Drovelis

Patient Information Leaflet: Information for the user

Drovelis 3 mg/14.2 mg film-coated tablets

drospirenone/estetrol
Important information about combined hormonal contraceptives (CHCs)

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

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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 pill used to prevent pregnancy.

• The 24 pink film-coated tablets are active tablets containing a small amount of two different female hormones called ethinylestradiol and drospirenone.
• The 4 white film-coated tablets are inactive tablets that do not contain hormones and are referred to as placebo tablets.
• Contraceptive pills that contain two different hormones, such as Drovelis, are called "combination" pills. They work together to prevent ovulation (the release of an egg from the ovaries) and reduce the likelihood that any released egg will be fertilized and result in pregnancy.

2. What you should know before taking Drovelis

General notes
Before starting to take Drovelis, you must read the information about blood clots contained in section 2. It is particularly important to read the text relating to symptoms of a blood clot – see section 2 “Blood clots”.
Before you can start taking 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 individual situation, may carry out additional tests.
This patient information leaflet describes various situations in which you must stop using the pill, or in which the reliability of the pill may be reduced. In these situations, you must either abstain from sexual intercourse or use additional non-hormonal contraceptive measures, such as a condom or another barrier method. Do not use methods based on biological rhythms or body temperature. These methods may be ineffective because the pill alters the normal variations in body temperature and cervical mucus that occur during the menstrual cycle.
Drovelis, like other hormonal contraceptives, does not protect against infection with the human immunodeficiency virus (HIV) (acquired immunodeficiency syndrome, AIDS) or other sexually transmitted diseases.

Do not take Drovelis
Do not take Drovelis if any of the conditions listed below apply to you. If any of the conditions listed below apply to you, inform your doctor. Your doctor will discuss with you other more suitable methods of birth control.

• if you are allergic to estetrol or drospirenone or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have previously had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• if you know you have a blood clotting disorder, for example protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are about to undergo surgery or need to remain bedridden for a prolonged period (see section “Blood clots”);
• if you have previously had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you suffer from any of the following conditions that may increase the risk of blood clots in the arteries:
• severe diabetes with vascular damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinaemia;
• if you have (or have previously had) a type of migraine called “migraine with aura”;
• if you have (or have previously had) a benign or malignant liver tumour;
• if you have (or have previously had) a serious liver disease and your liver is not yet functioning normally;
• if your kidneys do not function properly (renal insufficiency);
• if you have (or have previously had) or suspect you may have a tumour of the breast or genital organs;
• if you have vaginal bleeding of unknown origin.

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Drovelis.

When to contact your doctor
Contact your doctor urgently

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

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

Inform your doctor if any of the following conditions apply to you.
You must also inform your doctor if any of these conditions appear or worsen while taking Drovelis:

• if a close female relative has or has had breast cancer;
• if you have hereditary or acquired angioedema. Medicines containing estrogens may cause 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 with difficulty breathing;
• if you have a liver or gallbladder disease;
• if you have a kidney disease;
• if you have diabetes;
• if you suffer from depression;
• if you have epilepsy (see section 2 “Other medicines and Drovelis”);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s immune system);
• if you have haemolytic uraemic syndrome (HUS – a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are about to undergo surgery or need to remain bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, the risk of blood clots is higher. Ask your doctor how long after delivery you can start taking Drovelis;
• if you have inflammation of veins located under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have or have ever had chloasma (a skin pigmentation disorder, particularly on the face or neck, also known as “melasma”). In this case, avoid direct exposure to sunlight or ultraviolet light;
• if you have a condition that first appeared or worsened during pregnancy or during 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 sudden involuntary movements of the body [Sydenham’s chorea]).

