Microgynon 20 Ed Consumer Medicine Information

Levonorgestrel 100mcg and Ethinylestradiol 20mcg tablets

What is in this leaflet

Please read this leaflet carefully before you start using MICROGYNON 20 ED. It will advise you about how to take MICROGYNON 20 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 MICROGYNON 20 ED used for and how does it work

MICROGYNON 20 ED is a combined oral contraceptive (often called "the Pill"). Each small 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, MICROGYNON 20 ED is considered a low-dose combined oral contraceptive preparation. MICROGYNON 20 ED also contains 7 large white non-hormonal tablets that do not contain any active ingredients.

How does MICROGYNON 20 ED work?

Combined oral contraceptive Pills, such as MICROGYNON 20 ED, provide one of the most effective reversible methods of contraception known. Usually, when MICROGYNON 20 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 MICROGYNON 20 ED used for?

MICROGYNON 20 ED is used to prevent pregnancy. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low.

Before you use MICROGYNON 20 ED

Do not use MICROGYNON 20 ED if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use MICROGYNON 20 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 MICROGYNON 20 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
  • you have or have ever had a stoke
  • 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 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 have or have had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
  • you or someone in your immediate family have or have had high blood levels of cholesterol or triglycerides (fatty substances)
  • you have jaundice (yellowing of the skin) or severe liver disease
  • 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 tumour
  • you have any unexplained vaginal bleeding
  • you are pregnant or think you might be pregnant
  • you are allergic to any of the ingredients of MICROGYNON 20 ED

If any of these conditions appear for the first time while using MICROGYNON 20 ED, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

Tell your doctor if:

If MICROGYNON 20 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. 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
  • 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
  • you or anyone in your immediate family has or has had high blood levels of cholesterol or triglycerides (fatty substances)
  • 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 haemolytic uraemic syndrome (HUS; a disorder of blood coagulation 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

What else you should know

MICROGYNON 20 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 MICROGYNON 20 ED, or where the reliability of MICROGYNON 20 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 MICROGYNON 20 ED alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

MICROGYNON 20 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. It 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 MICROGYNON 20 ED you should stop smoking, especially if you are older than about 35 years of age.

If you develop high blood pressure while using MICROGYNON 20 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 immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill (such as MICROGYNON 20 ED) the risk may be even higher. Tell your doctor you are using MICROGYNON 20 ED well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking MICROGYNON 20 ED several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking MICROGYNON 20 ED again after you are back on your feet.

MICROGYNON 20 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 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.

MICROGYNON 20 ED and other medicines

Some oral medicines may stop MICROGYNON 20 ED from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. rifampicin, rifabutin) and HIV infections (e.g. ritonavir); antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases; and the herbal remedy St. John's wort (primarily used for the treatment of depressive moods). 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 MICROGYNON 20 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 MICROGYNON 20 ED. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

MICROGYNON 20 ED and breast-feeding

MICROGYNON 20 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.

MICROGYNON 20 ED and pregnancy

MICROGYNON 20 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 Microgynon 20 ED you should see your doctor as soon as possible.

MICROGYNON 20 ED and ability to drive

There are no observed effects.

How to use MICROGYNON 20 ED properly

When you follow the starting instructions and continue to take MICROGYNON 20 ED correctly, the contraceptive protection provided by MICROGYNON 20 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 MICROGYNON 20 ED has been prescribed for you personally. Do not share it with others.

When and how to take the tablets

The MICROGYNON 20 ED pack contains 21 small round pink 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 the 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. 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 MICROGYNON 20 ED

When no hormonal contraceptive has been used in the past month

Start taking MICROGYNON 20 ED on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. Take your first tablet from the green section. 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. MICROGYNON 20 ED will work immediately, it is not necessary to use an additional contraceptive method.

If you start on days 2-3 of your cycle, make sure that you use an additional contraceptive method (such as condoms) for the first 7 days of tablet-taking in the first cycle.

When you start taking MICROGYNON 20 ED your very first cycle may be shorter than usual.

When changing from a combined Pill

You can start taking MICROGYNON 20 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 MICROGYNON 20 ED on the day after taking the last hormonal tablet (if you are not sure which this is, ask your doctor or pharmacist).

When changing from a progestogen-only Pill (minipill)

You can stop taking the minipill any day and start taking MICROGYNON 20 ED the next day, at the same time. Take your first tablet from the green section marked with that day of the week. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

When changing from an injectable or implant

Start using MICROGYNON 20 ED when your next injection is due or on the day that your implant 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 contraceptive method (a barrier 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 MICROGYNON 20 ED. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take MICROGYNON 20 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 MICROGYNON 20 ED. In all situations where the reliability of MICROGYNON 20 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 MICROGYNON 20 ED from working properly and in the case of vomiting after taking MICROGYNON 20 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.

