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Microval(R)

Levonorgestrel Tablets
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Microval. 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 Microval against the benefits this medicine is expected to have for you.

If you have any questions about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.

You may need to read it again.

Buy prescription medication online from E-medical.

What Microval is used for

Microval is an oral contraceptive and is used to prevent pregnancy, particularly in women who cannot take contraceptives containing the hormone oestrogen. Oral contraceptives are commonly known as `the Pill`. The active ingredient in Microval tablets is the progestogen levonorgestrel, which can stop you from becoming pregnant if taken correctly. It is similar to a hormone your body normally produces.

Microval can prevent pregnancy in several different ways including:

• It changes the cervical mucus consistency making it difficult for the sperm to reach the egg
• It changes the lining of the uterus making it less suitable for implantation of a fertilised egg
• It prevents the release of the egg from the ovary in about half of the cycles.
• Your doctor may have prescribed Microval for another reason. Ask your doctor if you have any questions about why Microval has been prescribed for you.
• Microval is not habit forming.
• This medicine is available only with a doctor`s prescription.

Before you take Microval

When you must not take Microval

You must not take Microval if:

• 1.You are allergic to any of the ingredients found in Microval.
• The ingredients found in Microval are listed at the end of this leaflet.
• Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
• 2.You have any of the following medical conditions:
• Blood clots in the legs (thrombophlebitis or deep vein thrombosis), lungs (pulmonary embolism) or eyes.
• Breast cancer or think you have breast cancer or you have previously had breast cancer.
• Bleeding between your periods, which has not been diagnosed by a doctor.
• A liver tumour

If you are not sure whether any of these apply to you, or you are worried by anything in this list, tell your doctor.

• 3.You are pregnant or think you might be pregnant.

There are no benefits in taking Microval during pregnancy.

• 4.The packaging is torn or shows signs of tampering.

If this is the case, take the tablets back to your pharmacist

• 5.The expiry date (EXP) printed on the pack has passed.

Microval may have no effect at all, or worse, an entirely unexpected effect, if you take it after the expiry date.

• 6.Microval is not for use in girls who have not yet started to have menstrual periods.

If you are not sure whether you should start using Microval, contact your doctor.

Before you start to take Microval

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test before starting Microval.
Tell your doctor if:

• 1.You have any allergies to any other medicines or other substances, such as foods, preservatives or dyes.
• 2.You smoke

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

• 3.You or anyone in your family has had blood clots in the deep veins of the legs, a stroke or heart attack or you have any of the following conditions:
• Obesity
• Recent surgery or trauma
• Recently had a baby
• Lost a baby in the second trimester
• Confined to bed rest for long periods.

The risks of having blood clots in the deep veins of your legs, which can break away and block a blood vessel elsewhere in your body, are increased if you have any of these conditions and use an oral contraceptive tablet containing both oestrogen and progestogen. There is not enough information available to determine whether the use of progestogen-only oral contraceptives such as Microval is associated with the development of blood clots, blockage of blood vessels, heart attack and stroke. However, there have been reports of some of these conditions with the use of progestogen-only contraceptives.

• 4.You have any other health problems, especially:
• Breast lumps, abnormal breast X-ray or mammogram
• Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous use of oral contraceptives.

Taking oral contraceptives may be associated with

• Liver disease
• High blood pressure
• Migraine or other headaches
• Diabetes
• Epilepsy
• Gallbladder disease
• Heart conditions
• Fluid retention
• Kidney disease
• Asthma
• Depression.

Your doctor will need to check that Microval is not likely to make these illnesses worse.

• 5.You plan to become pregnant or think you are pregnant.
• Like most medicines, Microval is not recommended for use during pregnancy.
• 6.You are breastfeeding or plan to breastfeed.

Tell your Early Childhood Nurse that you are taking Microval.

• Microval is suitable for use in breastfeeding women. Microval does not appear to interfere with the quality or amount of your breast milk. Small amounts of Microval are found in breast milk but do not appear to affect the health of your nursing baby.

