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MARVELON 150/30 TABLETS

Active substance(s): DESOGESTREL / ETHINYLOESTRADIOL

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Technical Info

Package leaflet: Information for the user

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Desogestrel (150 micrograms)
Ethinyl estradiol (30 micrograms)

AMS Blue Braille Grid Version: 36.5 - 24-08-17

For Position Only

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 because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions or need more advice,
ask your doctor, family planning nurse or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, family
planning nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Marvelon is and what it is used for

2.
3.

What you need to know before you use Marvelon

4.
5.
6.

Possible side effects

How to take Marvelon
3.3 A missed pill

How to store Marvelon
Contents of the pack and other information

1. What Marvelon is and
what it is used for
Marvelon is a combined oral contraceptive pill (‘the Pill’). You
take it to prevent pregnancy.
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 Do 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 ‘Warnings and precautions’.
• 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 or have had a pancreatitis (an inflammation of
the pancreas) associated with high levels of fatty substances
in your blood;
• known or suspected pregnancy;
• 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 have hepatitis C and are taking medicinal products
containing ombitasvir/ paritaprevir/ ritonavir and dasabuvir
(see also section 2.3 “Other medicines and 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 Warnings and precautions
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 (see section 2.2.1
The Pill and Thrombosis).
• 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.
What are you
Are you experiencing any of these signs?
possibly suffering
from?
• swelling of one leg or along a vein in the leg Deep vein
thrombosis
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.
Pulmonary
• sudden unexplained breathlessness or
embolism
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.

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.
• 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)

Heart attack

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 The Pill and cancer

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).
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?
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.

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.
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 Other medicines and Marvelon
Tell your doctor, pharmacist or family planning nurse if you are
using, have recently used or might use any other medicines or
herbal products, even those not prescribed. Also tell any other
doctor or dentist who prescribes another medicine (or your
pharmacist) that you use Marvelon. This is because Marvelon
can also affect how well other medicines work, causing either
an increase in effect (e.g., ciclosporin) or a decrease in effect
(e.g., lamotrigine). Remind your doctor if you are taking these
in case your treatment needs to be adjusted.
Also check the leaflets that come with all your medicines to
see if they can be taken with hormonal contraceptives.
Some medicines may stop Marvelon from working
properly. These include medicines used for the treatment of:
• epilepsy (primidone, phenytoins, phenobarbital,
carbamazepine, oxcarbazepine, topiramate,
felbamate, modafinil);
• tuberculosis (rifampicin);
• HIV infection (ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infectious disease (e.g., griseofulvin);
• high blood pressure in the blood vessels of the
lungs (bosentan);
• depressive moods (the herbal remedy St. John’s wort).
If you are taking medicines or herbal products that might
make Marvelon less effective, a barrier contraceptive
method should also be used. Since the effect of another
medicine on Marvelon may last up to 28 days after stopping
the medicine, it is necessary to use the additional barrier
contraceptive method for that long.
Do not use Marvelon if you have Hepatitis C and are taking
medicinal products containing ombitasvir/ paritaprevir/
ritonavir and dasabuvir as this may cause increases in liver
function blood test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive
prior to start of the treatment with these medicinal products.
Marvelon can be restarted approximately 2 weeks after
completion of this treatment.
See section 2.1 “Do not use Marvelon”.

2.4 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.

Blood clots in an artery

2.7 Marvelon contains lactose

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

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

3. How to take Marvelon
3.1 How to take it
To prevent pregnancy, always take this medicine exactly as
described in this leaflet or as your doctor, family planning
nurse or pharmacist has told you. Check with your doctor,
family planning nurse or pharmacist if you are not sure.

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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.

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.
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 A lost pill
If you lose a pill,
Either take the last pill of the strip in place of the lost pill. Then
take all the other pills on their proper days. Your cycle will be one
day shorter than normal, but your contraceptive protection won’t
be affected. After your seven pill-free days you will have a new
starting day, one day earlier than before.
Or if you do not want to change the starting day of your cycle,
take a pill from a spare strip. Then take all the other pills from your
current strip as usual. You can then keep the opened spare strip in
case you lose any more pills.

3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea 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
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 When you want to get pregnant
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 Serious side effects – see a doctor straight
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 Possible side effects
Common (may affect up to 1 in 10 people):
• Headache;
• Putting on weight;
• Breast problems, such as painful or tender breasts;
• Depression or mood changes;
• Stomach problems, such as nausea; abdominal pain;
Uncommon (may affect up to 1 in 100 people):
• Migraine (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);
• Fluid retention (swollen hands, ankles or feet – a sign of fluid
retention);
• Decreased sexual desire;
• Vomiting;
• Diarrhoea;
• Skin problems, such as rash or hives;
• Breast enlargement;
Rare (may affect up to 1 in 1000 people):
• Changes in vaginal secretions–Irregular vaginal
bleeding - see section 4.3, Bleeding between periods should
not last long;
• Breasts producing a milky fluid from the nipples;
• Hypersensitivity reactions;
• Discomfort of the eyes if you wear contact lenses;
• Erythema nodosum (bruise-like swelling to the shins);
• Erythema multiforme (this is a skin condition);
• Decreased weight;
• Increased sexual desire;
• Harmful blood clots in a vein or artery for example:

When were you due to take the missed pill?







in a leg or foot (i.e. DVT);
in a lung (i.e. PE);
heart attack;
stroke;
mini-stroke or temporary stroke-like symptoms,
known as a transient ischaemic attack (TIA);
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, family planning
nurse or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store
Malta: ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal.

5. How to store Marvelon
Keep this medicine out of the sight and reach of children.
Do not use Marvelon after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Store Marvelon below 25°C but not in the fridge. Store it in the
original package, in order to protect from light and moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and
other information
What Marvelon contains

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

7 or more 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

BS 12_359
01
250512
361 x 435.5

Fewer than 7 pills left in the pack

• 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

For Position Only

The active substances are desogestrel and ethinyl estradiol. Each
tablet contains: 150 micrograms of the progestogen desogestrel,
and 30 micrograms of the oestrogen ethinyl estradiol.
The other ingredients are: dl-alpha-tocopherol, potato starch,
povidone, stearic acid, aerosol and lactose.
What Marvelon looks like and contents of the pack
Each box of Marvelon contains three strips of 21 tablets.
Each strip of Marvelon contains 21 white tablets.
The tablets are biconvex, round and 6 mm in diameter. Each tablet
is marked TR5 on one side and Organon* on the reverse side.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Merck Sharp & Dohme Limited,
Hertford Road,
Hoddesdon,
Hertfordshire, EN11 9BU, UK
Manufacturer
N.V. Organon, P.O. Box 20, 5340 BH Oss,
The Netherlands
This leaflet was last revised in September 2017.
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.
© Merck Sharp & Dohme Limited, 2017. All rights reserved.
PIL.MRV.16.UK.4873-II(CCDS-antiHCV drugs)

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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