Prospect: information for the user

Drovelis 3 mg/14.2 mg film-coated tablets

drospirenone/estetrol

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to others, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Drovelis is a contraceptive medication 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 medications that contain two different hormones, such as Drovelis, are called combined oral contraceptives. Combined oral contraceptives prevent pregnancy by preventing ovulation (release of an egg from the ovary) and reducing the likelihood that any released egg will be fertilized and you become pregnant.

Do not take Drovelis

You should 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 what other form of contraception would be more suitable.

• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• if you know that you have a disorder that affects 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 spend a lot of time unable to get up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• if you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• severe diabetes with vascular 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) a benign or malignant liver tumor.
• if you have (or have ever had) a liver disease and your liver is not functioning normally.
• if your kidneys are not functioning well (renal insufficiency).
• if you have (or have ever had) or suspect that you may have breast cancer or cancer of the reproductive organs.
• if you have unexplained vaginal bleeding;
• if you are allergic to estetrol or drospirenone, or to any of the other components of this medication (including those listed in section 6).

If any of these conditions appear for the first time while taking Drovelis, stop taking it immediately and consult your doctor. Meanwhile, 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.

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

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

• if a close relative has or has had breast cancer;
• if you have angioedema hereditaria. Medications containing estrogens can induce or worsen the symptoms of angioedema. Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or rashes, accompanied by difficulty breathing;
• if you have liver disease or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have epilepsy (see section 2, “Use of Drovelis with other medications”);
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• 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 if you spend a lot of time unable to get up (see section 2 “Blood Clots”);
• if you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Drovelis after childbirth;
• if you have superficial thrombophlebitis;
• if you have varicose veins;
• if you have (or have ever had) melasma (brown or dark patches, especially on the face). In that case, avoid direct exposure to sunlight or ultraviolet light;
• if you experience any condition that occurred during pregnancy or with the use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy [herpes gestational], a nervous disorder characterized by involuntary body movements [Sydenham's chorea]).

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drovelis increases your risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of suffering a harmful blood clot due to Drovelis is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

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 thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of 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 lodges in the lung, it may cause a pulmonary embolism.
• In rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same product or a different product) after a break of 4 weeks or more.

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

When you stop taking Drovelis, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of developing 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.
• Of every 10,000 women who are not using a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive containing etinilestradiol at low doses (<50levonorgestrel, noretisterone, or norgestimato), about 5-7 will develop a blood clot in a year.
• The risk of developing a blood clot with Drovelis is not yet known.

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

Your risk of a blood clot with Drovelis is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• if any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited disorder of blood clotting.
• if you need surgery or if you spend a lot of time unable to get up due to an injury or illness, or if you have your leg immobilized. You may need to stop taking Drovelis for several weeks before surgery or while you have limited mobility. If you need to stop taking Drovelis, ask your doctor when you can start taking it again.
• with increasing age (especially above about 35 years old).
• if you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (> 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you experience any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking Drovelis. If any of the conditions listed above change while you are using Drovelis, for example, a close relative experiences a blood clot without a known cause, or you gain a lot 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

• It is essential to note that the risk of a heart attack or stroke due to Drovelis is very small, but it may increase:
• with age (above about 35 years old);
• if you smoke. When using a combined hormonal contraceptive like Drovelis, you are advised to quit smoking. If you are unable to quit 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 (less than about 50 years old). You may also be at higher risk of a 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 have migraines, especially migraines with aura;
• if you have a heart condition (valve disorder, a rhythm disorder called atrial fibrillation);
• if you have diabetes.

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

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

Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined hormonal contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to the fact that women taking combined hormonal contraceptives are examined more frequently by their doctor. After stopping combined hormonal contraceptives, the increased risk decreases gradually. It is essential to explore your breasts regularly and consult your doctor if you notice any lump. You should also inform your doctor if a close relative has or has had breast cancer (see section 2, “When to have special care with Drovelis”).

In rare cases, benign liver tumors (non-cancerous) and, in even rarer cases, malignant liver tumors (cancerous) have been reported. Contact your doctor if you experience severe abdominal pain that is not usual.

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

Mental health disorders

Some women who use Drovelis have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting between periods

Your period will start normally while you are taking the white placebo pills in the Drovelis pack. During the first few months of taking Drovelis, you may experience unexpected bleeding (bleeding outside the days when you are taking the white placebo pills). Most of these bleedings are light and usually do not require the use of sanitary pads. If this bleeding persists for more than a few months or if it starts after some months, your doctor will need to investigate the cause.

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

If you have taken all the active pink pills correctly, have not had severe vomiting or 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 pills correctly, or if the expected bleeding does not occur on two consecutive occasions, you may be pregnant. Contact your doctor immediately. Only start the next pack if you are sure you are not pregnant. See also section 3 “If you vomit or have severe diarrhea” or section 2 “Other medications and Drovelis”.

Children and adolescents

Drovelis is only indicated after menarche (the first menstruation). There are no data on safety and efficacy in girls under 16 years old.

Other medications and Drovelis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Also, inform any other doctor or dentist who prescribes another medication (or 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 if you should change the use of some other medication.

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

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin);
• infections caused by HIV and hepatitis C virus (HCV) (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 pulmonary vessels (e.g., bosentan).

Herbal products containing St. John's Wort may make Drovelis less effective. If you want to use herbal products containing St. John's Wort while taking Drovelis, first consult your doctor.

If you are taking these medications or herbal products that may reduce the effectiveness of Drovelis, you should also use a barrier method. The barrier method should be used during the entire treatment period and for 28 days after its interruption. If the concomitant treatment extends beyond the active pink pills in the current pack, the white placebo pills should be discarded and the next pack of Drovelis should be started immediately.

If long-term treatment with the mentioned medications is required, you should use non-hormonal contraceptives. Consult your doctor or pharmacist.

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

• ciclosporin (a medication used to prevent tissue rejection after a transplant);
• lamotrigine (a medication used to treat epilepsy).

The combined treatment regimen for hepatitis C virus (HCV) infection

ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin may cause elevations in liver function test results (increased ALT levels) in women using AHCs containing etinilestradiol. Drovelis contains estetrol instead of etinilestradiol. It is unknown whether an increase in ALT levels may occur when Drovelis is used with this combined treatment regimen for HCV. Your doctor will inform you about this.

Ask your doctor or pharmacist before taking any medication.

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 may be pregnant should not use Drovelis. If you become pregnant while taking Drovelis, stop taking it immediately and contact your doctor.

If you want to become pregnant, you can stop taking Drovelis at any time (see section 3, “If you interrupt treatment with Drovelis”).

Drovelis is not recommended during breastfeeding. If you want to use a hormonal oral contraceptive during the breastfeeding period, consult your doctor.

Driving and operating machinery

The influence of Drovelis on your ability to drive and operate machinery is negligible or insignificant.

Drovelis contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

The active pink pill contains less than 1 mmol of sodium (23 mg) per pill, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How and when to take the tablets

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

Each time you start a new Drovelis blister, take the pink active tablet, identified with the number 1 (see "Start"). Choose one of the 7 stickers with the day indicators, starting with your start day. For example, if you start on a Wednesday, use the sticker that starts with "Wed". Stick it in 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 if you took your daily tablet.

Take one tablet each 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, and then the white placebo tablets.

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

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

Some users may not have a period every month while taking the white placebo tablets. If you have taken Drovelis every day according to these instructions, it is unlikely that you are pregnant.

Start of your first Drovelis package

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 menstruation, you will be immediately protected against pregnancy.

You can also start on days 2-5 of your cycle, but you must use additional protection measures (e.g., a condom) during the first 7 days of taking the tablets.

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

Start taking Drovelis preferably on the day after taking the last active tablet (the last tablet containing the active ingredients) of your previous oral contraceptive, and no later than the day after the pill-free period of your previous oral contraceptive (or after the last inactive tablet of your previous oral contraceptive). When switching from a vaginal ring or a transdermal patch, follow your doctor's recommendations.

If you switch from a method that only contains progestin (progestin-only oral contraceptive, injection, implant, or intrauterine system releasing progestin)

You can switch any day from a progestin-only oral contraceptive (from an implant or an intrauterine system on the day of its removal, from an injectable when the next injection should be administered) but, in all these cases, you must use additional protection measures (e.g., a condom) during the first 7 consecutive days you take the tablets.