If you have not told your doctor about any of the above, tell them before you start taking Microval.

Taking other medicines

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

• Some medicines may stop Microval from working properly. These include medicines such as:
• Rifampicin for the treatment of tuberculosis
• Medicines for epilepsy (such as phenytoin, carbamazepine, primidone and barbiturates)
• St. John`s wort, an ingredient in many medicines that you can buy without a prescription from a pharmacy, health food shop or supermarket
• Some medicines for HIV/AIDS.

While you are taking any of these medicines and for the next 7 days after stopping them, you must also use a non-hormonal back up method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods).

If you are taking rifampicin and some other medicines, you may need to use additional non-hormonal contraception for 4 weeks after finishing the course of treatment.

Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.

There have been occasional reports of contraceptive failure in women taking antibiotics at the same time as a progestogen-only oral contraceptive.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Microval.
If you are scheduled for any laboratory tests, tell your doctor you are taking Microval.

Some blood tests may be affected by taking Microval.

How to take Microval

Follow the directions on the blister pack.

Each blister pack of Microval contains 28 white tablets. On the pack each tablet is marked with the day of the week on which it is to be taken.

If your doctor has prescribed Microval for some other purpose than contraception, follow their directions closely, even if they are not the same as on the pack.

When to take Microval

You must take Microval every day, even if you do not have sex very often.

Microval must be taken at the same time every day, so choose a time that suits you and then take Microval at that time every day. Every time you take a tablet late, and especially if you miss a tablet, you are more likely to get pregnant.

If you are concerned about this, please speak to your doctor or pharmacist.

It does not matter if you take Microval before or after food.

How to take Microval

Swallow Microval with a glass of water.

Starting Microval for the first time

To start taking Microval follow these steps:

• 1.It is best to wait for your next period to start. On the first day of menstrual bleeding, take a tablet from the grey shaded section of the blister pack that has the day of the week on which you are taking the tablet written above it.

If you decide to start Microval on another day, you must use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

• 2.Then take one tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 28 tablets have gone. Continue taking the tablets even when you are menstruating.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.
If you do not understand the instructions on the blister pack, ask your doctor or pharmacist for help.
Going on to further packs:

• 1.Start the next pack on the day after you take the last tablet in your current pack. There is no break between packs. Start with the tablet from the grey shaded section that has the day of the week on which you are taking the tablet written above it. Each course of Microval is thus begun on the same day of the week as the first course.

If you start late, you must use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

If you start your new pack late, you may have started a normal fertile cycle.

You may have some bleeding between periods. Do not stop taking your tablets if this happens.

This is usually temporary and without significance. However if bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor.

Changing from a combined oral contraceptive

Follow these steps if your current oral contraceptive contains both an oestrogen and a progestogen.

• 1.Stop taking your current oral contraceptive after you have taken the last active tablet. If your current oral contraceptive pack also contains reminder tablets, do not take them.
• 2.The next day take a Microval tablet from the grey shaded section with the day of the week on which you are taking it written above it.

If you are not sure which tablet this is, ask your doctor or pharmacist.

• 3.Take one Microval tablet each day following the direction of the arrows until the pack is finished.

If you do not bleed and there is any chance that you have not followed all the instructions in this leaflet, see your doctor to check if you are pregnant.

Changing from a progestogen only contraceptive

If you are taking a progestogen-only tablet, you can switch to Microval any day.

Start taking Microval the day after stopping the progestogen-only tablet.
If you have been using a progestogen implant, start taking Microval on the day the implant is removed.
If you have been using a progestogen injection, start taking Microval on the day the next injection would be due.

In all cases start Microval by taking a tablet from the grey shaded section that matches the day of the week that it is.

You must use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

After having a baby

If you have just had a baby, talk to your doctor before you start taking MICROVAL.

If you are not breast-feeding, tablet taking may start immediately.

