Drovelis 3 mg/14.2 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drovelis 3 mg/14.2 mg film-coated tablets

drospirenone/estetrol

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report these adverse reactions.

Important things 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 blood clots in veins and arteries, particularly 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 the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Drovelis is and what it is used for
2. What you need to know before taking Drovelis
3. How to take Drovelis
4. Possible side effects
5. How to store Drovelis
6. Contents of the pack and other information

1. What Drovelis is and what it is used for

Drovelis is a contraceptive medicine used to prevent pregnancy.

• The 24 film-coated pink tablets are active tablets containing a small amount of two different female hormones called estetrol and drospirenone.
• The 4 film-coated white tablets are inactive tablets that do not contain hormones and are called placebo tablets.
• Contraceptive medicines that contain two different hormones, such as Drovelis, are called combined oral contraceptives. Combined oral contraceptives prevent pregnancy by inhibiting ovulation (release of an egg from the ovary) and by reducing the likelihood that any released egg will be fertilized, thus preventing pregnancy.

2. What you need to know before starting Drovelis

General considerations

Before starting Drovelis, 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”.

Before starting Drovelis, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other tests.

This leaflet describes several situations in which you should stop taking Drovelis, or in which the contraceptive effectiveness may be reduced. In these situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier contraceptive method. Do not use the rhythm or calendar method or the temperature method. These methods may not be reliable, as oral contraceptives can influence body temperature and cyclic changes in cervical mucus composition.

Drovelis, like other hormonal contraceptives, does not protect against infection with the human immunodeficiency virus (HIV) (acquired immunodeficiency syndrome, AIDS) or against any other sexually transmitted disease.

Do not take Drovelis

Do not take Drovelis 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 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 will 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 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 hyperhomocysteinemia.
• if you have (or have ever had) a type of migraine called “migraine with aura”.
• if you have (or have had) a tumor (benign or malignant) of the liver.
• if you have (or have had) a liver disease and your liver is still not functioning normally.
• if your kidneys do not work properly (renal insufficiency).
• if you have (or have had) or suspect you may have breast cancer or cancer of the genital organs.
• if you have unexplained vaginal bleeding;
• if you are allergic to estetrol or drospirenone, or to any of the other components of this medicine (listed in section 6).

If any of these conditions appear for the first time while you are taking Drovelis, stop taking it immediately and consult your doctor. In the meantime, use a non-hormonal contraceptive. See also “General considerations” in section 2 above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drovelis.

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot, which may mean 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 clot” below).

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

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

If the condition develops or worsens while you are taking Drovelis, you must also inform your doctor:

• if a close relative has or has ever had breast cancer;
• if you have hereditary angioedema. Medicines containing estrogens may induce or worsen symptoms of angioedema. Contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, accompanied by difficulty breathing;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have epilepsy (see section 2, “Use of Drovelis with other medicines”);
• 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 haemolytic uraemic 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 need surgery or will be immobile for a long time (see section 2 “Blood clots”);
• if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Drovelis after childbirth;
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have (or have ever had) chloasma (brown-golden pigmentation spots, known as “pregnancy mask”, especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet light;
• if you have a condition that first occurred during pregnancy or with previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy [herpes gestationis], a nerve disorder causing involuntary body movements [Sydenham’s chorea]).

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drovelis 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 can 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 or, very rarely, they may be fatal.

It is important to remember that the overall risk of developing a harmful blood clot due to Drovelis 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 along a vein, 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 a known cause or rapid breathing sudden cough without a clear cause, possibly bringing up blood sudden sharp chest pain that may worsen when breathing deeply severe dizziness or lightheadedness rapid or irregular heartbeat severe stomach 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)
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 problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination sudden, severe, and prolonged headache without a known cause loss of consciousness or fainting, with or without seizures.	Stroke
Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
swelling and slight bluish discoloration of a limb severe stomach 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 in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it may cause a pulmonary embolism (PE).
• 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 highest during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different one) after a break of 4 weeks or more.

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

When you stop taking Drovelis, 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 developing 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 Drovelis 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing low-dose ethinylestradiol (<50 micrograms of ethinylestradiol) combined with levonorgestrel, norethisterone, or norgestimate, 5 to 7 will develop a blood clot within one year.
• It is not yet known how the risk of blood clots with Drovelis compares to the risk with a combined hormonal contraceptive containing levonorgestrel.
• 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	Approximately 2 out of 10,000 women
Women using a combined oral contraceptive pill containing low-dose ethinylestradiol (<50 micrograms of ethinylestradiol) combined with levonorgestrel, norethisterone or norgestimate	Approximately 5–7 out of 10,000 women
Women using Drovelis	Not yet known

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

The risk of having a blood clot with Drovelis 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 or illness, or if your leg is in a cast. You may need to stop using Drovelis several weeks before surgery or while you are less mobile. If you need to stop using Drovelis, ask your doctor when you can start taking it again.
• as you get older (especially above approximately 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 (> 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 Drovelis. If any of the above conditions change while you are using Drovelis—for example, 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 lead to 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 a heart attack or stroke while using Drovelis is very small, but it may increase:
• with age (above approximately 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Drovelis, 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 a close relative has had a heart attack or stroke at a young age (less than approximately 50 years). In this case, you may also have a higher risk of heart attack or stroke;
• if you or a close relative has 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, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

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

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

Cancer

A slightly increased frequency of breast cancer has been observed in women taking combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to more frequent medical examinations in women using combined contraceptives, leading to earlier detection of tumors. After stopping combined hormonal contraceptives, the increased risk gradually decreases. It is important to regularly examine your breasts and consult your doctor if you notice any lumps. You should also inform your doctor if a close family member has or has had breast cancer (see section 2, "When you must be especially careful with Drovelis").

In rare cases, benign (non-cancerous) liver tumors have been reported, and even more rarely, malignant (cancerous) liver tumors. Contact your doctor if you experience unusual, severe abdominal pain.

Cervical cancer is caused by infection with the human papillomavirus (HPV). It has been reported to occur more frequently in women who use combined contraceptives for more than 5 years. It is not known whether this observation is due to the use of hormonal contraceptives or to other factors, such as differences in sexual behavior.

Psychiatric disorders

Some women using hormonal contraceptives such as Drovelis have reported depression or 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.

Bleeding between periods

Your period will normally start during the days you take the white placebo tablets in the Drovelis pack. During the first few months of taking Drovelis, you may experience unexpected bleeding (bleeding outside the days when you take the white placebo tablets). Most of these bleedings are mild and usually do not require the use of a sanitary pad. If this bleeding continues for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What should you do if there is no bleeding during the placebo days?

If you have taken all the active pink tablets correctly, have not had vomiting or severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant. Continue taking Drovelis as usual.

If you have not taken all the tablets correctly, or if you miss two consecutive withdrawal bleeds, you may be pregnant. Contact your doctor immediately. Only start the next pack if you are certain you are not pregnant. See also section 3, “If you vomit or have severe diarrhea,” or section 2, “Other medicines and Drovelis.”

Children and adolescents

Drovelis is only indicated after menarche (the first menstrual period). There is no data on safety and efficacy in adolescents under 16 years of age.

Other medicines and Drovelis

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Also, inform any other doctor or dentist who prescribes you a medicine (or the pharmacist) that you are taking Drovelis. They may advise you to take additional contraceptive precautions (e.g., use condoms), and if so, for how long, or whether you should change the use of any other medicine.

Some medicines may affect the levels of Drovelis in the blood and make it less effective in preventing pregnancy, or may cause unexpected bleeding. This includes medicines used to treat:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus (HCV) infections (e.g., protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (e.g., bosentan).

Herbal products containing St. John’s wort (Hypericum perforatum) may cause Drovelis to become ineffective. If you wish to use herbal products containing St. John’s wort while using Drovelis, you must first consult your doctor.

If you are taking these medicines or herbal products that may reduce the effectiveness of Drovelis, a barrier contraceptive method should also be used. The barrier method should be used throughout the period of concomitant treatment and for 28 days after stopping it. If the concomitant treatment extends beyond the active pink tablets in the current pack, the white placebo tablets should be discarded and the next pack of Drovelis should be started immediately.

If long-term treatment with the above-mentioned medicines is required, non-hormonal contraceptive methods should be used. Consult your doctor or pharmacist.

