MICROLUT®
(MY-crow-loot)
Contraceptive tablets for women

levonorgestrel

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Microlut. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Microlut against the benefits they expect it will have for you.

If you have any concerns, or are unsure about taking this medicine, ask your doctor or pharmacist for more advice.

Keep this leaflet with the medicine. You may need to read it again.

WHAT MICROLUT IS USED FOR

Microlut is an oral progestogen-only contraceptive, commonly known as the ‘Mini-pill’.

Microlut is used to prevent pregnancy.

When taken correctly, it prevents you from becoming pregnant in several ways:

• changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg
• changing the lining of the uterus, making it less suitable for implantation
• impairing mid-cycle functions, which may contribute to contraceptive action.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

BEFORE YOU TAKE MICROLUT

When you must not take it

Do not take Microlut if you have an allergy to:

• levonorgestrel the active ingredient in Microlut
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty in breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take Microlut if you have or have had a blood clot in:

• the blood vessels of the legs (deep vein thrombosis)
• the lungs (pulmonary embolism)
• the heart (heart attack)
• the brain (stroke)
• other parts of the body.

Do not take Microlut if you are concerned about an increased risk of blood clots.

Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities, or may even be fatal.

You are more at risk of having a blood clot when you take the Mini-pill. But the risk when taking the Mini-pill is less than the risk during pregnancy.

Do not take Microlut if you are concerned about an increased risk of blood clots because of age or smoking.

The risk of having a heart attack or stroke increases as you get older. It also increases if you smoke. You should stop smoking when using the Mini-pill, especially if you are older than 35 years of age.

Do not take Microlut if you have, or have had:

• angina pectoris or chest pain
• migraine, accompanied by visual symptoms, speech disability, or weakness or numbness in any part of your body
• diabetes mellitus with blood vessel damage
• jaundice (yellowing of the skin)
• severe liver disease
• cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• benign or malignant liver tumour
• unexplained vaginal bleeding.

Do not take Microlut if you are pregnant or think you might be pregnant.

Do not give Microlut to a child.

Do not take this medicine after the expiry date printed on the pack and blister.

The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 09 refers to November 2009). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering.

If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking Microlut, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if:

• you smoke
• you are overweight
• you or anyone in your immediate family has had blood clots in the legs (thrombosis), a heart attack, a stroke, breast cancer or high cholesterol.
• infrequent and/ or irregular periods
• you suffer migraines
• you have epilepsy
• you have ever had an extrauterine/ectopic pregnancy (where an embryo has developed outside the womb) or an impairment in your fallopian tube function (e.g. caused by inflammation).

Ask your doctor to check if you have:

• diabetes
• high blood pressure
• high cholesterol or triglycerides
• liver disease
• gall bladder disease
• sickle cell disease
• a condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g. cholestatic jaundice and/or pruritis (itching)
• chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid too much exposure to the sun or ultraviolet radiation.

If any of the above conditions appear for the first time, or recur or worsen while using Microlut, you should contact your doctor.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Microlut may interfere with each other. These include:

• medicines used to treat tuberculosis such as rifampicin, rifabutin
• medicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine
• medicines used to treat HIV, such as ritonavir or nevirapine
• antibiotics (penicillin, ampicillin, erythromycin, tetracycline)
• medicines used to treat fungal infections, such as ketoconazole and griseofulvin
• cyclosporin, an immunosuppressant medicine
• herbal medicines containing St John’s Wort.

These medicines may be affected by Microlut, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

You may need to use additional barrier methods of contraception (such as condoms or a diaphragm) while you are taking any of these medicines and for some time after stopping them.

Your doctor will be able to advise you about how long you will need to use additional contraceptive methods.

Your doctor and pharmacist have more information on medicines that you need to be careful with or avoid while taking this medicine.

HOW TO TAKE MICROLUT

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How to take it

Take one tablet at the same time everyday. An interval of exactly 24 hours should be maintained between tablets. This interval must not be exceeded by more than 3 hours. Even if one tablet is taken late (i.e. more than 27 hours since the last tablet was taken or more than 3 hours later than when it should have been taken) or even if one tablet is missed, protection against pregnancy may be impaired.

Swallow the tablets whole with a full glass of water.

Take your first tablet from the blister pack corresponding to the day of the week. Follow the direction of the arrows on the blister pack until all the tablets have been taken. Each blister pack is marked with the day of the week.

Tablets must be taken for 28 consecutive days. There is no break between packs. This means that when the first pack is finished the next should be started without interruption.

If you do not understand the instructions on the blister pack, ask your doctor or pharmacist for help.

Always start a new blister pack on the same day of the week as your previous pack.

When to take it

If you are starting Microlut after a natural cycle, and you have not used a hormonal contraceptive in the past month, start on the first day of your period, i.e. on the first day of your menstrual bleeding.

Your doctor will advise you when to start if you:

• are taking Microlut after having a baby
• are breast-feeding
• have had a miscarriage or an abortion.

Changing from a combined oral contraceptive:
If you are switching from a 28 day pack combined oral contraceptive, start taking Microlut on the day after taking the last active tablet in your previous pill pack. Do not take the placebo (sugar) tablets of your previous pack. You will be protected immediately if you start this way.

Ask your doctor or pharmacist if you are not sure which the active tablets were in your previous pill pack.

Your previous pill pack may have different colour tablets to those of Microlut.

Changing from a progestogen-only pill:
If you are switching from another progestogen-only Mini-pill, stop taking the Mini-pill on any day and start taking Microlut at the same time the next day, with out any break between Mini-pills.

Changing from an injectable or implant:
If you are switching from an injectable or implant, start taking Microlut when your next injection is due, or on the day that your implant is removed. Make sure you also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 7 days of tablet-taking.

If you forget to take it

If you miss a tablet, take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take your tablets at the usual time.

In addition, you should also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the next 7 days.

If you have had sexual intercourse in the week before, taking your tablet(s) late or missing a tablet(s), there is a high possibility of becoming pregnant. Seek advice from your doctor or pharmacist about what to do.

Please refer to diagram on last page of this leaflet for a Summary of advice if you are late taking your tablet or have missed a tablet.

Ask your doctor or pharmacist to answer any questions you may have.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Microlut. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

WHILE YOU ARE TAKING MICROLUT

Things you must do

Tell any doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Have regular check ups with your doctor

When you are taking Microlut, your doctor will tell you to return for regular check ups, including getting a pap smear test. Your doctor will advise how often you need a pap smear test. A pap smear test can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer.

If you are about to start on any new medicine, remind your doctor and pharmacist that you are taking Microlut.

Stop taking Microlut and see your doctor immediately if you notice possible signs of thrombosis. These include:

• 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.

If you are going to have surgery, tell the surgeon or anaesthetist beforehand that you are taking Microlut. 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 take the Mini-pill, the risk may be higher.

The excess risk of thrombosis is highest during the first year a woman takes a combined oral contraceptive. Your doctor may tell you to stop taking the Mini-pill several weeks before surgery, or at the time of immobilisation, and when you can start taking the Mini-pill again. If you notice possible signs of a thrombosis, stop taking the Mini-Pill and consult your doctor immediately.

Consult your doctor if you develop high blood pressure while taking Microlut – you may be told to stop taking it.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you vomit within 3-4 hours or have severe diarrhoea after taking a tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Follow the advice for missed tablets.

If you have unexpected bleeding and it continues, becomes heavy, or occurs again, tell you doctor.

When taking these tablets for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) 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 the Mini-pill, usually after about 3 months.

If you have missed a period, but you have taken all your tablets at the correct time, it is very unlikely that you are pregnant. Provided that:

• you have taken the tablets at the right time
• you have not been taking a medicine(s) that may interfere with your Mini-pill
• you have not vomited or had severe diarrhoea during this cycle.

If this is so, continue to take Microlut as usual. If you have any concerns consult your doctor or pharmacist.

If you miss your period twice in a row, you may be pregnant and you should seek advice from your doctor. Do not start the next pack of Microlut until your doctor has checked that you are not pregnant.

