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MARVELON

Active substance(s): DESOGESTREL / ETHINYL ESTRADIOL / ETHINYLOESTRADIOL

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Package leaflet: Information for the user

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Technical Info

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Desogestrel (150 micrograms)
Ethinyl estradiol (30 micrograms)

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

• They are one of the most reliable reversible methods of
contraception if used correctly.
• 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.
• Please be alert and see your doctor if you think you
may have symptoms of a blood clot (see section
2 “Blood clots”).
• Some women should not take the Pill because of
current medical problems or illnesses. Please read this
leaflet to make sure Marvelon is right for you.
• To prevent pregnancy it is important to take 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.
• If you have any questions or need more advice, ask
your doctor, family planning nurse or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them.
• If any of the side effects gets severe, or if you notice
any not listed in this leaflet, please tell your doctor,
family planning nurse or pharmacist.
In this leaflet:

1 What Marvelon does
2 What you need to know before you use Marvelon
3 Taking Marvelon
3.3 A missed Pill

4 Possible side effects
5 How to store Marvelon
6 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.
The benefits of taking the Pill include:
• it is one of the most reliable reversible methods of
contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less
painful
• it may help with pre-menstrual symptoms.
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 What you need to know

before you use Marvelon

General notes
Before you start using Marvelon 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 “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

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

While you’re on the Pill

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

2.1 When you should not use Marvelon
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You should not use Marvelon 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. See also section 2.2 ‘When to take special care
with Marvelon’.
• 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.
• 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.
• If you need an operation or if you are off your feet for a long time
(see section ‘Blood clots’).
• If you have ever had a heart attack or stroke.
• 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]).
• If you have any of the following diseases that may increase your
risk of a clot in the arteries:
- severe diabetes with blood vessel damage,
- very high blood pressure,
- a very high level of fat in the blood (cholesterol or triglycerides),
- a condition known as hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called ‘migraine
with aura’.
• If you have or have recently had a severe liver disease.
• If you have ever had a liver tumour.
• If you have cancer affected by sex hormones – such as some
cancers of the breast, womb lining or ovary.
• If you have vaginal bleeding that has not been explained by
your doctor.
• If you are allergic (hypersensitive) to any of the ingredients in
Marvelon.
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.

2.2 When to take special care with Marvelon
When should you contact your doctor?
Seek urgent medical attention
- 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”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Marvelon,
you should also tell your doctor.
• If you have ever had problems with your heart, circulation or
blood clotting.
• If you have diabetes.
• If you have ever had kidney or liver problems.
• If you have ever had severe depression.
• If you have ever had migraines.
• If you have had problems while pregnant or while using
the pill, like:
- itching of the whole body (pruritus)
- jaundice which was not caused by infection
- gall stones
- systemic lupus erythematosus (SLE)
- a blister-like rash, called herpes gestationis
- a hearing problem called otosclerosis
- other rare conditions called porphyria and hereditary
angioedema.
• If you have brown patches on your face or body (chloasma)
– if so avoid too much exposure to the sun or ultraviolet light.
• If you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE - a disease
affecting your natural defence system).
• If you have haemolytic uraemic syndrome (HUS - a disorder
of blood clotting causing failure of the kidneys).
• If you have sickle cell anaemia (an inherited disease of the
red blood cells).
• 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).
• If you need an operation, or you are off your feet for a long
time (see in section 2 ‘Blood clots’).
• 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 Marvelon.
• If you have an inflammation in the veins under the skin
(superficial thrombophlebitis).
• If you have varicose veins.

2.2.1.  he Pill and Thrombosis
T
BLOOD CLOTS
Using a combined hormonal contraceptive such as Marvelon,
increases your risk of developing a blood clot compared with not
using one. In rare cases a blood clot can block blood vessels and
cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• 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 a harmful
blood clot due to Marvelon 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 signs?

What are you
possibly suffering
from?