Drovelis may interfere with the effectiveness of other medicines, for example:

• cyclosporine (a medicine used to prevent tissue rejection after transplantation);
• lamotrigine (a medicine used to treat epilepsy).

The combination therapy for hepatitis C virus (HCV) infection

ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, may cause increases in blood test results for liver function (elevation of the liver enzyme ALT) in women using combined hormonal contraceptives (CHCs) containing ethinylestradiol. Drovelis contains estetrol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT can occur when using Drovelis with this combination HCV therapy. Your doctor will inform you about this.

Ask your doctor or pharmacist before taking any medicine.

Laboratory tests

If you need to have a blood or urine test, inform your doctor or laboratory staff that you are taking Drovelis, as it may affect the results of some tests.

Taking Drovelis with food and drinks

Drovelis can be taken with or without food, if necessary, with a small amount of water.

Pregnancy and breastfeeding

Women who are pregnant or think they might be pregnant should not use Drovelis. If you become pregnant while using Drovelis, you must stop taking it immediately and contact your doctor.

If you wish to become pregnant, you may stop taking Drovelis at any time (see section 3, “If you stop taking Drovelis”).

Drovelis is not recommended during breastfeeding. If you wish to use an oral hormonal contraceptive during breastfeeding, consult your doctor.

Driving and using machines

The influence of Drovelis on the ability to drive and use machines is negligible or none.

Drovelis contains lactose and sodium

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

The active pink tablet contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free.”

3. How to take Drovelis

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

How and when to take the tablets

The Drovelis blister pack contains 28 film-coated tablets: 24 active pink tablets containing active substances (numbers 1 to 24) and 4 inactive white placebo tablets without active substances (numbers 25 to 28).

Each time you start a new Drovelis blister pack, take the active pink tablet marked with number 1 (see "Starting"). Choose from the 7 day-of-the-week stickers the one that starts with your starting day. For example, if you start on a Wednesday, use the weekly sticker beginning with "Wed". Stick it onto the frame on the front of the blister, just above the symbol “*”. Each day will align with a row of tablets. This allows you to check whether you have taken your daily tablet.

Take one tablet every day, approximately at the same time; if necessary, with a little water.

Follow the direction of the arrows on the blister, so use the pink active tablets first, followed by the white placebo tablets.

Your menstruation will begin during the 4 days you take the white placebo tablets (this bleeding is called withdrawal bleeding). It usually starts 2 to 4 days after taking the last active pink tablet and may not have finished before you start the next blister pack.

Start the next blister pack immediately after the last white placebo tablet, even if your menstruation has not ended. This means you will always start a new blister pack on the same day of the week and will also have your period approximately on the same days each month.

Some women may not have a period every month while taking the white placebo tablets. If you have taken Drovelis every day as instructed, it is unlikely that you are pregnant.

Starting your first pack of Drovelis

If you have not used any hormonal contraceptive in the previous month

Start taking Drovelis on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Drovelis on the first day of your period, you will be immediately protected against pregnancy.

You may also start on day 2–5 of the cycle, but you must use additional contraceptive protection (e.g., a condom) during the first 7 days of tablet-taking.

If switching from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or combined transdermal patch)

Start taking Drovelis preferably the day after taking the last active tablet (the last tablet containing active substances) of your previous oral contraceptive, and at the latest the day after the tablet-free interval of your previous oral contraceptive (or after the last inactive tablet of your previous oral contraceptive). When switching from a vaginal ring or a combined transdermal patch, follow your doctor's recommendations.

If switching from a progestogen-only method (progestogen-only oral contraceptive, injection, implant, or intrauterine system (IUS) releasing progestogen)

You may switch on any day from a progestogen-only oral contraceptive, from an implant or intrauterine system (IUS) on the day of its removal, or from an injectable when the next injection would be due. However, in all these cases, you must use additional contraceptive protection (e.g., a condom) during the first 7 consecutive days of taking the tablets.

After a spontaneous or induced abortion

Follow your doctor's advice.

After giving birth

You may start taking Drovelis between 21 and 28 days after childbirth. If you start after day 28, you must use an additional barrier method (e.g., a condom) during the first 7 days of taking Drovelis. If you have had sexual intercourse after giving birth but before starting Drovelis, ensure you are not pregnant or wait until your next menstruation.

