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Drovelis 3 mg/14.2 mg. 28 tablets

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Drovelis is a contraceptive used to prevent pregnancy.

All 24 pink film-coated tablets are active and contain a small amount of two different female sex hormones called estetrol and drospirenone.

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What Drovelis is and what it is used for

Drovelis is a contraceptive used to prevent pregnancy.

All 24 pink film-coated tablets are active and contain a small amount of two different female sex hormones called estetrol and drospirenone.

The four white film-coated tablets are inactive tablets that do not contain hormones and are called placebo tablets.

Birth control pills that contain two different hormones, such as Drovelis, are called "combination" or "combination" pills. They work together to prevent ovulation (the release of an egg from the ovary) and reduce the chance that the released egg will be fertilized and you will become pregnant.

2. What you need to know before you take Drovelis

General notes

Before you start taking Drovelis, you should carefully read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot

- see point 2 “Blood clots”.

Before you can start taking Drovelis, your doctor will ask you a few questions about your health and that of your relatives. The doctor will measure your blood pressure and, depending on your condition, may also do some additional tests.

This leaflet describes several situations in which you should stop taking the tablets or in which their reliability may be reduced. In such situations, you should either not have sex, or you should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the calendar or temperature method. These methods may not be reliable because the tablets affect the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

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

Do not take Drovelis

If you have any of the conditions listed below, you should not use Drovelis. If you have any of these, you should inform your doctor. He 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 blood vessel of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE) or other organs;

if you are known to have a blood clotting disorder - for example protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V-Leiden or antiphospholipid antibodies;

if you need surgery or have been immobilized for a long time (see section "Blood clots");

if you have ever had a heart attack or stroke;

if you have (or have ever had) angina (a condition that causes severe chest pain and may be an early sign of a heart attack) or transient ischemic attack (TIA - transient symptoms of stroke);

if you have any of the following conditions that may increase the risk of a blood clot in the arteries:

severe diabetes with damage to blood vessels;

very high blood pressure;

a very high level of fat in the blood (cholesterol or triglycerides);

a condition known as hyperhomocysteinemia;

if you have (or have had) a type of migraine called 'migraine with aura';

if you have (or have had) a liver tumor (benign or malignant);

if you have (or have had) liver disease and your liver is still not working normally;

if your kidneys are not working well (kidney failure);

if you have (or have had), or may have, breast or genital cancer;

if you have unexplained vaginal bleeding;

if you are allergic to estetrol or drospirenone or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions appear for the first time while you are using Drovelis, stop taking it immediately and tell your doctor. In the meantime, use non-hormonal contraceptives. Also see "General Notes" in point 2 above

Talk to your doctor or pharmacist before taking Drovelis.

When should you contact your doctor?

Seek emergency medical attention

if you notice possible signs of a blood clot, which could mean a blood clot has formed in the leg (eg deep vein thrombosis), a blood clot in the lung (eg pulmonary embolism), heart attack or stroke (see Blood clots under -down).

For a description of the symptoms of these serious side effects, please read How to recognize a blood clot.

Tell your doctor if any of the conditions listed below apply to you.

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

if your close relative has or has ever had breast cancer;

if you have hereditary or acquired angioedema. Medicines that contain esters

Blood clots may form

in the veins (known as 'venous thrombosis', 'venous thromboembolism' or VTE)

in the arteries (known as 'arterial thrombosis', 'arterial thromboembolism' or ATE).

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

It is important to remember that the overall risk of a damaging blood clot from using Drovelis is small. HOW TO RECOGNIZE A BLOOD CLOT

Seek emergency medical attention if you notice any of the following signs or symptoms.

Do you have any of these signs? What could you be suffering from?

- swelling of one leg or along a vein in the leg or foot, especially when accompanied by:

- pain or soreness in the leg that can only be felt when standing up or walking - warmth in the affected leg

- a change in the color of the skin on the leg, for example it becomes pale, red or blue

Deep vein thrombosis

- sudden unexplained shortness of breath or rapid breathing;

- sudden cough for no apparent reason, in which blood may be coughed up;

- sharp pain in the chest, which may increase with a deep breath;

- strong lightheadedness or dizziness;

- fast or irregular heartbeat;

- severe stomach pain;

If you are not sure, talk to a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a milder illness, such as a respiratory infection (such as a cold).

Pulmonary embolism

Symptoms that most often occur in one eye:

- sudden loss of vision or

- painless blurring of vision that can progress to vision loss;

Retinal vein thrombosis (blood clot in the eye)

- pain, discomfort, tension, heaviness in the chest;

- feeling of tightness or heaviness in the chest, arm or under the sternum;

- feeling full, indigestion or choking;

- discomfort in the upper body, spreading to the back, jaw, throat, arm and stomach;

- sweating, nausea, vomiting or dizziness;

- excessive weakness, restlessness or shortness of breath;

- fast or irregular heartbeat.

Heart attack

- sudden weakness or numbness of the face, arm or leg, especially on one side of the body; - sudden confusion, difficulty speaking or difficulty understanding; - sudden difficulty seeing with one or both eyes;

- sudden difficulty walking, dizziness, loss of balance or coordination;

- sudden, severe or prolonged headache for no known reason;

- loss of consciousness or fainting with or without a seizure;

Sometimes the symptoms of a stroke can be short-lived with an almost immediate and full recovery, but you should still seek emergency medical attention as you may be at risk of another stroke.

Stroke

- edema and slight bruising of a limb;

- severe pain in the stomach ("sharp stomach").

Blood clots blocking other blood vessels

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. Most often, they occur during the first year of using 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 travels through the leg and enters the lung, it can cause a pulmonary embolism.

Very rarely, a clot can form in a vein in another organ, for example in the eye (retinal vein thrombosis).

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

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

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

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

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you use.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Drovelis is small.

- About 2 women in 10,000 who are not using any combined hormonal contraceptive and are not pregnant will develop a blood clot within a year.

- In about 5-7 women in 10,000 who use a combined hormonal contraceptive containing a low dose of ethinyl estradiol (- It is not yet known what the risk of blood clots with Drovelis is compared to the risk with a combined hormonal contraceptive

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

If any of the above conditions change while you are taking Drovelis, for example, you start smoking, a close relative develops thrombosis of unknown cause, or you gain a lot of weight, tell your doctor.

Crab

In women using combined contraceptives, breast cancer is found slightly more often, but it is not known whether it is caused by the therapy. For example, it may be because tumors are found more often in women taking combined contraceptives because they are seen more often by a doctor. After stopping the use of combined contraceptives, the increased risk gradually decreases. It is important to check your breasts regularly and contact your doctor if you feel a lump. You should also tell your doctor if your close relative has or has had breast cancer (see section 2 "Warnings and precautions").

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

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

Mental disorders

Some women who use hormonal contraceptives, including Drovelis, report depression or depressed mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, contact your doctor as soon as possible for further medical advice.

Bleeding between individual cycles

Your period will usually start while you are taking the white placebo tablets from the Drovelis pack. During the first few months that you take Drovelis, you may have unexpected bleeding (bleeding outside the usual placebo days). In most cases, this bleeding is mild and usually does not require sanitary protection. If this bleeding continues for more than a few months, or if it starts after a few months, the doctor should find out the cause.

What to do if the usual bleeding does not occur

If you have taken all the pink tablets correctly, have not had vomiting or severe diarrhoea, and have not taken any other medicines, it is unlikely that you are pregnant. Continue to take Drovelis as usual.

If you have not taken all the tablets correctly, or if you do not have two regular periods in a row, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant. See also in section 3 "If you are vomiting or have severe diarrhoea" or in section 2 "Other medicines and Drovelis"

Children and adolescents

Drovelis is indicated for use only after menarche (the first menstrual cycle). No efficacy and safety data are available in adolescents under 16 years of age.

Other medicines and Drovelis

Tell 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 another medicine (or pharmacist) that you are using Drovelis. They will let you know if you need to take extra contraceptive measures (eg using condoms) and if so, for how long, or if the other medicine you need needs to be changed.

Some medicines can affect the blood levels of Drovelis and may make Drovelis less effective at preventing pregnancy or cause unexpected bleeding. These include medicines to treat:

epilepsy (eg, barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);

tuberculosis (eg, rifampicin);

HIV and hepatitis C virus (HCV) infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, evafirenz);

fungal infections (eg, griseofulvin);

increasing the pressure in the blood vessels of the lungs (eg bosentan).

The herbal product St. John's wort (Hypericum perforatum) may also affect the action of Drovelis. If you want to use herbal products containing St. John's wort while taking Drovelis, you should consult your doctor first.

If you are taking these medicines or herbal products that may reduce the effect of Drovelis, you should also use a barrier contraceptive method. The barrier method should be used throughout the time of simultaneous treatment with the other drug and up to 28 days after its termination. If concomitant therapy continues after the pink active tablets of your current

Starting the first pack of Drovelis

When no hormonal contraceptive was used in the previous month

Start taking Drovelis on the first day of your menstrual cycle (this is the first day of your menstrual bleeding). If you start taking Drovelis on the first day of your period, you will immediately be protected from pregnancy.

You can also start taking it on day 2-5 of your period, but then you must use additional measures to prevent pregnancy (eg use a condom) for the first 7 days of taking the tablets.

If you take more Drovelis than you should

There have been no reports of serious adverse effects from taking too many Drovelis tablets.

