Microgynon 0.15 mg / 0.03 mg film-coated tablets: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Microgynon 0.15 mg / 0.03 mg coated tablets

levonorgestrel / ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important information you should know about combined hormonal contraceptives (CHCs):

They are one of the most reliable reversible contraceptive methods if used correctly.
They slightly increase the risk of developing a blood clot in the veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Package leaflet contents

What Microgynon is and what it is used for
What you need to know before taking Microgynon
How to take Microgynon
Possible side effects
How to store Microgynon
Contents of the pack and other information

1. What Microgynon is and what it is used for

Microgynon is a combined oral hormonal contraceptive. It inhibits ovulation and produces changes in cervical secretions (produced by the cervix). It is used to prevent pregnancy. Other indications for Microgynon are: dysmenorrhea (painful menstruation); endometriosis (presence of endometrial tissue (tissue lining the uterus) outside its normal location); ovulatory crises (severe ovulation pain or intermenstrual pain); anexitis (inflammation of the fallopian tubes and ovaries); and ovarian rest (reduction or cessation of ovarian activity).

2. What you need to know before starting to take Microgynon

General considerations

Before starting to use Microgynon, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Do not use Microgynon

You must not use Microgynon if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

If you are allergic to the active substances (levonorgestrel and ethinylestradiol) or to any of the other components of this medicine (listed in section 6).
If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you require surgery or if you are going to be immobile for a long time (see section “Blood clots”).
If you have ever had a heart attack or a stroke.
If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have any of the following conditions that may increase your risk of developing a clot in the arteries:
Severe diabetes with blood vessel damage.
Very high blood pressure.
Very high levels of fat in the blood (cholesterol or triglycerides).
A condition called hyperhomocysteinaemia.
If you have (or have ever had) a type of migraine called “migraine with aura”.
If you have thrombogenic valvular heart disease (heart valve disorders that may lead to clot formation).
If you have heart rhythm disorders with risk of clot formation (thrombogenic arrhythmias).
If you have or have had severe liver disease, as long as liver function test results have not returned to normal.
If you have or have had liver tumours (benign or malignant).
If you have or are suspected of having malignant conditions of the genital organs or of the breasts.
If you have vaginal bleeding of unknown cause.
If you are pregnant or think you might be pregnant.

Do not use Microgynon if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Microgynon”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot, which may indicate that you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

If any of the risk situations mentioned below are present, your doctor should assess the benefits of using Microgynon against the possible risks and discuss them with you before you decide to start using it.

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Microgynon, you must also inform your doctor.

If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anemia (an inherited red blood cell disorder).
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
If you have recently given birth, you are at higher risk of developing blood clots. You should ask your doctor when you can start taking Microgynon after childbirth.
If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you have heart diseases (those causing certain types of cardiac arrhythmias).
If you have high blood pressure, particularly if it worsens or does not improve with antihypertensive medications.
If you have severe and recurrent migraines.
If you have diabetes.
If you have depression or a history of depression, as it may worsen or reappear while using hormonal contraceptives.
If you have certain types of jaundice (yellowing of mucous membranes, eyes, and/or skin) or liver function disorders.
If you have itching, especially if it occurred during a previous pregnancy.
If you have permanent brown patches on the skin of your face, particularly if they appeared during a previous pregnancy. In such cases, avoid sunlight and ultraviolet radiation (e.g., sunbeds).
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Also contact your doctor if you think you might be pregnant.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Microgynon increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots may form:

In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
In arteries (called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Microgynon is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical help if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms—such as cough or shortness of breath—can be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or beneath the breastbone. Sensation of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision difficulty in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Microgynon, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Microgynon is small.

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as Microgynon, about 5–7 will develop a blood clot in one year.
Your individual risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel	About 5–7 in 10,000 women
Women who use Microgynon	About 5–7 in 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Microgynon is small, but certain conditions increase the risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
If you require surgery or will be immobile for long periods due to injury, illness, or if your leg is in a cast. You may need to stop using Microgynon several weeks before surgery or while you are less mobile. If you need to stop using Microgynon, ask your doctor when you can start taking it again.
As you get older (especially above about 35 years of age).
If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop using Microgynon.

If any of the conditions listed above change while you are using Microgynon, for example, if a close relative experiences a thrombosis without a known cause or you gain significant weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke from using Microgynon is very small, but it may increase:

With age (above about 35 years).
If you smoke. When using a combined hormonal contraceptive like Microgynon, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
If you are overweight.
If you have high blood pressure.
If any of your close relatives have had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
If you suffer from migraines, especially migraines with aura.
If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the conditions listed above change while you are using Microgynon—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Tumors
Cases of breast tumors have been observed slightly more frequently in women using contraceptive pills, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women using contraceptive pills because they visit the doctor more often. This increased frequency gradually decreases after stopping treatment. After ten years, the likelihood of having breast tumors will be the same as in women who have never used contraceptive pills.
Some studies have reported an increased risk of cervical cancer in women who have used combined oral contraceptives (COCs) for long periods, but controversy remains regarding how much this finding may be attributed to other factors such as sexual behavior and sexually transmitted infections.
Rarely, benign liver tumors and even more rarely, malignant ones, have been reported in users of COCs. These may cause internal bleeding leading to severe abdominal pain. If this occurs, you should contact your doctor immediately.
A slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (serious diseases of the cervix) has been observed. Given the biological influence of COCs on these lesions, it is recommended that, if prescribing a COC, periodic cervical cytology tests (Pap smears) should be performed.
Malignant tumors can be life-threatening or fatal.
Psychiatric disorders

Some women using hormonal contraceptives such as Microgynon have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

If a severe depressive episode occurs, treatment should be discontinued and an alternative contraceptive method used. Women with a history of depression should be closely monitored.

Other conditions
In women with hypertriglyceridemia (elevated triglycerides in the blood) or a family history of the same, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of COCs.
Women who have been treated for hyperlipidemias (elevated blood fats such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.
Small increases in blood pressure have been observed in many users during COC use, although clinically significant cases are rare. If sustained high blood pressure develops during COC use, consult your doctor.
In women with endometrial hyperplasia (thickening of the inner lining of the uterus), the doctor should carefully evaluate the risk-benefit ratio before prescribing COCs and monitor the patient closely during treatment, performing periodic cervical cytology tests.
The following conditions may appear or worsen during pregnancy and with the use of COCs: jaundice (yellowing of mucous membranes, eyes, and/or skin) and/or pruritus (itching) related to cholestasis (stagnation or reduced bile flow), gallstone formation, porphyria (a disorder of hemoglobin metabolism), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (a disease causing blood abnormalities), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucosal lesions appearing during pregnancy), and hearing loss due to otosclerosis (a type of ear disorder).
Acute or chronic liver function disorders require discontinuation of COC use until liver function markers return to normal. Recurrence of cholestatic jaundice (yellowing of mucous membranes, eyes, and/or skin related to stagnation or reduced bile flow) that previously occurred during pregnancy or prior use of sex hormones requires discontinuation of the COC.
COCs may alter peripheral insulin resistance and glucose tolerance. There is no evidence that the treatment regimen needs to be changed in diabetic women using low-dose COCs (containing < 0.05 mg ethinylestradiol). However, diabetic women should be carefully monitored while taking COCs.
The use of COCs has been associated with Crohn's disease and ulcerative colitis (inflammatory bowel diseases).
Chloasma (brown skin patches) may occasionally occur, especially in women with a history of chloasma gravidarum (occurring during pregnancy). If you are prone to chloasma, you should avoid exposure to sunlight or ultraviolet rays while taking COCs.
Women should be advised that oral contraceptives do not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Medical examination and consultations

Before starting or resuming treatment with Microgynon, your doctor must perform a complete medical history and physical examination to rule out contraindications and assess precautions. These should be repeated at least once a year during the use of combined oral contraceptives.

Reduced effectiveness

The effectiveness of COCs may decrease if you forget to take a tablet (see section "If you forgot to take Microgynon"), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see section "Advice in case of gastrointestinal disorders"), or if you take other medications simultaneously (see section "Taking Microgynon with other medicines").

Irregularities in cycle control

During the use of any COC, spotting or vaginal bleeding between periods may occur, especially during the first months of use. If these bleeding irregularities persist or occur after previously regular cycles, non-hormonal causes should be considered, and you should see your doctor so appropriate diagnostic measures can be taken to exclude malignancies, infections, or pregnancy.

In some women, withdrawal bleeding (period) may not occur during the rest week. If you have taken the COC according to the instructions in the section "How to take Microgynon," it is unlikely that you are pregnant. However, if you have not taken the COC according to these instructions before the first missed period, or if a second period is missed, pregnancy should be ruled out before continuing COC use.

Other medicines and Microgynon

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Certain medicines may interact, and in these cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are using any of the following medicines. The medicines listed below may prevent combined hormonal contraceptives from working properly, and if this occurs, you could become pregnant:

Treatment for hepatitis C and HIV (protease inhibitors and non-nucleoside reverse transcriptase inhibitors) and other infections (griseofulvin)
Treatment for tuberculosis (rifampicin, rifabutin)
Treatment for fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
Treatment for bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
Treatment for certain heart conditions and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
Treatment for arthritis and osteoarthritis (etoricoxib)
Some antiepileptic drugs (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide)
Antacids, including lansoprazole
Some mood-enhancing substances (modafinil)
Grapefruit juice

Troleandomycin may increase the risk of intrahepatic cholestasis (bile accumulation in the liver) when administered together with COCs.

You must not take herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with Microgynon, as its effectiveness may be reduced, with a risk of unintended pregnancy and intermenstrual bleeding. The reduced contraceptive effect lasts up to two weeks after stopping the St. John's wort preparation.

It is advisable to use another reliable contraceptive method if you are taking any of the above-mentioned medicines. The effect of some of these medicines may last up to 28 days after stopping treatment.

Microgynon may reduce the effect of oral anticoagulants, analgesics (such as paracetamol and salicylates), fibrates (medicines to reduce triglyceride and/or cholesterol levels), lamotrigine (an anticonvulsant), oral antidiabetics, and insulin, and may increase the effect of other drugs such as β-blockers (metoprolol), theophylline (for asthma treatment), corticosteroids (such as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizine (increasing the risk of lactation), midazolam, melatonin, and tizanidine.

You should never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Do not take Microgynon if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Microgynon can be taken again approximately 2 weeks after completion of this treatment. See the section "Do not use Microgynon."

Consult the prescribing information of any medicines you are taking concurrently to identify possible interactions.

Laboratory tests

The use of oral contraceptives may affect the results of certain laboratory tests.

If you are scheduled for any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Microgynon is not indicated during pregnancy. If you become pregnant, you must stop taking Microgynon immediately and consult your doctor.

Small amounts of oral contraceptives may be excreted in breast milk during COC use. These amounts may affect the infant, so COCs generally should not be used until breastfeeding has ended.

If you wish to use Microgynon after childbirth or after a second-trimester abortion: see section "How to take Microgynon."

Driving and use of machines

No effects on the ability to drive or use machinery have been observed.

Microgynon contains lactose and sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

3. How to take Microgynon

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again.

Remember to take your medicine, as forgetting coated tablets may reduce the effectiveness of the preparation.

Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase if tablets are forgotten or taken incorrectly.

The first tablet should be taken from one of the compartments marked with the corresponding day of the week (e.g., "MO" for Monday). Tablets must be taken every day at approximately the same time, with a little liquid if necessary, and in the order indicated on the blister pack. One tablet should be taken daily for 21 consecutive days. A new pack should be started after a 7-day tablet-free interval, during which withdrawal bleeding (a period) usually occurs. Withdrawal bleeding, similar to a period, will typically appear two or three days after taking the last tablet, and may not have finished before starting the next pack.

How to start taking Microgynon

If you have not previously taken any hormonal contraceptive (in the previous month)

Tablets should be started on day 1 of the woman's natural cycle (i.e., the first day of menstrual bleeding). Alternatively, you may start between days 2 and 5 of the cycle; however, in this case, it is recommended to additionally use a barrier method, such as a condom, during the first 7 days of tablet intake.

To replace a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You should preferably start taking Microgynon the day after taking the last active tablet of your previous COC, but no later than the day after the usual tablet-free interval or placebo tablet period of your previous COC ends. This means that treatment with Microgynon must be started no later than the day a new pack (blister) of the previous COC would have been started. If you have been using a vaginal ring or transdermal patch, you should preferably start taking Microgynon on the day of removal of the last ring or patch of a cycle pack, or at the latest when the next application would have been due.

To replace a progestogen-only method (progestogen-only pill, injection, implant), or a progestogen-releasing intrauterine system (IUS)

You may switch from a progestogen-only pill to Microgynon on any day (if using an implant or IUS, on the same day of removal; if using an injectable, on the day the next injection would be due); however, in all cases, it is recommended to additionally use a barrier method, such as a condom, during the first 7 days of tablet intake.

After a first-trimester abortion

You may start taking Microgynon immediately. In this case, no additional contraceptive measures are necessary.

After childbirth or a second-trimester abortion

It is recommended to start taking Microgynon 21–28 days after childbirth or a second-trimester abortion. If you start later, you should use an additional barrier method for the first 7 days. However, if sexual intercourse has already occurred, pregnancy must be ruled out before starting the COC, or you should wait until your first menstrual period.

Recommendations in case of gastrointestinal disorders

In the case of severe gastrointestinal disturbances, absorption may not be complete, and additional contraceptive measures should be taken.

If you vomit within 3–4 hours after taking a tablet, follow the advice regarding missed tablets; see section “If you forget to take Microgynon”. If you do not wish to change your normal tablet-taking schedule, take the necessary extra tablet(s) from another pack.

How to delay withdrawal bleeding (period)

To delay a period, continue with the next pack of Microgynon without taking the usual 7-day break. You may continue this for as long as desired until the second pack is finished. During this time, you may experience breakthrough bleeding or spotting. After this, take the usual 7-day tablet-free interval and then resume regular intake of Microgynon.

To shift your period to a different day of the week than your current cycle, you may shorten the tablet-free interval by as many days as desired. The shorter the interval, the greater the risk of no withdrawal bleeding (period) occurring and of experiencing intermenstrual bleeding or spotting during the next pack (as occurs when delaying a period).

Special populations

Pediatric population

Microgynon is only indicated after menarche (the onset of the first menstrual period).

Geriatric population

Not applicable. Microgynon is contraindicated after menopause.

Patients with impaired hepatic function

Microgynon is contraindicated in women with severe liver disease.

Patients with impaired renal function

Microgynon has not been specifically studied in patients with impaired renal function. There are no available data suggesting a need to modify treatment in this patient population.

If you take more Microgynon than you should

If you have taken more Microgynon than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Tel: 91 562 04 20), stating the medicine and amount taken. It is recommended to bring the packaging and leaflet to the healthcare professional.

No serious adverse reactions due to overdose have been reported. Symptoms that may occur in such cases are: nausea, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine. There is no antidote, and treatment should be symptomatic.

If you forget to take Microgynon

Contraceptive protection is not reduced if a tablet is taken less than 12 hours late. In this case, take the tablet as soon as you remember and continue taking the following tablets at your usual time (even if this means taking two tablets on the same day). In this case, no additional contraceptive measures are necessary.

If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The following rules apply in case of a missed tablet:

You must not stop taking tablets for more than 7 days.
It is necessary to take tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, and following the above guidance, the following advice may be given in daily practice:

Week 1

Take the most recently missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Additionally, use a barrier method, such as a condom, for the next 7 days. If you had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets you have missed and the closer you are to the tablet-free week, the higher the risk of pregnancy.

Week 2

Take the most recently missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. If you have taken all tablets correctly in the 7 days before the missed tablet, you do not need additional contraceptive precautions. However, if you have missed more than one tablet, it is advisable to use additional precautions for 7 days.

Week 3

The risk of reduced efficacy is imminent due to the proximity of the tablet-free week. However, by adjusting the tablet-taking schedule, a decrease in contraceptive protection can still be prevented. Therefore, if you follow one of the two options below, you do not need additional contraceptive precautions, provided you took all tablets correctly in the 7 days before the first missed tablet. If this is not the case, follow the first of the two options below and use additional contraceptive precautions for the next 7 days.

Take the most recently missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Start the next blister pack immediately after finishing the current one, leaving no gap between packs. Withdrawal bleeding (period) is unlikely until the end of the second pack, but you may experience spotting or breakthrough bleeding during tablet intake.
You may also stop taking tablets from the current blister pack. Then complete a tablet-free interval of up to 7 days, including the days when you missed tablets, and then restart with the next blister pack.

If you do not experience withdrawal bleeding (period) during the first tablet-free interval after missing tablets, consider the possibility of pregnancy.

In case of doubt, consult your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to Microgynon, consult your doctor.

Serious adverse effects

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information about the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting Microgynon”.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

The adverse effects listed below are classified according to their frequency using the following criteria:

Very common: May affect more than 1 in 10 people
Common: May affect up to 1 in 10 people
Uncommon: May affect up to 1 in 100 people
Rare: May affect up to 1 in 1,000 people
Very rare: May affect up to 1 in 10,000 people

Infections and infestations

Common: vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Immune system disorders

Rare: hypersensitivity (abnormal increased skin sensitivity), allergic-type reactions such as very rare cases of severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness.

Very rare: worsening of systemic lupus erythematosus (chronic inflammatory autoimmune disorder).

Metabolism and nutrition disorders

Uncommon: changes in appetite (increase or decrease), fluid retention.

Rare: glucose intolerance.

Very rare: worsening of porphyria (a disorder of haemoglobin metabolism).

Psychiatric disorders

Common: mood changes, including depression.

Uncommon: decreased libido (sexual desire).

Rare: increased libido.

Nervous system disorders

Common: headaches, nervousness, dizziness.

Uncommon: migraine.

Very rare: worsening of chorea (a disorder causing abnormal movements).

Eye disorders

Rare: intolerance to contact lenses.

Very rare: optic neuritis, retinal vascular thrombosis (abnormalities in the eyes and visual disturbances).

Vascular disorders

Rare: harmful blood clots in a vein or artery, for example:

In a leg or foot (i.e., DVT).
In a lung (i.e., PE).
Heart attack.
Stroke.
Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
Blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: worsening of varicose veins.

Gastrointestinal disorders

Common: nausea, abdominal pain.

Uncommon: vomiting, diarrhoea, colic, bloating.

Very rare: pancreatitis (inflammation of the pancreas), hepatic adenomas (common non-cancerous liver tumours), hepatocellular carcinoma (malignant liver tumour).

Hepatobiliary disorders

Rare: cholestatic jaundice (yellowing of mucous membranes, eyes and/or skin related to interruption or reduction of bile flow).

Very rare: cholelithiasis (gallbladder disorders), including gallstones.

Skin and subcutaneous tissue disorders

Common: acne.

Uncommon: skin rash, urticaria (itching), chloasma (skin pigmentation) which may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: erythema nodosum (a type of skin inflammation with nodules appearing on the legs), erythema multiforme (a type of skin inflammation).

Renal and urinary disorders

Very rare: haemolytic uraemic syndrome (a kidney disease with blood abnormalities).

Reproductive system and breast disorders

Very common: bleeding, spotting.

Common: breast pain, breast tenderness, dysmenorrhoea (painful menstruation), changes in menstrual flow and cervical ectropion (alteration of the mucosa of the cervix), amenorrhoea (absence of menstruation).

Uncommon: breast enlargement.

Rare: vaginal discharge, breast discharge.

General disorders and administration site conditions

Common: oedema (swelling).

Investigations

Common: weight gain.

Uncommon: increased blood pressure, changes in blood lipid levels (fats), including hypertriglyceridaemia.

Rare: weight loss, decreased blood levels of folates (folic acid derivatives).

Description of selected adverse reactions

Listed below are very uncommon adverse reactions or those with delayed onset considered related to combined oral contraceptives (COCs) (see sections “Do not take Microgynon” and “Warnings and precautions”).

Tumours

The frequency of breast cancer diagnosis among users of COCs is very slightly increased. Since breast cancer is rare in women under 40 years of age, this increase is small in relation to the overall risk of breast cancer. Causality related to COC use is unknown.
Liver tumours (benign and malignant)

Other disorders

Women with hypertriglyceridaemia (increased blood fats resulting in increased risk of pancreatitis when COCs are used)
Hypertension
Onset or worsening of conditions whose association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis (blocked bile flow); gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a disease involving blood clots); a neurological disorder called Sydenham's chorea; herpes gestationis (a type of skin disorder occurring during pregnancy); hearing loss related to otosclerosis
Liver function abnormalities
Changes in glucose tolerance or effects on peripheral insulin resistance
Crohn's disease, ulcerative colitis
Chloasma

Interactions

Interactions between oral contraceptives and other medicines (e.g. St John's wort, medicines for epilepsy, tuberculosis, HIV and other infections) may lead to unexpected bleeding and/or contraceptive failure (see section “Taking Microgynon with other medicines”).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Microgynon

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Microgynon

The active substances are: levonorgestrel and ethinylestradiol.

Each coated tablet of Microgynon contains 0.15 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other components are: lactose monohydrate, corn starch, povidone 25,000, talc, magnesium stearate, sucrose, povidone 700,000, macrogol 6000, calcium carbonate, glycerol 85% (E-422), titanium dioxide (E171), yellow iron oxide (E172), and glycolized montan wax.

Appearance of the product and contents of the pack

Microgynon is presented in a 21-tablet blister pack (the packaging containing the coated tablets), with beige coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer AG

Müllerstrasse 178

13353 Berlin – Germany

Bayer Weimar GmbH und Co. KG, Weimar

Doebereinerstrasse 20

99427 Weimar – Germany

Date of the most recent review of this leaflet: 10/2022

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.