• swelling of one leg or along a vein in the leg
or foot especially when accompanied by:
• pain or tenderness in the leg which
may be felt only when standing or
walking,
• increased warmth in the affected leg,
• change in colour of the skin on the
leg e.g. turning pale, red or blue.

Deep vein
thrombosis

• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach.
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’).

Pulmonary
embolism

Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision.

Retinal vein
thrombosis
(blood clot in the
eye)

• chest pain, discomfort, pressure,
heaviness;
• sensation of squeezing or fullness in the
chest, arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the
back, jaw, throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness
of breath;
• rapid or irregular heartbeats.

Heart attack

• sudden weakness or numbness of the
Stroke
face, arm or leg, especially on one side of
the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of
balance or coordination;
• sudden, severe or prolonged headache
with no known cause;
• 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.
• swelling and slight blue discolouration of
an extremity;
• severe pain in your stomach (acute abdomen)

Blood clots
blocking other
blood vessels

to stop smoking and are older than 35 your doctor may
advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart
attack or stroke at a young age (less than about 50). In
this case you could also have a higher risk of having a
heart attack or stroke;
• if you, or someone in your immediate family, have a high
level of fat in the blood (cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder,
disturbance of the rhythm called atrial fibrillation);
• if you have diabetes.
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
Marvelon, 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.

2.2.2  he Pill and cancer
T
The Pill reduces your risk of cancer of the ovary and womb
if used in the long term. However, it also 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, 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 number of cases of breast cancer in current and
recent users of the Pill is small.
For example:
• Of 10,000 women who have never taken the Pill,
about 16 will have breast cancer by the time they are
35 years.
• 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.
• Of 10,000 women who have never taken the Pill,
about 100 will have breast cancer by the time they are
45 years old.
• Of 10,000 women who take the Pill for 5 years in
their early thirties, about 110 will have breast cancer
by the time they are 45 years old.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• 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.
• If a blood clot forms in a vein in the leg or foot it can cause a
deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
• 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 Marvelon your risk of a blood clot returns to normal
within a few weeks.

• if you have a close relative (mother, sister or
grandmother) who has had breast cancer
• if you are seriously overweight
See a doctor as soon as possible if you notice any
changes in your breasts, such as dimpling of the skin,
changes in the nipple or any lumps you can see or feel.
Taking the Pill has also been linked to liver diseases, such as
jaundice and 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.

What is the risk of developing a blood clot?

2.3  aking other medicines
T

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
Marvelon is small.
• 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.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone,
or norgestimate about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains desogestrel such as Marvelon
between about 9 and 12 women will develop a blood clot in a
year.
• 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” below).
Risk of developing a
blood clot in a year
Women who are not using a combined About 2 out of
hormonal pill/patch/ring and are not
10,000 women
pregnant
Women using a combined hormonal
About 5-7 out of
contraceptive pill containing
10,000 women
levonorgestrel, norethisterone or
norgestimate
Women using Marvelon
About 9-12 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Marvelon is small but some conditions
will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• 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;
• 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 Marvelon may need to be stopped several
weeks before surgery or while you are less mobile. If you need
to stop Marvelon ask your doctor when you can start using it
again.
• as you get older (particularly above about 35 years);
• 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 Marvelon
needs to be stopped.
If any of the above conditions change while you are using
Marvelon, 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 Marvelon is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive
like Marvelon you are advised to stop smoking. If you are unable

Your risk of breast cancer is higher:

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 (primidone,
phenytoins, barbiturates, carbamazepine, oxcarbazepine,
topiramate, felbamate);
• medicine to treat tuberculosis (rifampicin);
• certain HIV medicines (ritonavir);
• certain antibiotics (penicillins, tetracyclines);
• St. John’s Wort (a herbal remedy);
• Griseofulvin (an antifungal drug).
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 ciclosporin and lamotrigine. Remind your
doctor if you are taking these in case your treatment needs
to be adjusted.

