MARVELON 150/30 TABLETS

Active substance: ETHINYLOESTRADIOL

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Technical Info

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Package leaflet: Information for the user

Desogestrel (150 micrograms)
Ethinyl estradiol (30 micrograms)
 ive important things to know about
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the Pill.

•  he Pill is a reliable contraceptive and may
T
reduce your risk of cancer of the ovary and
womb if used in the long term.
•  he Pill will not protect you against sexually
T
transmitted diseases.
•  his medicine can increase your risk of problems
T
such as blood clots and breast cancer.
•  ome women should not take the Pill because
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of current medical problems or illnesses. Please
read this leaflet to make sure Marvelon is right
for you.
•  o prevent pregnancy it is important to take
T
Marvelon as instructed and to 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.
• Keep this leaflet. You may need to read it again.
• f you have any questions or need more advice,
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ask your doctor, family planning nurse or
pharmacist.
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•  his medicine has been prescribed for you. Do
not pass it on to others. It may harm them.
• f any of the side effects gets severe, or if you
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notice any not listed in this leaflet, please tell
your doctor, family planning nurse or pharmacist.
In this leaflet:

1
2
3

What Marvelon does
Make sure Marvelon is OK for you
T
 aking Marvelon
3.3 A missed Pill

4
5
6

Possible side effects
How to store Marvelon
What is in Marvelon and who makes it

1 What Marvelon does
Marvelon is a combined oral contraceptive pill (‘the
Pill’). You take it to stop you getting pregnant.
This low-dose contraceptive contains two types of
female sex hormones, oestrogen and progestogen.
These hormones prevent an egg being released
from your ovaries so you can’t get pregnant.
Marvelon also makes the fluid (mucus) in your cervix
thicker which makes it more difficult for sperm to
enter the womb.
Marvelon is a 21-day pill – you take one each day for
21 days, followed by 7 days when you take no pills.

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

2 Make sure Marvelon

is OK for you

It’s important that you understand the benefits
and risks of taking the Pill before you start taking
it, or when deciding whether to carry on taking it.
Although the Pill is suitable for most healthy women
it isn’t suitable for everyone.
 Tell your doctor if you have any of the illnesses
or risk factors mentioned in this leaflet.

Before you start taking the Pill

•  our doctor will ask about you and your family’s
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medical problems and check your blood
pressure. You may also need other checks, such
as a breast examination.

While you’re on the Pill

•  ou will need regular check-ups with your
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doctor or family planning nurse, usually when
you need another prescription of the Pill.
• You should go for regular cervical smear tests.
•  heck your breasts and nipples every month for
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changes – tell your doctor if you can see or feel
anything odd, such as lumps or dimpling of the skin.
• f you need a blood test tell your doctor that
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you are taking the Pill, because the Pill can affect
the results of some tests.
• f you’re going to have an operation, make
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sure your doctor knows about it. You may need
to stop taking the Pill about 4–6 weeks before
the operation. This is to reduce the risk of a
blood clot (see section 2.1). Your doctor will tell
you when you can start taking the Pill again.

2.1 The Pill and blood clots
The Pill may slightly increase your risk of having
a blood clot (called a thrombosis) especially in
the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or
DVT) – is not always serious. However, if it moves
up the veins to the lungs, it can cause chest pain,
breathlessness, collapse or even death. This is
called a pulmonary embolism and is very rare.

Your chances of having a blood clot are
only increased slightly by taking the Pill.

•  f 100,000 women who are not on the Pill and not
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pregnant, about 5 will have a blood clot in a year.
•  f 100,000 women taking a Pill such as
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Marvelon, about 25 will have a blood clot in a
year.
•  f 100,000 women who are pregnant, around
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60 will have a blood clot in a year.

You are more at risk of having a blood
clot in your veins:

as you get older
if you are seriously overweight
if you have a heart valve problem
if you or any of your close family have had blood clots

if you have any blood clotting problem that

needs treatment with a medicine such as warfarin
• f you have certain rare medical conditions such
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as systemic lupus erythematosus (SLE) or
Crohn’s disease
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• f you’re off your feet for a long time because
of major surgery, injury or illness
• if you have recently had a baby.