If you have taken several tablets at the same time, nausea, vomiting or vaginal bleeding may occur. Even girls who have not yet menstruated but have accidentally taken this medicine may experience vaginal bleeding.

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

If you forget to take Drovelis

The last 4 white tablets in the blister pack are placebo tablets. If you forget to take one of these tablets, it will not affect the reliability of Drovelis. Discard the missed white placebo tablet.

If you miss taking a pink, active tablet (tablets 1-24 of the blister), you should do the following:

If you are less than 24 hours late taking a pink active pill, contraceptive reliability is not reduced. Take the tablet as soon as you remember, and take the next tablets at the usual time.

if you are 24 hours or more late taking a pink active pill, contraceptive reliability may be reduced. The more tablets you have missed, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is particularly high if you have missed pink active tablets from the beginning and end of the blister. Therefore, you must follow the rules listed below (see also the diagram):

More than one tablet is missed from the blister:

Contact your doctor.

One pink active tablet is missed between days 1-7

Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue to take the tablets at the usual time and use additional contraceptive methods, for example a condom, for the next 7 days while taking the tablets correctly. If you had sexual intercourse in the week before you missed the tablet, you should know that there is a risk of pregnancy. In this case, contact your doctor.

One pink active tablet is missed between days 8-17

Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue to take the tablets at the usual time. Pregnancy protection is not reduced and you do not need to use additional precautions.

One pink active tablet is missed between days 18-24

You can choose from the following two options:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue to p

You have missed more than one tablet from this blister

Follow your doctor's instructions.

If you are vomiting or have severe diarrhoea

If you vomit within 3-4 hours after taking a pink active tablet or have severe diarrhea, there is a risk that the active substances of the pill have not been fully absorbed in your body. The situation is similar to that if you forgot to take a tablet. After vomiting or diarrhea, you should take another pink active tablet from the spare blister as soon as possible. If possible, take it within 24 hours of your usual tablet intake. If this is not possible or 24 hours or more have passed, you should follow the advice given in "If you forget to take Drovelis".

Period delay: what you need to know

Although not recommended, you can delay your period by not taking the white placebo tablets in the 4th row and start a new Drovelis blister immediately and take the tablets until the blister is finished. You may have light or period-like bleeding while taking the second blister. Complete the second blister by taking the 4 white placebo tablets.

Then start a new blister. Before you decide to postpone your period, you may want to consult your doctor.

If you want to change the start day of your period

If you take the tablets as directed, your period will start during the placebo days. If you need to change this day, decrease the placebo days - when you take the white placebo tablets, but never increase them (4 days is the maximum). For example, if you start taking the white placebo tablets on Friday and want to change it to Tuesday (3 days earlier) you should start a new blister 3 days earlier than usual. Bleeding may not occur during the shortened white placebo tablet period. Spotting (drops or spots of blood) or breakthrough bleeding may occur while you are using the next blister on the days you take the active pink tablets.

If you are not sure what to do, ask your doctor or pharmacist. If you have stopped taking Drovelis

You can stop taking Drovelis at any time. If you do not want to get pregnant, first ask your doctor about other birth control methods.

If you stop taking Drovelis because you want to get pregnant, it is recommended that you wait until you have regular menstrual bleeding before trying to get pregnant. This will help you determine when your baby is due.

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

inflammation of the chest;

benign breast growth;

hypersensitivity (allergy);

5. How to store Drovelis

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP/EXP. The expiration date corresponds to the last day of the specified month.

This medicine does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Drovelis contains

The active substances are drospirenone and estetrol.

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

Each white placebo tablet contains no active substances.

The other excipients are:

Pink active film-coated tablets:

Tablet core:

Lactose monohydrate (see section 2 "Drovelis contains lactose and sodium"), sodium starch glycolate (see section 2 "Drovelis contains lactose and sodium"), maize starch, povidone K30, magnesium stearate (E470b).

Tablet coating:

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

White placebo film-coated tablets:

Tablet core:

Lactose monohydrate (see section 2 "Drovelis contains lactose and sodium"), maize starch, magnesium stearate (E470b).

Tablet coating:

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

What Drovelis looks like and contents of the pack

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

Placebo film-coated tablets are white or off-white, 6 mm in diameter, round, biconvex with an engraved logo on one side.

Drovelis is available in blisters of 28 film-coated tablets (24 pink active tablets and 4 white placebo tablets), packed in a cardboard box. The Drovelis carton contains, in addition to the blisters, an outer storage pack as well as 1, 3, 6 or 13 self-adhesive stickers with the days of the week. The number of self-adhesive stickers depends on the number of blisters.

Pack size: 28 (1 x 28), 84 (3 x 28), 168 (6 x 28) and 364 (13 x 28) film-coated tablets. Not all types of packaging can be put on sale.

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