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

2.5  regnancy and breast-feeding
P
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.
Marvelon is not recommended for use during breastfeeding. Ask your doctor or family planning nurse about
alternative contraception. Breast-feeding may not stop you
getting pregnant.

2.6  riving and using machines
D
Marvelon has no known effect on the ability to drive or use
machines.

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

2.8  se in adolescents
U
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.
• Start by taking a pill marked with the correct day of the
week.
• Follow the direction of the arrows on the strip. Take one
pill each day, until you have finished all 21 pills.
• Swallow each pill whole, with water if necessary. Do not
chew the pill.

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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

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

3.4  lost pill
A
If you lose a pill,

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  tarting Marvelon
S
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
• If you are currently on a 21-day Pill: start 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.
• If 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.
• Or if you are taking a progestogen-only Pill
(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 progestogen-only 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.

Changing to Marvelon from a progestogen-only
injection, implant of progestogen releasing
intrauterine device (IUD)

Start taking Marvelon when your next injection is due or
on the day that your implant or IUD is removed. Make sure
you also use an additional contraceptive method, such as
a condom, for the first 7 days that you are taking Marvelon.

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:
• you can start taking Marvelon three weeks after the
birth or,
• you can start taking Marvelon more than three
weeks after the birth but you need to use extra
contraception, such as a condom until you have taken
the first seven pills correctly.
• If you have had sex since the birth there is a 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.

3.3 A missed pill
If you miss a pill, follow these instructions:
START HERE

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.

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 f you are sick or have diarrhoea
I
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 vomit within 3 to 4 hours after taking your pill, this is like
missing a pill. You must follow the advice for missed pills – see
section 3.3, A missed pill.
If you have severe diarrhoea for 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 pregnant?
M
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 not cause
T
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.

3.9  hen you want to get pregnant
W
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.

4 Possible side effects
Like all medicines, Marvelon 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 Marvelon, please talk to your doctor.
An increased risk of blood clots in your veins (venous
thromboembolism (VTE)) or blood clots in your arteries (arterial
thromboembolism (ATE)) is present for all women taking 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
Marvelon”.

4.1  erious side effects – see a doctor straight
S
away
Signs of deep vein thrombosis include;

• swelling of one leg or along a vein in the leg or foot especially
when accompanied by:
• pain or tenderness in the leg which may be felt only when
standing or walking;
• increased warmth in the affected leg;
• change in colour of the skin on the leg e.g. turning pale, red or blue.
Signs of a pulmonary embolism:
• sudden unexplained breathlessness or rapid breathing;
• sudden cough without an obvious cause, which may bring up blood;
• sharp chest pain which may increase with deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach.
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’).
Signs of retinal vein thrombosis (blood clot in the eye):
• Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress to loss of vision.
Signs of heart attack:
• chest pain, discomfort, pressure, heaviness;
• sensation of squeezing or fullness in the chest, arm or below the
breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the back, jaw, throat, arm
and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeats.
Signs of a stroke:
• sudden weakness or numbness of the face, arm or leg,
especially on one side of the body;
• sudden confusion, trouble speaking or understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of balance or
coordination;
• sudden, severe or prolonged headache with no known cause;
• 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.
Signs of blood clots blocking other blood vessels:
• swelling and slight blue discolouration of an extremity;
• severe pain in your stomach (acute abdomen).

Signs of a severe allergic reaction to Marvelon

• swelling of the face, lips, mouth, tongue or 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:

• vaginal discharge that smells and contains 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   ossible side effects
P
Common (more than 1 in 100 people who take Marvelon are affected)
• Migraine or headache (see a doctor as soon as 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
• Breast problems, such as painful or tender breasts; producing
a milky fluid from the nipples
• Depression or mood changes
• Changes in sexual desire
• Heart or circulation problems, such as increased blood
pressure, swollen hands, ankles or feet– a sign of fluid retention
• Changes in vaginal secretions
• Irregular vaginal bleeding -see section 4.3, Bleeding between
periods should not last long
• Skin problems, such as rash; bruise-like swelling to the shins
(erythema nodosom)
• Stomach problems, such as nausea; vomiting
• Discomfort of the eyes if you wear contact lenses

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

• Take the delayed pill straight away, and further pills
as usual. This may mean taking two pills in one day.
• Don’t worry, your contraceptive protection should
not be reduced.