 Tell your doctor if any of these apply to you.
Taking the Pill may add to this risk so Marvelon may
not be suitable for you.

Signs of a blood clot include:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing

 See a doctor as soon as possible. Do not take
any more Marvelon until your doctor says you
can. Use another method of contraception, such as
condoms, in the meantime.
Very rarely, blood clots can also form in the blood
vessels of the heart (causing a heart attack) or the
brain (causing a stroke). In healthy young women
the chance of having a heart attack or stroke is
extremely small.

You are more at risk of having a heart
attack or stroke:

as you get older
if you have high blood pressure
if you smoke cigarettes (or other tobacco)
if you drink too much alcohol
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f you have an irregular heartbeat (atrial fibrillation)
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f you or someone in your close family has had a
heart attack or stroke at a young age
• if you have migraines
• if you have diabetes.








seems to slightly increase your risk of cancer of
the cervix – although this may be due to having
sex without a condom rather than the Pill itself. All
women should have regular smear tests.
If you have breast cancer, of 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
number of cases of breast cancer in current and
recent users of the Pill is small.
For example:
•  f 10,000 women who have never taken the
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Pill, about 16 will have breast cancer by the time
they are 35 years.
•  f 10,000 women who take the Pill for 5 years
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in their early twenties, about 17-18 will have
breast cancer by the time they are 35 years.
•  f 10,000 women who have never taken the
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Pill, about 100 will have breast cancer by the
time they are 45 years old.
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•  f 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:

• f you have a close relative (mother, sister or
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grandmother) who has had breast cancer
• if you are seriously overweight

 See a doctor as soon as possible if you notice
any changes in your breasts, such as dimpling of
the skin, changes in the nipple or any lumps you can
see or feel.
Taking the Pill has also been linked to liver diseases,
such as jaundice and 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 Marvelon.

 Tell your doctor if any of these apply to you.
Taking the Pill may add to this risk so Marvelon may
not be suitable for you.

2.3  arvelon should not be taken by
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some women

Signs of a heart attack or stroke include:

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

•  udden sharp pains in your chest which may
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reach your left arm or sharp pains in your
stomach
•  udden weakness or numbness in one side or
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part of your body
•  aving a migraine for the first time or any
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migraine that is worse than normal
•  lurred speech or any other difficulties affecting
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your speech
•  ny sudden changes to your eyesight (such as
a
loss of vision or blurred vision)
• dizziness, fainting, collapse or seizures.

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

2.2 The Pill and cancer
The Pill reduces your risk of cancer of the ovary
and womb if used in the long term. However, it also

Do not take Marvelon if any of the following
apply to you. Taking Marvelon would put your
health at risk:
• f you are pregnant or might be pregnant, or if
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you are breast-feeding
• f you have cancer affected by sex hormones
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– such as some cancers of the breast, womb
lining or ovary
• f you have vaginal bleeding that has not been
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explained by your doctor
• f you have excessive thickening of the womb
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lining
• If you have ever had a severe liver disease
• f you are allergic (hypersensitive) to any of the
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ingredients in Marvelon
• f you or anyone in your close family has ever
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had a problem with their blood circulation.
This includes a blood clot (thrombosis) in the
legs (deep vein thrombosis), lungs (pulmonary
embolism), heart (heart attack), brain (stroke) or
any other parts of the body

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• f you have any condition which makes you more
at risk of a blood clot (thrombosis - see section
2.1, The Pill and blood clots)
• f you have moderate or severe high blood
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pressure (hypertension)
• f you have high fat levels in your blood (high
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cholesterol or triglyceride levels)
• If you have gall stones
• f you have had any of the following problems
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while pregnant or while using steroids:
- itching of the whole body (pruritus)
- jaundice which was not caused by infection
-  blister-like rash, called pemphigoid gestationis
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- a hearing problem called otosclerosis
• f you have ever had the disease systemic lupus
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erythematosus
 If you suffer from any of these, or get them for
the first time while taking Marvelon, contact your
doctor as soon as possible. Do not take Marvelon.