Microlut will not protect you from HIV-AIDS, human papilloma virus (HPV) or any other Sexually Transmitted Diseases (STDs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, and syphilis. To protect yourself from HIV-AIDS and STDs, you will need to use additional barrier contraceptives (e.g. condoms).

Things you must not do

Do not take Microlut to treat any other conditions, unless your doctor tells you to.

Do not give Microlut to anyone else.

Do not stop taking Microlut or change the dosage without checking with your doctor.

You may become pregnant if you are not using any other contraceptive and you stop taking Microlut, or do not take a tablet every day.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Microlut.

This medicine helps most women, although a few may have unwanted side effects.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you feel unwell.

Other side effects not listed on the following pages may also occur in some people.

The following list includes the more common side effects of your medicine. These are usually mild and lessen with time.

If you notice any of the following side effects and they worry you, tell your doctor or pharmacist:

• nausea
• bleeding/ spotting
• vomiting
• dizziness
• headache, including migraines
• mood changes, including depression
• breast tenderness
• amenorrhoea (absence of periods)
• contact lens intolerance
• changes in libido
• skin disorders and/ or acne
• vaginal discharge
• ovarian follicles (cysts).

These may occur during the use of Microlut. These may have no symptoms, although some may cause symptoms such as pelvic pain or painful sexual intercourse.

The following list includes very serious but rare side effects. You may need urgent medical attention or hospitalisation.

If you experience any of the following, tell your doctor immediately, or go to the Emergency Department at your nearest hospital:

• chest pain
• breathlessness and/or difficulty breathing
• painful swelling in your leg(s)
• weakness, numbness or bad ‘pins and needles’ of an arm or leg
• severe, sudden stomach pains
• a bad fainting attack, or you collapse
• unusual headaches or migraines that are worse than usual
• sudden problems with your speech or eyesight

The side effects listed above are possible signs of a thrombosis.

• jaundice (yellowing skin or yellowing eyes)
• you cough up blood
• breast lumps
• unexplained lower abdominal pain, including loss of periods or heavy bleeding. In rare cases pregnancies may occur during use of the mini-pill. These pregnancies are more likely to be extrauterine/ectopic (where the embryo grows outside of the womb).

Thrombosis and the Pill

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

Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis (DVT)). If a blood clot breaks away from the veins where it has formed, it may reach and block the arteries of the lungs, causing pulmonary embolism (PE).

Blood clots are a rare occurrence and can develop whether or not you are taking an oral contraceptive. They can also happen during pregnancy. The risk of having blood clots is higher in OC users than in non users, but not as high as during pregnancy.

Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases.

If you notice possible signs of a thrombosis, stop taking Microlut and consult your doctor immediately.

Cancer and the Mini-pill

Breast cancer has been diagnosed slightly more often in women who use the Mini-pill than in women of the same age who do not use the Mini-pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after women stop taking the Mini-pill.

It is not known whether the difference is caused by the Mini-pill. It may be that these women were examined more often, so that the breast cancer was noticed earlier.

In rare cases benign liver tumours and, even more rarely, malignant liver tumours have been reported in users of the Mini-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 who have been using the Mini-pill for a long time. This finding may not be caused by the Mini-pill, but may be related to sexual behaviour and other factors.

AFTER TAKING MICROLUT

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car. Heat and damp can destroy some medicines.

Keep Microlut where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Microlut comes in a box containing 4 blister packs. Each blister pack contains 28 white active tablets.

The blister pack is marked with days of the week next to each tablet.

Ingredients

Active ingredients:

• Microlut - 30 microgram of levonorgestrel per tablet

Each tablet also contains:

• lactose
• maize starch
• magnesium stearate
• purified talc
• sucrose
• calcium carbonate
• macrogol 6000
• povidone
• glycol montanate

Supplier

Made in Germany for:
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Australian Registration Number

Microlut - AUST R 10696

Date of Preparation

March 2010

See TGA website (www.tga.gov.au) for latest Australian Consumer Medicine Information.

® Registered Trademark of Bayer AG, Germany
© Bayer Australia Ltd
All rights reserved.

Published by MIMS/myDr June 2010

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