MICROGYNON 30 TABLETS
Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL
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85648373_06.indd 1
11/15/2017 1:37:19 PM
Microgynon® 30
Levonorgestrel
Ethinylestradiol
Anja
Bern
wald
Packaging Technology Berlin sgqwx
page 1
Bayer AG
client: 0021
material-no.: 85648373
PZ: 2589A-3A
code-no.: 368
name: LF-INS-Microgynon 30 SCT 21
country: GB/-/BAG
colors: Black
version: 15.11.2017/06
Restricted Document
dimension: 594 x 297 mm
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.
RThe Pill will not protect you
against sexually transmitted
diseases.
RThis medicine can increase your
risk of problems such as blood
clots and breast cancer.
RSome women should not take
the Pill because of current
medical problems or illnesses.
Please read this leaflet to make
sure Microgynon 30 is right for
you.
RTo prevent pregnancy it is
important to take Microgynon
30 as instructed and start each
pack on time. Please make sure
that you understand what to do
if you miss a pill or if you think
you are pregnant.
Read all of this leaflet carefully
before you start taking this
medicine.
RKeep this leaflet. You may need
to read it again.
R If you have any questions or
need more advice, ask your
doctor, family planning nurse
or pharmacist.
R This medicine has been
prescribed for you. Do not pass
it on to others. It may harm
them.
R If any of the side effects gets
severe, or if you notice any not
listed in this leaflet, please tell
your doctor, family planning
nurse or pharmacist.
In this leaflet:
1. What Microgynon 30 does
2. What you need to know before
you use Microgynon 30
3. Taking Microgynon 30
3.3 A missed pill
4. Possible side effects
5. How to store Microgynon 30
6. What is in Microgynon 30 and
who makes it
1. What Microgynon 30
does
Microgynon 30 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 is a 21-day
Pill – you take one each day
for 21 days, followed by
7 days when you take no
pills.
The benefits of taking the
Pill include:
R it is one of the most
reliable reversible
methods of
contraception if used
correctly
R it doesn’t interrupt sex
R it usually makes your periods
regular, lighter and less painful
R it may help with pre-menstrual
symptoms.
Microgynon 30 will not protect you
against sexually transmitted
infections, such as Chlamydia or
HIV. Only condoms can help to do
this.
Microgynon 30 needs to be taken
as directed to prevent pregnancy.
2. What you need to
know before you use
Microgynon 30
General notes
Before you start using Microgynon
30 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.
. Tell your doctor if you have
any of the illnesses or risk
factors mentioned in this
leaflet.
Before you start taking the Pill
R Your doctor will ask about you
and your family’s medical
problems, check your blood
pressure and exclude the
likelihood of you being
pregnant. You may also need
other checks, such as a breast
examination, but only if these
examinations are necessary for
you, or if you have any special
concerns.
While you’re on the Pill
R You will need regular checkups with your doctor or family
planning nurse, usually when
you need another prescription
of the Pill.
R You should go for regular
cervical smear tests.
R Check your breasts and
nipples every month for
changes – tell your doctor if you
can see or feel anything odd,
such as lumps or dimpling of
the skin.
R If you need a blood test tell
your doctor that you are taking
the Pill, because the Pill can
affect the results of some tests.
R If you’re going to have an
operation, make sure your
doctor knows about it. You may
need to stop taking the Pill
about 4–6 weeks before the
operation. This is to reduce the
risk of a blood clot (see section
2.3). Your doctor will tell you
when you can start taking the
Pill again.
2.1 When you should not
use Microgynon 30
You should not use Microgynon 30
if you have any of the conditions
listed below. If you do have any of
the conditions listed below, you
must tell your doctor. Your doctor
will discuss with you what other
form of birth control would be
more appropriate.
Do not use Microgynon 30:
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
R If you have (or have ever had)
angina pectoris (a condition
that causes severe chest pain
and may be a first sign of a
heart attack) or transient
ischaemic attack (TIA –
temporary stroke symptoms)
R If you have any of the following
diseases that may increase your
risk of a clot in the arteries:
P severe diabetes with blood
vessel damage
P very high blood pressure
P a very high level of fat in the
blood (cholesterol or
triglycerides)
P a condition known as
hyperhomocysteinaemia
R If you have (or have ever had) a
type of migraine called
‘migraine with aura’
R If you have or have ever had
breast cancer
R If you have ever had a severe
liver disease, and you have been
told by your doctor that your
liver function test results are
not yet back to normal
R If you have ever had liver
tumours
R If you are allergic
(hypersensitive) to any of the
ingredients in Microgynon 30.
Do not use Microgynon 30 if you
have hepatitis C and are taking the
medicinal products containing
ombitasvir/paritaprevir/ritonavir
and dasabuvir (see also in section
“Taking other medicines”).
. Tell your doctor or family
planning nurse if you have any
medical problems or illnesses.
2.2 When to take special
care with
Microgynon 30
When should you contact your
doctor?
Seek urgent medical attention
R if you notice possible signs of
a blood clot that may mean
you are suffering from a blood
clot in the leg (i.e. deep vein
thrombosis), a blood clot in
the lung (i.e. pulmonary
embolism), a heart attack or a
stroke (see ‘Blood clots’
section below).
For a description of the
symptoms of these serious side
effects please go to “How to
recognise a blood clot”.
Some of the conditions listed below
can be made worse by taking the
Pill. Or they may mean it is less
suitable for you. You may still be
able to take Microgynon 30 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.
This area must be identical on both sides!
Package leaflet: Information for the user
If the condition develops, or gets
worse while you are using
Microgynon 30, you should also
tell your doctor.
R If you have Crohn’s disease or
ulcerative colitis (chronic
inflammatory bowel disease)
R If you have systemic lupus
erythematosus (SLE – a disease
affecting your natural defence
system)
R If you have haemolytic uraemic
syndrome (HUS – a disorder of
blood clotting causing failure of
the kidneys)
R If you have sickle cell anaemia
(an inherited disease of the red
blood cells)
R If you have inflammation of the
pancreas (pancreatitis)
R If you have elevated levels of
fat in the blood
(hypertriglyceridaemia) or a
positive family history for this
condition.