• Take the most recently missed pill straight away.
• Leave any earlier missed pills in the strip.
• Take your further pills as usual. This may mean taking two pills in
one day.
• Use extra precautions (condoms, for instance) for the next
7 days.
• 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

• Don’t forget to use extra precautions for the next 7 days.
• When you have finished the strip, leave the usual 7-day
break before starting the next strip.
• 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.

• Don’t forget to use extra precautions for the next 7 days.
• When you finish the strip of pills, start the next strip the next day
without a break.
• If you do not have a withdrawal bleed after you have finished the
second strip, do a pregnancy test before starting another strip.
• 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.

Rare (less than 1 in 1000 people who take Marvelon are
affected)
• Harmful blood clots in a vein or artery for example:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known
as a transient ischaemic attack (TIA)
o 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.)
• Severe allergic reaction to Marvelon
• Breast cancer
• Cancer of the cervix
• Severe liver problems
• High blood pressure
• Gall stones
• Chorea (a problem with the nervous system causing jerky
movements that you can’t control)
• Worsening of systemic lupus erythematosus (SLE;
when your immune system attacks your body causing, for
example, joint ache and tiredness)
• Stomach and intestine problems such as pancreatitis;
Crohn’s disease; ulcerative colitis
• Worsening of otosclerosis (a hearing problem)
• Problems with blood sugar
• Worsening of a rare condition called porphyria
• Worsening of skin problems, such as brown patches on
your face or body (chloasma) blister-like rash, (herpes
gestationis)
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 should not
B
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.
Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
• carries on for more than the first few months
• starts after you’ve been taking Marvelon for a while
• carries on even after you’ve stopped taking 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: dl-alphatocopherol, 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.
This leaflet was last updated in April 2014.
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.
PIL-MRV-UK-15-4496-article 31 referral

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Technical Info

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56510402

Package leaflet: Information for the user

2 What you need to know before
you use Marvelon

Desogestrel (150 micrograms)
Ethinyl estradiol (30 micrograms)

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

• They are one of the most reliable reversible methods of
contraception if used correctly.
• 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.
• Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”).
• Some women should not take the Pill because of current
medical problems or illnesses. Please read this leaflet to make
sure Marvelon is right for you.
• To prevent pregnancy it is important to take 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.
• If you have any questions or need more advice, ask your
doctor, family planning nurse or pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them.
• If any of the side effects gets severe, or if you notice any
not listed in this leaflet, please tell your doctor, family planning
nurse or pharmacist.
In this leaflet:

1 What Marvelon does
2 What you need to know before you use Marvelon
3 Taking Marvelon


3.3 A missed Pill

4 Possible side effects
5 How to store Marvelon
6 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.
The benefits of taking the Pill include:
• it is one of the most reliable reversible methods of
contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms.
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.

LF OMD-00021037
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520 x 248

General notes
Before you start using Marvelon 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 “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

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

While you’re on the Pill

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

2.1 When you should not use Marvelon
You should not use Marvelon 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. See also section 2.2 ‘When
to take special care with Marvelon’.
• 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;
• 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;
• if you need an operation or if you are off your feet for a long time
(see section ‘Blood clots’);
• if you have ever had a heart attack or stroke;
• 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]).
• if you have any of the following diseases that may increase your
risk of a clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine
with aura’;
• If you have or have recently had a severe liver disease
• If you have ever had a liver tumour
• If you have cancer affected by sex hormones – such as some
cancers of the breast, womb lining or ovary
• If you have vaginal bleeding that has not been explained by your
doctor
• If you are allergic (hypersensitive) to any of the ingredients in Marvelon.
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.

