Microgynon 30


Description

 Microgynon 30 is a combined contraceptive pill, usually just called ‘the pill’. It contains two hormones – an oestrogen and a progestogen.

Most women take Microgynon to prevent an unwanted pregnancy, but it’s also prescribed for women who have problems with particularly heavy, painful or irregular periods. Taking it usually results in lighter, less painful and more regular menstrual bleeding.

Microgynon 30 is the same as other combined pills containing ethinylestradiol 30 micrograms and levonorgestrel 150 micrograms. These include Levest, Ovranette and Rigevidon.

How does Microgynon 30 work?

Each Microgynon 30 tablet contains two active ingredients, ethinylestradiol 30 micrograms and levonorgestrel 150 micrograms. These are synthetic versions of the naturally occurring female sex hormones, oestrogen and progesterone.

Combined pills like Microgynon over-ride your natural menstrual cycle and work mainly by stopping your ovaries from releasing an egg each month (ovulation). They also increase the thickness of the natural mucus at the neck of the womb, making it more difficult for sperm to cross from the vagina into the womb, as well as thinning the womb lining (endometrium), making it more difficult for any successfully fertilised eggs to implant there. You take one pill every day for three weeks, then have a week break before starting the next packet. During your pill-free week the levels of hormones in your blood fall and you’ll usually get a withdrawal bleed that’s like your period.

Key facts about Microgynon 30

  • Microgynon 30 is most often prescribed for young women who don’t have any major health issues. It’s not suitable for women who have an increased risk of getting a blood clot, including women over 35 who smoke.
  • Microgynon is more than 99% effective when taken correctly, but missing pills, vomiting, diarrhoea and taking certain other medicines can make it less effective. See below.
  • Microgynon 30 won’t protect you against sexually transmitted infections; you’ll still need to use condoms for that.
  • The most common side effects of Microgynon include headaches, feeling sick, breast tenderness and mood changes.
  • Breakthrough bleeding, spotting and missed periods can be common in the first few months. See your doctor if this persists. If you don’t have a period for two consecutive months, do a pregnancy test before starting the next month’s packet of pills.
  • Blood clots are a rare but serious side effect of the pill. See below for more details.

BEFORE YOU TAKE MICROGYNON 30 ED

When you must not take it

Do not take Microgynon 30 ED if you have an allergy to:

  • ethinylestradiol and/or levonorgestrel (the active ingredients in Microgynon 30 ED)
  • 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 Microgynon 30 ED if you have or have had a blood clot in:

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

Do not take Microgynon 30 ED if you have or are concerned about an increased risk of blood clots. Blood clots are rare. Very occasionally blood clots may cause serious permanent disability, and may even be fatal.

You are more at risk of having a blood clot when you take the Pill. However, the risk of having a blood clot when taking the Pill is less than the risk of having a blood clot during pregnancy.

Do not take Microgynon 30 ED 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 taking the Pill, especially if you are older than 35 years of age.

Do not take Microgynon 30 ED if you are taking any antiviral medicines which contain ombitasvir, paritaprevir and/or dasabuvir. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus (HCV)).

Do not take Microgynon 30 ED if you have, or have had:

  • any blood clotting disorders such as Protein C deficiency, Protein S deficiency, Leiden Factor V mutation, Antithrombin III deficiency or other inherited blood clotting conditions
  • a confirmed blood test showing:
    – increased levels of homocysteine
    – antiphospholipid antibodies (APLAs) e.g. anticardiolipin-antibodies and lupus anticoagulant. These may increase your risk for blood clots or pregnancy losses (miscarriage)
  • major surgery after which you have not been able to move around for a period of time
  • angina (chest pain)
  • a mini-stroke (also known as TIA or transient ischaemic attack)
  • migraine, where you have also had problems with seeing, speaking or had or weakness or numbness in any part of your body
  • high risk of blood clots due to conditions such as diabetes with blood vessel damage, severe high blood pressure or severe high or low level of fats in your blood
  • pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood
  • severe liver disease and your liver function has not returned to normal
  • cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
  • a benign or malignant liver tumour
  • unexplained vaginal bleeding.