Start with a tablet from the grey shaded section that matches the day of the week on which you are taking it. You must also use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

If you are breastfeeding

If you are breastfeeding and want to take Microval, talk to your doctor first. In women who are fully breast-feeding (not giving your baby any food or formula), tablet taking may start six weeks after delivery. If you are partially breastfeeding (giving your baby some food or formula), your doctor will advise you when to start taking Microval.

Start with a tablet from the grey shaded section that matches the day of the week on which you are taking it. You must also use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

After a miscarriage or abortion

If you have had a miscarriage or abortion, you can start Microval the next day.

Start with a tablet from the grey shaded section that matches the day of the week on which you are taking it. You must also use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.

How long to take Microval

Your doctor may prescribe Microval for long periods, until you no longer need or want contraception. If you want to stop taking Microval, you can do so at any time, but if you remain sexually active and don`t wish to become pregnant, you must use another birth control method.

If you are not sure how long you should be taking Microval, ask your doctor.

If you forget to take your tablets

If you forget to take Microval every day, it may not work as well in protecting you from becoming pregnant. The more tablets in a row you miss, the higher the risk of getting pregnant. The effectiveness of Microval in preventing pregnancy may be reduced if you are more than 3 hours late taking a tablet.

If you forget one or two tablets

• If one tablet is missed but is less than 3 hours late, you are still protected from pregnancy.

Take the missed tablet immediately and the next tablet at your usual time.

• If one tablet is missed and is more than 3 hours late, or if two tablets are missed you may not be protected from pregnancy.

Take the last missed tablet as soon as you remember and the next tablet at the usual time.

• This may mean taking two tablets in one day.

You must also use a non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex during the next 7 days.
If you forget three or more tablets
If you forget to take three or more tablets, do not take them.

• The possibility of pregnancy should be ruled out before you start taking Microval again.

You must use a non-hormonal method of contraception such as condoms or a diaphragm, but not the rhythm or temperature methods) every time you have sex until it is confirmed that you are not pregnant and for the next 7 days after resuming Microval.
If you are not sure what to do, ask your doctor or pharmacist.

• If you have trouble remembering to take Microval, ask your pharmacist for some hints.

If you vomit after taking Microval

If you have vomiting within 3 to 4 hours after taking Microval, follow the advice for missed tablets under the section “If you forget to take your tablets”. Take the missed tablet(s) from another pack.

• The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.

If you take too much (overdose)

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

You may need urgent medical attention. If you take too much Microval, some of the symptoms you may have include:

• feeling sick or vomiting,
• dizziness
• feeling sleepy or tired.

Women may also experience menstrual bleeding.

While you are taking Microval

Things you must do

Tell all other doctors, dentists, and pharmacists who are treating you that you are using Microval.
If you become pregnant while taking Microval, tell your doctor immediately.

Stop taking Microval if pregnancy is confirmed.

You should get a pregnancy test:

• If your period is late and you took one or more tablets late or missed taking them and had sex without a non-hormonal back-up method of contraception
• Any time you miss 2 periods in a row and have other signs that you might be pregnant such as morning sickness or breast changes.

If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally.

Sometimes you might not have a menstrual period while taking Microval.

If you miss a period and you have not taken your tablets correctly see your doctor for a pregnancy test as soon as possible. Keep taking your tablets until it is confirmed if you are pregnant or not.

Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.

Have regular check ups from your doctor, including a Pap smear.

Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer. Cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.

Perform regular breast self-examination.

Breast cancer has been found slightly more often in women who use an oral contraceptive containing both an oestrogen and progestogen than in women of the same age who do not use an oral contraceptive. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you.

Microval will not protect you from HIV-AIDS or any other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

Tell your doctor you are using Microval at least 4 weeks before any planned hospitalisation or surgery.

Your doctor may tell you to stop taking Microval several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Microval after you are back on your feet.

To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.

Things you must not do

Do not give Microval to anyone else even if they have the same condition as you.
Do not use Microval to treat any other complaints unless your doctor tells you to.
Do not stop taking Microval, or change the dosage, without checking with your doctor.