2.2 When to take special care with Marvelon
When should you contact your doctor?
Seek urgent medical attention
– 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”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Marvelon,
you should also tell your doctor.
• If you have ever had problems with your heart, circulation or
blood clotting
• If you have diabetes
• If you have ever had kidney or liver problems
• If you have ever had severe depression
• If you have ever had migraines
• If you have had problems while pregnant or while using the
pill, like:
- itching of the whole body (pruritus)
- jaundice which was not caused by infection
- gall stones
- systemic lupus erythematosus (SLE)
- a blister-like rash, called herpes gestationis
- a hearing problem called otosclerosis
- other rare conditions called porphyria and hereditary
angiodema
• If you have brown patches on your face or body (chloasma)
– if so avoid too much exposure to the sun or ultraviolet light
• if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE - a disease
affecting your natural defence system);
• if you have haemolytic uraemic syndrome (HUS - a disorder of
blood clotting causing failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red
blood cells);
• 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);
• if you need an operation, or you are off your feet for a long time
(see in section 2 ‘Blood clots’);
• 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 Marvelon;
• if you have an inflammation in the veins under the skin
(superficial thrombophlebitis);
• if you have varicose veins;

2.2.1. The Pill and Thrombosis
BLOOD CLOTS
Using a combined hormonal contraceptive such as Marvelon,
increases your risk of developing a blood clot compared with not
using one. In rare cases a blood clot can block blood vessels and
cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• 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 a harmful
blood clot due to Marvelon 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 signs?
• swelling of one leg or along a vein in the leg or
foot especially when accompanied by:
• pain or tenderness in the leg which may
be felt only when standing or walking
• increased warmth in the affected leg
• change in colour of the skin on the leg
e.g. turning pale, red or blue
• sudden unexplained breathlessness or rapid
breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach;
If you are unsure, talk to a doctor as some of
these symptoms such as coughing or being short
of breath may be mistaken for a milder condition
such as a respiratory tract infection (e.g. a
‘common cold’).
Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress
to loss of vision
• chest pain, discomfort, pressure, heaviness;
• sensation of squeezing or fullness in the
chest, arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the back,
jaw, throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of
breath;
• rapid or irregular heartbeats
• sudden weakness or numbness of the face,
arm or leg, especially on one side of the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of
balance or coordination;
• sudden, severe or prolonged headache with
no known cause;
• 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.
• swelling and slight blue discolouration of an
extremity;
• severe pain in your stomach (acute abdomen)

What are
you possibly
suffering from?
Deep 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 Marvelon your risk of a blood clot returns to normal
within a few weeks.

What is the risk of developing a blood clot?
Pulmonary
embolism

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

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
Marvelon is small.
• 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.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone, or
norgestimate about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains desogestrel such as Marvelon
between about 9 and 12 women will develop a blood clot in a year.
• 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” below).

Women who are not using a
combined hormonal pill/patch/ring
and are not pregnant
Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate
Women using Marvelon

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 9-12 out of
10,000 women

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

Blood clots
blocking other
blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• 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.
• If a blood clot forms in a vein in the leg or foot it can cause a deep
vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the
eye (retinal vein thrombosis).

The risk of a blood clot with Marvelon is small but some conditions
will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• 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;
• 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 Marvelon may need to be stopped several weeks
before surgery or while you are less mobile. If you need to stop
Marvelon ask your doctor when you can start using it again.
• as you get older (particularly above about 35 years);
• 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 Marvelon
needs to be stopped.
If any of the above conditions change while you are using Marvelon,
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 Marvelon is very small but can increase:
• with increasing age (beyond about 35 years);

• if you smoke. When using a combined hormonal contraceptive
like Marvelon 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;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or
stroke at a young age (less than about 50). In this case you could
also have a higher risk of having a heart attack or stroke;
• if you, or someone in your immediate family, have a high level of
fat in the blood (cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder, disturbance
of the rhythm called atrial fibrillation)
• if you have diabetes.
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 Marvelon,
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.