Hypertriglyceridaemia has been
associated with an increased
risk of developing pancreatitis
(inflammation of the pancreas)
R If you need an operation, or you
are off your feet for a long time
(see in section 2 ‘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
R If you have an inflammation in
the veins under the skin
(superficial thrombophlebitis)
R If you have varicose veins
R If you have diabetes
R If you or your close family have
ever had problems with your
heart, or circulation such as
high blood pressure
R If you or your close family have
ever had problems with blood
clotting
R If you have the inherited
disease called porphyria
R If you are overweight (obese)
R If you have migraines
R If you have any illness that
worsened during pregnancy or
previous use of the Pill (see
section 4.2)
2.3 Blood clots
Using a combined hormonal
contraceptive such as
Microgynon 30 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 is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing any of these
What are you possibly suffering
signs?
from?
R swelling of one leg or along a
Deep vein thrombosis
vein in the leg or foot especially
when accompanied by:
P pain or tenderness in the leg
which may be felt only when
standing or walking
P increased warmth in the
affected leg
P change in colour of the skin
on the leg e.g. turning pale,
red or blue
Pulmonary embolism
R sudden unexplained
breathlessness or rapid
breathing
R sudden cough without an
obvious cause, which may bring
up blood
R sharp chest pain which may
increase with deep breathing
R severe light headedness or
dizziness
R rapid or irregular heartbeat
R severe pain in your stomach
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 Retinal vein thrombosis (blood clot
one eye:
in the eye)
R immediate loss of vision or
R painless blurring of vision which
can progress to loss of vision
R chest pain, discomfort, pressure, Heart attack
heaviness
R sensation of squeezing or
fullness in the chest, arm or
below the breastbone
R fullness, indigestion or choking
feeling
R upper body discomfort radiating
to the back, jaw, throat, arm and
stomach
R sweating, nausea, vomiting or
dizziness
R extreme weakness, anxiety, or
shortness of breath
R rapid or irregular heartbeats
R sudden weakness or numbness Stroke
of the face, arm or leg, especially
on one side of the body
R sudden confusion, trouble
speaking or understanding
R sudden trouble seeing in one or
both eyes
R sudden trouble walking,
dizziness, loss of balance or
coordination
R sudden, severe or prolonged
headache with no known cause
R loss of consciousness or fainting
with or without seizure
Sometimes the symptoms of stroke
can be brief with an almost
immediate and full recovery, but
you should still seek urgent medical
attention as you may be at risk of
another stroke.
R swelling and slight blue
Blood clots blocking other blood
discolouration of an extremity
vessels
R severe pain in your stomach
(acute abdomen)
. See a doctor as soon as possible. Do not take any more
Microgynon 30 until your doctor says you can. Use another method
of contraception, such as condoms, in the meantime.
BLOOD CLOTS IN A VEIN
What can happen if a blood clot
forms in a vein?
R The use of combined hormonal
contraceptives has been
connected with an increase in
the risk of blood clots in the
vein (venous thrombosis).
However, these side effects are
rare. Most frequently, they
occur in the first year of use of a
combined hormonal
contraceptive.
R If a blood clot forms in a vein in
the leg or foot it can cause a
deep vein thrombosis (DVT).
R If a blood clot travels from the
leg and lodges in the lung it
can cause a pulmonary
embolism.
R Very rarely a clot may form in a
vein in another organ such as
the eye (retinal vein
thrombosis).
When is the risk of developing a
blood clot in a vein highest?
The risk of developing a blood clot
in a vein is highest during the first
year of taking a combined
hormonal contraceptive for the
first time. The risk may also be
higher if you restart taking a
combined hormonal contraceptive
(the same product or a different
product) after a break of 4 weeks or
more.
After the first year, the risk gets
smaller but is always slightly
higher than if you were not using a
combined hormonal contraceptive.
When you stop Microgynon 30 your
risk of a blood clot returns to
normal within a few weeks.
What is the risk of developing a
blood clot?
The risk depends on your natural
risk of VTE and the type of
combined hormonal contraceptive
you are taking.
The overall risk of a blood clot in
the leg or lung (DVT or PE) with
Microgynon 30 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, about 5-7 will
develop a blood clot in a year.
R The risk of having a blood clot
will vary according to your
personal medical history (see
“Factors that increase your risk
of a blood clot in a vein” below).
Women who are not using a
combined hormonal pill and are
not pregnant
Women using a combined
hormonal contraceptive pill
containing levonorgestrel
Women using Microgynon 30
Factors that increase your risk of
a blood clot in a vein
The risk of a blood clot with
Microgynon 30 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 may need to be
stopped several weeks before
surgery or while you are less
mobile. If you need to stop
Microgynon 30 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 needs to be stopped.
If any of the above conditions
change while you are using
Microgynon 30, for example a close
family member experiences a
thrombosis for no known reason,
or you gain a lot of weight, tell
your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot
forms in an artery?
Like a blood clot in a vein, a clot in
an artery can cause serious
problems. For example, it can
cause a heart attack or a stroke.
Factors that increase your risk of
a blood clot in an artery
It is important to note that the risk
of a heart attack or stroke from
using Microgynon 30 is very small
but can increase:
R with increasing age (beyond
about 35 years)
Risk of developing a blood clot in
a year
About 2 out of 10,000 women
About 5-7 out of 10,000 women
About 5-7 out of 10,000 women
R if you smoke. When using a
combined hormonal
contraceptive like Microgynon
30, you are advised to stop
smoking. If you are unable to
stop smoking and are older
than 35 your doctor may advise
you to use a different type of
contraceptive
R if you are overweight
R if you have high blood pressure
R if a member of your immediate
family has had a heart attack or
stroke at a young age (less than
about 50). In this case you
could also have a higher risk of
having a heart attack or stroke
R if you, or someone in your
immediate family, have a high
level of fat in the blood
(cholesterol or triglycerides)
R if you get migraines, especially
migraines with aura
R if you have a problem with your
heart (valve disorder,
disturbance of the rhythm
called atrial fibrillation)
R if you have diabetes.
If you have more than one of these
conditions or if any of them are
particularly severe the risk of
developing a blood clot may be
increased even more.
If any of the above conditions
change while you are using
Microgynon 30, 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 also provide
the same protective effects.
However, it also seems that taking
the Pill slightly increases your risk
of cancer of the cervix – although
this may be due to having sex
without a condom, rather than the
Pill. All women should have regular
smear tests.
If you have breast cancer, or have
had it in the past, you should not
take the Pill. The Pill slightly
increases your risk of breast cancer.
This risk goes up the longer you’re
on the Pill, but returns to normal
within about 10 years of stopping
it. Because breast cancer is rare in
women under the age of 40, the
extra cases of breast cancer in
current and recent Pill users is
small. For example:
R Of 10,000 women who have
never taken the Pill, about 16
will have breast cancer by the
time they are 35 years old.
