MICROGYNON 30ED is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant. MICROGYNON 30ED prevents pregnancy in several ways:

• inhibiting the egg release by stopping it maturing;
• changing the cervical mucus consistency making it difficult for the sperm to reach the egg;
• changing the lining of the uterus making it less suitable for implantation.

When taken as directed MICROGYNON 30ED is very effective at preventing pregnancy. Oral contraceptives such as MICROGYNON 30ED may have the following theoretical benefits:

• a decrease in the amount of blood you lose each month during your period;
• a decrease in iron deficiency (called anaemia);
• a decrease in period pain;
• a decrease in pelvic inflammatory disease;
• a decrease in developing ovarian cysts;
• an improvement in acne;
• a reduced risk of tubal (ectopic) pregnancy;
• a reduced risk of benign breast disease (breast lumpiness);
• a reduced risk of getting cancer of the uterus (womb) lining and ovaries.

Before using Microgynon 30 ED

Before being prescribed MICROGYNON 30ED your doctor should perform a thorough medical and gynaecological examination (including the breasts). Your doctor will also note your family medical history.

The use of Oral Contraceptives such as MICROGYNON 30ED by cigarette smokers may increase the risk of cardiovascular disease. This risk increases with heavy smoking and advancing age and is quite marked in women over the age of 35 years. You should therefore stop smoking if you want to use an oral contraceptive such as MICROGYNON 30ED.

Do not use MICROGYNON 30ED if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use MICROGYNON 30ED. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.

• If you have, or have ever had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), or other parts of the body (see also the section later in this leaflet called "The Pill and thrombosis").
• If you have or have had a stroke (caused by a blood clot or a rupture of a blood vessel in the brain).
• If 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).
• If you have a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of your body.
• If you have diabetes mellitus with blood vessel damage.
• If you have or have had pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If 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).
• If you have or have had a benign or malignant liver tumor.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant.
• If you are hypersensitive (allergic) to ethinyloestradiol or levonorgestrel or any of the other ingredients of MICROGYNON 30ED.

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

Before you start using Microgynon 30 ED

If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use MICROGYNON 30 ED:

• 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 a thrombosis, a heart attack or a stroke;
• you suffer from migraine;
• you or someone 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 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 hemolytic uremic 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. pruritus related to cholestasis, gallstone formation, otosclerosis related 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.

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

Directions

The MICROGYNON 30ED pack contains 28 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 liquid if necessary. Follow the direction of the arrows on the pack until all 28 tablets have been taken. Usually a period will start on day 2-3 after the last active MICROGYNON 30ED tablet (i.e. while you are taking tablets from the last row of your pack). Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.

If you forget to take Microgynon 30 ED

If you forgot to take the white placebo tablets (row 4 of your blister), you are still protected against pregnancy because they do not contain any active ingredients. However, to make sure you do not change your pill taking rhythm, which is important for the contraceptive reliability of your Pill, you should proceed with your next tablet at the normal time and discard the forgotten inactive tablets to avoid any confusion. If you forgot the last tablet from row 4 of your current pack it is important that you still take the first tablet from the next pack at the correct time.

The following advice refers to missing active beige tablets

If you are less than 12 hours late in taking any tablet, contraceptive protection is not reduced. You should take the tablet as soon as you remember and take further tablets at the usual time.

If you are more than 12 hours late in taking any active tablet, contraceptive protection may be reduced. The more consecutive tablets you have missed the higher the risk that the contraceptive effect is decreased.

You should take the missed tablet as soon as you remember (even if it means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days.

There is an increased risk of becoming pregnant if you have missed active tablets at the beginning or end of the pack. If you have missed tablets at these times and have had sexual intercourse in the week before missing the tablet, there is a possibility of becoming pregnant. So tell your doctor immediately.

If you miss a period

If you have taken all of your tablets at the right time, and you have not vomited, nor had severe diarrhoea while taking pills, or used other medicines then you are very unlikely to be pregnant. Continue to take MICROGYNON 30ED 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 30ED until your doctor has checked you are not pregnant.

If you have unexpected bleeding

With all pills, 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 the tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

Advice in case of vomiting

If you vomit, or have severe diarrhoea after taking the active beige tablets , the active ingredients may not have been completely absorbed. If you vomit within 3 to 4 hours after taking your tablet, this is like missing a tablet. Therefore follow the advice for missed tablets. If you have severe diarrhoea, please contact your doctor. Vomiting or diarrhoea while taking placebo tablets (row 4) does not have an influence on the contraceptive reliability.

Side Effects

Serious side effects

Serious reactions associated with the use of the Pill, as well as the related symptoms, are described in the following sections: "The Pill and thrombosis/The Pill and cancer". Please read these sections for additional information and consult your doctor at once where appropriate.

Other possible side effects

The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.

• breast tenderness, pain and secretion;
• headache, migraine;
• changes in sexual drive; depressive mood/mood changes;
• contact lens intolerance;
• nausea, vomiting and other intestinal or stomach complaints;
• changes in vaginal secretion;
• various skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions

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

If you notice any side effects not mentioned in this leaflet, please inform your doctor.

Overdose

There have been no reports of serious harmful effects from taking too many MICROGYNON 30ED active 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 30ED, ask your doctor for advice.

Storage

MICROGYNON 30ED should be stored below 30°C (86°F). It should not be used after the expiry date printed on the blister platform and outer box.

   Inhouse Pharmacy (UK)