Consumer Medicine Information
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.
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:
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.
Do not take Microlut if you have an allergy to:
Some of the symptoms of an allergic reaction may include:
Do not take Microlut if you have or have had a blood clot in:
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:
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.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if:
Ask your doctor to check if you have:
If any of the above conditions appear for the first time, or recur or worsen while using Microlut, you should contact your doctor.
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:
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.
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.
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.
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:
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.
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.
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:
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:
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).
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.
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:
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:
The side effects listed above are possible signs of a thrombosis.
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.
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.
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.
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.
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.
Each tablet also contains:
Made in Germany for:
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
Microlut - AUST R 10696
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.
|Summary of advice when late taking or missing a Mini-pill|
|If it has been more than 27 hours since your last tablet was taken or you have missed a tablet, then:||Take the tablet you missed even if this means taking two at the same time. Use barrier contraception for the next 7 days.Continue taking tablets at usual time.||If you had sex in the 7 days prior to taking your tablet late or missing a tablet, the risk of pregnancy is increased.Contact your doctor or pharmacist for advice|
Published by MIMS June 2010