2.4  arvelon can make some
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illnesses worse
Some of the conditions listed below can be made
worse by taking the Pill. Or they may mean it is
less suitable for you. You may still be able to take
Marvelon but you need to take special care and
have check ups more often.
• f you have ever had problems with your heart,
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circulation or blood clotting, such as sickle cell
disease
• If you have diabetes
• f you have any gynaecological problems, such
I
as fibroids or endometriosis
• f you have ever had kidney or liver problems,
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or have had gall stones in the past
• If you have ever had severe depression
• If you have ever had epilepsy or migraines
• f you have brown patches on your face or
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body (chloasma).
 Tell your doctor or family planning nurse if
any of these apply to you. Also tell them if you get
any of these for the first time while taking the Pill, or
if any get worse or come back, because you may
need to stop taking Marvelon.

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 Marvelon. Also
check the leaflets that come with all your medicines to
see if they can be taken with hormonal contraceptives.
Some medicines can stop Marvelon from
working properly – for example:
• some medicines used to treat epilepsy
• certain antibiotics
• certain sedatives (called barbiturates)
• St. John’s Wort (a herbal remedy)
• Griseofulvin (an antifungal drug)
• certain laxatives and medical charcoal.
If you do need to take one of these medicines,
Marvelon may not be suitable for you, or you may be
able to take Marvelon and use extra contraception
for a while. Your doctor, pharmacist or dentist can
tell you if this is necessary and for how long.
Marvelon can also affect how well other
medicines work. For example, if you have diabetes,
you may need to take more insulin or other anti-

diabetic drugs while you take Marvelon. Your doctor
will tell you if this is necessary.

2.6  aking Marvelon with food and
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drink
There are no special instructions about food and
drink while on Marvelon.

2.7 Pregnancy and breast-feeding
Do not use Marvelon if you are pregnant. If you
think you might be pregnant, do a pregnancy test
to confirm that you are before you stop taking
Marvelon.
 If you are breast-feeding, you should not take
Marvelon. Ask your doctor or family planning nurse
about alternative contraception. Breast-feeding will
not stop you getting pregnant.

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

2.9 Marvelon contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before using Marvelon.

2.10 Use in adolescents
No clinical data on efficacy and safety are available
in adolescents below 18 years.

3 Taking Marvelon
3.1 How to take it
To prevent pregnancy, always take Marvelon exactly
as described below. Check with your doctor or
family planning nurse if you are not sure.
Take Marvelon every day for 21 days
Marvelon comes in strips of 21 pills, each marked
with a day of the week.
• Take your pill at the same time every day.
•  tart by taking a pill marked with the correct day
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of the week.
•  ollow the direction of the arrows on the strip.
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Take one pill each day, until you have finished all
21 pills.
•  wallow each pill whole, with water if necessary.
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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 Marvelon after the
seven pill-free days – even if you are still bleeding.
Always start the new strip on time.
As long as you take Marvelon correctly, you will
always start each new strip on the same day of the
week.

3.2 Starting Marvelon
As a new user or starting the Pill again
after a break
Either take your first Marvelon pill on the first day
of your next period. By starting in this way, you will
have contraceptive protection with your first pill.
Or if your period has already begun start taking
Marvelon on day 5 (counting the first day of your
period as day 1) whether or not your bleeding has
stopped. You must also use extra contraception,
such as condoms, until you have taken the first
seven pills correctly.

Changing to Marvelon from another
contraceptive Pill
• f you are currently on a 21-day Pill: start
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taking Marvelon the next day after the end of
the previous strip. You will have contraceptive
protection with your first pill but you will not have
a bleed until after you finish your first strip of
Marvelon.
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• f you are currently on a 28-day Pill: start
taking Marvelon the day after your last active pill.
You will have contraceptive protection with your
first pill. You will not have a bleed until after you
finish your first strip of Marvelon.
•  r if you are taking a progestogen-only Pill
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(mini-Pill or POP): start Marvelon on the first day
of bleeding, even if you have already taken the
POP for that day. You will have contraceptive
cover straight away. If you don’t usually have any
bleeding while you are taking a progestogenonly Pill, you can stop taking it any day and start
Marvelon the next day. You will need to use extra
contraception, such as a condom, for seven
days.

Starting Marvelon after a miscarriage or
abortion
If you have had a miscarriage or an abortion, your
doctor may tell you to start taking Marvelon straight
away. This means that you will have contraceptive
protection with your first pill.

