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MARVELON TABLETS

Active substance(s): DESOGESTREL / ETHINYLESTRADIOL / ETHINYLOESTRADIOL / DESOGESTREL / ETHINYLESTRADIOL / ETHINYLOESTRADIOL / DESOGESTREL / ETHINYLESTRADIOL / ETHINYLOESTRADIOL

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S0409 LEAFLET Marvelon 20170622

Add/Amend to move position of the the sub-heading "3.3 A missed pill".

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;




Previously assessed against the UK PIL dated
June 2016.
S0409 LEAFLET Marvelon 20170622

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)

Worsening of otosclerosis (a hearing problem)

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.

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.

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.



severe pain in your stomach (acute abdomen).

Signs of a severe allergic reaction to 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

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.

3. How to take Marvelon
A missed pill

If you have ever had severe depression.
If you have ever had migraines.



Marvelon is a combined oral contraceptive pill (‘the Pill’). You take
it to prevent pregnancy.




Do not use after the expiry date printed on the carton label or
blister strip.

If you have had problems while pregnant or while using the
pill, like:



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

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.

1. What Marvelon is and what it is used for

The benefits of taking the Pill include:

-

a hearing problem called otosclerosis,



it is one of the most reliable reversible methods of contraception
if used correctly

-

other rare conditions called porphyria and hereditary
angioedema.

What Marvelon contains



it doesn’t interrupt sex





it usually makes your periods regular, lighter and less painful



it may help with pre-menstrual symptoms.

6. Contents of the pack and other information



Each tablet contains 150 micrograms of the active ingredient
desogestrel and 30 micrograms of the active ingredient
ethinylestradiol.
Marvelon also contains the following inactive ingredients: dlalpha-tocopherol, potato starch, povidone, stearic acid, colloidal
silicon dioxide and lactose.

Marvelon is available as calendar blister strips of 21 tablets with
1x21 or 3x21 tablets in a pack.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

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
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.

Depression or mood changes;





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;



N.V. Organon, Oss, The Netherlands.



Organon Ireland, Ltd., Drynam Road, Swords, 2857 County
Dublin, Ireland.

POM

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

PL 19488/0409


Leaflet revision date: 22 June 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.

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.

Marvelon® is a registered trademark of Marck Sharp & Dohme
B.V., Netherland



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;

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’.



Increased sexual desire;





Harmful blood clots in a vein or artery for example:

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]);

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

2.1 Do not use Marvelon
S0409 LEAFLET Marvelon 20170622



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.

General notes

Before you start taking the Pill

Diarrhoea;

gall stones,
systemic lupus erythematosus (SLE),

This product is manufactured by either of the below manufacturers-



-

a blister-like rash, called herpes gestationis,

Manufacturer

Vomiting;

jaundice which was not caused by infection,

-

Breast problems, such as painful or tender breasts;



itching of the whole body (pruritus),

-

Marvelon is a 21-day pill – you take one each day for 21 days,
followed by 7 days when you take no pills.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Putting on weight;

Decreased sexual desire;

-

-





If you have ever had problems with your heart, circulation or
blood clotting.

Store blisters in the original pouches to protect from light and
moisture.



Fluid retention (swollen hands, ankles or feet – a sign of fluid
retention);





Headache;



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 kidney or liver problems.



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);

For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.



Product Licence holder



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).

Do not store above 25°C. Do not refrigerate.

yellow skin or eyes (jaundice).

Stomach problems, such as nausea; abdominal pain;

-



severe pain in your upper abdomen;

Uncommon (may affect up to 1 in 100 people):

 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.

If you have diabetes.





if you are allergic (hypersensitive) to any of the ingredients in
Marvelon.











6. Contents of the pack and other information

Marvelon tablets are round, biconvex, white tablet with ‘ORGANON’
and a star on one side and ‘TR 5’ on the other.

Common (may affect up to 1 in 10 people):

if you have vaginal bleeding that has not been explained by
your doctor;

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

How to store Marvelon

What Marvelon looks like and contents of the pack

4.2 Possible side effects



1. What Marvelon is and what it is used for
2. What you need to know before you use Marvelon

4. Possible side effects

Signs of severe liver problems include:

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

if you have cancer affected by sex hormones – such as some
cancers of the breast, womb lining or ovary;



5.





known or suspected pregnancy;



5. How to store Marvelon

Signs of breast cancer include:
dimpling of the skin;

What is in this leaflet

3.3

at: www.mhra.gov.uk/yellowcard

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





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.

loss of consciousness or fainting with or without seizure.

swelling and slight blue discolouration of an extremity;

if you have or have had a pancreatitis (an inflammation of the
pancreas) associated with high levels of fatty substances in
your blood;



carries on even after you’ve stopped taking Marvelon.





Seek urgent medical attention



Signs of blood clots blocking other blood vessels:

if you have ever had a liver tumour;

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.

Signs of a stroke:

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.

if you have or have recently had a severe liver disease;





starts after you’ve been taking Marvelon for a while





2.2 Warnings and precautions

carries on for more than the first few months

sudden, severe or prolonged headache with no known cause;

a condition known as hyperhomocysteinaemia;

if you have (or have ever had) a type of migraine called
‘migraine with aura’;

When should you contact your doctor?