BLOOD CLOTS
Using a combined hormonal contraceptive such as Drovelis increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from thrombosis is not always complete. Rarely, serious effects may persist, and very rarely, these may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Drovelis is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor urgently if you experience any of the following signs or symptoms.
Do you notice any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or excessive tenderness in the leg, which may occur only when standing or walking
• unusual warmth in the affected leg
• change in skin colour of the leg, such as paleness, redness, or bluish discolouration
• unexplained shortness of breath or rapid breathing starting suddenly;
• sudden cough without obvious cause, possibly with coughing up of blood;
• sharp chest pain, which may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain;

If in doubt, consult your doctor, as some of these symptoms,
such as cough or shortness of breath, may be mistaken for a less
serious illness, for example a respiratory tract infection (such as
a common cold).

More commonly, symptoms affect only one eye: Retinal vein thrombosis

• sudden loss of vision or blurred vision without pain, which may progress to complete vision loss
• pain, discomfort, pressure, or heaviness in the chest; Heart attack
• sensation of tightness or pressure in the chest, arm, or behind the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body spreading to the back, jaw, throat, arm, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat
• sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; Stroke
• sudden confusion or difficulty speaking or understanding;
• sudden difficulty seeing in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden, severe, or prolonged headache without known cause;

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 side effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism (PE).
• Very rarely, a clot may form in a vein of another organ such as the eye (retinal venous thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 weeks or more.
After the first year, the risk decreases but remains slightly higher than the risk in women who do not use a combined hormonal contraceptive.
When you stop taking Drovelis, the risk of blood clots returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Drovelis is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a clot in 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, about 5–7 will develop a clot in one year.
• The risk of blood clots associated with Drovelis compared to that associated with a combined hormonal contraceptive containing levonorgestrel is not yet known.
• The risk of developing a blood clot varies depending on your personal medical history (see below “Factors that increase the risk of a blood clot”).

Factors that increase the risk of a blood clot in a vein
The risk of developing a blood clot with Drovelis is low, but it increases in the presence of certain conditions. The risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (e.g., before approximately 50 years of age). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden due to injury or illness, or if you have a leg in a cast. You may need to stop taking Drovelis several weeks before surgery or during periods of reduced mobility. If you need to discontinue Drovelis, ask your doctor when you can start taking it again;
• with increasing age (particularly above approximately 35 years);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions apply to you.
Air travel (lasting more than 4 hours) may temporarily increase the risk of blood clots, especially if you have other risk factors listed above.
It is important to inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide that you should stop using Drovelis.
If any of the conditions listed above change while you are using Drovelis—for example, if a close relative develops thrombosis without a known cause, or if 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 may lead to a heart attack or stroke.

Factors that increase the risk of a blood clot in an artery
It is important to note that the risk of heart attack or stroke due to the use of Drovelis is very low, but it may increase:

• with increasing age (after approximately 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Drovelis, you should 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 (before approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraines, especially migraines with aura;
• if you have a heart condition (a heart valve disease, or a rhythm disorder called atrial fibrillation);
• if you have diabetes.

If more than one of these conditions applies to you, or if one of them is particularly severe, the risk of developing a blood clot may be even greater.
If any of the conditions listed above change while you are using Drovelis—for example, if you start smoking, a close relative develops thrombosis without a known cause, or you gain significant weight—inform your doctor.

Cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, more cancers may be diagnosed in women using combined pills because these women visit their doctor more frequently. After stopping the combined pill, the increased risk gradually decreases. It is important to examine your breasts regularly and contact your doctor if you notice lumps.
Also inform your doctor if a close relative has or has previously had breast cancer (see section 2 “Warnings and precautions”).

Rarely, benign (non-cancerous) liver tumors and, even more rarely, malignant (cancerous) liver tumors have been reported in women using oral contraceptives. Contact your doctor if you experience unusual and particularly severe abdominal pain.

Cervical cancer is caused by infection with human papillomavirus (HPV). This cancer has been reported more frequently in women who use the pill for more than 5 years. It is not known whether this 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, including Drovelis, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

Bleeding between periods
Your menstrual period will begin 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 placebo days). This bleeding is usually light and generally does not require sanitary protection. If bleeding persists for more than a few months or starts after several months of use, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo days
If you have taken all the pink active tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant. Continue taking Drovelis as usual.
If you have not taken the tablets correctly, or if the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are certain you are not pregnant. See also section 3 “In case of vomiting or severe diarrhea” or section 2 “Other medicines and Drovelis”.