Contraception after having a baby
If you have just had a baby, ask your doctor for
advice about contraception.
If you are not breast-feeding:
•  ou can start taking Marvelon three weeks after
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the birth or,
•  ou can start taking Marvelon more than three
y
weeks after the birth but you need to use extra
contraception, such as a condom until you have
taken the first seven pills correctly.
• f you have had sex since the birth there is a
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chance that you could be pregnant, you should
therefore use another form of contraception,
such as a condom. In this case, take your first
Marvelon pill on the first day of your next period.

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3.3 A missed pill

3.4 A lost pill

3.9 When you want to get pregnant

If you miss a pill, follow these instructions:

If you lose a pill,

If you are planning a baby, it’s best to use another
method of contraception after stopping Marvelon
until you have had a proper period. Your doctor or
midwife relies on the date of your last natural period
before you get pregnant 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.

START HERE

When were you due to take the missed Pill?

Less than 12 hours ago

More than 12 hours ago, or you have missed more than
one 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. 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
•  ake the delayed pill straight away, and further pills
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as usual. This may mean taking two pills in one day.
•  on’t worry, your contraceptive protection should
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not be reduced.

7 or more pills left in the pack

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•  ake the most recently missed pill straight away.
•  eave any earlier missed pills in the strip.
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•  ake your further pills as usual. This may mean taking two pills in
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one day.
•  se extra precautions (condoms, for instance) for the next
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7 days.
• 
Check how many pills are left in the strip after the most recently
missed pill.

Fewer than 7 pills left in the pack

If you are sick (vomit) or have very bad diarrhoea
your body may not get its usual dose of hormones
from that pill. If you are better within 12 hours of
taking Marvelon, take another pill from a spare
strip. Carry on taking your pills as normal. You won’t
need to use extra protection.
If you are still sick or have diarrhoea more than 12
hours after taking Marvelon follow the instructions
for if you are more than 12 hours late – see section
3.3, A missed pill.
 Talk to your doctor if your stomach upset
carries on or gets worse. He or she may
recommend another form of contraception.

3.6  issed a period – could you be
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pregnant?
•  on’t forget to use extra precautions for the next 7 days.
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•  hen you have finished the strip, leave the usual 7-day
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break before starting the next strip.
• f you have missed one or more pills from the first
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week of your strip (days 1 to 7) and you had sex in that
week, you could become pregnant. Contact your doctor,
family planning nurse or pharmacist for advice as soon
as possible. They may recommend you use emergency
contraception.

If you have missed any of the pills in a strip, and
you do not bleed in the first
pill-free break, you may be pregnant. Contact
your doctor or family planning clinic, or do a
pregnancy test yourself.
If you start a new strip of pills late, or make your
“week off” longer than seven days, you may not be
protected from pregnancy. If you had sex in the last
seven days, ask your doctor, family planning nurse
or pharmacist for advice. You may need to consider
emergency contraception. You should also use extra
contraception, such as a condom, for seven days.

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•  on’t forget to use extra precautions for the next 7 days.
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•  hen you finish the strip of pills, start the next strip the next day
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without a break.
• f you do not have a withdrawal bleed after you have finished the
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second strip, do a pregnancy test before starting another strip.
• f you have missed one or more pills from the first week of
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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.

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
Marvelon and see your doctor.

3.7  aking more than one pill should
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not cause harm
It is unlikely that taking more than one pill will do
you any harm, but you may feel sick, vomit or have
some vaginal bleeding. Talk to your doctor if you
have any of these symptoms.

3.8 You can delay a period
If you want to delay having a period, finish the strip
of pills you are taking. Start the next strip the next
day without a break. Take this strip the usual way.
After the second strip, leave seven pill-free days as
usual, then start your next strip of pills in the normal
way. When you use the second strip, you may have
some unexpected bleeding or spotting on the days
that you take the pill, but don’t worry.

4 Possible side effects
Like all medicines, Marvelon can cause side effects,
although not everybody gets them.
 Tell your doctor, pharmacist or family planning
nurse if you are worried about any side effects
which you think may be due to Marvelon.

4.1  erious side effects – see a
S
doctor straight away
Signs of a blood clot include:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.