After a spontaneous or induced abortion

Follow your doctor's advice.

After giving birth

You can start taking Drovelis between 21 and 28 days after delivery. If you start after day 28, you must use an additional barrier method (e.g., a condom) during the first 7 days you take Drovelis. If, after giving birth, you have had sex before starting to take Drovelis, make sure you are not pregnant or wait until your next menstruation.

If you are breastfeeding and want to start Drovelis (again) after having a child

Read the "Breastfeeding" section.

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

If you take more Drovelis than you should

No serious side effects have been reported for 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 who have taken this medication by accident, may experience vaginal bleeding.

If you have taken too many Drovelis tablets, or if you discover that a child has taken Drovelis, ask your doctor for advice.

If you forget to take Drovelis

The last 4 white tablets in the blister are the placebo tablets. If you forget one of these tablets, it will have no effect on the reliability of Drovelis. You must throw away the forgotten white placebo tablet.

If you forget apink active tablet(tablets 1 to 24 of your blister), you must do the following:

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

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

There is a risk of incomplete protection against pregnancy if you forget to take a pink active tablet from the start or end of the blister. Therefore, you should follow the following instructions (see also the diagram):

More than one tablet forgotten in this blister:

Consult your doctor.

One pink active tablet forgotten between days 1 to 7

Take the tablet you forgot as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time and use additional precautions, such as a condom, during the next 7 days while taking the tablets correctly. If you have had sex in the week before forgetting to take the tablets, you should consider that there is a risk of pregnancy. In that case, consult your doctor immediately.

One pink active tablet forgotten between days 8 to 17

Take the tablet you forgot as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and no additional precautions are necessary.

One pink active tablet forgotten between days 18 to 24

You can follow the two options indicated below:

1. Take the tablet you forgot to take as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets of this blister, discard them and start the next blister (the start day will be different).

It is likely that you will have a period at the end of the second blister (while taking the white placebo tablets) but you may experience light bleeding or similar to menstruation during the second blister.

1. You can also leave taking the pink active tablets and go directly to the 4 white placebo tablets. Before taking the white placebo tablets, note the day you forgot to take your tablet. The period with placebo should not exceed 4 days. If you want to start a new blister on the day you always do, take the white placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will still be protected against pregnancy.

If you forgot to take one of the tablets from a blister, and you do not have bleeding during the placebo days, this may mean that you are pregnant. You must consult your doctor before starting the next blister.

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

Morethan one tablet forgotten in this blister

Follow your doctor's advice.

If you vomit or have intense diarrhea

If you vomit within 3 or 4 hours of taking a pink active tablet, or if you have intense diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed by the body. This situation is similar to forgetting to take a tablet. After vomiting or diarrhea, you must take, as soon as possible, another pink active tablet from a reserve blister. If possible, take it within 24 hours of the usual time. If this is not possible or if more than 24 hours have passed, you should follow the recommendation under "If you forgot to take Drovelis".

Delaying menstruation: what you should know

Although not recommended, you can delay your period by nottaking the white placebo tablets of the 4th row and going directly to a new blister of Drovelis and finishing it. You may experience light bleeding or similar to menstruation while using this second blister. Finish this second blister by taking the 4 white placebo tablets. Then, start the next blister. You can ask your doctor for advice before deciding to delay your menstrual period.

If you want to change the start day of your menstruation

If you take the tablets according to the instructions, your period will start during the days you take the placebo. If you need to change this day, reduce the number of days you take the placebo, i.e., when you take the white placebo tablets, but never increase it (the maximum is 4). For example, if you start taking the placebo tablets on a Friday, and you want to change it to a Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. You may not experience bleeding during the shortened period when you take the white placebo tablets. While using the next blister, you may experience some bleeding (spots or streaks of blood) or intermenstrual bleeding on the days you take the pink active tablets.

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

If you interrupt treatment with Drovelis

You can stop taking Drovelis at any time. If you do not want to become pregnant, ask your doctor about other contraceptive methods.

If you stop taking Drovelis because you want to become pregnant, it is recommended that you wait until you have had a natural menstruation before trying to conceive. This will help you determine the due date more easily.

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

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

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Drovelis”.

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

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

• Mood and libido disorders;
• Headaches;
• Abdominal pain, nausea;
• Acne;
• Breast pain, painful menstruation, vaginal bleeding (during or outside of periods, heavy irregular bleeding);
• Weight fluctuations.

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

• Fungal infections, vaginal infections, urinary tract infections;
• Changes in appetite (appetite disorders);
• Depression, emotional disorders, anxiety disorders, stress, sleep problems;
• Migraines, dizziness, tingling sensation, drowsiness;
• Seizures;
• Abdominal swelling (belly), vomiting, diarrhea;
• Hair loss, excessive sweating (hyperhidrosis), dry skin, skin rash, skin swelling;
• Back pain;
• Mastitis, breast lumps, abnormal genital bleeding, painful sex, fibrocystic breast disease (presence of one or more cysts in the breast), heavy menstrual bleeding, amenorrhea, menstrual disorders, premenstrual syndrome, uterine contractions, vaginal or uterine bleeding including spotting, vaginal discharge, vulvovaginal disorders (dryness, pain, odor, discomfort);
• Fatigue, swelling of different parts of the body, e.g., ankles (edema), chest pain, abnormal sensation;
• Blood tests showing an increase in liver enzymes, changes in certain types of blood fats (lipids).

Rare (may affect up to 1 in 1000 people):

• Mastitis;
• Benign breast mass;
• Hypersensitivity (allergy);
• Fluid retention, increased potassium levels in the blood;
• Nervousness;
• Memory loss;
• Dry eyes, blurred vision, visual deterioration;
• Drowsiness;
• High or low blood pressure, inflammation of a vein with the formation of a blood clot (thrombophlebitis), varicose veins;
• Constipation, dry mouth, indigestion, swelling of the lips, flatulence, intestinal inflammation, gastroesophageal reflux, abnormal intestinal contractions;
• Allergic reactions on the skin, brown-golden patches (chloasma) and other pigmentation disorders, male pattern hair growth, excessive hair growth, skin diseases such as dermatitis and pruritic dermatitis, dandruff, and other skin disorders;
• Muscle cramps, muscle and joint pain;
• Urinary tract pain, abnormal urine odor;
• Ectopic pregnancy;
• Ovarian cyst, spontaneous milk flow, pelvic pain, breast discoloration, bleeding during sex, endometrial disorders, nipple disorders, abnormal uterine bleeding;
• General discomfort and feeling of unease, increased body temperature, pain;
• Increased blood pressure, changes in blood tests (abnormal renal function tests, increased potassium in the blood, increased blood glucose, decreased hemoglobin, decreased iron reserves in the blood, blood in the urine);
• Deleterious blood clots in a vein, for example:
• In a leg or foot (i.e., DVT)
• In a lung (i.e., PE)
• Heart attack
• Stroke
• Mild or transient stroke-like symptoms, known as transient ischemic attack (TIA)
• Blood clots in the liver, stomach/intestine, kidneys, or eye

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

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if it is about possible side effects that do not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and the box after CAD and EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Drovelis

The active principles 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 active principles.

The other components are:

Active pink tablets with film coating:

Tablet core:

monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), sodium starch glycolate (see section 2 “Drovelis contains lactose and sodium”), cornstarch, 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 tablets with film coating:

Tablet core:

monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), cornstarch, 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 package

The active tablets with film coating are pink, 6 mm in diameter, round, biconvex, with a drop-shaped logo engraved on one face.

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

Drovelis is presented in blisters of 28 tablets with film coating (24 active pink tablets and 4 white placebo tablets), packaged in a cardboard box. In addition to the blisters, the Drovelis box contains a conservation pouch and 1, 3, 6, or 13 adhesive labels marked with the days of the week. The number of adhesive labels depends on the number of blisters.

Package sizes: 28 (1 × 28), 84 (3 × 28), 168 (6 × 28), and 364 (13 × 28) tablets with film coating.

Only some package sizes may be marketed.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Responsible for manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Last review date of this leaflet:

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