R Of 10,000 women who take the
Pill for 5 years in their early
twenties, about 17–18 will
have breast cancer by the time
they are 35 years old.
R Of 10,000 women who have
never taken the Pill, about 100
will have breast cancer by the
time they are 45 years old.
M
Digitally signed by
Anja Bernwald
DN: o=Bayer
Business Services,
email=anja.bernw
ald@bayer.com,
cn=Anja Bernwald
Date: 2017.11.16
11:19:12 +01'00'
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. 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 and can stop it
from working properly – for
example:
R some medicines used to
treat epilepsy
R some medicines used to
treat HIV and Hepatitis C
Virus infections (so-called
protease inhibitors and
non-nucleoside reverse
transcriptase inhibitors)
R griseofulvin (an anti-fungal
medicine)
R certain antibiotics
R certain sedatives (called
barbiturates)
R St. John’s Wort (a herbal
remedy).
If you do need to take one of
these medicines, Microgynon 30
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 can also affect
how well other medicines
work. Your doctor may need to
adjust the dose of your other
medicine.
In addition, Microgynon 30 can
also interfere with the results of
some blood tests, so always tell
your doctor that you are taking
Microgynon 30 if you have a
blood test.
Do not use Microgynon 30 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). Your doctor will
prescribe another type of
contraceptive prior to start of the
treatment with these medicinal
products. Microgynon 30 can be
restarted approximately 2 weeks
after completion of this
treatment. See section “Do not
use Microgynon 30”.
2.6 Taking
Microgynon 30 with
food and drink
There are no special instructions
about food and drink while on
Microgynon 30.
2.7 Pregnancy and
breast-feeding
Do not use Microgynon 30 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.
If you are breast-feeding, your
doctor or family planning nurse
may advise you not to take
Microgynon 30. They will be
able to suggest alternative
contraception. Breast-feeding
may not stop you getting
pregnant.
2.8 Driving and using
machines
Microgynon 30 has no known
effect on the ability to drive or
use machines.
2.9 Microgynon 30
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.
3. Taking
Microgynon 30
3.1 How to take it
To prevent pregnancy, always
take Microgynon 30 as described
below. Check with your doctor or
family planning nurse if you are
not sure.
Take Microgynon 30 every day
for 21 days
Microgynon 30 comes in strips of
21 pills, each marked with a day
of the week.
R Take your pill at the same
time every day.
R Start by taking a pill marked
with the correct day of the
week.
R Follow the direction of the
arrows on the strip. Take one
pill each day, until you have
finished all 21 pills.
R Swallow each pill whole, with
water if necessary. Do not
chew the pill.
Then have seven pill-free days
After you have taken all 21 pills
in the strip, you have seven days
when you take no pills. So if you
take the last pill of one pack on
a Friday, you will take the first
pill of your next pack on the
Saturday of the following week.
Within a few days of taking the
last pill from the strip, you
should have a withdrawal bleed
like a period. This bleed may not
have finished when it is time to
start your next strip of pills.
You don’t need to use extra
contraception during these seven
pill-free days – as long as you
have taken your pills correctly
and start the next strip of pills
on time.
Then start your next strip
Start taking your next strip of
Microgynon 30 after the seven
pill-free days – even if you are
still bleeding. Always start the
new strip on time.
As long as you take Microgynon
30 correctly, you will always
start each new strip on the same
day of the week.
3.3 A missed pill
If you miss a pill, follow these instructions:
When were you due to take the missed pill?
Less than 12 hours ago
R Take the delayed pill straight away and further pills
as usual. This may mean taking two pills in one day.
R Don’t worry, your contraceptive protection should
not be reduced.
3.2 Starting
Microgynon 30
As a new user or starting the
Pill again after a break
It is best to take your first
Microgynon 30 pill on the first
day of your next period. By
starting in this way, you will
have contraceptive protection
with your first pill.
Changing to Microgynon 30
from another contraceptive
Pill
R If you are currently taking
a 21-day Pill: start
Microgynon 30 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.
R If you are taking a 28-day
Pill: start taking Microgynon
30 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.
R Or, if you are taking a
progestogen-only Pill (POP
or ‘mini Pill’): start
Microgynon 30 on the first
day of bleeding, even if you
have already taken the
progestogen-only Pill for that
day. You will have
contraceptive cover straight
away.
Starting Microgynon 30 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 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 should be started
21 days after delivery provided
that you are fully mobile. You do
not have to wait for a period. You
will need to use another method
of contraception, such as a
condom, until you start
Microgynon 30 and for the first
7 days of pill taking.
More than 12 hours ago, or you
have missed more than one pill.
R Take the most recently missed pill straight away.
R Leave any earlier missed pills in the strip.
R Take your further pills as usual. This may mean
taking two pills in one day.
R Use extra precautions (condoms, for instance) for
the next 7 days.
R Check how many pills are left in the strip after
the most recently missed pill.
7 or more pills left in the pack
Fewer than 7 pills left in the pack
R Don’t forget to use extra precautions for the
R Don’t forget to use extra precautions for the next
next 7 days.
R When you have finished the strip, leave the
usual 7-day break before starting the next strip.
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.
7 days.
R When you finish the strip of pills, start the next
strip the next day without a break.
R If you do not have a withdrawal bleed after you
have finished the second strip, do a pregnancy
test before starting another strip.
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.
If you have missed any of the
pills in a strip, and you do not
bleed in the first pill-free
break, you may be pregnant.
Contact your doctor or family
planning clinic, or do a
pregnancy test yourself.
If you start a new strip of pills
late, or make your ‘week off’
longer than seven days, you
may not be protected from
pregnancy. If you had sex in the
last seven days, ask your doctor,
family planning nurse or
pharmacist for advice. You may
need to consider emergency
contraception. You should also
use extra contraception, such as
a condom, for seven days.
gets worse. He or she may
recommend another form of
contraception.
3.4 A lost pill
If you lose a pill,
Either take the last pill of the
strip in place of the lost pill.
Then take all the other pills on
their proper days. Your cycle will
be one day shorter than normal,
but your contraceptive
protection won’t be affected.
After your seven pill-free days
you will have a new starting day,
one day earlier than before.
Or if you do not want to change
the starting day of your cycle,
take a pill from a spare strip if
you have one. Then take all the
other pills from your current
strip as usual. You can then keep
the opened spare strip in case
you lose any more pills.
3.5 If you are sick or
have diarrhoea
If you are sick (vomit) or have
very bad diarrhoea within 4
hours of taking the Pill, your
body may not get its usual dose
of hormones from that pill. If
you are better within 12 hours
of taking Microgynon 30,
follow the instructions in section
3.4 A lost pill, which describes
how to take another pill.