If any of these conditions appear for the first time while using the Pill, stop taking it at once and tell your doctor. In the meantime, use non-hormonal (barrier) methods of contraception (such as condoms or a diaphragm).

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

Do not give this medicine to a child. Microgynon 30 ED is not intended for use in females whose periods have not yet started.

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 18 refers to November 2018). 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 this medicine, talk to your doctor.

HOW TO TAKE MICROGYNON 30 ED

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 on the pack, ask your doctor or pharmacist for help.

How to take it

Take one tablet daily at about the same time every day. You must take Microgynon 30 ED every day regardless of how often you have sex. This will also help you remember when to take it.

Swallow the tablet whole with a full glass of water. It does not matter if you take it before or after food.

Each blister pack is marked with the day of the week. Take your first tablet from the red area on 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.

A period should begin 2 to 3 days after starting to take the white inactive tablets (last row) and may not have finished before the next pack is started.

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

Taking Microgynon 30 ED for the first time

If you are starting Microgynon 30 ED 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. the first day of menstrual bleeding. You must also use additional barrier contraceptive precautions (e.g. condoms or a cap or diaphragm with spermicide) for the first 14 days of tablet-taking when having intercourse.

Your doctor will advise you when to start if you:

  • are taking Microgynon 30 ED after having a baby
  • have had a miscarriage or an abortion.

Changing from another contraceptive

Changing from a combined oral contraceptive:
Start taking Microgynon 30 ED on the day after taking the last active tablet in your previous Pill pack. Bleeding may not occur until the end of the first pack of Microgynon 30 ED.

If you are not sure which were the active/inactive tablets in your previous Pill pack, ask your doctor or pharmacist. Your previous Pill pack may have different colour tablets to those of Microgynon 30 ED.

Changing from a vaginal ring:
Start taking Microgynon 30 ED on the day of removal of the ring but at the latest when the next application would have been due.

Changing from a progestogen-only pill (‘minipill’):
Stop taking the minipill on any day and start taking Microgynon 30 ED at the same time the day after your last minipill.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 14 days of tablet-taking when having intercourse.

Changing from a progestogen-only injection, implant or intrauterine system (IUS):
Start taking Microgynon 30 ED when your next injection is due, or on the day that your implant or IUS is removed.

You must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm) for the first 14 days of tablet-taking when having intercourse.

Stopping Microgynon 30 ED

You can stop taking Microgynon 30 ED at any time. If you are considering becoming pregnant, it is recommended that you begin taking a vitamin supplement containing folic acid. It is best that you start taking folic acid tablets before you stop taking Microgynon 30 ED and not stop until your doctor advises this. Ask your doctor or pharmacist about suitable supplements. It is both safe and recommended that you take folic acid during pregnancy.

Additional contraceptive precautions

When additional contraceptive precautions are required you should either abstain from sex, or use a barrier method of contraception, a cap (or diaphragm) plus spermicide, or a condom. Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle e.g. changes in temperature and cervical mucus.

If you forget to take Microgynon 30 ED

If you miss a tablet and take the missed tablet within 12 hours of missing it, you should still be protected against pregnancy.

If you are more than 12 hours late follow these detailed instructions:

For Microgynon 30 ED to be most effective, beige active tablets need to be taken uninterrupted for 7 days.

If you have been taking the beige active tablets for 7 uninterrupted days and miss a beige active tablet, take the missed tablet as soon as you remember, then go back to taking your Pill as you would normally, even if this means taking two tablets in one day, at the same time. You should still be protected against pregnancy.

The chance of pregnancy after missing a beige active tablet depends on when you missed the tablet.

There is a higher risk of becoming pregnant if you miss a tablet at the beginning or end of a pack.