Children and adolescents
Drovelis is indicated only after menarche (the first menstrual period).

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

Some medicines can affect the blood levels of Drovelis and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include 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., so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin);
• high blood pressure in the pulmonary blood vessels (e.g., bosentan).

The herbal product St. John’s wort (Hypericum perforatum) may also prevent Drovelis from working properly. If you wish to use herbal products containing St. John’s wort while taking Drovelis, consult your doctor first.

If you are taking medicines or herbal products that could reduce the effectiveness of Drovelis, you should also use a barrier contraceptive method. The barrier method should be used throughout the entire duration of concomitant medicinal treatment and for 28 days after stopping it. If the concomitant medicinal treatment continues beyond the end of the pink active tablets in the current pack, the white placebo tablets should be omitted and the next pack of Drovelis should be started immediately.

If long-term treatment with the above-mentioned medicines is required, you should use non-hormonal contraceptive methods. Ask your doctor or pharmacist for advice.

Drovelis may affect the action of other medicines, for example: ­ cyclosporine (a medicine used to prevent tissue rejection after surgical transplants); ­ lamotrigine (a medicine used to treat epilepsy).

The HCV combination therapy regimen containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, as well as the regimens containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, may cause increases in liver function blood test results (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Drovelis contains estetrol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT values may occur when using Drovelis with these HCV combination therapies. Your doctor will advise you accordingly.

Ask your doctor or pharmacist for advice before taking any medicine.

Laboratory tests
If you undergo blood tests or urine tests, inform your doctor that you are taking Drovelis, as it may affect the results of certain tests.

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

Pregnancy and breastfeeding
This medicine must not be taken by women who are pregnant or suspect they may be pregnant.
If you become pregnant while using Drovelis, 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”).

This medicine is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.

Driving and using machines
Drovelis does not affect or affects negligibly the ability to drive and use machines.

Drovelis contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
The pink active tablet contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Drovelis

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

When and how to take the tablets

The blister contains 28 film-coated tablets: 24 pink active tablets with active substances (days 1–24) and 4 white placebo tablets without active substances (days 25–28).
Each time you start a new Drovelis blister pack, take the first pink active tablet marked "1" (see "Starting"). Choose from the adhesive labels showing the 7 days of the week the one starting with your starting day. For example, if you start on Wednesday, use the adhesive label beginning with “Wed.”. Attach it to the frame on the front of the blister card at the symbol “*”.

Each day will then align with a row of pills. This allows you to check whether you have taken your daily tablet.
Take one tablet every day at approximately the same time, with some water if necessary.
Follow the direction of the arrows on the blister: take the pink active tablets first, followed by the white placebo tablets.

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

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

Some women may not have a menstrual 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.

How to start the first pack of Drovelis

If you have not used hormonal contraceptives in the previous month
Start taking Drovelis on the first day of your cycle (i.e., the first day of your menstrual period). If you start Drovelis on the first day of your period, you will be immediately protected against pregnancy.
You may also start between days 2 and 5 of your cycle, but in this case you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet-taking.

Switching from another combined hormonal contraceptive or from a combined vaginal ring/combined transdermal patch
You may start taking Drovelis the day after taking the last active tablet (the last tablet containing active substances) of your previous contraceptive, but no later than the day after the end of the tablet-free interval of your previous pill (or after the last inactive tablet of your previous pill). If switching from a combined contraceptive vaginal ring or a transdermal patch, follow your doctor’s advice.

Switching from a progestogen-only method (progestogen-only pill, injectable, implant, or progestogen-releasing intrauterine device [IUD])
You may switch from the progestogen-only pill on any day (from an implant or IUD on the day of removal, from an injectable contraceptive on the day the injection was due). However, in all these cases, you must use additional contraceptive precautions (e.g., a condom) for the first 7 consecutive days of taking Drovelis.