If you are still sick or have
diarrhoea more than 12 hours
after taking Microgynon 30,
see section 3.3, A missed pill.
. Talk to your doctor if your
stomach upset carries on or
3.6 Missed a period –
could you be
pregnant?
Occasionally, you may miss a
withdrawal bleed. This could
mean that you are pregnant, but
that is very unlikely if you have
taken your pills correctly. Start
your next strip at the normal
time. If you think that you might
have put yourself at risk of
pregnancy (for example, by
missing pills or taking other
medicines), or if you miss a
second bleed, you should do a
pregnancy test. You can buy
these from the chemist or get a
free test at your family planning
clinic or doctors surgery. If you
are pregnant, stop taking
Microgynon 30 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 until you have
had a proper period. Your doctor
or midwife relies on the date of
your last natural period to tell
you when your baby is due.
However, it will not cause you or
the baby any harm if you get
pregnant straight away.
4. Possible side effects
Like all medicines, Microgynon
30 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, 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”.
. 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.
4.1 Serious side effects –
see a doctor straight
away
Rare side effects (between
1 and 10 in every 10,000 users
may be affected)
R harmful blood clots in a vein
or artery for example:
P in a leg or foot (i.e. DVT)
P in a lung (i.e. PE)
P heart attack
P stroke
P mini-stroke or temporary
stroke-like symptoms,
known as a transient
ischaemic attack (TIA)
P blood clots in the liver,
stomach/intestine,
kidneys or eye.
The chance of having a blood
clot may be higher if you have
any other conditions that
increase this risk (see section 2
for more information on the
conditions that increase risk for
blood clots and the symptoms of
a blood clot).
Signs of a blood clot (see
section 2.3 ‘Blood clots’)
Signs of a severe allergic
reaction or worsening of
hereditary angioedema:
R swelling of the hands, face,
lips, mouth, tongue or
throat. A swollen tongue/
throat may lead to difficulty
swallowing and breathing
R a red bumpy rash (hives) and
itching.
Signs of breast cancer include:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or
feel.
Signs of cancer of the cervix
include:
R vaginal discharge that
smells and/or contains blood
R unusual vaginal bleeding
R pelvic pain
R painful sex.
Signs of severe liver problems
include:
R severe pain in your upper
abdomen
R yellow skin or eyes
(jaundice)
R inflammation of the liver
(hepatitis)
R your whole body starts
itching.
. If you think you may have
any of these, see a doctor
straight away. You may
need to stop taking
Microgynon 30.
4.2 Less serious side
effects
Common side effects (between
100 and 1000 in every 10,000
users may be affected)
R feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood
swings
R sore or painful breasts
Uncommon side effects
(between 10 and 100 in every
10,000 users may be affected)
R being sick and stomach
upsets
R fluid retention
R migraine
R loss of interest in sex
R breast enlargement
R skin rash, which may be itchy
Rare side effects (between 1
and 10 in every 10,000 users
may be affected)
R poor tolerance of contact
lenses
R losing weight
R increase of interest in sex
R vaginal or breast discharge
Other side effects reported
R Bleeding and spotting
between your periods can
sometimes occur for the first
few months but this usually
stops once your body has
adjusted to Microgynon 30.
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
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
R Conditions that may
worsen during pregnancy
or previous use of the Pill:
P yellowing of the skin
(jaundice)
P persistent itching
(pruritus)
P kidney or liver problems
P gall stones
P certain rare medical
conditions such as
systemic lupus
erythematosus
P blister-like rash (herpes
gestationis) whilst
pregnant
P an inherited form of
deafness (otosclerosis)
P a personal or family
history of a form of sickle
cell disease
P swelling of body parts
(hereditary angioedema)
P an inherited disease called
porphyria
P cancer of the cervix
. 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. Also tell them if any
existing conditions get worse
while you are taking
Microgynon 30.
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, 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 as
usual. The problem
should disappear
after the first few
strips.
You may also have
unexpected
bleeding if you are
not taking your pills
regularly, so try to
take your pill at the
same time every
day. Also,
unexpected
bleeding can
sometimes be
caused by other
medicines.
. Make an appointment to
see your doctor if you get
breakthrough bleeding or
spotting that:
R carries on for more than the
first few months
R starts after you’ve been
taking Microgynon 30 for a
while
R carries on even after you’ve
stopped taking
Microgynon 30.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this
leaflet. You can also report side
effects directly via the Yellow
Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information
on the safety of this medicine.
Packaging Technology Berlin sgqwx
page 2
Bayer AG
client: 0021
material-no.: 85648373
PZ: 2589A-3A
code-no.: 368
name: LF-INS-Microgynon 30 SCT 21
country: GB/-/BAG
colors: Black
version: 15.11.2017/06
Restricted Document
dimension: 594 x 297 mm
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
. See a doctor as soon as
possible if you notice any
changes in your breasts,
such as dimpling of the skin,
changes in the nipple or any
lumps you can see or feel.
Taking the Pill has also been
linked to liver diseases, such as
jaundice and non-cancer liver
tumours, but this is rare. Very
rarely, the Pill has also been
linked with some forms of liver
cancer in women who have
taken it for a long time.
. 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.
5. How to store
Microgynon 30
Keep all medicines out of the
sight and reach of children.
Do not use Microgynon 30 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.
6. What is in
Microgynon 30 and
who makes it
What is in Microgynon 30
Each box of Microgynon 30
contains three strips of 21 beige
tablets.
Each beige sugar-coated tablet
contains: 150 micrograms of the
progestogen levonorgestrel, and
30 micrograms of the oestrogen
ethinylestradiol.
Microgynon 30 also contains the
inactive ingredients:
Lactose, maize starch, povidone,
magnesium stearate (E572),
sucrose, macrogol 6000, calcium
carbonate (E170), talc, montan
glycol wax, titanium dioxide
(E171), glycerin (E422), ferric
oxide pigment yellow (E172).
The company that holds the
product licence for
Microgynon 30 is:
Bayer plc
400 South Oak Way
Reading
RG2 6AD
Microgynon 30 is made by:
Bayer AG, Mullerstrasse 178,
13353 Berlin, Germany
or Bayer Weimar GmbH & Co KG,
Weimar, Germany
or Delpharm Lille SAS, Lys-LezLannoy, France.
This leaflet was last updated
in October 2017.
Microgynon® 30
85648373
85648373
This area must be identical on both sides!
