The memo-pack contains 21 pink tablets, diameter 5.7 mm, containing 100 ug levonorgestrel and 20 ug ethinyloestradiol and in addition, 7 white placebo tablets diameter 6.8 mm.

Actions

The contraceptive effect of Microgynon 20 ED is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. When Microgynon 20 ED is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilised, the cervical mucus remains thick so as to constitute a barrier to sperm, and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, combined oral contraceptives (COCs) have several positive properties, which, next to the negative properties (see Warnings and Precautions and Adverse Effects), can be useful in deciding on the method of birth control. With COCs the cycle is more regular and menstruation is often less painful and bleeding is lighter. The latter may result in a decrease in the occurrence of iron deficiency. Apart from this there is evidence of a reduced risk of endometrial cancer and ovarian cancer. Furthermore, the higher-dosed COCs containing 0.05 mg ethinyloestradiol have been shown to reduce the incidence of ovarian cysts, pelvic inflammatory disease, benign breast disease and ectopic pregnancy. Whether this also applies to lower-dosed COCs remains to be confirmed.

Pharmacokinetics

Levonorgestrel

Orally administered levonorgestrel is rapidly and completely absorbed. Peak serum concentrations of 2.3 ng/mL are reached 1.3 hours after single ingestion. Levonorgestrel is almost completely bioavailable after oral administration. Distribution Levonorgestrel is bound to serum albumin and sex hormone binding globulin (SHBG). Only around 1.1% of the total serum medicine concentrations are present as free steroid, approximately 65% are specifically bound to SHBG and about 34% non-specifically bound to albumin. The ethinyloestradiol-induced increase in SHBG influences the proportion of levonorgestrel bound to the serum proteins, causing an increase of the SHBG-bound fraction and a decrease of the albumin-bound fraction. The apparent volume of distribution of levonorgestrel is 129 L after single administration.

Levonorgestrel is completely metabolised by known pathways of steroid metabolism. The metabolic clearance rate from serum is approximately 1.0 mL/min/kg.

Levonorgestrel serum levels decrease in two phases. The terminal disposition phase is characterised by a half-life of approximately 25 hours. Levonorgestrel is not excreted in unchanged form. Its metabolites are excreted at a urinary to biliary ratio of about 1:1. The half-life of metabolite excretion is approximately 1 day.

Following daily ingestion, medicine serum levels increase about three-fold reaching steady-state conditions during the second half of the treatment cycle. Levonorgestrel pharmacokinetics are influenced by SHBG levels, which are increased

Ethinyloestradiol

Orally administered ethinyloestradiol is rapidly and completely absorbed. Peak serum concentrations of approximately 50 pg/mL are reached within 1 - 2 hours. During absorption and first-pass liver passage, ethinyloestradiol is metabolised extensively, resulting in a mean oral bioavailability of approximately 45% with a large interindividual variation of approximately 20 - 65%.

Ethinyloestradiol is highly but non-specifically bound to serum albumin (approximately 98%), and induces an increase in the serum concentrations of SHBG. An apparent volume of distribution of approximately 2.8 - 8.6 L/kg was reported.

Ethinyloestradiol is subject to presystemic conjugation in both small bowel mucosa and the liver. Ethinyloestradiol is primarily metabolised by aromatic hydroxylation but a wide variety of hydroxylated and methylated metabolites are formed, and these are present as free metabolites and as conjugates with glucuronides and sulfate. The metabolic clearance rate was reported to be 2.3 - 7 mL/min/kg.

Ethinyloestradiol serum levels decrease in two disposition phases characterised by half-lives of about 1 hour and 10 - 20 hours, respectively. Ethinyloestradiol is not excreted unchanged. Ethinyloestradiol metabolites are excreted at a urinary to biliary ratio of 4:6. The half-life of metabolite excretion is approximately 1 day.

Ethinyloestradiol serum concentrations increase about two-fold after daily oral administration of Microgynon 20 ED. According to the variable half-life of the terminal disposition phase from serum and the daily ingestion, steady-state serum levels of ethinyloestradiol will be reached after approximately one week.

DOSAGE AND ADMINISTRATION

Combined oral contraceptives, such as Microgynon 20 ED, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

How to take Microgynon 20 ED

Tablets must be taken in the order directed on the package every day at about the same time with some water as needed. Tablet-taking is continuous following the directional arrows. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2 - 3 after starting the white placebo tablets and may not have finished before the next pack is started.

How to start Microgynon 20 ED

START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH THAT DAY OF THE WEEK, in accordance with one of the following:

No preceding hormonal contraceptive use (in the past month)

Tablet taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2 - 3 of the menstrual cycle is allowed, but during the first cycle an additional barrier contraceptive method is recommended for the first 7 days of tablet taking.

Changing from another combined oral contraceptive (COC), vaginal ring or transdermal patch

The woman should start with Microgynon 20 ED preferably on the day after her last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start taking Microgynon 20 ED preferably on the day of removal of the ring or patch, but at the latest when the next application would have been due.

Changing from a progestogen-only method (minipill, injection, implant) or progestogen-releasing intrauterine system (IUS)

The woman may switch any day from the minipill, or from an implant or IUS on the day of its removal, or from an injectable when the next injection would be due. In all of these cases, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking.

Following first-trimester abortion

The woman may start tablet-taking immediately. When doing so, she does not need additional contraceptive measures.

Following delivery or second-trimester abortion

The woman should be advised to start on day 21 to 28 after delivery or second-trimester abortion. When starting later than this, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking. However, if intercourse has

already occurred, pregnancy should be excluded before starting Microgynon 20 ED or the woman has to wait for her first menstrual period. For breast feeding women, see Use in Lactation.

Management of Missed Tablets

Errors in taking the white placebo tablets contained in Microgynon 20 ED can be ignored. However, they should be discarded to avoid unintentionally prolonging the placebo tablet phase. The following advice only refers to missed pink active tablets (rows 1-3 of the blister): If the woman is less than 12 hours late in taking any pink active tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take subsequent tablets at the usual time. If the woman is more than 12 hours late in taking any pink active tablet, contraceptive protection may be reduced. There is a particularly high risk of pregnancy if tablets are missed just before or immediately after taking the white placebo tablets. If tablets are missed in the first week of taking the pink active tablets following the white placebo tablets and intercourse took place in the preceding 7 days, the possibility of pregnancy should be considered. The management of missed tablets can be guided by the following two basic rules:

These rules form the basis of the instructions to patients provided in the package insert.

Extra Contraceptive Precautions

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

If the woman missed tablets and subsequently has no withdrawal bleed in the white placebo tablet phase, the possibility of a pregnancy should be considered.

Advice in Case of Gastrointestinal Disturbances

In case of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or severe diarrhoea occurs within 3 - 4 hours after taking a pink active tablet, the advice concerning missed tablets is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.

How to Shift Periods or How to Delay a Period

To delay a period the woman should continue with the pink active tablets from another pack of Microgynon 20 ED without taking the white placebo tablets from her current pack. The extension can be carried on for as long as desired until the end of the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of Microgynon 20 ED is then resumed after the usual 7 day placebo tablet phase. To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming placebo tablet phase by as many days as she likes. The shorter the hormone-free interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough-bleeding and spotting during the second pack (just as when delaying a period).

CONTRAINDICATIONS

Combined oral contraceptives should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during their use, the product should be stopped immediately.

WARNINGS AND PRECAUTIONS

The clinical and epidemiological evidence for COCs like Microgynon 20 ED is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of Microgynon 20 ED. If any of the conditions/risk factors mentioned below are present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start taking it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her doctor. The doctor should then decide whether the COC should be discontinued.

Circulatory Disorders

Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE) and of cerebrovascular accidents. These events occur rarely. Venous thromboembolism (VTE), manifesting as DVT and/or PE, may occur during the use of all COCs. The risk of VTE is highest during the first year a woman takes a COC. This increased risk is present after initially starting a COC or restarting (following a 4 week or greater pill free interval) the same or a different COC. Data from a large, prospective 3-arm cohort study suggest that this increased risk is mainly present during the first 3 months.

This study has shown that the frequency of VTE diagnosis ranges from 8 to 10 per 10,000 woman years in low oestrogen dose (< 50 ug ethinyloestradiol) COC users. The most recent data suggests that the frequency of VTE diagnosis is approximately 4.4 per 10,000 woman years in non-pregnant non-COC users and ranges from 20 to 30 per 10,000 pregnant women or post partum. Overall the risk of VTE in users of low oestrogen dose (< 50 ug ethinyloestradiol) COCs is two to threefold higher than for non-users of COCs who are not pregnant and remains lower than the risk associated with pregnancy and delivery. VTE may be life-threatening, or in 1-2% of cases may be fatal. Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in COC users. There is no consensus as to whether the occurrence of these events is associated with the use of COCs. Symptoms of venous (includes PE and DVT) or arterial thrombosis/thromboembolic (includes MI, vascular occlusion and cerebrovascular accident) events can include: unilateral leg pain and/or swelling; 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, severe pain in the chest which may increase with deep breathing; 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; rapid or irregular heartbeat; sudden onset of unexplained shortness of breath or rapid breathing; sudden onset of coughing which may bring up blood; sudden, severe, prolonged headache with no known cause; sudden, partial or complete loss of vision; diplopia; sense of anxiety; dizziness; sudden confusion; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; "acute" abdomen; fullness, indigestion or choking feeling; sweating; nausea; vomiting. Some of these symptoms (e.g. "shortness of breath", "coughing") are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections). Arterial thromboembolic events may be life-threatening or may have a fatal outcome. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increased risk may be greater than a simple cumulative risk of the factors. A COC should not be prescribed in case of a negative risk benefit assessment (see Contraindications). The risk of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident increases with: age smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age) a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age). If a hereditary predisposition is known or suspected, the woman should be referred to a specialist for advice before deciding about any COC use. obesity (body mass index over 30 kg/m2)

dyslipoproteinaemia hypertension migraine valvular heart disease atrial fibrillation prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. In these situations it is advisable to discontinue COC use (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilisation. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism. The increased risk of thromboembolism in the puerperium must be considered. Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC. Biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include Activated Protein C (APC) resistance, hyperhomocysteinaemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). When considering risk/benefit, the doctor should take into account that adequate treatment of a condition may reduce the associated risk of thrombosis and that the risk associated with pregnancy is higher than that associated with low-dose COCs (< 0.05 mg ethinyloestradiol).

Tumours

The most important risk factor for cervical cancer is persistent human papilloma virus (HPV) infection. Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e.g. cervical screening and sexual behaviour including use of barrier contraceptives. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently taking COCs. The excess risk gradually disappears during the course of the 10 years after cessation of COC use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs. In isolated cases, these tumours have led to life- threatening intra-abdominal haemorrhages. A liver tumour should be considered in the

differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra- abdominal haemorrhage occur in women taking COCs. Malignancies may be life-threatening or may have a fatal outcome.

Other Conditions

Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when taking COCs. Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare. However, if a sustained clinically significant hypertension develops during the use of a COC, then it is prudent for the doctor to withdraw the COC and treat the hypertension. Where considered appropriate, COC use may be resumed if normotensive values can be achieved with antihypertensive therapy. The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss. In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema. Acute or chronic disturbances of liver or kidney function may necessitate the discontinuation of COC use until markers of liver or kidney function return to normal. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs. Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics taking low-dose COCs (containing < 0.05 mg ethinyloestradiol). However, diabetic women should be carefully observed while taking COCs. Crohn's disease and ulcerative colitis have been associated with COC use. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs. Each pink active tablet contains 33 mg of lactose; each white placebo tablet contains 34 mg of lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose free diet should take this amount into consideration.

Medical Examination/Consultation

A complete medical history and physical examination should be taken prior to the initiation or reinstitution of Microgynon 20 ED, guided by the Contraindications and Warnings and Precautions sections. This should be repeated at least annually during the use of Microgynon 20 ED. Periodic medical assessment is also of importance because contraindications (e.g. a transient ischemic attack, etc.) or risk factors (e.g. a family history of venous or arterial thrombosis) may appear for the first time during the use of a COC. The frequency and nature of these assessments should be based on established practice guidelines and adapted to the individual woman but should generally include special

reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.

Sexually Transmitted Infections (STIs) including Human Immunodeficiency Virus (HIV) infections and Acquired Immune Deficiency Syndrome (AIDS)

Women should be advised that oral contraceptives like Micrognyon 20 ED do not protect against HIV infections (AIDS) and other sexually transmissible infections (STIs). The woman should be advised that additional barrier contraceptive measures are needed to prevent transmission of STIs.

Reduced Efficacy

The efficacy of Microgynon 20 ED may be reduced in the event of missed pink active tablets (see Dosage and Administration - Management of Missed Tablets), gastrointestinal disturbances (see Dosage and Administration - Advice in Case of Gastrointestinal Disturbances) or concomitant medication (see Interactions).

Reduced Cycle Control

With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about three cycles. If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy. These may include curettage. In some women withdrawal bleeding may not occur while taking the 7 white placebo tablets. If the COC has been taken according to the directions described in the Dosage and Administration section, it is unlikely that the woman is pregnant. However, if the COC has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before COC use is continued.

Use in Pregnancy (Category B31) Microgynon 20 ED is contraindicated during pregnancy (see Contraindications). If pregnancy occurs during treatment with Microgynon 20 ED, further intake must be stopped. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy.

Use in Lactation

Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk. Therefore the use of COCs should generally not be recommended until the nursing mother has completely weaned her child.

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

Use in Children

Use in the Elderly

Patients with Hepatic Impairment

Microgynon 20 ED is contraindicated in women with severe hepatic disease as long as liver values have not returned to normal (see CONTRAINDICATIONS).

Patients with Renal Impairment

Microgynon 20 ED has not been specifically studied in renally impaired patients. There is no data suggesting the need for a dosage adjustment in patients with renal impairment.

Effects on Ability to Drive and Use Machines

No studies on effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of COCs.

Preclinical Safety Data

Preclinical data reveal no special risks for humans based on conventional studies of repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. However, it should be borne in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumours.

ADVERSE EFFECTS

Serious undesirable effects of Microgynon 20 ED have been referred to in the Contraindications and Warnings and Precautions sections. In addition, the following undesirable effects have been reported in users of COCs such as Microgynon 20 ED, although the causal relationships have not been confirmed:

System Organ Class	Common (>= 1/100)	Uncommon (>= 1/1000 and < 1/100)	Rare (< 1/1000)
Eye Disorders			Contact lens intolerance
Gastrointestinal Disorders	Nausea, abdominal pain	Vomiting, diarrhoea
Immune System Disorders			Hypersensitivity
Investigations	Increased weight		Decreased weight
Metabolism and Nutrition Disorders		Fluid retention
Nervous System Disorders	Headache	Migraine

131029 Microgynon 20 ED DS 11

System Organ Class	Common (>= 1/100)	Uncommon (>= 1/1000 and < 1/100)	Rare (< 1/1000)
Psychiatric Disorders	Depressed mood, altered mood	Decreased libido	Increased libido
Reproductive System and Breast Disorders	Breast pain, breast tenderness	Breast hypertrophy	Vaginal discharge, breast discharge
Skin and Subcutaneous Tissue Disorders		Rash, urticaria	Erythema nodosum, erythema multiforme

In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema

INTERACTIONS

Effects of Other Medicines on Microgynon 20 ED

Interactions can occur with medicines that induce microsomal enzymes which can result in increased clearance of sex hormones and which may lead to breakthrough bleeding and/or oral contraceptive failure. Women on treatment with any of these medicines should temporarily use a barrier method in addition to the COC or choose another method of contraception. The barrier method should be used during the time of concomitant medicine administration and for 28 days after its discontinuation. If the period during which the barrier method is used runs beyond the end of the pink active tablets in the COC pack, the white placebo tablets should be omitted and the next COC pack be started.

Substances increasing the clearance of COCs (diminished efficacy of COCs by enzyme-induction), e.g.:

Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St John's Wort.

Substances with variable effects on the clearance of COCs, e.g.:

When co-administered with COCs, many human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of oestrogen or progestogen. These changes may be clinically relevant in some cases.

Antibiotics (interference with enterohepatic circulation)

Some clinical reports suggest that enterohepatic circulation of oestrogens may decrease when certain antibiotic agents are given, which may reduce ethinyloestradiol concentrations (e.g. penicillins and tetracyclines). Women prescribed antibiotics (except rifampicin and griseofulvin) should use a barrier method until 7 days after completing a course of antibiotics. If the period in which the barrier method is used runs beyond the end of the active tablets in the Microgynon 20 ED pack, the white placebo tablets should be omitted and the next Microgynon 20 ED pack should be started.

Influence of Microgynon 20 ED on other Medicines

Oral contraceptives such as Microgynon 20 ED may interfere with the metabolism of other medicines. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporin) or decrease (e.g. lamotrigine). The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory Tests

The use of preparations like Microgynon 20 ED may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of carrier proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

OVERDOSAGE

Symptoms

Symptoms that may occur in case of taking an overdose of pink active tablets are nausea, vomiting and, in young girls, slight vaginal bleeding.

Treatment

PHARMACEUTICAL PRECAUTIONS

Shelf life:

Special precautions for storage:

MEDICINE SCHEDULE

PACKAGE QUANTITIES

3 calendar-packs each containing 28 tablets. Microgynon 20 ED tablets are contained in blister packs consisting of transparent film made of polyvinyl chloride and metallic foils made of aluminium (mat side hot sealable).

FURTHER INFORMATION

List of Excipients

Lactose monohydrate, maize starch, pregelatinised maize starch, povidone, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, purified talc, glycerol, iron oxide yellow, iron oxide red, titanium dioxide, glycol montanate, purified water.

Instructions for Use/Handling

NAME AND ADDRESS

Bayer New Zealand Limited 3 Argus Place Hillcrest North Shore Auckland 0627 Free Phone: 0800 233 988

DATA SHEET

MICROGYNON(r) 20 ED

PRESENTATION

Microgynon 20 ED:

USES