DROVELIS 3 mg/14.2 mg FILM-COATED TABLETS

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 for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Drovelis and what is it used for
2. What you need to know before you start taking Drovelis
3. How to take Drovelis
4. Possible side effects
5. Storing Drovelis
6. Package contents and further information

1. What is Drovelis and what is it used for

Drovelis is a contraceptive medicine used to prevent pregnancy.

• The 24 film-coated tablets, pink in color, are active tablets that contain a small amount of two different female hormones called estetrol and drospirenone.
• The 4 film-coated tablets, white in color, are inactive tablets that do not contain hormones and are called placebo tablets.
• Contraceptive medicines that contain two different hormones, like Drovelis, are called combined oral contraceptives. Combined oral contraceptives prevent pregnancy by preventing ovulation (release of an egg from the ovary) and reducing the possibility of any released egg being fertilized and you becoming pregnant.

2. What you need to know before taking Drovelis

General considerations

Before starting to take Drovelis, you should 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".

2 "Blood clots".

Before starting to take 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 also perform other tests.

In this prospectus, several situations are described in which you should stop taking Drovelis, or in which the effectiveness of the contraceptive may be reduced. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, using 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 since oral contraceptives can influence body temperature and cyclic changes in cervical mucus composition.

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

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.

protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.

• 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 any of these conditions appear for the first time while 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

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Tell your doctor if you suffer from any of the following conditions.

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drovelis increases your risk of having 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 the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

It is important to remember that the overall risk of having 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.

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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very 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 having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same product or a different product) again after an interruption 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 having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with Drovelis is small.
• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains low-dose ethinylestradiol (<50 micrograms of ethinylestradiol) combined with levonorgestrel, norethisterone, or norgestimate, 5-7 will have a blood clot in year.< li>
• It is not yet known how the risk of a blood clot with Drovelis compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
• The risk of having a blood clot will depend on your personal medical history (see "Factors that increase your risk of a blood clot" below).

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

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

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

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

It is important to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Drovelis. If any of the above conditions change while you are using Drovelis, for example, you start smoking, a close relative experiences a thrombosis without 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 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

. When using a combined hormonal contraceptive like 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 have more than one of these conditions or if any of them are particularly severe, the risk of having a blood clot may be increased further.

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

Cancer

There have been reports of breast cancer with a slightly higher frequency in women taking combined contraceptives, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected in women taking combined contraceptives because they are examined more frequently by their doctor. After stopping combined hormonal contraceptives, the increased risk decreases gradually. It is important that you regularly examine your breasts 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 (non-cancerous) liver tumors and, even more rarely, malignant (cancerous) liver tumors 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 contraceptives for more than 5 years. It is not known if this observation is due to the use of hormonal contraceptives or to other factors, such as differences in sexual behavior.

Psychiatric disorders

Some women who use hormonal contraceptives like Drovelis have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes, consult your doctor.

3. How to take Drovelis

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

How and when to take the pills

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

Each time you start a new Drovelis blister pack, take the active pink pill, identified with the number 1 (see “Start”). Choose from the 7 stickers with day indicators, the one that starts with your start day. For example, if you start on a Wednesday, use the day-of-the-week sticker that starts with “Wed”. Stick it on the frame of the front of the blister pack, just above the symbol “”. Each day will align with a row of pills. This allows you to check if you took your daily pill.

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

Follow the direction of the arrows on the blister pack, so first use the active pink pills, and then the white placebo pills.

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

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

Some users may not have menstruation every month while taking the white placebo pills. 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 day 2-5 of your cycle, but you must use additional protection measures (e.g., a condom) during the first 7 days of pill taking.

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

Start taking Drovelis preferably the day after you took the last active pill (the last pill that contains the active ingredients) of your previous oral contraceptive, and at the latest the day after the pill-free period of your previous oral contraceptive (or after the last inactive pill 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 progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) that releases progestogen)

You can switch any day from a progestogen-only pill (from an implant or an intrauterine system (IUS) on the day of its removal, from an injectable when the next injection is due) but, in all these cases, you must use additional protection measures (e.g., a condom) during the first 7 consecutive days you take the pills.

After a spontaneous or induced abortion

Follow your doctor's advice.

After having a baby

You can start taking Drovelis between 21 and 28 days after giving birth. If you start later than 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 sexual intercourse 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 baby

Read the section “Breastfeeding”.

Ask your doctor or pharmacist what to do if you are not sure when to start.

If you take more Drovelis than you should

No serious adverse effects have been reported due to taking too many Drovelis pills. If you have taken several pills 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 pills, 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 pills in the blister pack are the placebo pills. If you forget one of these pills, it has no effect on the reliability of Drovelis. You should discard the forgotten white placebo pill.

If you forget an active pink pill(pills 1 to 24 of your blister pack), you should do the following:

• if less than 24 hours have passed since you forgot the active pink pill, protection against pregnancy is not reduced. Take the pill as soon as you remember and continue taking the next pills at the usual time

• if more than 24 hours have passed since you forgot the active pink pill, protection against pregnancy may be reduced. The more pills you have forgotten, the higher the risk of becoming pregnant.