-

If you have any further questions or need more advice, ask your
doctor, family planning nurse or pharmacist.



sudden trouble walking, dizziness, loss of balance or
coordination;

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.

a very high level of fat in the blood (cholesterol or
triglycerides),

Keep this leaflet. You may need to read it again.

rapid or irregular heartbeats.





-



extreme weakness, anxiety, or shortness of breath;

sudden trouble seeing in one or both eyes;

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.

severe diabetes with blood vessel damage,
very high blood pressure,









-

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

sweating, nausea, vomiting or dizziness;

sudden confusion, trouble speaking or understanding;

Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”).



if you have any of the following diseases that may increase your
risk of a clot in the arteries:

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.







4.3 Bleeding between periods should not last long



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

Your medicine is known as Marvelon Tablets but will be referred to
as Marvelon throughout the following leaflet.



 Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:



(desogestrel/ ethinylestradiol)

Stomach and intestine problems such as pancreatitis;
Crohn’s disease; ulcerative colitis





®

MARVELON TABLETS





Mock up

By Aneela Mahmood at 10:40 am, Jun 22, 2017

PACKAGE LEAFLET: INFORMATION FOR THE USER

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’).

What are
you possibly
suffering
from?
Deep vein
thrombosis

Pulmonary
embolism

Are you experiencing any of these signs?
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?
Retinal vein
thrombosis
(blood clot
in the eye)

Heart attack



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;

Marvelon comes in strips of 21 pills, each marked with a day of the
week.



if you have high blood pressure;



Take your pill at the same time every day.



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;



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.



if you, or someone in your immediate family, have a high level
of fat in the blood (cholesterol or triglycerides);



Swallow each pill whole, with water if necessary. Do not chew
the pill.



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.

2.2.2 The Pill and cancer

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 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.

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
hormonal pill/patch/ring and are not
pregnant

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.

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.



you can start taking Marvelon three weeks after the birth or,

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.

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.

3.2 Starting Marvelon



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.

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.

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.

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.

As a new user or starting the Pill again after a break

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.

START HERE
Less than 12 hours ago


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.



Take the most recently missed pill straight away.



Leave any earlier missed pills in the strip.

Don’t worry, your contraceptive protection should not be
reduced.



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.

 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.

7 or more pills left in the pack


Don’t forget to use extra precautions for the next 7 days.



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.



When you finish the strip of pills, start the next strip the next
day without a break.

2.3 Other medicines and Marvelon



If you have missed one or more pills from the first week
of your strip (days 1 to 7) and you had sex in that week,
you could become pregnant. Contact your doctor, family
planning nurse or pharmacist for advice as soon as possible.
They may recommend you use emergency contraception.



If you 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.

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 can stop Marvelon from working properly.
These include medicines used for the treatment of:


epilepsy (primidone, phenytoins, phenobarbital,
carbamazepine, oxcarbazepine, topiramate, felbamate,
modafinil);

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



other infectious disease (e.g., griseofulvin);

If you lose a pill,

Women using Marvelon

About 9-12 out of



high blood pressure in the blood vessels of the lungs
(bosentan);

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.



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.

Fewer than 7 pills left in the pack

 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.

Hepatitis C virus infection (e.g., boceprevir, telaprevir);

as you get older (particularly above about 35 years);

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






If you miss a pill, follow these instructions:

Take the delayed pill straight away, and further pills as usual.
This may mean taking two pills in one day.

10,000 women

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.

3.3 A missed pill

When were you due to take the missed Pill?

HIV infection (ritonavir, nelfinavir, nevirapine, efavirenz);



Contraception after having a baby



About 5-7 out of

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 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.

As long as you take Marvelon correctly, you will always start each
new strip on the same day of the week.

Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate



Starting Marvelon after a miscarriage or abortion

If you have just had a baby, ask your doctor for advice about
contraception.

Then start your next strip

tuberculosis (rifampicin);

if you are very overweight (body mass index or BMI over
2
30kg/m );

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.

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.







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



The risk of a blood clot with Marvelon is small but some conditions
will increase the risk. Your risk is higher:

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.

Then have seven pill-free days

10,000 women

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



If you are not breast-feeding:

About 2 out of

10,000 women

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.

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.

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.



Take Marvelon every day for 21 days



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.

What can happen if a blood clot forms in a vein?



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.

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.

Blood clots in a vein


3. How to take Marvelon

It is important to note that the risk of a heart attack or stroke from
using Marvelon is very small but can increase:

Stroke

Blood clots
blocking
other blood
vessels

Changing to Marvelon from another contraceptive Pill

Factors that increase your risk of a blood clot in an artery

• 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.
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.
2.7 Marvelon contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before using Marvelon.
2.8 Use in adolescents
No clinical data on efficacy and safety are available in adolescents
below 18 years.

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.
1.5 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.

3.7 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

3.6 Missed a period – could you be pregnant?

Signs of deep vein thrombosis include:

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.



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.

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.

S0409 LEAFLET Marvelon 20170622

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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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