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 ciclosporin and lamotrigine. Remind your doctor if you are
taking these in case your treatment needs to be adjusted.

2.2.2 The Pill and cancer

2.7 Marvelon contains lactose

The Pill reduces your risk of cancer of the ovary and womb if used
in the long term. However, it also 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, 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 number of cases of breast
cancer in current and recent users of the Pill is small.
For example:
• Of 10,000 women who have never taken the Pill, about 16 will
have breast cancer by the time they are 35 years.
• 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.
• Of 10,000 women who have never taken the Pill, about
100 will have breast cancer by the time they are 45 years old.
• Of 10,000 women who take the Pill for 5 years in their early
thirties, about 110 will have breast cancer by the time they are
45 years old.

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

Your risk of breast cancer is higher:

• if you have a close relative (mother, sister or grandmother) who
has had breast cancer
• if you are seriously overweight
See a doctor as soon as possible if you notice any changes in
your breasts, such as dimpling of the skin, changes in the nipple or
any lumps you can see or feel.
Taking the Pill has also been linked to liver diseases, such as
jaundice and 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.

2.3 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 (primidone, phenytoins,
barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• medicine to treat tuberculosis (rifampicin)
• certain HIV medicines (ritonavir)
• certain antibiotics (penicillins, tetracyclines)
• St. John’s Wort (a herbal remedy)
• Griseofulvin (an antifungal drug).

2.4 Taking Marvelon with food and drink
There are no special instructions about food and drink while on Marvelon.

2.5 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.
Marvelon is not recommended for use during breast-feeding. Ask
your doctor or family planning nurse about alternative contraception.
Breast-feeding may not stop you getting pregnant.

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

2.8 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.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each
day, until you have finished all 21 pills.
• Swallow each pill whole, with water if necessary. Do not chew the pill.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven days
when you take no pills. So if you take the last pill of one pack on a
Friday, you will take the first pill of your next pack on the Saturday of
the following week.
Within a few days of taking the last pill from the strip, you should have
a withdrawal bleed like a period. This bleed may not have finished
when it is time to start your next strip of pills. You don’t need to use
extra contraception during these seven 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.

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Technical Info

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Changing to Marvelon from another contraceptive Pill

• If you are currently on a 21-day Pill: start 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.
• If 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.
• Or if you are taking a progestogen-only Pill (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 progestogen-only 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.

Changing to Marvelon from a progestogen-only injection,
implant of progestogen releasing intrauterine device (IUD)

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:
• you can start taking Marvelon three weeks after the birth or,
• you can start taking Marvelon more than three weeks after
the birth but you need to use extra contraception, such as a
condom until you have taken the first seven pills correctly.
• If you have had sex since the birth there is a 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.

3.3 A missed pill

If you miss a pill, follow these instructions:

Start taking Marvelon when your next injection is due or on the day
that your implant or IUD is removed. Make sure you also use an
additional contraceptive method, such as a condom, for the first
7 days that you are taking Marvelon.
START HERE

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.

An increased risk of blood clots in your veins (venous
thromboembolism (VTE)) or blood clots in your arteries (arterial
thromboembolism (ATE)) is present for all women taking 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 Marvelon”.

3.4 A lost pill

Signs of deep vein thrombosis include;

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. 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

When were you due to take the missed Pill?

Less than 12 hours ago

• Take the delayed pill straight away, and further pills
as usual. This may mean taking two pills in one day.
• Don’t worry, your contraceptive protection should
not be reduced.

More than 12 hours ago, or you have missed more than
one Pill

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

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 vomit within 3 to 4 hours after taking your pill, this is like
missing a pill. You must follow the advice for missed pills – see
section 3.3, A missed pill.
If you have severe diarrhoea for 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 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 Marvelon 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. Talk to your
doctor if you have any of these symptoms.

3.8 You can delay a period
7 or more pills left in the pack

Fewer than 7 pills left in the pack

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.