85648373_06.indd 2
11/15/2017 1:38:01 PM
11/15/2017 1:37:19 PM
Microgynon® 30
Levonorgestrel
Ethinylestradiol
Anja
Bern
wald
Packaging Technology Berlin sgqwx
page 1
Bayer AG
client: 0021
material-no.: 85648373
PZ: 2589A-3A
code-no.: 368
name: LF-INS-Microgynon 30 SCT 21
country: GB/-/BAG
colors: Black
version: 15.11.2017/06
Restricted Document
dimension: 594 x 297 mm
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.
RThe Pill will not protect you
against sexually transmitted
diseases.
RThis medicine can increase your
risk of problems such as blood
clots and breast cancer.
RSome women should not take
the Pill because of current
medical problems or illnesses.
Please read this leaflet to make
sure Microgynon 30 is right for
you.
RTo prevent pregnancy it is
important to take Microgynon
30 as instructed and start each
pack on time. Please make sure
that you understand what to do
if you miss a pill or if you think
you are pregnant.
Read all of this leaflet carefully
before you start taking this
medicine.
RKeep this leaflet. You may need
to read it again.
R If you have any questions or
need more advice, ask your
doctor, family planning nurse
or pharmacist.
R This medicine has been
prescribed for you. Do not pass
it on to others. It may harm
them.
R If any of the side effects gets
severe, or if you notice any not
listed in this leaflet, please tell
your doctor, family planning
nurse or pharmacist.
In this leaflet:
1. What Microgynon 30 does
2. What you need to know before
you use Microgynon 30
3. Taking Microgynon 30
3.3 A missed pill
4. Possible side effects
5. How to store Microgynon 30
6. What is in Microgynon 30 and
who makes it
1. What Microgynon 30
does
Microgynon 30 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 is a 21-day
Pill – you take one each day
for 21 days, followed by
7 days when you take no
pills.
The benefits of taking the
Pill include:
R it is one of the most
reliable reversible
methods of
contraception if used
correctly
R it doesn’t interrupt sex
R it usually makes your periods
regular, lighter and less painful
R it may help with pre-menstrual
symptoms.
Microgynon 30 will not protect you
against sexually transmitted
infections, such as Chlamydia or
HIV. Only condoms can help to do
this.
Microgynon 30 needs to be taken
as directed to prevent pregnancy.
2. What you need to
know before you use
Microgynon 30
General notes
Before you start using Microgynon
30 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.
. Tell your doctor if you have
any of the illnesses or risk
factors mentioned in this
leaflet.
Before you start taking the Pill
R Your doctor will ask about you
and your family’s medical
problems, check your blood
pressure and exclude the
likelihood of you being
pregnant. You may also need
other checks, such as a breast
examination, but only if these
examinations are necessary for
you, or if you have any special
concerns.
While you’re on the Pill
R You will need regular checkups with your doctor or family
planning nurse, usually when
you need another prescription
of the Pill.
R You should go for regular
cervical smear tests.
R Check your breasts and
nipples every month for
changes – tell your doctor if you
can see or feel anything odd,
such as lumps or dimpling of
the skin.
R If you need a blood test tell
your doctor that you are taking
the Pill, because the Pill can
affect the results of some tests.
R If you’re going to have an
operation, make sure your
doctor knows about it. You may
need to stop taking the Pill
about 4–6 weeks before the
operation. This is to reduce the
risk of a blood clot (see section
2.3). Your doctor will tell you
when you can start taking the
Pill again.
2.1 When you should not
use Microgynon 30
You should not use Microgynon 30
if you have any of the conditions
listed below. If you do have any of
the conditions listed below, you
must tell your doctor. Your doctor
will discuss with you what other
form of birth control would be
more appropriate.
Do not use Microgynon 30:
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
R If you have (or have ever had)
angina pectoris (a condition
that causes severe chest pain
and may be a first sign of a
heart attack) or transient
ischaemic attack (TIA –
temporary stroke symptoms)
R If you have any of the following
diseases that may increase your
risk of a clot in the arteries:
P severe diabetes with blood
vessel damage
P very high blood pressure
P a very high level of fat in the
blood (cholesterol or
triglycerides)
P a condition known as
hyperhomocysteinaemia
R If you have (or have ever had) a
type of migraine called
‘migraine with aura’
R If you have or have ever had
breast cancer
R If you have ever had a severe
liver disease, and you have been
told by your doctor that your
liver function test results are
not yet back to normal
R If you have ever had liver
tumours
R If you are allergic
(hypersensitive) to any of the
ingredients in Microgynon 30.
Do not use Microgynon 30 if you
have hepatitis C and are taking the
medicinal products containing
ombitasvir/paritaprevir/ritonavir
and dasabuvir (see also in section
“Taking other medicines”).
. Tell your doctor or family
planning nurse if you have any
medical problems or illnesses.
2.2 When to take special
care with
Microgynon 30
When should you contact your
doctor?
Seek urgent medical attention
R if you notice possible signs of
a blood clot that may mean
you are suffering from a blood
clot in the leg (i.e. deep vein
thrombosis), a blood clot in
the lung (i.e. pulmonary
embolism), a heart attack or a
stroke (see ‘Blood clots’
section below).
For a description of the
symptoms of these serious side
effects please go to “How to
recognise a blood clot”.
Some of the conditions listed below
can be made worse by taking the
Pill. Or they may mean it is less
suitable for you. You may still be
able to take Microgynon 30 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.
This area must be identical on both sides!
Package leaflet: Information for the user
If the condition develops, or gets
worse while you are using
Microgynon 30, you should also
tell your doctor.
R If you have Crohn’s disease or
ulcerative colitis (chronic
inflammatory bowel disease)
R If you have systemic lupus
erythematosus (SLE – a disease
affecting your natural defence
system)
R If you have haemolytic uraemic
syndrome (HUS – a disorder of
blood clotting causing failure of
the kidneys)
R If you have sickle cell anaemia
(an inherited disease of the red
blood cells)
R If you have inflammation of the
pancreas (pancreatitis)
R If you have elevated levels of
fat in the blood
(hypertriglyceridaemia) or a
positive family history for this
condition.
Hypertriglyceridaemia has been
associated with an increased
risk of developing pancreatitis
(inflammation of the pancreas)
R If you need an operation, or you
are off your feet for a long time
(see in section 2 ‘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
R If you have an inflammation in
the veins under the skin
(superficial thrombophlebitis)
R If you have varicose veins
R If you have diabetes
R If you or your close family have
ever had problems with your
heart, or circulation such as
high blood pressure
R If you or your close family have
ever had problems with blood
clotting
R If you have the inherited
disease called porphyria
R If you are overweight (obese)
R If you have migraines
R If you have any illness that
worsened during pregnancy or
previous use of the Pill (see
section 4.2)
2.3 Blood clots
Using a combined hormonal
contraceptive such as
Microgynon 30 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 is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing any of these
What are you possibly suffering
signs?
from?
R swelling of one leg or along a
Deep vein thrombosis
vein in the leg or foot especially
when accompanied by:
P pain or tenderness in the leg
which may be felt only when
standing or walking
P increased warmth in the
affected leg
P change in colour of the skin
on the leg e.g. turning pale,
red or blue
Pulmonary embolism
R sudden unexplained
breathlessness or rapid
breathing
R sudden cough without an
obvious cause, which may bring
up blood
R sharp chest pain which may
increase with deep breathing
R severe light headedness or
dizziness
R rapid or irregular heartbeat
R severe pain in your stomach
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 Retinal vein thrombosis (blood clot
one eye:
in the eye)
R immediate loss of vision or
R painless blurring of vision which
can progress to loss of vision
R chest pain, discomfort, pressure, Heart attack
heaviness
R sensation of squeezing or
fullness in the chest, arm or
below the breastbone
R fullness, indigestion or choking
feeling
R upper body discomfort radiating
to the back, jaw, throat, arm and
stomach
R sweating, nausea, vomiting or
dizziness
R extreme weakness, anxiety, or
shortness of breath
R rapid or irregular heartbeats
R sudden weakness or numbness Stroke
of the face, arm or leg, especially
on one side of the body
R sudden confusion, trouble
speaking or understanding
R sudden trouble seeing in one or
both eyes
R sudden trouble walking,
dizziness, loss of balance or
coordination
R sudden, severe or prolonged
headache with no known cause
R loss of consciousness or fainting
with or without seizure
Sometimes the symptoms of stroke
can be brief with an almost
immediate and full recovery, but
you should still seek urgent medical
attention as you may be at risk of
another stroke.
R swelling and slight blue
Blood clots blocking other blood
discolouration of an extremity
vessels
R severe pain in your stomach
(acute abdomen)
. See a doctor as soon as possible. Do not take any more
Microgynon 30 until your doctor says you can. Use another method
of contraception, such as condoms, in the meantime.
BLOOD CLOTS IN A VEIN
What can happen if a blood clot
forms in a vein?
R The use of combined hormonal
contraceptives has been
connected with an increase in
the risk of blood clots in the
vein (venous thrombosis).
However, these side effects are
rare. Most frequently, they
occur in the first year of use of a
combined hormonal
contraceptive.
R If a blood clot forms in a vein in
the leg or foot it can cause a
deep vein thrombosis (DVT).
R If a blood clot travels from the
leg and lodges in the lung it
can cause a pulmonary
embolism.
R Very rarely a clot may form in a
vein in another organ such as
the eye (retinal vein
thrombosis).
When is the risk of developing a
blood clot in a vein highest?
The risk of developing a blood clot
in a vein is highest during the first
year of taking a combined
hormonal contraceptive for the
first time. The risk may also be
higher if you restart taking a
combined hormonal contraceptive
(the same product or a different
product) after a break of 4 weeks or
more.
After the first year, the risk gets
smaller but is always slightly
higher than if you were not using a
combined hormonal contraceptive.
When you stop Microgynon 30 your
risk of a blood clot returns to
normal within a few weeks.
What is the risk of developing a
blood clot?
The risk depends on your natural
risk of VTE and the type of
combined hormonal contraceptive
you are taking.
The overall risk of a blood clot in
the leg or lung (DVT or PE) with
Microgynon 30 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, about 5-7 will
develop a blood clot in a year.
R The risk of having a blood clot
will vary according to your
personal medical history (see
“Factors that increase your risk
of a blood clot in a vein” below).
Women who are not using a
combined hormonal pill and are
not pregnant
Women using a combined
hormonal contraceptive pill
containing levonorgestrel
Women using Microgynon 30
Factors that increase your risk of
a blood clot in a vein
The risk of a blood clot with
Microgynon 30 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 may need to be
stopped several weeks before
surgery or while you are less
mobile. If you need to stop
Microgynon 30 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 needs to be stopped.
If any of the above conditions
change while you are using
Microgynon 30, for example a close
family member experiences a
thrombosis for no known reason,
or you gain a lot of weight, tell
your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot
forms in an artery?
Like a blood clot in a vein, a clot in
an artery can cause serious
problems. For example, it can
cause a heart attack or a stroke.
Factors that increase your risk of
a blood clot in an artery
It is important to note that the risk
of a heart attack or stroke from
using Microgynon 30 is very small
but can increase:
R with increasing age (beyond
about 35 years)
Risk of developing a blood clot in
a year
About 2 out of 10,000 women
About 5-7 out of 10,000 women
About 5-7 out of 10,000 women
R if you smoke. When using a
combined hormonal
contraceptive like Microgynon
30, you are advised to stop
smoking. If you are unable to
stop smoking and are older
than 35 your doctor may advise
you to use a different type of
contraceptive
R if you are overweight
R if you have high blood pressure
R if a member of your immediate
family has had a heart attack or
stroke at a young age (less than
about 50). In this case you
could also have a higher risk of
having a heart attack or stroke
R if you, or someone in your
immediate family, have a high
level of fat in the blood
(cholesterol or triglycerides)
R if you get migraines, especially
migraines with aura
R if you have a problem with your
heart (valve disorder,
disturbance of the rhythm
called atrial fibrillation)
R if you have diabetes.
If you have more than one of these
conditions or if any of them are
particularly severe the risk of
developing a blood clot may be
increased even more.
If any of the above conditions
change while you are using
Microgynon 30, 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 also provide
the same protective effects.
However, it also seems that taking
the Pill slightly increases your risk
of cancer of the cervix – although
this may be due to having sex
without a condom, rather than the
Pill. All women should have regular
smear tests.
If you have breast cancer, or have
had it in the past, you should not
take the Pill. The Pill slightly
increases your risk of breast cancer.
This risk goes up the longer you’re
on the Pill, but returns to normal
within about 10 years of stopping
it. Because breast cancer is rare in
women under the age of 40, the
extra cases of breast cancer in
current and recent Pill users is
small. For example:
R Of 10,000 women who have
never taken the Pill, about 16
will have breast cancer by the
time they are 35 years old.
R Of 10,000 women who take the
Pill for 5 years in their early
twenties, about 17–18 will
have breast cancer by the time
they are 35 years old.
R Of 10,000 women who have
never taken the Pill, about 100
will have breast cancer by the
time they are 45 years old.
M
Digitally signed by
Anja Bernwald
DN: o=Bayer
Business Services,
email=anja.bernw
ald@bayer.com,
cn=Anja Bernwald
Date: 2017.11.16
11:19:12 +01'00'
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. 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 and can stop it
from working properly – for
example:
R some medicines used to
treat epilepsy
R some medicines used to
treat HIV and Hepatitis C
Virus infections (so-called
protease inhibitors and
non-nucleoside reverse
transcriptase inhibitors)
R griseofulvin (an anti-fungal
medicine)
R certain antibiotics
R certain sedatives (called
barbiturates)
R St. John’s Wort (a herbal
remedy).
If you do need to take one of
these medicines, Microgynon 30
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 can also affect
how well other medicines
work. Your doctor may need to
adjust the dose of your other
medicine.
In addition, Microgynon 30 can
also interfere with the results of
some blood tests, so always tell
your doctor that you are taking
Microgynon 30 if you have a
blood test.
Do not use Microgynon 30 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). Your doctor will
prescribe another type of
contraceptive prior to start of the
treatment with these medicinal
products. Microgynon 30 can be
restarted approximately 2 weeks
after completion of this
treatment. See section “Do not
use Microgynon 30”.
2.6 Taking
Microgynon 30 with
food and drink
There are no special instructions
about food and drink while on
Microgynon 30.
2.7 Pregnancy and
breast-feeding
Do not use Microgynon 30 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.
If you are breast-feeding, your
doctor or family planning nurse
may advise you not to take
Microgynon 30. They will be
able to suggest alternative
contraception. Breast-feeding
may not stop you getting
pregnant.
2.8 Driving and using
machines
Microgynon 30 has no known
effect on the ability to drive or
use machines.
2.9 Microgynon 30
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.
3. Taking
Microgynon 30
3.1 How to take it
To prevent pregnancy, always
take Microgynon 30 as described
below. Check with your doctor or
family planning nurse if you are
not sure.
Take Microgynon 30 every day
for 21 days
Microgynon 30 comes in strips of
21 pills, each marked with a day
of the week.
R Take your pill at the same
time every day.
R Start by taking a pill marked
with the correct day of the
week.
R Follow the direction of the
arrows on the strip. Take one
pill each day, until you have
finished all 21 pills.
R Swallow each pill whole, with
water if necessary. Do not
chew the pill.
Then have seven pill-free days
After you have taken all 21 pills
in the strip, you have seven days
when you take no pills. So if you
take the last pill of one pack on
a Friday, you will take the first
pill of your next pack on the
Saturday of the following week.
Within a few days of taking the
last pill from the strip, you
should have a withdrawal bleed
like a period. This bleed may not
have finished when it is time to
start your next strip of pills.
You don’t need to use extra
contraception during these seven
pill-free days – as long as you
have taken your pills correctly
and start the next strip of pills
on time.
Then start your next strip
Start taking your next strip of
Microgynon 30 after the seven
pill-free days – even if you are
still bleeding. Always start the
new strip on time.
As long as you take Microgynon
30 correctly, you will always
start each new strip on the same
day of the week.
3.3 A missed pill
If you miss a pill, follow these instructions:
When were you due to take the missed pill?
Less than 12 hours ago
R Take the delayed pill straight away and further pills
as usual. This may mean taking two pills in one day.
R Don’t worry, your contraceptive protection should
not be reduced.
3.2 Starting
Microgynon 30
As a new user or starting the
Pill again after a break
It is best to take your first
Microgynon 30 pill on the first
day of your next period. By
starting in this way, you will
have contraceptive protection
with your first pill.
Changing to Microgynon 30
from another contraceptive
Pill
R If you are currently taking
a 21-day Pill: start
Microgynon 30 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.
R If you are taking a 28-day
Pill: start taking Microgynon
30 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.
R Or, if you are taking a
progestogen-only Pill (POP
or ‘mini Pill’): start
Microgynon 30 on the first
day of bleeding, even if you
have already taken the
progestogen-only Pill for that
day. You will have
contraceptive cover straight
away.
Starting Microgynon 30 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 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 should be started
21 days after delivery provided
that you are fully mobile. You do
not have to wait for a period. You
will need to use another method
of contraception, such as a
condom, until you start
Microgynon 30 and for the first
7 days of pill taking.
More than 12 hours ago, or you
have missed more than one pill.
R Take the most recently missed pill straight away.
R Leave any earlier missed pills in the strip.
R Take your further pills as usual. This may mean
taking two pills in one day.
R Use extra precautions (condoms, for instance) for
the next 7 days.
R Check how many pills are left in the strip after
the most recently missed pill.
7 or more pills left in the pack
Fewer than 7 pills left in the pack
R Don’t forget to use extra precautions for the
R Don’t forget to use extra precautions for the next
next 7 days.
R When you have finished the strip, leave the
usual 7-day break before starting the next strip.
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.
7 days.
R When you finish the strip of pills, start the next
strip the next day without a break.
R If you do not have a withdrawal bleed after you
have finished the second strip, do a pregnancy
test before starting another strip.
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.
If you have missed any of the
pills in a strip, and you do not
bleed in the first pill-free
break, you may be pregnant.
Contact your doctor or family
planning clinic, or do a
pregnancy test yourself.
If you start a new strip of pills
late, or make your ‘week off’
longer than seven days, you
may not be protected from
pregnancy. If you had sex in the
last seven days, ask your doctor,
family planning nurse or
pharmacist for advice. You may
need to consider emergency
contraception. You should also
use extra contraception, such as
a condom, for seven days.
gets worse. He or she may
recommend another form of
contraception.
3.4 A lost pill
If you lose a pill,
Either take the last pill of the
strip in place of the lost pill.
Then take all the other pills on
their proper days. Your cycle will
be one day shorter than normal,
but your contraceptive
protection won’t be affected.
After your seven pill-free days
you will have a new starting day,
one day earlier than before.
Or if you do not want to change
the starting day of your cycle,
take a pill from a spare strip if
you have one. Then take all the
other pills from your current
strip as usual. You can then keep
the opened spare strip in case
you lose any more pills.
3.5 If you are sick or
have diarrhoea
If you are sick (vomit) or have
very bad diarrhoea within 4
hours of taking the Pill, your
body may not get its usual dose
of hormones from that pill. If
you are better within 12 hours
of taking Microgynon 30,
follow the instructions in section
3.4 A lost pill, which describes
how to take another pill.