After a spontaneous or induced abortion
Follow your doctor’s instructions.

After childbirth
You may start taking Drovelis between 21 and 28 days after childbirth. If you start later than day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using Drovelis. If you have had sexual intercourse after childbirth before starting Drovelis, you must first ensure you are not pregnant or wait for the onset of your next menstrual period.

If you are breastfeeding and wish to start (or restart) Drovelis after childbirth
See the section “Breast-feeding”.

Ask your doctor or pharmacist for advice if you are unsure about when to start.

If you take more Drovelis than you should

No serious harmful effects have been reported in cases of overdose with Drovelis tablets.
If you take several tablets at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Even girls who have not yet started menstruating may experience such bleeding if they have accidentally taken this medicine.
If you have taken too many Drovelis tablets, or if you find that a child has taken any, consult your doctor or pharmacist.

If you forget to take Drovelis

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

If you forget a pink active tablet (tablets 1–24 in your blister strip), follow the instructions below:

• If you are less than 24 hours late in taking a tablet, contraceptive protection remains effective. Take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.
• If you are more than 24 hours late in taking a pink active tablet, protection against pregnancy may be reduced. The more consecutive tablets you miss, the higher the risk of becoming pregnant.

The risk of pregnancy is particularly high if you miss active pink tablets at the beginning or end of the strip. In such cases, follow the instructions below (see also the diagram):

More than one tablet missed in this strip
Contact your doctor.

One pink active tablet missed between days 1–7
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time and use additional contraceptive precautions (e.g., a condom) for the next 7 days during correct tablet-taking. If you had sexual intercourse during the week before missing the tablet, be aware of the risk of pregnancy. In this case, contact your doctor.

One pink active tablet missed between days 8–17
Take the missed tablet as soon as possible, 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 you do not need additional contraceptive precautions.

One pink active tablet missed between days 18–24
You have two options:

1. Take the missed tablet as soon as possible, 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 strip, discard them and immediately start the next strip (your starting day will now be different). You will most likely get your period at the end of the second strip, while taking the white placebo tablets, but you may experience light bleeding or spotting during the second strip.
2. You may also stop taking the pink active tablets and go directly to the 4 white placebo tablets. Before taking the placebo tablets, note the day on which you missed the tablet. The placebo period must not exceed 4 days. If you wish to start a new strip on your usual starting day, take fewer than 4 white placebo tablets.

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

If you have missed any tablet in a strip and do not have any bleeding during the placebo days, you may be pregnant. Contact your doctor before starting the next strip.

Flowchart for delays exceeding 24 hours in taking pink active tablets
More than one tablet missed in this strip
Follow your doctor’s instructions.

In case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a pink active tablet or have severe diarrhoea, there is a risk that the active substances in the tablet are not completely absorbed by your body. This situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another pink active 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 more than 24 hours have passed, follow the advice given under “If you forget to take Drovelis”.

Delaying your period: what you need to know

Although not recommended, you can delay your period by skipping the white placebo tablets in the fourth row and starting a new complete strip of Drovelis immediately. During use of this second strip, you may experience light spotting or breakthrough bleeding. Finish this second strip by taking the 4 white placebo tablets. Then start the next strip. You may wish to consult your doctor before deciding to delay your period.

If you wish to change the day your period starts

If you take the tablets as directed, your period will start during the placebo tablet days. If you wish to change this day, reduce the number of placebo days (i.e., the days when you take the white placebo tablets), but never extend them (4 is the maximum). For example, if you usually start taking the white placebo tablets on Friday and wish to shift to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. During this shorter placebo interval, you may not have any bleeding. While using the next blister pack, you may experience spotting or breakthrough bleeding during the days you take the pink active tablets.

If you are unsure what to do, contact 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 alternative methods of contraception before stopping.

If you stop taking Drovelis because you wish to become pregnant, it is advisable to wait until your first natural menstrual period before trying to conceive. This will help you calculate your expected due date more easily.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (VTE) or arteries (ATE). For more information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you need to know before taking Drovelis".