4.1  erious side effects – see a doctor straight
S
away
• swelling of one leg or along a vein in the leg or foot especially when
accompanied by:
• pain or tenderness in the leg which may be felt only when
standing or walking
• increased warmth in the affected leg
• change in colour of the skin on the leg e.g. turning pale, red or blue
Signs of a pulmonary embolism:
• sudden unexplained breathlessness or rapid breathing;
• sudden cough without an obvious cause, which may bring up blood;
• sharp chest pain which may increase with deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach;
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’).
Signs of retinal vein thrombosis (blood clot in the eye):
• Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress to loss of vision
Signs of heart attack:
• chest pain, discomfort, pressure, heaviness;
• sensation of squeezing or fullness in the chest, arm or below the
breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the back, jaw, throat, arm and
stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeats
Signs of a stroke:
• sudden weakness or numbness of the face, arm or leg,
especially on one side of the body;
• sudden confusion, trouble speaking or understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of balance or
coordination;
• sudden, severe or prolonged headache with no known cause;
• 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.
Signs of blood clots blocking other blood vessels:
• swelling and slight blue discolouration of an extremity;
• severe pain in your stomach (acute abdomen)

Signs of a severe allergic reaction to Marvelon

• swelling of the face, lips, mouth, tongue or throat.

3.9 When you want to get pregnant
• Don’t forget to use extra precautions for the next 7 days.
• When you have finished the strip, leave the usual 7-day
break before starting the next strip.
• 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.

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• Don’t forget to use extra precautions for the next 7 days.
• When you finish the strip of pills, start the next strip the next day
without a break.
• If you do not have a withdrawal bleed after you have finished the
second strip, do a pregnancy test before starting another strip.
• 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.

Signs of breast cancer include:

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.

Signs of cancer of the cervix include:

4 Possible side effects
Like all medicines, Marvelon 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 Marvelon, please talk to your doctor.

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

• vaginal discharge that smells and contains 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 Possible side effects
Common (more than 1 in 100 people who take Marvelon are affected)
• Migraine or headache (see a doctor as soon as 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
• Breast problems, such as painful or tender breasts; producing a
milky fluid from the nipples
• Depression or mood changes
• Changes in sexual desire
• Heart or circulation problems, such as increased blood
pressure, swollen hands, ankles or feet– a sign of fluid retention
• Changes in vaginal secretions
• Irregular vaginal bleeding -see section 4.3, Bleeding between
periods should not last long
• Skin problems, such as rash; bruise-like swelling to the shins
(erythema nodosom)
• Stomach problems, such as nausea; vomiting
• Discomfort of the eyes if you wear contact lenses
Rare (less than 1 in 1000 people who take Marvelon are affected)
• Harmful blood clots in a vein or artery for example:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
o 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.)
• Severe allergic reaction to Marvelon
• Breast cancer
• Cancer of the cervix
• Severe liver problems
• High blood pressure
• Gall stones
• Chorea (a problem with the nervous system causing jerky
movements that you can’t control)
• Worsening of systemic lupus erythematosus (SLE; when your
immune system attacks your body causing, for example, joint
ache and tiredness)
• Stomach and intestine problems such as pancreatitis; Crohn’s
disease; ulcerative colitis
• Worsening of otosclerosis (a hearing problem)
• Problems with blood sugar
• Worsening of a rare condition called porphyria
• Worsening of skin problems, such as brown patches on your
face or body (chloasma) blister-like rash, (herpes gestationis)
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 Bleeding between periods 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.
Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
• carries on for more than the first few months
• starts after you’ve been taking Marvelon for a while
• carries on even after you’ve stopped taking Marvelon.

5 How to store Marvelon

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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: dl-alpha-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:
Organon (Ireland) Ltd., Drynam Road, P.O. Box 2857, Swords,
Co. Dublin, Ireland
This leaflet was last updated in April 2014.
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.
PIL-MRV-UK-15-4496-article 31 referral


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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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