Signs of heart attack or stroke include:

•  migraine for the first time, or a migraine that is
a
worse than normal
•  ny sudden changes to your eyesight (such as
a
loss of vision or blurred vision)
• dizziness, fainting, collapse or seizures
•  udden weakness or numbness in one side or
s
part of your body
•  lurred speech or any other difficulties affecting
s
your speech
•  udden sharp pains in your chest which may
s
reach your left arm or sharp pains in your
stomach.

Signs of a severe allergic reaction to
Marvelon

•  welling of the face, lips, mouth, tongue or
s
throat.

Signs of breast cancer include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Signs of cancer of the cervix include:

•  aginal discharge that smells and contains
v
blood
• Unusual vaginal bleeding
• pelvic pain
• painful sex.

Signs of severe liver problems include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).

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

4.2 Other possible side effects
•  igraine or headache (see a doctor as soon as
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possible if this is your first migraine or it’s worse
than usual, or if the headache is severe, unusual
or long lasting)
• Putting on weight or losing weight
• Problems with blood sugar
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•  reast problems, such as sore or larger breasts;
producing a milky fluid from the nipples
• Depression or mood changes
•  eart or circulation problems, such as
H
increased blood pressure, swollen hands, ankles
or feet
•  ynaecological and vaginal problems, such
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as fibroids or endometriosis (disorders of the
womb) may get worse; changes in secretions;
fungal infection, such as thrush; delay in return
to normal periods after stopping the pill
B
•  leeding and spotting between your periods
for the first few months (though this usually
stops when your body adjusts to Marvelon) -see
section 4.3, Bleeding between periods should
not last long
S
•  kin problems, such as rash; brown patches
on your face or body (chloasma); bruise-like
swelling to the shins (erythema nodosom)
• Stomach problems, such as nausea; vomiting
•  iscomfort of the eyes if you wear contact
D
lenses
• Gall stones
•  horea (a problem with the nervous system
C
causing jerky movements that you can’t control)
•  ystemic lupus erythematosus (SLE; when
S
your immune system attacks your body causing,
for example, joint ache and tiredness)
 Tell your doctor, pharmacist or family planning
nurse if you are worried about any side effects
which you think may be due to Marvelon. Also tell
them if any existing conditions get worse while you
are taking Marvelon.

4.3  leeding between periods
B
should not last long
A few women have a little unexpected bleeding or
spotting while they are taking Marvelon, especially
during the first few months. Normally, this bleeding
is nothing to worry about and will stop after a day
or two. Keep taking Marvelon 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.
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  ake an appointment to see your doctor if you
get breakthrough bleeding or spotting that:
• carries on for more than the first few months
•  tarts after you’ve been taking Marvelon for a
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while
•  arries on even after you’ve stopped taking
c
Marvelon.

5 How to store Marvelon
Keep all medicines out of the reach and sight of
children.
Store Marvelon below 25°C but not in the fridge.
Store it in the original pack to protect it from light
and moisture.
Do not use Marvelon after the expiry date shown on
the packet. The expiry date refers to the last day of
that month.
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 Marvelon
and who makes it

What is in Marvelon
Each box of Marvelon contains three strips of 21
tablets.
Each strip of Marvelon contains 21 white tablets.
Each tablet is round, measures 6mm across, has
TR5 marked on one side and ORGANON * on the
other side.
Each tablet contains: 150 micrograms of the
progestogen desogestrel, and 30 micrograms of the
oestrogen ethinyl estradiol.
Marvelon also contains the inactive ingredients: dlalpha-tocopherol, potato starch, povidone, stearic
acid, aerosol and lactose.
The company that holds the product licence for
Marvelon is:
Merck Sharp & Dohme Limited,
Hertford Road,
Hoddesdon,
Hertfordshire, EN11 9BU, UK
Marvelon is made by:
N.V. Organon, P.O. Box 20, 5340 BH Oss, The
Netherlands., or
Organon (Ireland) Ltd., Drynam Road, P.O. Box
2857, Swords, Co. Dublin, Ireland
This leaflet was last updated in April 2013.
In correspondence please quote packing number.
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Marvelon
Reference Number: PL 00025/0596
This is a service provided by the Royal National
institute of Blind people.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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