If you are still sick or have
diarrhoea more than 12 hours
after taking Microgynon 30,
see section 3.3, A missed pill.
. Talk to your doctor if your
stomach upset carries on or
3.6 Missed a period –
could you be
pregnant?
Occasionally, you may miss a
withdrawal bleed. This could
mean that you are pregnant, but
that is very unlikely if you have
taken your pills correctly. Start
your next strip at the normal
time. If you think that you might
have put yourself at risk of
pregnancy (for example, by
missing pills or taking other
medicines), or if you miss a
second bleed, you should do a
pregnancy test. You can buy
these from the chemist or get a
free test at your family planning
clinic or doctors surgery. If you
are pregnant, stop taking
Microgynon 30 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 until you have
had a proper period. Your doctor
or midwife relies on the date of
your last natural period to tell
you when your baby is due.
However, it will not cause you or
the baby any harm if you get
pregnant straight away.
4. Possible side effects
Like all medicines, Microgynon
30 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, 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”.
. 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.
4.1 Serious side effects –
see a doctor straight
away
Rare side effects (between
1 and 10 in every 10,000 users
may be affected)
R harmful blood clots in a vein
or artery for example:
P in a leg or foot (i.e. DVT)
P in a lung (i.e. PE)
P heart attack
P stroke
P mini-stroke or temporary
stroke-like symptoms,
known as a transient
ischaemic attack (TIA)
P blood clots in the liver,
stomach/intestine,
kidneys or eye.
The chance of having a blood
clot may be higher if you have
any other conditions that
increase this risk (see section 2
for more information on the
conditions that increase risk for
blood clots and the symptoms of
a blood clot).
Signs of a blood clot (see
section 2.3 ‘Blood clots’)
Signs of a severe allergic
reaction or worsening of
hereditary angioedema:
R swelling of the hands, face,
lips, mouth, tongue or
throat. A swollen tongue/
throat may lead to difficulty
swallowing and breathing
R a red bumpy rash (hives) and
itching.
Signs of breast cancer include:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or
feel.
Signs of cancer of the cervix
include:
R vaginal discharge that
smells and/or contains blood
R unusual vaginal bleeding
R pelvic pain
R painful sex.
Signs of severe liver problems
include:
R severe pain in your upper
abdomen
R yellow skin or eyes
(jaundice)
R inflammation of the liver
(hepatitis)
R your whole body starts
itching.
. If you think you may have
any of these, see a doctor
straight away. You may
need to stop taking
Microgynon 30.
4.2 Less serious side
effects
Common side effects (between
100 and 1000 in every 10,000
users may be affected)
R feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood
swings
R sore or painful breasts
Uncommon side effects
(between 10 and 100 in every
10,000 users may be affected)
R being sick and stomach
upsets
R fluid retention
R migraine
R loss of interest in sex
R breast enlargement
R skin rash, which may be itchy
Rare side effects (between 1
and 10 in every 10,000 users
may be affected)
R poor tolerance of contact
lenses
R losing weight
R increase of interest in sex
R vaginal or breast discharge
Other side effects reported
R Bleeding and spotting
between your periods can
sometimes occur for the first
few months but this usually
stops once your body has
adjusted to Microgynon 30.
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
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
R Conditions that may
worsen during pregnancy
or previous use of the Pill:
P yellowing of the skin
(jaundice)
P persistent itching
(pruritus)
P kidney or liver problems
P gall stones
P certain rare medical
conditions such as
systemic lupus
erythematosus
P blister-like rash (herpes
gestationis) whilst
pregnant
P an inherited form of
deafness (otosclerosis)
P a personal or family
history of a form of sickle
cell disease
P swelling of body parts
(hereditary angioedema)
P an inherited disease called
porphyria
P cancer of the cervix
. 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. Also tell them if any
existing conditions get worse
while you are taking
Microgynon 30.
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, 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 as
usual. The problem
should disappear
after the first few
strips.
You may also have
unexpected
bleeding if you are
not taking your pills
regularly, so try to
take your pill at the
same time every
day. Also,
unexpected
bleeding can
sometimes be
caused by other
medicines.
. Make an appointment to
see your doctor if you get
breakthrough bleeding or
spotting that:
R carries on for more than the
first few months
R starts after you’ve been
taking Microgynon 30 for a
while
R carries on even after you’ve
stopped taking
Microgynon 30.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this
leaflet. You can also report side
effects directly via the Yellow
Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information
on the safety of this medicine.
Packaging Technology Berlin sgqwx
page 2
Bayer AG
client: 0021
material-no.: 85648373
PZ: 2589A-3A
code-no.: 368
name: LF-INS-Microgynon 30 SCT 21
country: GB/-/BAG
colors: Black
version: 15.11.2017/06
Restricted Document
dimension: 594 x 297 mm
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
. See a doctor as soon as
possible if you notice any
changes in your breasts,
such as dimpling of the skin,
changes in the nipple or any
lumps you can see or feel.
Taking the Pill has also been
linked to liver diseases, such as
jaundice and non-cancer liver
tumours, but this is rare. Very
rarely, the Pill has also been
linked with some forms of liver
cancer in women who have
taken it for a long time.
. 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.
5. How to store
Microgynon 30
Keep all medicines out of the
sight and reach of children.
Do not use Microgynon 30 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.
6. What is in
Microgynon 30 and
who makes it
What is in Microgynon 30
Each box of Microgynon 30
contains three strips of 21 beige
tablets.
Each beige sugar-coated tablet
contains: 150 micrograms of the
progestogen levonorgestrel, and
30 micrograms of the oestrogen
ethinylestradiol.
Microgynon 30 also contains the
inactive ingredients:
Lactose, maize starch, povidone,
magnesium stearate (E572),
sucrose, macrogol 6000, calcium
carbonate (E170), talc, montan
glycol wax, titanium dioxide
(E171), glycerin (E422), ferric
oxide pigment yellow (E172).
The company that holds the
product licence for
Microgynon 30 is:
Bayer plc
400 South Oak Way
Reading
RG2 6AD
Microgynon 30 is made by:
Bayer AG, Mullerstrasse 178,
13353 Berlin, Germany
or Bayer Weimar GmbH & Co KG,
Weimar, Germany
or Delpharm Lille SAS, Lys-LezLannoy, France.
This leaflet was last updated
in October 2017.
Microgynon® 30
85648373
85648373
This area must be identical on both sides!
85648373_06.indd 2
11/15/2017 1:38:01 PM
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.