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 have missed any of the pills in a strip, and you do not
bleed while taking the large white inactive pills, you may be
pregnant. Contact your doctor or family planning clinic, or
do a pregnancy test yourself.

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If you start a new strip of pills late, you may not be
protected from pregnancy. If you had sex in the last seven
days, ask your doctor, family planning nurse or pharmacist for
advice. You may need to consider emergency contraception. You
should also use extra contraception, such as a condom, for
seven days.

3.4 A lost pill
If you lose an active pill,
Either take the last active pill of the strip in place of the lost
pill. Then take all the other pills on their proper days. Your cycle
will be one day shorter than normal, but your contraceptive
protection won’t be affected. After taking the large white
inactive pills you will have a new starting day, one day earlier
than before.
R

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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. Then take all the other pills from
your current strip as usual. You can then keep the opened spare
strip in case you lose any more pills.
If you lose an inactive pill, don’t worry, just continue taking the
remaining tablets at the correct time. Your contraceptive
protection won’t be affected.

3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea within 4 hours
of taking the Pill, your body may not get its usual dose of
hormones from that pill. If you are better within 12 hours of
taking Microgynon 30 ED, follow the instructions in section 3.4
A lost pill, which describes how to take another pill.
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If you are still sick or have diarrhoea more than 12 hours after
taking Microgynon 30 ED, see section 3.3, A missed pill.
J 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
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test at your family planning clinic or doctors surgery. If you are
pregnant, stop taking Microgynon 30 ED 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. Even girls who have not yet started to menstruate but
have accidentally taken this medicine, may experience such
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 Microgynon 30 ED until you have
had a proper period. Your doctor or midwife relies on the date of
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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.

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o

Possible side effects

Like all medicines, Microgynon 30 ED can cause side effects,
although not everybody gets them. If you get any side effect,
particularly if severe and persistent, or have any change to your
health that you think may be due to Microgynon 30 ED, please
talk to your doctor.
An increased risk of blood clots in the veins (venous
thromboembolism (VTE)) or blood clots in the arteries (arterial
thromboembolism (ATE)) is present for all women using
combined hormonal contraceptives. For more detailed
information on the different risks from taking combined
hormonal contraceptives please see section 2 “What you need to
know before you use Microgynon 30 ED”.
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J Tell your doctor, pharmacist or family planning nurse if
you are worried about any side effects which you think may
be due to Microgynon 30 ED.

4.1 Serious side effects – see a doctor straight away
Rare side effects (between 1 and 10 in every 10,000 users may
be affected)
R harmful blood clots in a vein or artery for example:
R in a leg or foot (i.e. DVT)
R in a lung (i.e. PE)
R heart attack
R stroke
R mini-stroke or temporary stroke-like symptoms, known
as a transient ischaemic attack (TIA)
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R 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

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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.
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J If you think you may have any of these, see a doctor
straight away. You may need to stop taking
Microgynon 30 ED.

4.2 Less serious side effects
Common side effects (between 100 and 1000 in every 10,000
users may be affected)
R feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood swings
R sore or painful breasts
R

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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
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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 Microgynon 30 ED. If
it continues, becomes heavy or starts again, contact your
doctor (see section 4.3).
R Chloasma (yellow brown patches on the skin). This may
happen even if you have been using Microgynon 30 ED for a
number of months. Chloasma may be reduced by avoiding
too much sunlight and/or UV lamps
R Occurrence or deterioration of the movement disorder
chorea
R Crohn’s disease or ulcerative colitis
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R Conditions that may worsen during pregnancy or
previous use of the Pill:
R yellowing of the skin (jaundice)
R persistent itching (pruritus)
R kidney or liver problems
R gall stones
R certain rare medical conditions such as systemic lupus
erythematosus
R blister-like rash (herpes gestationis) whilst pregnant
R an inherited form of deafness (otosclerosis)
R a personal or family history of a form of sickle cell
disease
R swelling of body parts (hereditary angioedema)
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R an inherited disease called porphyria
R cancer of the cervix
J Tell your doctor, pharmacist or family planning nurse if
you are worried about any side effects which you think may
be due to Microgynon 30 ED. Also tell them if any existing
conditions get worse while you are taking
Microgynon 30 ED.

4.3 Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting
while they are taking Microgynon 30 ED, especially during the
first few months. Normally, this bleeding is nothing to worry
about and will stop after a day or two. Keep taking
Microgynon 30 ED as usual. The problem should disappear after
R
the first few strips.

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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.
J 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 Microgynon 30 ED for a while
R carries on even after you’ve stopped taking
Microgynon 30 ED.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
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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.

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p

How to store Microgynon 30 ED

Keep all medicines out of the sight and reach of children.
Do not use Microgynon 30 ED after the expiry date shown on
the strip.
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.

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q

What is in Microgynon 30 ED and who makes it

What is in Microgynon 30 ED
Each box of Microgynon 30 ED contains three strips of 28
tablets, and each strip of tablets has its own set of 7 selfadhesive strips showing the days of the week.
Each strip of Microgynon 30 ED contains 21 beige sugar-coated
tablets containing 150 micrograms of the progestogen
levonorgestrel and 30 micrograms of the oestrogen
ethinylestradiol and 7 larger, white, inactive tablets.
Microgynon 30 ED also contains the inactive ingredients:
Lactose, maize starch, povidone, magnesium stearate (E572),
sucrose, macrogol 6000, calcium carbonate (E170), talc,
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montan glycol wax , titanium dioxide (E171), glycerin (E422),
ferric oxide pigment yellow (E172).
The company that holds the product licence for
Microgynon 30 ED is:
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Microgynon 30 ED is made by:
Bayer AG, Mullerstrasse 178,
13353 Berlin, Germany
or
Bayer Weimar GmbH & Co KG, Weimar, Germany
or
Delpharm Lille SAS, Lys-Lez-Lannoy, France.
This booklet was last updated in August 2017.
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86007312

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+ 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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