If you are breastfeeding and wish to start (or restart) Drovelis after having a baby

Read the section “Breast-feeding”.

Ask your doctor or pharmacist what to do if you are unsure about when to start.

If you take more Drovelis than you should

No serious adverse effects have been reported from taking too many Drovelis tablets. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Even girls who have not yet started menstruating but have accidentally taken this medicine may experience vaginal bleeding.

If you have taken too many Drovelis tablets, or if you find that a child has taken Drovelis, seek advice from your doctor.

If you forget to take Drovelis

The last 4 white tablets in the blister are placebo tablets. If you forget one of these tablets, this has no effect on the reliability of Drovelis. Discard the forgotten white placebo tablet.

If you forget an active pink tablet (tablets 1 to 24 in your blister strip), you should do the following:

• If less than 24 hours have passed since you missed the active pink tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and then continue taking the tablets at your usual time.

• If more than 24 hours have passed since you missed the active pink tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of becoming pregnant.

There is a risk of incomplete protection against pregnancy if you miss an active pink tablet at the beginning or end of the pack. Therefore, follow the instructions below (see also the diagram):

More than one tablet missed in this pack:

Contact your doctor.

One active pink tablet missed between days 1 to 7

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions, for example, a condom, for the next 7 days while taking the tablets correctly. If you had sexual intercourse in the week before missing the tablet, consider that there may be a risk of pregnancy. In that case, consult your doctor immediately.

One active pink tablet missed between days 8 to 17

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and additional precautions are not necessary.

One active pink tablet missed between days 18 to 24

Either of the two options below may be followed:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack (your starting day will be different).

You will most likely have a period at the end of the second pack (while taking the white placebo tablets), but you may experience light bleeding or menstruation-like bleeding during the second pack.

2. You may also stop taking the active pink tablets and go directly to the 4 white placebo tablets. Before taking the placebo tablets, note the day on which you missed your tablet. The placebo period must not exceed 4 days. If you wish to start a new pack on the day you usually do, take the white placebo tablets for fewer than 4 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you missed any tablets in a pack and do not have a bleed during the placebo days, this may mean you are pregnant. You should contact your doctor before starting the next pack.

Calendar: If more than 24 hours have passed since you were due to take the active pink tablets

More than one tablet missed in this pack

Follow your doctor's advice.

If you vomit or have severe diarrhoea

If you vomit within 3 to 4 hours after taking an active pink tablet, or if you have severe diarrhoea, there is a risk that the active substances in the tablet have not been completely absorbed by your body. This situation is similar to missing a tablet. After vomiting or having diarrhoea, take another active pink tablet from a spare blister pack as soon as possible. If possible, take it within 24 hours of your usual tablet-taking time. If this is not possible, or if 24 hours or more have passed, follow the recommendations under “If you forget to take Drovelis”.

Delaying your period: what you need to know

Although not recommended, you may delay your period by not taking the white placebo tablets in the 4th row and instead going directly to a new Drovelis blister pack and completing it. You may experience light bleeding or menstruation-like bleeding while using this second pack. Finish this second pack by taking the 4 white placebo tablets. Then start the next pack. You may wish to consult your doctor before deciding to delay your menstrual period.

If you wish to change the starting day of your period

If you take the tablets as instructed, your period will begin during the days you take the placebo. If you need to change this day, shorten the number of days you take the placebo (i.e., when you take the white placebo tablets), but never extend it (maximum is 4 days). For example, if you usually start taking the placebo tablets on Friday and wish to change it to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. You may not experience bleeding during the shortened placebo period. While using the next pack, you may experience spotting or intermenstrual bleeding on the days you take the pink active tablets.

If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Drovelis

You may stop taking Drovelis at any time. If you do not wish to become pregnant, consult your doctor about other contraceptive methods before stopping.

If you stop taking Drovelis because you wish to become pregnant, it is recommended that you wait until you have had one natural menstrual period before trying to conceive. This will help you determine the due date of delivery more easily.

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

4. Possible adverse effects

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

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in 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 Drovelis”.

The following adverse effects have been associated with the use of Drovelis:

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

• Mood and libido disturbances and changes;
• headache;
• abdominal pain, nausea;
• acne;
• breast pain, painful menstruation, vaginal bleeding (during or between periods, heavy irregular bleeding);
• weight fluctuation.

