Microdiol 0.15 mg/0.03 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Microdiol 0.15mg/0.03mg tablets

desogestrel/ethinylestradiol

Important things you need to 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 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”).

Read all of this 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Microdiol tablets are and what they are used for
2. What you need to know before you start taking Microdiol tablets
3. How to take Microdiol tablets
4. Possible side effects
5. How to store Microdiol tablets
6. Contents of the pack and other information

1. What Microdiol tablets are and what they are used for

Microdiol belongs to a group of medicines called monophasic oral contraceptives ("combined pill"). All tablets in the pack contain the same combination of active substances.

Microdiol is indicated for the prevention of pregnancy.

2. What you need to know before starting to take Microdiol tablets

General considerations

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

Do not take Microdiol

You must not use Microdiol 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. Also see the section “When you must be especially careful with Microdiol”.

• 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 need 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 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 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 hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have or have ever had inflammation of the pancreas (pancreatitis), together with high levels of fats in your blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have ever had cancer influenced by sex hormones (e.g. of the breast or genital organs).
• If you have or have ever had a liver tumour.
• If you have unexplained vaginal bleeding.
• If you have abnormal growth of the internal tissue of the uterus.
• If you are pregnant or think you might be pregnant.
• If you are allergic to desogestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6).
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Taking Microdiol with other medicines”).

If any of these conditions occur for the first time while you are taking the pill, stop taking it immediately and consult your doctor without delay. In the meantime, use non-hormonal contraceptive methods.

Warnings and precautions

When you must be especially careful with Microdiol

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 adverse effects, see “How to recognize a blood clot”.

Before starting treatment with Microdiol

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

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

• If you are a smoker.
• If you have diabetes.
• If you are overweight.
• If you have high blood pressure.
• If you have heart rhythm disorders or certain cardiac conditions.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close relative has had thrombosis, heart attack, or stroke.
• If you suffer from migraine.
• If you have epilepsy.
• 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 a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Microdiol after childbirth.
• If a close relative has had breast cancer.
• If you have liver or gallbladder disease.
• 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 a condition that developed or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disorder called porphyria, a skin condition called herpes gestationis, or a condition called Sydenham's chorea).
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by difficulty breathing, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.
• If you have or have had chloasma (yellowish-brown patches on the skin, particularly on the face); in this case, avoid intense exposure to sunlight or ultraviolet radiation.

If any of the above conditions occur for the first time, recur, or worsen during treatment with the pill, consult your doctor, who may advise you to stop taking the pill.

Microdiol, like all contraceptive pills, does not protect against HIV/AIDS or any other sexually transmitted infections.

Once treatment with Microdiol has started

While taking the pill, your doctor will require you to have periodic check-ups, generally once a year.

Contact your doctor as soon as possible in the following cases:

• If you notice possible signs of a blood clot, which may indicate 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 adverse effects, see “How to recognize a blood clot”.

• If you notice any change in your health, especially any of the points mentioned in this leaflet (see also “When not to use Microdiol” and “What you need to know before starting Microdiol”); do not forget the points concerning your close relatives either;
• If you detect a lump in your breast;
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by difficulty breathing (see also the section “When to exercise special caution with Microdiol”);
• If you are going to take other medicines (see also “Taking Microdiol with other medicines”);
• If you are to be immobilized or are undergoing surgery, as the risk of thrombosis increases temporarily in these cases; consult your doctor at least four weeks in advance;
• If you have unusual and heavy vaginal bleeding;
• If you miss tablets in the first week of the pack and have had sexual intercourse in the previous seven days;
• If you have severe diarrhea;
• If you miss two periods in a row or suspect you are pregnant, do not start the next pack until your doctor advises you to do so.

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention 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, may 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).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling 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 problems 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 urgent medical attention is still required 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 events are rare. They occur more 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 of first using a combined hormonal contraceptive. The risk may also be increased if you restart taking 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 Microdiol, 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 on 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 Microdiol 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, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.

• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as Microdiol, between 9 and 12 women will develop a blood clot in one year.