There is a risk of incomplete protection against pregnancy if you forget to take an active pink pill at the beginning or end of the blister pack. Therefore, you should follow these instructions (also see the diagram):

More than one pill forgotten in this blister pack:

Contact your doctor.

An active pink pill forgotten between days 1 to 7

Take the pill you forgot as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time and use additional precautions, such as a condom, for the next 7 days while taking the pills correctly. If you have had sexual intercourse in the week before you forgot to take the pill, you should consider the risk of pregnancy. In this case, consult your doctor immediately.

An active pink pill forgotten between days 8 to 17

Take the pill you forgot as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Protection against pregnancy is not reduced, and no additional precautions are necessary.

An active pink pill forgotten between days 18 to 24

You can follow the two options indicated below:

1. Take the pill you forgot to take as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Instead of taking the white placebo pills from this blister pack, discard them and start the next blister pack (the start day will be different).

It is likely that you will have a period at the end of the second blister pack (while taking the white placebo pills) but you may have a light or menstrual-like bleeding during the second blister pack.

1. You can also stop taking the active pink pills and go directly to the 4 white placebo pills. Before taking the white placebo pills, note the day you forgot to take your pill. The period with placebo should not exceed 4 days. If you want to start a new blister pack on the day you always do, take the white placebo pills 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 any of the pills from a blister pack, and you do not have bleeding during the placebo days, this may mean that you are pregnant. You should contact your doctor before starting the next blister pack.

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

More than one pill forgotten in this blister pack

Follow your doctor's advice.

If you vomit or have severe diarrhea

If you vomit within 3 or 4 hours after taking an active pink pill, or if you have severe diarrhea, there is a risk that the active ingredients of the pill have not been fully absorbed into the body. This situation is similar to if you forget to take a pill. After vomiting or having diarrhea, you should take another active pink pill from a reserve blister pack as soon as possible. If possible, take it within 24 hours after the usual time you take the pill. If this is not possible or if 24 hours or more have passed, you should follow the recommendation under “If you forget to take Drovelis”.

Delaying menstruation: what you should know

Although it is not recommended, you can delay your period by not taking the white placebo pills from the 4th row and going directly to a new Drovelis blister pack and finishing it. You may experience light or menstrual-like bleeding while using this second blister pack. Finish this second blister pack by taking the 4 white placebo pills. Then, start the next blister pack. 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 pills according to the instructions, menstruation will start during the days you take the placebo pills. If you need to change this day, reduce the number of days you take the placebo pills, i.e., when you take the white placebo pills, but never increase them (the maximum is 4). For example, if you start taking the placebo pills on Friday, and you want to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. You may not experience bleeding during the shortened period you take the white placebo pills. While using the next blister pack, you may experience some bleeding (spots or drops of blood) or intermenstrual bleeding on the days you take the active pink pills.

If you are not sure what to do, consult your doctor or pharmacist.

If you stop 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 first.

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 date of birth more easily.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side 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 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 you start taking Drovelis”.

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

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

• mood disorder and alteration of libido;
• headache;
• abdominal pain, nausea;
• acne;
• breast pain, painful menstruation, vaginal bleeding (during or outside of periods, irregular heavy 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 disorder, anxiety disorder, stress, sleep disorders;
• migraine, dizziness, tingling sensation, somnolence;
• hot flashes;
• abdominal swelling (abdominal bloating), vomiting, diarrhea;
• hair loss, excessive sweating (hyperhidrosis), dry skin, skin rash, skin swelling;
• back pain;
• breast inflammation, breast lumps, abnormal genital bleeding, painful 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, odor, discomfort);
• fatigue, swelling of different parts of the body, e.g., ankles (edema), 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 1000 people):

• breast inflammation;
• benign breast tumor;
• hypersensitivity (allergy);
• fluid retention, increased potassium levels in the blood;
• nervousness;
• memory loss;
• dry eye, blurred vision, visual impairment;
• stupor;
• high or low blood pressure, inflammation of a vein with blood clot formation (thrombophlebitis), varicose veins;
• constipation, dry mouth, indigestion, lip swelling, flatulence, intestinal inflammation, gastroesophageal reflux, abnormal intestinal contractions;
• allergic reactions on the skin, brown-gold pigmented spots (chloasma) and other pigmentation disorders, male pattern hair growth, excessive hair growth, skin diseases such as dermatitis and itchy dermatitis, dandruff, and oily skin (seborrhea) and other skin disorders;
• cramps, muscle and joint pain and discomfort;
• urinary tract pain, abnormal urine odor;
• pregnancy that occurs outside the uterus (ectopic pregnancy);
• ovarian cyst, spontaneous increase in milk flow, pelvic pain, breast discoloration, bleeding during intercourse, endometrial disorders, nipple disorders, abnormal uterine bleeding;
• discomfort and general feeling of malaise, increased body temperature, pain;
• increased blood pressure, changes in blood tests (abnormal kidney function tests, increased potassium in the blood, increased glucose in the blood, decreased hemoglobin, decreased iron reserves in the blood, blood in the 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
• mild or temporary stroke-like symptoms, called a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye

The risk 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 a possible side effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional 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 active substances.

The other ingredients are:

Active pink film-coated tablets:

Tablet core: