LEVLEN® ED

Levonorgestrel 0.15 mg and Ethinylestradiol 0.03 mg tablets

What is in this leaflet

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

LEVLEN ED is a combined oral contraceptive (often called "the Pill")
consisting of 21 hormonal tablets and 7 non-hormonal tablets. Each small beige
hormonal 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, LEVLEN ED is considered to be a low-dose
combined oral contraceptive preparation. LEVLEN ED also contains 7 large white
non-hormonal tablets that do not contain any active ingredients.

How does LEVLEN ED work?

Combined oral contraceptive Pills, such as LEVLEN ED, provide one of the most
effective reversible methods of contraception known. Usually, when LEVLEN 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
fertilised. 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 fertilised egg to grow in.

What is LEVLEN ED used for?

LEVLEN 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 LEVLEN ED

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

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

Tell your doctor if:

If LEVLEN 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. 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

LEVLEN 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 LEVLEN ED, or where the reliability of LEVLEN 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
LEVLEN ED alters the usual changes in temperature and cervical mucus that occur
during the menstrual cycle.

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

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

• LEVLEN 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.

• LEVLEN ED and other medicines

Some medicines may stop LEVLEN ED 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 LEVLEN 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 LEVLEN ED. They can tell
you if you need to take additional contraceptive precautions and if so, for how
long.

• LEVLEN ED and breast-feeding

LEVLEN 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.

• LEVLEN ED and pregnancy

LEVLEN 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 LEVLEN ED
you should see your doctor as soon as possible.

• LEVLEN ED and ability to drive

There are no observed effects.

How to use LEVLEN ED properly

When you follow the starting instructions and continue to take LEVLEN ED
correctly, the contraceptive protection provided by LEVLEN 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 LEVLEN ED has been prescribed for you personally. Do not share
it with others.

When and how to take the tablets

The LEVLEN ED pack contains 21 small round beige 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 LEVLEN ED

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

Start taking LEVLEN 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 LEVLEN ED your very first
cycle may be shorter than usual. LEVLEN ED will work immediately, it is not
necessary to use an additional contraceptive method.

You may also start taking LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN ED. Sometimes it is
possible to start sooner. Your doctor will advise you. If you are breast-feeding
and want to take LEVLEN 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 LEVLEN ED. In all situations where the reliability of LEVLEN 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 LEVLEN ED from working properly and in
the case of vomiting or severe diarrhea after taking LEVLEN 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 LEVLEN ED

If you vomit or have severe diarrhea within 3 to 4 hours after taking your
LEVLEN 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 LEVLEN ED

Some medicines may stop LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN ED until your doctor has
checked that you are not pregnant.

When you want to stop taking LEVLEN ED

You can stop taking LEVLEN 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
LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN 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 LEVLEN ED").
• you feel a lump in your breast
• you are going to use other medications. (See also the section called "LEVLEN
  ED 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 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 LEVLEN 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 LEVLEN ED.

Serious side effects

Serious side effects associated with the use of combined oral contraceptives
such as LEVLEN ED, as well as the related symptoms, are described in the
following sections "The Pill and thrombisis" 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 LEVLEN 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 LEVLEN 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	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 LEVLEN 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, LEVLEN 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. 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 LEVLEN ED, but so far this has only
  been confirmed for endometrial and ovarian cancer.

LEVLEN ED tablets contain:

active substances (per tablet):

levonorgestrel (0.15mg) and ethinylestradiol (0.03mg)

other substances:

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

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