WHAT TO DO IF ..........

..... you forget tablets

  • If you have forgotten to take one or more of the large white non-hormonal tablets - there is no need to be concerned, simply take your next tablet, the next day as usual.
  • If you are less than 12 hours late in taking one of the small hormonal MICROGYNON 20 ED tablets, you are still protected against pregnancy. Take the tablet as soon as you remember and take the next one at your usual time. This may mean that you are taking 2 tablets in one day.
  • If you are more than 12 hours late in taking one of your small hormonal MICROGYNON 20 ED tablets you will not be protected. Take the last tablet as soon as you remember and take the next one at your normal time. This may mean taking 2 tablets in one day. You must take extra contraceptive precautions and you must follow the 7 day rule. Read the section on "Extra contraceptive precautions" and "The 7 day rule" carefully.
  • If you forgot tablets in the first week after taking the large non-hormonal tablets and had intercourse in the seven days before, consult your doctor as the possibility of pregnancy should be considered.
  • If you have forgotten to take your small hormonal MICROGYNON 20 ED tablets for a few days, consult your doctor to be sure you are not pregnant, then discard the missed tablets and follow the 7 day rule.

Extra contraceptive precautions

When you need extra contraceptive precautions, either:
  • don't have sex; or
  • use a cap plus spermicide; or
  • use a condom
Do not use the rhythm or temperature methods as extra contraceptive precautions. This is because oral contraceptives alter the usual menstrual cycle changes, such as changes in temperature and cervical mucus.

 

The 7 day rule

  • Continue taking your Pills
  • You will not be protected from pregnancy until you have taken your daily small hormone Pill for the next 7 days in a row
  • Use another method of contraception (Extra contraceptive precautions) such as condoms or do not have sexual intercourse for these next 7 days
  • If there are fewer than 7 small hormone pills left before the large white non-hormonal pills, go straight on to the small hormone pills in the green section of the pack. This means that you miss out the large white non-hormonal pills. You may not have a period until the end of the next pack. This is not harmful.

If you vomit or have severe diarrhoea after taking MICROGYNON 20 ED

If you vomit or have severe diarrhoea within 3 to 4 hours after taking your MICROGYNON 20 ED, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

If you are taking medicines that affect MICROGYNON 20 ED

Some oral medicines may stop MICROGYNON 20 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. If you make the duration of taking the large non-hormonal tablets very short (e.g. 3 days or less), you may not have a 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 MICROGYNON 20 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 MICROGYNON 20 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 or used other medicines, then you are very unlikely to be pregnant. Continue to take MICROGYNON 20 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 MICROGYNON 20 ED until your doctor has checked you are not pregnant.

Overdosage

There have been no reports of serious harmful effects from taking too many MICROGYNON 20 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 MICROGYNON 20 ED, ask your doctor for advice.

When using MICROGYNON 20 ED

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a blood clot while you are taking MICROGYNON 20 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
  • 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 forgot tablets in the first week after taking the large non-hormonal tablets and had intercourse in the seven days before
  • you have severe diarrhoea
  • you miss 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 MICROGYNON 20 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 effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by MICROGYNON 20 ED.

Serious side effects

Serious reactions associated with the use of combined oral contraceptives such as MICROGYNON 20 ED, as well as the related symptoms, are described in the section "Before you use MICROGYNON 20 ED". Please read this section carefully and consult your doctor where appropriate.

Other possible side effects

The following have been reported in users of combined oral contraceptives such as MICROGYNON 20 ED, although they may not be caused by the contraceptive Pill. Such undesirable effects that occur in the first few months that you are using MICROGYNON 20 ED will probably lessen with time.

  • breast tenderness, pain, enlargement and secretion
  • headache, migraine
  • changes in sexual drive; depressive moods, mood changes
  • contact lens intolerance
  • nausea, vomiting and feeling sick
  • changes in vaginal secretion
  • various skin reactions
  • fluid retention
  • 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

Like other combined oral contraceptive Pills, MICROGYNON 20 ED may also have non-contraceptive health benefits.

  • Your period may be lighter and shorter. As a result, the risk of anaemia 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 MICROGYNON 20 ED.

MICROGYNON 20 ED tablets contain:

active substances (per tablet)

levonorgestrel (0.10mg) and ethinylestradiol (0.02mg)

other substances

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

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

This leaflet was last revised March 30th 2003