MICROLUT®

Levonorgestrel 30mcg tablets

What is in this leaflet

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

MICROLUT contains the oral progestogen levonorgestrel in a very low dose.
Such progestogen-only preparations for contraception are also called the "Minipill".
The pregnancy rate of progestogen-only contraceptives such as MICROLUT is
slightly higher than that of combined progestogen-estrogen contraceptives (the
combined "Pill"). However, MICROLUT offers a high degree of reliability when
taken correctly and the chance of becoming pregnant is very low.

How does MICROLUT work?

The continuous daily intake of one MICROLUT tablet prevents pregnancy in
several different ways. These include changes in the cervical mucus, which makes
the migration and ascent of sperm difficult and changes to the lining of the
womb. The release of eggs is not inhibited by MICROLUT in the majority of women,
but MICROLUT has an influence on the hormonal regulation circuit, which may
contribute to the contraceptive action.

What is MICROLUT used for?

MICROLUT is used as an oral contraceptive.

Before you use MICROLUT

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

• you have 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
• 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
  ischaemic attack or small reversible stroke)
• you have or have had a severe liver disease and your liver function values
  have not returned to normal (symptoms of liver disease include yellowing of
  the skin and/or itching of the whole body)
• you have diabetes mellitus with blood vessel damage
• you have high blood levels of cholesterol or triglycerides (fatty
  substances)
• you have or have had cancer of the breast or the genital organs
• you have or have had a benign or malignant liver tumour
• you have any unexplained vaginal bleeding
• you are pregnant or think you might be pregnant
• you have had a previous ectopic pregnancy
• you are allergic to any of the ingredients of MICROLUT

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

Tell your doctor if:

If MICROLUT is used in the presence of any of the conditions listed below or
they appear for the first time or 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
• anyone in your immediate family has had thrombosis, a heart attack or a
  stroke
• anyone in your immediate family has had breast cancer
• you have liver disease
• you suffer from migraine
• you suffer from epilepsy
• you have ovarian cysts
• you have fibroids
• 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

What else you should know

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

• MICROLUT 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 of venous
thromboembolism (deep venous thrombosis, pulmonary embolism) appears to be
slightly higher in Minipill users than in non-users, but not as high as during
pregnancy or during use of the (combined) Pill.

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.

It is also generally accepted that the risk for venous thromboembolism
increases with increasing age and increases if you are overweight and if you or
anyone in your immediate family has had a thrombosis at a relatively early age.

The risk of thromboembolism is also increased shortly after childbirth.

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

• MICROLUT and cancer

The following findings from the combined Pill may also hold true for MICROLUT
users, although the evidence is not as strong for the Minipill compared to the
Pill.

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 10 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 tumours have
been reported in users of the Pill. These tumours may lead to internal bleeding.
Contact your doctor immediately if you have severe pain in your abdomen.

Cervical cancer has been reported to occur more often in women using the Pill
for a long time. This finding may not be caused by the Pill but may be related
to sexual behaviour and other factors.

• MICROLUT and other conditions

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

If, in exceptional cases, pregnancy occurs while taking MICROLUT, there is a
higher likelihood of an ectopic pregnancy (a pregnancy occurring outside the
uterus) compared to the combined Pill. If you experience unexplained pain in the
lower part of your abdomen together with an irregular cycle pattern (no monthly
bleeding or no monthly bleeding followed by persistent bleeding), you should
contact your doctor immediately because an ectopic pregnancy must be considered.

Persistent ovarian follicles (often referred to as "functional ovarian
cysts") may occur during the use of MICROLUT. Most of these follicles are not
combined with any symptoms, although some may be accompanied by pelvic pain or
painful sexual intercourse. In this case inform your doctor. In most cases, the
enlarged follicles disappear spontaneously during 2 - 3 months of observation.

• MICROLUT and other medicines

Some oral medicines may stop MICROLUT from working properly. These include
medicines used for the treatment of epilepsy (e.g. primidone, phenytoin,
barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g.
ampicillin, tetracyclines, griseofulvin) for some other infectious diseases.
Always tell the doctor who prescribes MICROLUT which medicines you are already
using. Also tell any other doctor or dentist who prescribes another medicine (or
the dispensing pharmacist) that you use MICROLUT. They can tell you if you need
to take additional contraceptive precautions and if so, for how long.

• MICROLUT and breast-feeding

Hormonal contraceptives such as MICROLUT are not recommended as the
contraceptive method of first choice during lactation. However, MICROLUT is
often considered as the next choice. There appear to be no adverse effects on
infant growth or development if MICROLUT is started six weeks after childbirth.
MICROLUT does not appear to affect the quantity or quality of breast milk,
however very small amounts of the hormone can be found in the breast milk.

• MICROLUT and pregnancy

MICROLUT must not be used by women who are pregnant, or who think they may be
pregnant.

• MICROLUT and ability to drive

There are no observed effects.

How to use MICROLUT properly

The contraceptive protection provided by MICROLUT is continuous. Additional
contraceptive precautions are only required when special circumstances (e.g.
failing to take your tablet at the usual time) reduce the reliability of the
preparation.

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

When and how to take the tablets

The MICROLUT pack contains 28 small round white 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 the same time each day, with some water if necessary. Follow the
direction of the arrows until all the tablets have been taken. Start your next
pack on the very next day as MICROLUT is taken continuously without any break.

You should always try to maintain an interval of exactly 24 hours between
tablets. This interval should not be exceeded by more than 3 hours. For example,
if you choose 7 a.m. as the time for taking your tablets, you should try to
always take them at this time. Whenever this is impossible, the tablet must be
taken by 10 a.m. at the very latest, otherwise you may not be protected against
conception. The greatest possible reliability of MICROLUT can be assured only by
adhering as closely as possible to the 24-hour intervals.

Starting your first pack of MICROLUT

When no hormonal contraceptive has been used in the past month

Start taking MICROLUT on the first day of your cycle, i.e. the first day of
menstrual bleeding.

When changing from a combined Pill

You should start taking MICROLUT immediately on the day after the last
hormonal tablet from your present Pill pack (this means no tablet-free break).

When changing from another progestogen-only Pill (Minipill)

When switching from another Minipill, you may start with MICROLUT on any day,
without a break between the tablets. If you are not sure about the type of Pill
you have used, contact your doctor or pharmacist.

When changing from an injectable or implant

If you have used a progestogen-only implant or injections to prevent
pregnancy, you may switch from an implant on the day of its removal or from an
injectable when the next injection would be due. In both cases you should use a
barrier method for the first 7 days of tablet taking.

After having a baby

If you are breast-feeding, please read the section on MICROLUT and
breast-feeding.

If you are not breast-feeding, you should start in the fourth week after
delivery. When starting later, you may either wait for your first menstrual
period or you may start straight away provided you use a barrier method for the
first 7 days of tablet taking. However, if you have already had intercourse, the
possibility of pregnancy should be excluded before starting MICROLUT.

After a miscarriage or an abortion

You may start immediately.

Special circumstances

The following describes special circumstances that could alter the way you
take MICROLUT. In all situations where the reliability of MICROLUT 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 MICROLUT from working properly and in
the case of vomiting or diarrhoea after taking MICROLUT.

If you forget to take your tablets

If you forget to take your tablets at the usual time, follow the instructions
below. This is often called the "7 day rule". This advice should also be
followed in situations where other medicines may stop MICROLUT from working
properly and in the case of vomiting or diarrhoea after taking MICROLUT.

If even one tablet is taken late (i.e. it is more than 27 hours since the last
tablet was taken), protection against contraception may be impaired. You should
take the last missed tablet as soon as you remember, even if this means taking 2
tablets at the same time. Then continue to take tablets at your usual time. In
addition, a barrier method should be used for the next 7 days. If intercourse
took place in the preceding 7 days, the possibility of a pregnancy should be
considered and you should contact your doctor. The more tablets you miss, the
higher the risk of a pregnancy.

The pattern of menstrual bleeding with MICROLUT

• Menstrual bleeding

Menstrual bleeding occurs at normal intervals and is of normal duration and
intensity in the majority of cases. However, both shortened and lengthened
intervals are observed.

The changes occur mainly during the first few months of use, but with
continuing treatment the cycle pattern tends to stabilise, and in most cases an
individual pattern is established. Keep a record of bleeding on the calendar
contained in each pack.

• Procedure in the event of intermenstrual bleeding

Intermenstrual bleeding of varying intensity may occur, particularly during
the first few months. Normally, MICROLUT does not need to be withdrawn in such
cases but you should inform your doctor in any case because it may be necessary
to rule out other potential causes.

• Absence of withdrawal bleeding

It may happen that your monthly bleeding does not occur, in most cases only
for one or two menstrual periods. In rare cases bleeding may fail to occur for
prolonged periods of time.

If no menstrual bleeding has occurred within 6 weeks after the last menstrual
bleeding, you need to contact your doctor to have the possibility of pregnancy
excluded before going on to the next pack of MICROLUT.

Overdosage

There have been no reports of serious harmful effects from taking too many
MICROLUT 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 MICROLUT, ask your doctor for advice.

When using MICROLUT

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a
blood clot while you are taking MICROLUT. Warning signs 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
• you feel a lump in your breast
• you are going to use other medications
• 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 miss your period within 6 weeks after the last menstrual bleeding or
  suspect you are pregnant (do not start the next pack until told to by your
  doctor).
• you experience unexplained pain in the lower part of your abdomen together
  with an irregular cycle pattern (no monthly bleeding or no monthly bleeding
  followed by persistent bleeding). You should contact your doctor
  immediately because an ectopic pregnancy must be considered.

Regular check-ups

When you are using MICROLUT, 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 effect, especially if severe or
persistent, or if there is a change in your health that you think might be
caused by MICROLUT.

Serious side effects

Serious reactions associated with the use of oral contraceptives such as
MICROLUT, as well as the related symptoms, are described in the section "Before
you use MICROLUT". Please read this section carefully and consult your doctor
where appropriate.

Other possible side effects

The following have been reported in users of the Minipill such as MICROLUT,
although they may not be caused by the Minipill. Such undesirable effects that
occur in the first few months that you are using MICROLUT will probably lessen
with time.

• menstrual disturbances (frequent and/or irregular bleeding or no bleeding)
• breast tenderness
• headache
• dizziness
• changes in sexual drive; depressive moods
• contact lens intolerance
• nausea or vomiting
• changes in vaginal secretion
• various skin reactions (including acne or hair growth)
• changes in body weight
• hypersensitivity reactions

Storage

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

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

Further information

MICROLUT tablets contain:

active substances (per tablet)

levonorgestrel (0.03mg)

other substances

lactose monohydrate, maize starch, polyvidone 25 000, talc, magnesium
stearate, sucrose, polyvidone 700 000, macrogol 6000, precipitated calcium
carbonate, montanglycol wax

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