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

• Fungal infection, vaginal infection, urinary tract infection;
• changes in appetite (appetite disorder);
• depression, emotional disturbance, anxiety disorder, stress, sleep problems;
• migraine, dizziness, tingling sensation, drowsiness;
• hot flushes;
• abdominal swelling (bloating), vomiting, diarrhoea;
• hair loss, excessive sweating (hyperhidrosis), dry skin, skin rash, skin swelling;
• back pain;
• breast swelling, breast lumps, abnormal genital bleeding, pain during sexual intercourse, fibrocystic breast disease (presence of one or more cysts in the breast), heavy menstrual bleeding, absence of menstruation, menstrual disorders, premenstrual syndrome, uterine contractions, uterine or vaginal bleeding including spotting, vaginal discharge, vulvovaginal disorders (dryness, pain, odour, discomfort);
• fatigue, swelling of various parts of the body, e.g., ankles (oedema), chest pain, abnormal sensation;
• blood tests showing increased liver enzymes, changes in certain types of blood fats (lipids).

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

• breast swelling;
• benign breast mass;
• hypersensitivity (allergy);
• fluid retention, increased blood potassium levels;
• nervousness;
• memory loss;
• dry eyes, blurred vision, visual deterioration;
• dizziness;
• high or low blood pressure, inflammation of a vein with formation of a blood clot (thrombophlebitis), varicose veins;
• constipation, dry mouth, indigestion, lip swelling, flatulence, intestinal inflammation, gastric reflux, abnormal intestinal contractions;
• allergic skin reactions, brownish-gold pigmented spots (chloasma) and other pigment disorders, male-pattern hair growth, excessive hair growth, skin disorders such as dermatitis and itchy dermatitis, dandruff and oily skin (seborrhoea), and other skin disorders;
• cramps, muscle and joint pain and discomfort;
• urinary tract pain, abnormal urine odour;
• pregnancy occurring outside the uterus (ectopic pregnancy);
• ovarian cyst, spontaneous milk flow increase, pelvic pain, breast discoloration, bleeding during sexual intercourse, endometrial disorders, nipple disorders, abnormal uterine bleeding;
• discomfort and general malaise, increased body temperature, pain;
• increased blood pressure, changes in blood tests (abnormal kidney function tests, increased blood potassium, increased blood glucose, decreased haemoglobin, decreased iron stores in the blood, blood in urine);
• harmful blood clots in a vein, 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).

Reporting of adverse effects

If you experience adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drovelis

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drovelis

The active substances are drospirenone and estetrol.

Each active pink tablet contains 3 mg of drospirenone and estetrol monohydrate equivalent to 14.2 mg of estetrol.

The white placebo tablets do not contain any active substances.

Other components are:

Active pink film-coated tablets:

Tablet core:

monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), sodium starch glycolate (see section 2 “Drovelis contains lactose and sodium”), corn starch, povidone K30, magnesium stearate (E470b).

Tablet coating:

hypromellose (E464), hydroxypropylcellulose (E463), talc (E553b), hydrogenated cottonseed oil, titanium dioxide (E171), iron oxide red (E172).

White placebo film-coated tablets:

Tablet core:

monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), corn starch, magnesium stearate (E470b).

Tablet coating:

hypromellose (E464), hydroxypropylcellulose (E463), talc (E553b), hydrogenated cottonseed oil, titanium dioxide (E171).

Appearance of the product and contents of the pack

The active film-coated tablets are pink, 6 mm in diameter, round, biconvex, with a droplet-shaped logo engraved on one side.

The placebo film-coated tablets are white to off-white, 6 mm in diameter, round, biconvex, with a droplet-shaped logo engraved on one side.

Drovelis is available in 28 film-coated tablets per blister (24 pink active tablets and 4 white placebo tablets), packed in a cardboard box. In addition to the blisters, the Drovelis box contains a storage case and 1, 3, 6, or 13 self-adhesive labels marked with the days of the week. The number of self-adhesive labels depends on the number of blisters.

Pack sizes: 28 (1 × 28), 84 (3 × 28), 168 (6 × 28), and 364 (13 × 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.