If you stop taking Microval or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Side effects

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

When used correctly, Microval is an effective contraceptive, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

The most common side effect of Microval is a change in menstrual bleeding. Your periods may be either early or late, shorter or longer and/or you may have some spotting between periods. Taking tablets late or missing tablets can also result in some spotting or bleeding.

Tell your doctor immediately if you notice any of the following:

• Severe pain or tenderness in the stomach.

This may be a sign that you have an ectopic pregnancy An ectopic pregnancy is a pregnancy outside the womb. Because Microval protects against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking Microval, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.

• Sharp or crushing chest pain, coughing of blood or sudden shortness of breath
• Weakness, numbness in an arm or leg
• A sharp pain or swelling in the calf muscle
• Breast lumps
• Sudden severe headache or vomiting, dizziness or fainting
• Migraine headaches for the first time
• More frequent migraines if you are a migraine sufferer
• Slurred speech or loss of speech
• Sudden changes or loss of sight
• Jaundice or yellowing of the skin or eyeballs, especially if it occurs with fever, tiredness, loss of appetite, dark coloured urine or light coloured bowel motions
• Itchy rash, throat tightness and a puffy face.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor if you notice any of the following and they worry you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reproductive or breast problems such as:

• Breast pain, tenderness, enlargement or milky discharge
• Changes in vaginal discharge or inflammation of the vagina
• Missed periods, but if you have not taken Microval as directed, check whether you are pregnant
• Painful periods
• Breakthrough bleeding or spotting or other menstrual irregularities.

Slight “spotting” of blood between your menstrual periods usually stops by itself within a few days.

If this bleeding keeps going or is heavy, see your doctor.

• Decreased sex drive.

Stomach problems such as:

• Nausea or vomiting
• Stomach pain, bloating or cramps.

Abdominal pain may be associated with ovarian cysts are small sacs of fluid in the ovary. They are more common among progestogen-only contraceptive users than among users of most other birth control methods.

Difficulties thinking or working because of:

• Mood disturbances, including depression
• Headache
• Nervousness
• Dizziness.

Changes in your appearance such as:

• Hair loss or excessive hair growth on the face and body
• Darkening areas of skin, especially on the face that may persist
• Acne
• Leg cramps or pain
• Tiredness
• Fluid retention
• Weight changes (increase or decrease) or changes in appetite.

Worsening of conditions you may already have such as:

• Porphyria

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After stopping Microval

If your periods do not return within 2 to 3 months of stopping Microval tell your doctor.

Some women have short-term problems getting pregnant after stopping Microval, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

After taking Microval

Storage

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they will not keep well.

Keep the tablets in a cool dry place where the temperature stays below 30 degrees C. Do not store Microval or any other medicine in the bathroom or near a sink. Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Microval or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Microval comes in a box containing 4 blister packs. Each blister pack contains 28 white tablets. The pack is marked with days of the week next to each tablet.

Ingredients

The active ingredient in Microval is levonorgestrel.

Each tablet contains 30 micrograms of levonorgestrel and the following inactive ingredients:

• Lactose
• Maize starch
• Povidone
• Talc
• Magnesium stearate
• Sucrose
• Macrogol 6000
• Calcium carbonate
• White wax
• Carnauba wax.

Microval does not contain gluten, tartrazine or any other azo dyes.

Supplier

• Microval is supplied by:
• Wyeth Australia Pty Ltd, ABN 16 000 296 211
• 17 – 19 Solent Circuit, Norwest Business Park, Baulkham Hills NSW 2153
• Telephone numbers: (02) 9761 8200 or (02) 8850 8200
• For further information please contact Wyeth Australia on toll-free 1800 500 498 or E-mail: medinfo@wyeth.com
• Australian Registration Number: AUST R 94249
• This leaflet was prepared on 8th March 2006
• (R) Registered Trade Mark

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