If after taking your missed tablet you have less than 7 days of beige active tablets left in a row, you should finish the active tablets in your pack but skip the white inactive tablets. Start taking the beige active tablets in your next pack corresponding to the correct day of the week. This is the best way to maintain contraceptive protection. However, you may not have a period until the end of the beige active tablets of the second pack. You may have spotting or breakthrough bleeding on tablet-taking days.

If you have been taking the beige active tablets for less than 7 days and miss a beige active tablet, take the missed tablet as soon as you remember, then go back to taking your Pill as you would normally, even if this means taking two tablets in one day, at the same time. In addition, you must 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 preceding 7 days, there is a possibility of pregnancy and you may need emergency contraception. You should discuss this with your doctor or pharmacist.

If you forget to take more than one beige active tablet, seek advice from your doctor or pharmacist about what to do.

If you have had sexual intercourse in the week before missing your tablets, there is a possibility of becoming pregnant.

If you miss a large white inactive tablet, you do not need to take them later because they do not contain any active ingredients. However, it is important that you discard the missed white tablet(s) to make sure that the number of days between taking active tablets is not increased as this would increase the risk of pregnancy. Continue with the next tablet at the usual time

Please see the table at the end of this leaflet, “Summary of advice if you missed a tablet more than 12 hours ago”.

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

WHILE YOU ARE TAKING MICROGYNON 30 ED

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 the Pill, your doctor will tell you to return for regular check-ups, including getting a Cervical Screening Test. Your doctor will advise how often you need a Cervical Screening Test. A Cervical Screening 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 Microgynon 30 ED.

Stop taking Microgynon 30 ED and see your doctor immediately if you notice the following signs:

  • one-sided swelling of the leg and/or foot or along a vein in the leg
  • pain or tenderness in the leg which may be felt only when standing or walking
  • increased warmth in the affected leg; red or discoloured skin on the leg
  • sudden onset of unexplained shortness of breath or rapid breathing
  • sudden coughing or coughing up of blood
  • sharp chest pain or sudden severe pain in the chest which may increase with deep breathing
  • severe light headedness or dizziness
  • rapid or irregular heartbeat
  • sudden pain, swelling and slight blue discoloration of an extremity
  • sudden numbness or weakness of the face, arm or leg, especially on one side of the body
  • sudden trouble walking, dizziness, loss of balance or coordination
  • sudden confusion, slurred speech or aphasia; sudden partial or complete loss of vision, double vision, painless blurring of vision which can progress to loss of vision
  • sudden, severe or prolonged headache with no known cause
  • loss of consciousness or fainting with or without seizure
  • pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest arm, or below the breastbone
  • discomfort radiating to the back, jaw, throat, arm, stomach
  • feeling of being full, having indigestion or choking
  • sweating, nausea, vomiting
  • extreme weakness and anxiety.

If you are going to have surgery, tell the surgeon or anaesthetist beforehand that you are taking Microgynon 30 ED. The risk of having blood clots is temporarily increased as a result of major surgery, any surgery to the legs or pelvis, neurosurgery or major trauma. In women who take Microgynon 30 ED, the risk may be higher.

In women at risk of prolonged immobilisation (including major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma), your doctor may tell you to stop taking (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. Another method of contraception should be used to avoid unintentional pregnancy. Your doctor may prescribe other treatment (e.g. treatment for blood clots) if Microgynon 30 ED has not been discontinued in advance.

Other risk factors for blood clotting include temporary immobilisation including air travel of greater than 4 hours, particularly in women with other risk factors. Consult your doctor if you plan to air travel for greater than 4 hours..

Consult your doctor if you develop high blood pressure while taking Microgynon 30 ED – 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 to 4 hours, or have severe diarrhoea after taking a beige active 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 your doctor. When taking this Pill for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary products, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill, usually after about 3 months.

If you have missed a period, but you have taken all your tablets, it is unlikely that you are pregnant, as long as:

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

If this is so, continue to take Microgynon 30 ED 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, even if you have taken the Pill correctly. Stop taking Microgynon 30 ED and seek advice from your doctor. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) until your doctor rules out pregnancy.

Microgynon 30 ED will not protect you from HIV-AIDS or any other sexually transmitted infections (STIs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papillomavirus and syphilis.

To protect yourself from STIs, you will need to use additional barrier contraceptives (e.g. condoms).

Things you must not do

Do not take Microgynon 30 ED to treat any other conditions, unless your doctor tells you to.

Do not give your medicine to anyone else.

Do not stop taking your medicine 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 Microgynon 30 ED, 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 Microgynon 30 ED. This Pill helps most women, but it may have unwanted side effects in some women.

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.

The following list includes the more common side effects of your Pill. 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:

  • acne
  • nausea
  • stomach pain
  • changes in weight
  • headache, including migraines
  • mood changes, including depression
  • breast tenderness or pain
  • hair loss or hair growth.

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 Accident and Emergency Department at your nearest hospital:

  • pain in the chest, arm or below the breastbone
  • pain or discomfort that goes to your back
  • breathlessness and/or difficulty breathing
  • swelling, pain or tenderness of one leg
  • sudden weakness, numbness or bad ‘pins and needles’ of the face, arm or leg, especially on one side of the body
  • sudden trouble walking, dizziness, loss of balance or coordination
  • severe, sudden stomach pains
  • a fainting attack or you collapse
  • unusual headaches or migraines that are worse than usual
  • sudden problems with speaking, seeing or understanding what people are saying to you
    The side effects listed above are possible signs of a blood clot (thrombosis).
  • jaundice (yellowing skin or yellowing eyes)
  • you cough up blood
  • breast lumps
  • unexplained vaginal bleeding.

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

Blood clots and the Pill

Blood clots may block blood vessels in your body. This type of blood clot is also called thrombosis.

Blood clots sometimes occur in the deep veins of the legs. If a blood clot breaks away from the veins where it has formed, it may reach and block the blood vessels of the lungs, causing pulmonary embolism.

Blood clots can also occur in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).

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

The risk of a blood clot is highest during the first year of taking the Pill for the first time, or after having a break from the Pill for 4 weeks or more.

If you notice possible signs of a blood clot, stop taking Microgynon 30 ED and consult your doctor immediately. To prevent pregnancy, you must also use additional barrier contraceptive precautions (e.g. condoms or a diaphragm).

If you are concerned about an increased risk of blood clots while on Microgynon 30 ED, speak to your doctor.

Cancer and the Pill

Breast cancer has been diagnosed slightly more often in women who take the Pill than in women of the same age who do not take the 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 Pill.

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

It is important that you check your breasts regularly and contact your doctor if you feel any lumps.

In rare cases benign liver tumours 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 who have been taking 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.

AFTER TAKING MICROGYNON 30 ED

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 your tablets or any other medicine in the bathroom, near a sink, or on a window-sill. Do not leave medication in the car. Heat and damp can destroy some medicines.

Keep Microgynon 30 ED 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 our pharmacist.

PRODUCT DESCRIPTION

What Microgynon 30 ED looks like

Microgynon 30 ED active tablets are beige and round.

Microgynon 30 ED inactive tablets are white and round.

Microgynon 30 ED comes in a box containing 1,2, 3 or 4 blister packs. Not all pack sizes may be marketed.

Each blister pack contains 21 beige active tablets and 7 white inactive tablets.

Ingredients

Each Microgynon 30 ED beige active tablet contains:

Active ingredients:

  • 30 microgram of ethinylestradiol
  • 150 microgram of levonorgestrel

Inactive ingredients:

  • calcium carbonate
  • glycerol
  • glycol montanate
  • iron oxide yellow
  • lactose monohydrate
  • macrogol 6000
  • magnesium stearate
  • maize starch
  • povidone
  • purified talc
  • sucrose
  • titanium dioxide

Each white inactive tablet contains:

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

Tablets do not contain gluten. Tablets also do not contain tartrazine or any other azo dyes.

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