MICROGYNON® 50 ED

Levonorgestrel 0.125 mg and Ethinylestradiol 0.05 mg tablets

What is in this leaflet

Please read this leaflet carefully before you start using MICROGYNON 50 ED.
It will advise you about how to take MICROGYNON 50 ED properly and when to
tell your doctor about health-related conditions. If you have any questions or
need more advice, ask your doctor, professional health care provider or
pharmacist.

What is MICROGYNON 50 ED used for and how does it work

MICROGYNON 50 ED is a combined oral contraceptive (often called "the Pill")
consisting of 21 hormonal tablets and 7 non-hormonal tablets. Each small ochre
hormonal tablet contains a small amount of two different female hormones.
These are levonorgestrel (a progestogen) and ethinylestradiol (an estrogen).
MICROGYNON 50 ED also contains 7 large white non-hormonal tablets that do not
contain any active ingredients.

How does MICROGYNON 50 ED work?

Combined oral contraceptive Pills, such as MICROGYNON 50 ED, provide one of
the most effective reversible methods of contraception known. Usually, when
MICROGYNON 50 ED is taken according to the instructions, the egg cells
(normally released by the ovary each month) are prevented from maturing to the
point where they can be fertilized. In addition, the cervical mucus remains
thick, so it is more difficult for a man's sperm to enter the womb. Also, the
lining of the womb is not prepared sufficiently for a fertilized egg to grow
in.

What is MICROGYNON 50 ED used for?

MICROGYNON 50 ED is used to prevent pregnancy. Combined oral contraceptives
are a very effective method of birth control. When taken correctly (without
missing tablets) the chance of becoming pregnant is very low (approximately 1%
per year). The failure rate may increase when tablets are missed or taken
incorrectly.

Before you use MICROGYNON 50 ED

Do not use MICROGYNON 50 ED if you have any of the conditions listed below.
If any of these apply to you, tell your doctor before starting to use
MICROGYNON 50 ED. Your doctor may advise you to use a different type of
hormonal contraception or an entirely different (non-hormonal) method of birth
control.

You must not use MICROGYNON 50 ED if:

• you have, or have ever had a disorder affecting the blood circulation.
  In particular, those conditions relating to thrombosis. Thrombosis is the
  formation of a blood clot. This may occur in the blood vessels of the legs
  (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart
  attack), the brain (stroke), or other parts of the body. (See also the
  section later in this leaflet called "MICROGYNON 50 ED and thrombosis").
• you have or have ever had a stroke caused by a rupture of a blood vessel
  in the brain
• you have or have ever had a condition that may be a first sign of a
  heart attack (such as angina pectoris or chest pain) or stroke (such as
  transient ischemic attack or small reversible stroke)
• you have a history of migraine accompanied by visual symptoms or speech
  disability or weakness or numbness in any part of your body
• you have diabetes mellitus with blood vessel damage
• you or someone in your immediate family has or has had high blood levels
  of cholesterol or triglycerides (fatty substances)
• you have or have had pancreatitis (an inflammation of the pancreas)
  associated with high levels of fatty substances in your blood
• you have jaundice (yellowing of the skin) or severe liver disease, as
  long as liver function test results have not returned to normal
• you have or have had a cancer that may grow under the influence of sex
  hormones (e.g. of the breast or the genital organs)
• you have or have had a benign or malignant liver tumor
• you have any unexplained vaginal bleeding
• you are pregnant or think you might be pregnant
• you are allergic (hypersensitive) to any of the ingredients of
  MICROGYNON 50 ED.

If any of these conditions appear for the first time while using MICROGYNON
50 ED, stop taking it at once and consult your doctor. In the meantime, use
non-hormonal contraceptive measures.

Tell your doctor if:

If MICROGYNON 50 ED is used in the presence of any of the conditions listed
below or they appear for the first time, recur or worsen during treatment, you
may need to be kept under close observation. Your doctor can explain this to
you. You should tell your doctor if:

• you smoke
• you have diabetes
• you are overweight
• you have high blood pressure
• you have a heart valve disorder or a certain heart rhythm disorder
• you have an inflammation of your veins (superficial phlebitis)
• you have varicose veins
• anyone in your immediate family has had thrombosis, a heart attack or a
  stroke
• you suffer from headaches
• you suffer from epilepsy
• anyone in your immediate family has had breast cancer
• you have liver, kidney or gallbladder disease
• you have Crohn's disease or ulcerative colitis (chronic inflammatory
  bowel disease)
• you have systemic lupus erythematosus (SLE; a disease affecting the skin
  all over the body)
• you have hemolytic uremic syndrome (HUS; a blood clotting disorder
  causing failure of the kidneys)
• you have sickle cell disease
• you have a condition that occurred for the first time or worsened during
  pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic
  disease called porphyria, a skin disease called herpes gestationis, a
  neurological disease called Sydenham's chorea)
• you have or have had chloasma (yellowish-brown pigmentation patches on
  the skin, particularly of the face); if so, avoid too much exposure to the
  sun or ultraviolet radiation
• you have hereditary angioedema; taking estrogens may induce or
  exacerbate symptoms of angioedema. You should see your doctor immediately if
  you experience symptoms of angioedema such as swollen face, tongue and/or
  throat and/or difficulty swallowing or hives together with difficulty
  breathing.

What else you should know

MICROGYNON 50 ED does not protect against HIV infection (AIDS) or any
other sexually transmitted disease.

In this leaflet, several situations are described where you should stop
taking MICROGYNON 50 ED, or where the reliability of MICROGYNON 50 ED may be
decreased. In such situations you should not have sex or you should take extra
non-hormonal contraceptive precautions, e.g. use a condom or another barrier
method. Do not use rhythm or temperature methods. These methods can be
unreliable because MICROGYNON 50 ED alters the usual changes in temperature
and cervical mucus that occur during the menstrual cycle.

• MICROGYNON 50 ED and thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel.

Thrombosis sometimes occurs in the deep veins of the legs (deep venous
thrombosis). If this blood clot breaks away from the veins where it is formed,
it may reach and block the arteries of the lungs, causing a so-called
"pulmonary embolism". Deep venous thrombosis is a rare occurrence. The risk is
highest during the first year a woman ever uses the Pill.

Venous thrombosis can develop whether or not you are taking the Pill. It
can also happen if you become pregnant. The risk is higher in Pill users than
in non-users, but not as high as during pregnancy.

Blood clots can also occur very rarely in the blood vessels of the heart
(causing a heart attack) or the brain (causing a stroke). Extremely rarely,
blood clots can occur in the liver, gut, kidney or eye.

Very occasionally a thrombosis may cause serious permanent disabilities or
may even be fatal.

The risk of having a heart attack or stroke increases as you get older. It
also increases the more you smoke.

When using MICROGYNON 50 ED you should stop smoking, especially if you
are older than about 35 years of age.

If you develop high blood pressure while using MICROGYNON 50 ED, you may be
told to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a
result of an operation or immobilization (for example, when you have your leg
or legs in plaster or splints). In women who use the Pill (such as MICROGYNON
50 ED) the risk may be even higher. Tell your doctor you are using MICROGYNON
50 ED well in advance of any expected hospitalization or surgery. Your doctor
may tell you to stop taking MICROGYNON 50 ED several weeks before surgery or
at the time of immobilization. Your doctor will also tell you when you can
start taking MICROGYNON 50 ED again after you are back on your feet.

If you notice possible signs of thrombosis, stop taking the Pill and
consult your doctor immediately. (See also the section called "Tell your
doctor if:")

• MICROGYNON 50 ED and cancer

Breast cancer has been diagnosed slightly more often in women who use the
Pill than in women of the same age who do not use the Pill. This slight
increase in the numbers of breast cancer diagnoses gradually disappears during
the course of the ten years after stopping use of the Pill. It is not known
whether the difference is caused by the Pill. It may be that the women were
examined more often, so that the breast cancer was noticed earlier.

In rare cases, benign, and even more rarely, malignant liver tumors have
been reported in users of the Pill. These tumors may lead to internal
bleeding. Contact your doctor immediately if you have severe pain in your
abdomen.

The most important risk factor for cervical cancer is persistent human
papilloma virus infection. Some studies have indicated that long-term use of
the Pill may further contribute to this increased risk, but there continues to
be controversy about the extent to which this finding is attributable to other
factors, e.g. cervical screening and sexual behavior including use of barrier
contraceptives.

• MICROGYNON 50 ED and other medicines

Some medicines may stop MICROGYNON 50 ED from working properly. These
include medicines used for the treatment of epilepsy (e.g. primidone,
phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate and
felbamate); and tuberculosis (e.g. rifampicin and rifabutin) and HIV
infections (e.g. ritonavir and nevirapine); antibiotics (e.g. penicillins,
tetracyclines and griseofulvin) for some other infectious diseases; and the
herbal remedy St. John's wort (primarily used for the treatment of depressive
moods).

The Pill may also interfere with the working of other medicines (e.g.
medicines containing cyclosporin or the anti-epileptic lamotrigine).

Please inform your doctor or pharmacist if you are taking or have recently
taken any other medicines or herbal products, even those not prescribed.

Always tell the doctor who prescribes MICROGYNON 50 ED which medicines you
are already using. Also tell any other doctor or dentist who prescribes
another medicine (or the dispensing pharmacist) that you use MICROGYNON 50 ED.
They can tell you if you need to take additional contraceptive precautions and
if so, for how long.

• MICROGYNON 50 ED and breast-feeding

MICROGYNON 50 ED is generally not recommended for use during
breast-feeding. If you wish to take the Pill while breast-feeding, please seek
the advice of your doctor.

• MICROGYNON 50 ED and pregnancy

MICROGYNON 50 ED must not be used by women who are pregnant, or who think
they may be pregnant. If you suspect that you are pregnant while you are using
MICROGYNON 50 ED you should see your doctor as soon as possible.

• MICROGYNON 50 ED and ability to drive and use Machines

There are no observed effects.

How to use MICROGYNON 50 ED properly

When you follow the starting instructions and continue to take MICROGYNON
50 ED correctly, the contraceptive protection provided by MICROGYNON 50 ED is
continuous. This includes the week when you take the non-hormonal tablets.

Additional contraceptive precautions are only required when special
circumstances (e.g. forgetting tablets) reduce the reliability of the
preparation.

Remember that MICROGYNON 50 ED has been prescribed for you personally. Do
not share it with others.

When and how to take the tablets

The MICROGYNON 50 ED pack contains 21 small round ochre hormonal tablets
and 7 large white non-hormonal tablets. On the pack each tablet is marked with
the day of the week on which it is to be taken. Take your tablet at about the
same time each day, with some water if necessary. Follow the direction of the
arrows until all 28 tablets have been taken. A period (the withdrawal bleed)
should begin during the 7 days of taking the large white non-hormonal tablets.
Start taking your next pack on the very next day after you have completed your
last pack even if your period continues. This means that you will always start
new packs on the same day of the week, and also that you will have your
withdrawal bleed on or about the same day each month.

Starting your first pack of MICROGYNON 50 ED

• When no hormonal contraceptive has been used in the past month

Start taking MICROGYNON 50 ED on the first day of your cycle, i.e. the
first day of menstrual bleeding. Take your first tablet from the green section
marked with that day of the week. For example, if your period starts on a
Monday, take the tablet marked Monday from the green section of the pack. Then
follow the days in order of the directional arrows. When you start taking
MICROGYNON 50 ED your very first cycle may be shorter than usual. MICROGYNON
50 ED will work immediately, it is not necessary to use an additional
contraceptive method.

You may also start taking MICROGYNON 50 ED on days 2-3 of your cycle, but
in this case make sure that you use an additional barrier contraceptive method
(such as condoms) for the first 7 days of tablet-taking in the first cycle.

• When changing from a combined Pill, vaginal ring or transdermal
  (contraceptive) patch

You can start taking MICROGYNON 50 ED the day after you take the last
tablet from your present Pill pack (this means no tablet-free break). Take
your first tablet from the green section marked with that day of the week. If
your present Pill pack also contains non-hormonal tablets you can start
MICROGYNON 50 ED on the day after taking the last hormonal tablet (if
you are not sure which this is, ask your doctor or pharmacist).

You can also start later, but never later than the day following the
tablet-free break of your present Pill (or the day after the last non-hormonal
tablet of your present Pill). In case you have used a vaginal ring or
transdermal patch, you should start using MICROGYNON 50 ED preferably on the
day of removal, but at the latest when the next application would have been
due. If you follow these instructions, it is not necessary to use an
additional contraceptive method.

• When changing from a progestogen-only Pill (minipill)

You can stop taking the minipill any day and start taking MICROGYNON 50 ED
the next day, at the usual time. Take your first tablet from the green section
marked with that day of the week. But make sure you also use an additional
barrier contraceptive method for the first 7 days of tablet-taking when having
intercourse.

• When changing from an injectable, an implant or a progestogen-releasing
  intrauterine device (IUD)

Start using MICROGYNON 50 ED when your next injection is due or on the day
that your implant or IUD is removed. Take your first tablet from the green
section marked with that day of the week. But make sure you also use an
additional barrier contraceptive method for the first 7 days of tablet-taking
when having intercourse.

• After having a baby

If you have just had a baby, your doctor may tell you to wait until after
your first normal period before you start taking MICROGYNON 50 ED. Sometimes
it is possible to start sooner. Your doctor will advise you. If you are
breast-feeding and want to take MICROGYNON 50 ED, you should discuss this
first with your doctor.

• After a miscarriage or an abortion

Your doctor will advise you.

Special circumstances

The following describes special circumstances that could alter the way you
take MICROGYNON 50 ED. In all situations where the reliability of MICROGYNON
50 ED is reduced (such as missing tablets) additional contraceptive
precautions are required following the advice given below. This advice should
also be followed in situations where other medicines may stop MICROGYNON 50 ED
from working properly and in the case of vomiting or severe diarrhea after
taking MICROGYNON 50 ED.

If you forget to take your tablets

If you forget to take your tablets, follow the instructions below. This
is often called the "7 day rule". The more tablets you have missed, the
higher the risk that the contraceptive effect is decreased. There is a
particularly high risk of becoming pregnant if you miss tablets just before or
immediately after taking the non-hormonal tablets.

If you vomit or have severe diarrhea after taking MICROGYNON 50 ED

If you vomit or have severe diarrhea within 3 to 4 hours after taking your
MICROGYNON 50 ED hormonal tablets, the active ingredients may not have been
completely absorbed. This is like missing a tablet. Therefore, follow the
advice for missed tablets. If vomiting or diarrhea occurs while taking the
non-hormonal tablets, this does not have an influence on the contraceptive
reliability.

If you are taking medicines that affect MICROGYNON 50 ED

Some medicines may stop MICROGYNON 50 ED from working properly. These
medicines are listed in an earlier section. For the time that you are taking
the medicine and for the next 7 days follow the advice for missed tablets. If
you are taking rifampicin, or you are taking these medicines continuously,
your doctor will advise you on the length of time you need to take extra
contraceptive precautions.

If you want to delay a period

You can delay your period if you miss out the large non-hormonal tablets
and go straight to the small hormonal tablets in the green section of your
next pack. Continue with this pack until this pack is empty. Your period will
start while you are taking the large white non-hormonal tablets in the next
pack. You may have some breakthrough bleeding or spotting while you are taking
the small hormonal tablets.

If you want to change the starting day of your period

If you take your tablets as directed, you will have your period on about
the same day every 4 weeks. If you want to change this, just shorten, (never
lengthen) the duration of taking the non-hormonal tablets. For example, if
your period usually starts on a Friday and in future you want it to start on
Tuesday (3 days earlier) you should start your next pack 3 days sooner than
you usually do, discard the 3 remaining large white tablets of your previous
pack and then continue with the next pack without having a break between the
packs. If you make the duration of taking the large non-hormonal tablets very
short (e.g. 3 days or less), you may not have bleeding during the break. You
may have some breakthrough bleeding or spotting during the use of the next
pack.

If you have unexpected bleeding

As with other Pills, for the first few months, you can have irregular
vaginal bleeding (spotting or breakthrough bleeding) with MICROGYNON 50 ED
between your periods. You may need to use sanitary protection, but continue to
take your tablets as normal. Irregular vaginal bleeding usually stops once
your body has adjusted to MICROGYNON 50 ED (usually after about 3
tablet-taking cycles). If it continues, becomes heavy or starts again, tell
your doctor.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not
vomited, had severe diarrhea or used other medicines, then you are very
unlikely to be pregnant. Continue to take MICROGYNON 50 ED as usual.

If you miss your period twice in a row, you may be pregnant. Tell your
doctor immediately. Do not start the next pack of MICROGYNON 50 ED until your
doctor has checked that you are not pregnant.

When you want to stop taking MICROGYNON 50 ED

You can stop taking MICROGYNON 50 ED at any time you want. If you stop
because you want to get pregnant, it is generally recommended that you wait
until you have had a natural period before trying to conceive. This helps you
to work out when the baby will be due.

If you do not want to become pregnant, ask your doctor about other methods
of birth control.

Overdosage

There have been no reports of serious harmful effects from taking too many
MICROGYNON 50 ED tablets at one time. If you have taken several tablets at a
time, you may have nausea, vomiting or vaginal bleeding. If you discover that
a child has taken MICROGYNON 50 ED, ask your doctor for advice. Taking the
large white non-hormonal tablets is harmless because they do not contain any
active ingredients.

When using MICROGYNON 50 ED

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a
blood clot, heart attack or stroke while you are taking MICROGYNON 50 ED.
Warning signs for a blood clot, heart attack or stroke to look out for are:

• an unusual cough
• severe pain in the chest which may reach the left arm
• breathlessness
• any unusual, severe, or prolonged headache or migraine attack
• partial or complete loss of vision, or double vision
• slurring or speech disability
• sudden changes to your hearing, sense of smell, or taste
• dizziness or fainting
• weakness or numbness in any part of your body
• severe pain in your abdomen
• severe pain or swelling in either of your legs

Tell your doctor if:

Contact your doctor as soon as possible if:

• you notice any changes in your own health, especially involving any of
  the items mentioned in this leaflet; do not forget about the items related
  to your immediate family. (See also the section called "Before you use
  MICROGYNON 50 ED").
• you feel a lump in your breast
• you are going to use other medications. (See also the section called
  "MICROGYNON 50 ED and other medicines").
• you are to be immobilized or are to have surgery (consult your doctor at
  least four weeks in advance)
• you have unusual, heavy vaginal bleeding
• you forgot tablets in the first week after taking the large non-hormonal
  tablets and had intercourse in the seven days before
• you have severe diarrhea
• you have missed your period twice in a row or suspect you are pregnant
  (do not start the next pack until told to by your doctor)

Regular check-ups

When you are using MICROGYNON 50 ED, your doctor will tell you to return
for regular check-ups. In general, you should have a check-up every year.

Side effects

Tell your doctor if you notice any unwanted side effects, especially if
severe or persistent, or if there is a change in your health that you think
might be caused by MICROGYNON 50 ED.

Serious side effects

Serious side effects associated with the use of combined oral
contraceptives such as MICROGYNON 50 ED, as well as the related symptoms, are
described in the following sections "The Pill and thrombosis" and
"The Pill and cancer". Please read these sections for additional
information and consult your doctor at once where appropriate.

Other possible side effects

The following side effects have been reported in users of combined oral
contraceptives such as MICROGYNON 50 ED, although they may not be caused by
the contraceptive Pill. Such side effects that occur in the first few months
that you are using MICROGYNON 50 ED will probably lessen with time.

System Organ Class	Common (≥ 1/100)	Uncommon (≥ 1/1000 and < 1/100)	Rare (< 1/1000)
Eye Disorders			Contact lens intolerance
Gastrointestinal Disorders	Nausea, abdominal pain	Vomiting, diarrhea
Immune System Disorders			Hypersensitivity reactions
Investigations	Weight gain		Weight loss
Metabolism and Nutrition Disorders		Fluid retention
Nervous System Disorders	Headache	Migraine
Psychiatric Disorders	Depression, mood changes	Decreased libido	Increased libido
Reproductive System and Breast Disorders	Breast pain, breast tenderness	Breast enlargement	Vaginal discharge, breast discharge
Skin and Subcutaneous Tissue Disorders		Rash, hives	Skin reactions (erythema nodosum and erythema multiforme)

If you have hereditary angioedema, taking estrogens may induce or
exacerbate symptoms of angioedema. (See also "Before you start to use
MICROGYNON 50 ED").

If you notice any side effects not mentioned in this leaflet, please inform
your doctor or pharmacist.

Storage

Do not use after the expiry date stated on the package.

Store all medicines properly and keep them out of reach of children.

Further information

Like other combined oral contraceptive Pills, MICROGYNON 50 ED may also
have non-contraceptive health benefits.

• Your period may be lighter and shorter. As a result, the risk of anemia
  may be lower. Your period pains may become less severe or may completely
  disappear.
• Some serious disorders have been reported to occur less frequently in
  users of "high-dose" oral contraceptive Pills such as MICROGYNON 50 ED.
  These are benign breast disease, ovarian cysts, pelvic infections (pelvic
  inflammatory disease or PID), ectopic pregnancy (pregnancy in which the
  embryo implants outside of the womb) and cancer of the endometrium (lining
  of the womb) and ovaries.

MICROGYNON 50 ED tablets contain:

active substances (per tablet):

levonorgestrel (0.125 mg) and ethinylestradiol (0.05 mg)

other substances:

lactose monohydrate, maize starch, polyvidone 25 000, magnesium stearate,
sucrose, polyvidone 700 000, macrogol 6000, calcium carbonate, purified talc,
glycerol 85%, ferric oxide pigment (yellow), titanium dioxide, montanglycol
wax

If you have any further questions please consult your doctor or
pharmacist.