• Your 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 pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
Women who use Microdiol	About 9–12 out of 10,000 women

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

The risk of having a blood clot with Microdiol 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 need surgery or will be immobile for a long time due to injury, illness, or having a leg in a cast. You may need to stop taking Microdiol several weeks before surgery or while you are less mobile. If you need to stop taking Microdiol, ask your doctor when you can start taking it again.
• As you get older (especially over 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 listed risk factors.

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

If any of the above conditions change while you are using Microdiol—for example, a close relative experiences a thrombosis without a known cause or you gain a significant amount of 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 while using Microdiol is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Microdiol, 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 disorders, heart rhythm disorders such as 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 above conditions change while you are using Microdiol—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Blood pressure

If you have hypertension (high blood pressure) or any condition related to hypertension (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use hormonal contraceptives, your blood pressure should be monitored regularly. However, if your blood pressure increases and cannot be controlled with medication, you must stop treatment.

Tumors

Breast tumors have been diagnosed slightly more frequently in women using contraceptive pills compared to women of the same age who do not use them. This slight increase in diagnosed breast tumors gradually decreases over the ten years following discontinuation of treatment. It is not known whether this difference is due to the pill treatment. It could be that women who use contraceptive pills visit their doctor more frequently.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women using contraceptive pills. This may cause internal bleeding leading to severe abdominal pain. If this occurs, you must contact your doctor immediately.

The factor most affecting the risk of cervical (cervix) tumors is persistent infection with human papillomavirus (HPV). In women who use contraceptive pills for many years, the likelihood of developing cervical cancer is slightly higher. However, it is unclear whether the contraceptive pill plays a direct role in this risk, or whether sexual habits and other factors (such as more frequent medical check-ups) are responsible.

Vaginal bleeding

You may not have your "period" during the rest week. If the contraceptive pill has been taken correctly, it is very unlikely that you are pregnant. However, if you miss two periods, you should consult your doctor, as pregnancy must be ruled out. If you have not taken the contraceptive pill according to the instructions in section “3. How to take Microdiol tablets” and you miss a period, you must stop treatment and use a non-hormonal contraceptive method until pregnancy has been ruled out.

Microdiol may cause vaginal bleeding or spotting between periods. If this happens, continue taking Microdiol, but if the bleeding continues beyond the first three cycles, consult your doctor immediately. Incorrect use of the pill may also cause spotting and light vaginal bleeding.

When you stop using Microdiol, you may experience irregular or light bleeding, or no bleeding at all, especially during the first 3 months, and particularly if your periods were already irregular before starting hormonal treatment.

Psychiatric disorders

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

Children and adolescents

There are no clinical data available on safety and efficacy in adolescents under 18 years of age.

Other medicines and Microdiol

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any doctor or dentist (or pharmacist) who prescribes another medicine that you are using Microdiol. They can advise you whether you need to take additional contraceptive measures (for example, use of condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines:

• may affect the levels ofMicrodiolin the blood
• may make itless effective in preventing pregnancy**
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g.: primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g.: rifampicin, rifabutin);
• HIV infection (e.g.: ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g.: boceprevir, telaprevir);
• other infectious diseases (e.g.: griseofulvin);
• high blood pressure in the blood vessels leading to the lungs (bosentan);
• depressive mood disorders (the herbal remedy St. John's wort).

If you are taking medicines or herbal remedies that could make Microdiol less effective, you should also use a barrier contraceptive method. Since the effect of the other medicine on Microdiol may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during that time.

Microdiol may influence the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).

Do not take Microdiol if you have hepatitis C and are taking medicines containing

ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as increases in liver function test results (elevation of liver enzyme ALT) may occur.

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

medicines.

Microdiol can be used again approximately 2 weeks after completion of this treatment. See section “Do not take Microdiol”.

Laboratory tests

The use of hormonal contraceptives may affect the results of certain laboratory tests. If you are scheduled for any laboratory test, inform your doctor that you are taking Microdiol.

Pregnancy and breastfeeding

Microdiol must never be used by pregnant women or women who suspect they may be pregnant.

Microdiol is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.

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

Driving and use of machines

No effects have been observed.

Microdiol contains lactose

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

3. How to take Microdiol tablets

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The Microdiol blister pack contains 21 tablets marked with the days of the week. Take your tablet at approximately the same time each day, with liquid if necessary.

Each time you start a new Microdiol blister pack, take the tablet in the top row corresponding to the day of the week on which you begin.

Follow the direction of the arrows until you have taken all 21 tablets.

During the following 7 days, do not take Microdiol tablets. During this time, you will have a withdrawal bleed (period), which usually starts two or three days after the last Microdiol tablet. Start the next blister pack on the eighth day, even if you are still bleeding. In this way, you will always start a new blister pack on the same day of the week and have your withdrawal bleed approximately on the same days each month.

Use in children and adolescents

There are no clinical data available on safety and efficacy in adolescents under 18 years of age.

Starting the first Microdiol blister pack

If you have not used hormonal contraception in the previous month

Begin taking Microdiol on the first day of your cycle, that is, the first day of menstruation. Microdiol will start working immediately. You do not need to use additional contraceptive measures. You may also start between days 2 and 5 of your cycle, but in this case, make sure to use an additional contraceptive method (e.g. a barrier method) during the first 7 tablets of the first cycle. Do not use methods based on menstrual cycle tracking or body temperature, as these methods are not reliable while taking the pill.

Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch)

You may start taking Microdiol the day after taking the last active tablet of your current pack. This means you do not need a break period. If your current preparation includes inactive tablets, start Microdiol the day after the last active tablet (if you are unsure, consult your doctor or pharmacist). You may also start later, but never later than the end of the break period of your current preparation (or after the last inactive tablet of your current preparation). If you are using a vaginal ring or transdermal patch, you should preferably start taking Microdiol on the same day the ring is removed or the patch is taken off. Alternatively, you may start, but no later than the day the next patch or ring application would have been due.

If you have taken the pill, or used the vaginal ring or patch correctly and continuously, and are certain you are not pregnant, you may stop taking your current method or remove the ring or patch on any day of your cycle and start Microdiol immediately.

If you follow these instructions, you do not need to use an additional contraceptive method.

Switching from a progestogen-only pill

You may stop taking your current pill on any day and start taking Microdiol the following day at the same time. However, make sure to use an additional contraceptive method (e.g. a barrier method) during the first 7 tablets if you have sexual intercourse.

Switching from a progestogen-only injectable, implant, or intrauterine system (IUS)

Start taking Microdiol on the day you are due for your next injection, or on the day your implant or IUS is removed. However, ensure you use an additional contraceptive method (barrier method) during the first 7 tablets if you have sexual intercourse.

After childbirth

If you have recently given birth, your doctor may advise you to wait until you have your first natural period before starting Microdiol. Sometimes it may be possible to start earlier, but your doctor will advise you accordingly. If you are breastfeeding and wish to use Microdiol, discuss this first with your doctor.

After an abortion

Consult your doctor.

You may stop taking Microdiol at any time. If you stop Microdiol because you wish to become pregnant, it is generally recommended to wait until you have had your first natural period before trying to conceive, as this will help calculate the due date.

If you take more Microdiol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

No serious effects have been reported from taking an excessive amount of Microdiol tablets at one time. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

If you forget to take Microdiol

If less than 12 hours have passed since your usual time, contraceptive protection remains reliable. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

If more than 12 hours have passed since your usual time, contraceptive protection may be reduced. The more consecutive tablets you miss, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. Therefore, follow the recommendations below (see also the diagram).

If you miss more than one tablet in a pack

Consult your doctor.

If you miss 1 tablet in the first week

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Use additional contraceptive precautions (barrier method) for the next 7 days.

If you had sexual intercourse during the previous week, there is a possibility you may be pregnant. Inform your doctor immediately.

If you miss 1 tablet in the second week

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Contraceptive protection remains effective, and you do not need to use additional contraceptive precautions.

If you miss 1 tablet in the third week

You may choose either of the following options, without needing additional contraceptive precautions:

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue taking the remaining tablets at your usual time. Start the next blister pack the day after finishing the current pack without a break between packs. You may not have a withdrawal bleed until the end of the second pack, although you may experience spotting or a light bleed while taking the tablets in the second pack.

Or,

2. Stop taking the tablets in the current pack, take a break of up to 7 days (including the day you missed the tablet), and then start the next blister pack. By following this method, you can always start your next blister pack on the same day of the week as usual.

If you have missed tablets in a pack and do not have the expected withdrawal bleed during the first normal break period, you may be pregnant.

Consult your doctor before starting the next blister pack.

If you vomit or have severe diarrhoea

If you vomit or have severe diarrhoea within 3 to 4 hours after taking your Microdiol tablet, the active substances may not be completely absorbed, which is equivalent to missing a tablet. Therefore, follow the recommendations for a missed tablet.

In the case of severe diarrhoea, consult your doctor.

If you wish to change the day your period starts

If you take the tablets as instructed, your period will occur approximately on the same day every 4 weeks. If you wish to change this day, you must shorten (never extend) the following tablet-free interval. For example, if your period usually starts on a Friday and you wish it to start on a Tuesday in the future (i.e. three days earlier), you should start the next blister pack three days earlier than usual. If the tablet-free interval becomes very short (1 to 3 days), you may not have bleeding during the break and may experience some spotting during the next blister pack.

If you have unexpected bleeding

As with all oral contraceptives, irregular vaginal bleeding (called spotting or intermenstrual bleeding) may occur between periods during the first few months. In this case, continue taking the tablets as usual. This irregular vaginal bleeding usually stops once your body has adapted to the pill, typically after three cycles.

If the bleeding continues, becomes heavier, or recurs, consult your doctor.

If your period does not occur

If you have taken all tablets at the same time each day and have not vomited, had severe diarrhoea, or taken other medications, it is very unlikely that you are pregnant. Continue taking Microdiol as usual.

If you miss two consecutive periods, you may be pregnant and should inform your doctor immediately. Do not start the next blister pack of Microdiol until your doctor has confirmed that you are not pregnant.

4. Possible adverse effects

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

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 on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Microdiol”.

Contact your 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 possibly accompanied by difficulty breathing (see also section 2 “What you need to know before starting to take Microdiol tablets”).

Adverse effects are listed below, classified according to frequency based on the following criteria:

Frequent: (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).

Frequent (may affect up to 1 in 10 people):

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast discomfort
• weight gain

Uncommon (may affect up to 1 in 100 people):

• fluid retention
• decreased sexual drive
• migraine
• vomiting, diarrhoea
• skin rashes, urticaria
• breast enlargement

Rare (may affect up to 1 in 1,000 people):

• 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).

• allergic reactions
• increased sexual drive
• contact lens intolerance
• erythema nodosum, erythema multiforme (which are skin disorders)
• altered menstrual bleeding, breast discharge
• weight loss

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Microdiol tablets

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

Do not store above 30 °C.

Store in the original packaging.

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

Do not use this medicine if you notice, for example, any change in colour, broken tablets, or any other visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Microdiol

• The active substances are: desogestrel and ethinylestradiol. One tablet contains 0.15 mg of desogestrel and 0.03 mg of ethinylestradiol.

• The other components are: anhydrous colloidal silica, all-rac-alpha-tocopherol, lactose monohydrate, potato starch, povidone and stearic acid.

Appearance of the product and contents of the pack

The tablets are white, biconvex, round and 6 mm in diameter. Each tablet is marked with a code: TR over 5 on one side and Organon with an asterisk on the other side.

Microdiol is available in aluminum/PVC blisters of 21 tablets, packed in a sealed laminated aluminum foil pouch. The pouches are packaged in cartons containing 1x21 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6,

5349 AB, Oss,

The Netherlands

Date of the most recent revision of the package leaflet: September 2022.

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