MICROGYNON® 30

Levonorgestrel 0.15 mg and Ethinylestradiol 0.03 mg tablets

What is in this leaflet

Please read this leaflet carefully before you start using MICROGYNON 30. It
will advise you about how to take MICROGYNON 30 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 30 used for and how does it work

MICROGYNON 30 is a combined oral contraceptive (often called "the Pill").
Each small beige tablet contains a small amount of two different female
hormones. These are levonorgestrel (a progestogen) and ethinylestradiol (an
estrogen). Because of the small amount of hormones, MICROGYNON 30 is considered
to be a low-dose combined oral contraceptive preparation.

How does MICROGYNON 30 work?

Combined oral contraceptive Pills, such as MICROGYNON 30, provide one of the
most effective reversible methods of contraception known. Usually, when
MICROGYNON 30 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 30 used for?

MICROGYNON 30 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 30

Do not use MICROGYNON 30 if you have any of the conditions listed below. If
any of these apply to you, tell your doctor before starting to use MICROGYNON
30. 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 30 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 30 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
  30

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

Tell your doctor if:

If MICROGYNON 30 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. You 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 30 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 30, or where the reliability of MICROGYNON 30 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 30 alters the usual changes in temperature and
cervical mucus that occur during the menstrual cycle.

• MICROGYNON 30 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 30 you should stop smoking, especially if you are
older than about 35 years of age.

If you develop high blood pressure while using MICROGYNON 30, 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 30)
the risk may be even higher. Tell your doctor you are using MICROGYNON 30 well
in advance of any expected hospitalization or surgery. Your doctor may tell you
to stop taking MICROGYNON 30 several weeks before surgery or at the time of
immobilization. Your doctor will also tell you when you can start taking
MICROGYNON 30 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 30 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 30 and other medicines

Some medicines may stop MICROGYNON 30 from working properly. These include
medicines used for the treatment of epilepsy (e.g. primidone, phenytoin,
barbiturates, carbamazepine, oxcarbazepine, topiramate and felbamate);
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 30 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 30. They can
tell you if you need to take additional contraceptive precautions and if so, for
how long.

• MICROGYNON 30 and breast-feeding

MICROGYNON 30 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 30 and pregnancy

MICROGYNON 30 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 30 you should see your doctor as soon as possible.

• MICROGYNON 30 and ability to drive and use Machines

There are no observed effects.

How to use MICROGYNON 30 properly

When you follow the starting instructions and continue to take MICROGYNON 30
correctly, the contraceptive protection provided by MICROGYNON 30 is continuous.
This includes your tablet-free week.

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

Remember that MICROGYNON 30 has been prescribed for you personally. Do not
share it with others.

When and how to take the tablets

The MICROGYNON 30 pack contains 21 small round beige 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 21 tablets have been taken. During
the next 7 days you take no tablets. A period (the withdrawal bleed) should
begin during these 7 days. Start taking your next pack on the 8^th day
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 30

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

Start taking MICROGYNON 30 on the first day of your cycle, i.e. the first day
of menstrual bleeding. Take a tablet marked with that day of the week. For
example, if your period starts on a Monday, take the tablet marked Monday. Then
follow the days in order of the directional arrows. When you start taking
MICROGYNON 30 your very first cycle may be shorter than usual. MICROGYNON 30
will work immediately, it is not necessary to use an additional contraceptive
method.

You may also start taking MICROGYNON 30 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 30 the day after you take the last tablet
from your present Pill pack (this means no tablet-free break). If your present
Pill pack also contains non-hormonal tablets you can start MICROGYNON 30 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 30 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 30 the
next day, at the usual time. 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 30 when your next injection is due or on the day that
your implant or IUD is removed. 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 30. Sometimes it is
possible to start sooner. Your doctor will advise you. If you are breast-feeding
and want to take MICROGYNON 30, 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 30. In all situations where the reliability of MICROGYNON 30 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 30 from working properly
and in the case of vomiting or severe diarrhea after taking MICROGYNON 30.

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 at the beginning
or at the end of the pack.

If you vomit or have severe diarrhea after taking MICROGYNON 30

If you vomit or have severe diarrhea within 3 to 4 hours after taking your
MICROGYNON 30 tablets, the active ingredients may not have been completely
absorbed. This is like missing a tablet. Therefore, follow the advice for missed
tablets.

If you are taking medicines that affect MICROGYNON 30

Some medicines may stop MICROGYNON 30 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 start your next pack of MICROGYNON 30
immediately after finishing your current pack. You can continue with this pack
for as long as you wish, until the pack is empty. When you wish your period to
begin again, just stop tablet taking. While using the second pack, you may have
some breakthrough bleeding or spotting on tablet-taking days. Start your
following pack after the usual 7 day tablet-free break.

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 next tablet-free break. 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. If you make your
tablet-free break 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 30 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 30 (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 30 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 30 until your doctor has
checked that you are not pregnant.

When you want to stop taking MICROGYNON 30

You can stop taking MICROGYNON 30 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 30 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 30, ask your doctor for advice.

When using MICROGYNON 30

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 30. 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
  30").
• you feel a lump in your breast
• you are going to use other medications. (See also the section called "MICROGYNON
  30 and other medicines").
• you are to be immobilised 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 of the pack 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 30, 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 30.

Serious side effects

Serious side effects associated with the use of combined oral contraceptives
such as MICROGYNON 30, 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 30, 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 30 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	Increased libido	Decreased 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 30").

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 30 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. 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. This may also
  be the case for "low-dose" Pills such as MICROGYNON 30, but so far this has
  only been confirmed for endometrial and ovarian cancer.

MICROGYNON 30 tablets contain:

active substances (per tablet):

levonorgestrel (0.15 mg) and ethinylestradiol (0.03 mg)

other substances:

lactose monohydrate, maize starch, povidone 25 000, magnesium stearate, sucrose,
povidone 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.