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

Common (may affect up to 1 in 10 people)

• Mood disorders and mood changes, libido disorders;
• Headache;
• Abdominal pain, nausea;
• Acne;
• Breast pain, painful menstruation, vaginal bleeding (during or outside of menstruation, 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 disorders);
• Depression, emotional disorder, anxiety disorder, stress, sleep problems;
• Migraine, dizziness, sensation of "pins and needles", drowsiness;
• Hot flushes;
• Abdominal bloating (in the stomach), vomiting, diarrhoea;
• Hair loss, excessive sweating (hyperhidrosis), dry skin, rash, skin swelling;
• Back pain;
• Breast swelling, breast nodules, abnormal genital bleeding, pain during intercourse, fibrocystic breast disease (presence of one or more cysts in a breast), heavy menstruation, absence of menstruation, menstrual disorders, premenstrual syndrome, uterine contraction, vaginal or uterine bleeding including spotting, vaginal discharge, vulvovaginal disorder (dryness, pain, odour, discomfort);
• Fatigue, swelling of parts of the body, e.g., ankles (oedema), chest pain, abnormal sensation;
• Blood tests showing increased liver enzymes, changes in certain blood fats (lipids).

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

• Breast inflammation;
• Benign breast mass;
• Hypersensitivity (allergy);
• Fluid retention, increased potassium levels in the blood;
• Nervousness;
• Memory loss;
• Dry eyes, blurred vision, visual impairment;
• 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, golden-brown pigmented spots (melasma) and other pigmentary disorders, hirsutism, excessive hair growth, skin disorders such as dermatitis and pruritic dermatitis, dandruff and oily skin (seborrhoea) and other skin disorders;
• Muscle spasms and joint swelling, pain and discomfort;
• Urinary tract pain, abnormal urine odour;
• Ectopic pregnancy (extrauterine pregnancy);
• Ovarian cyst, increased spontaneous milk flow, pelvic pain, breast discoloration, bleeding during sexual intercourse, endometrial disorders, nipple disorders, abnormal uterine bleeding;
• Malaise, also general, increased body temperature, pain;
• Increased blood pressure, changes in blood test results (abnormal kidney function test, increased potassium in blood, increased blood glucose, decreased haemoglobin, decreased iron stores in blood, blood in urine);
• Harmful blood clots in a vein, for example:
• in a leg or foot (e.g., DVT)
• in a lung (e.g., PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, also known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, 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 on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the outer carton after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Drovelis contains
The active substances are drospirenone and estetrol.
Each pink active tablet contains 3 mg of drospirenone and estetrol monohydrate equivalent to 14.2 mg of estetrol.
The white placebo tablet does not contain any active substances.

Other components are:

Film-coated pink active tablets
Tablet core
Monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), sodium glycolate starch (see section 2 “Drovelis contains lactose and sodium”), maize starch, povidone K30, magnesium stearate (E 470b).
Tablet coating
Hypromellose (E 464), hydroxypropylcellulose (E 463), talc (E 553b), hydrogenated cottonseed oil, titanium dioxide (E 171), red iron oxide (E 172).

Film-coated white placebo tablets
Tablet core
Monohydrate lactose (see section 2 “Drovelis contains lactose and sodium”), maize starch, magnesium stearate (E 470b).
Tablet coating
Hypromellose (E 464), hydroxypropylcellulose (E 463), talc (E 553b), hydrogenated cottonseed oil, titanium dioxide (E 171).

Description of the appearance of Drovelis and the contents of the pack
The film-coated active tablets are pink, round, 6 mm in diameter, biconvex, with a droplet-shaped logo imprinted on one side.
The film-coated placebo tablets are white or almost white, round, 6 mm in diameter, biconvex, with a droplet-shaped logo imprinted on one side.

Drovelis is available in blister packs containing 28 film-coated tablets (24 pink active tablets and 4 white placebo tablets) packed in a box. In addition to the blister, the Drovelis box contains a storage case and 1, 3, 6, or 13 adhesive labels marked with the days of the week. The number of 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.
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu