Rigevidon

Leaflet accompanying the packaging: information for the user

Rigevidon, 0.03 mg + 0.15 mg, coated tablets
Ethinylestradiol + Levonorgestrel

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots").

Table of contents of the leaflet

• 1. What is Rigevidon and what is it used for
• 2. Important information before using Rigevidon
• 3. How to use Rigevidon
• 4. Possible side effects
• 5. How to store Rigevidon
• 6. Contents of the packaging and other information

1. What is Rigevidon and what is it used for

Rigevidon is a combined oral contraceptive, also known as a contraceptive pill. It contains two types of female hormones: estrogen - ethinylestradiol and progestogen - levonorgestrel in a low dose.
The combined contraceptive pill prevents pregnancy based on three mechanisms.
The mentioned hormones:

• 1. each month, they inhibit the release of an egg from the ovaries (ovulation),
• 2. they also thicken the mucus (on the cervix) making it difficult for sperm to reach the egg,
• 3. they change the lining of the uterus to reduce the likelihood of implantation of a fertilized egg.

Taken correctly, the contraceptive pill is an effective, reversible method of contraception.
However, in certain circumstances, the effectiveness of the pill may be reduced or its use should be discontinued (see below). In such situations, you should not have sexual intercourse or use an additional non-hormonal method of contraception (such as a condom or other mechanical method) to ensure effective contraception.

2. Important information before using Rigevidon

Before starting to take Rigevidon, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot - see section 2 "Blood clots".
Before you can start using Rigevidon, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some other tests.
The leaflet describes several situations in which you should stop using Rigevidon or when the effectiveness of Rigevidon may be reduced. In such situations, you should not have sexual intercourse or use an additional non-hormonal method of contraception, such as a condom or other mechanical method. You should not use symptom-thermal methods. These methods may be unreliable because Rigevidon affects the monthly changes in body temperature and cervical mucus consistency.
Rigevidon, like other hormonal oral contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.
You should not use Rigevidon if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

When not to use Rigevidon

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know that you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have had a heart attack or stroke;
• if you have had angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have had a type of migraine called "migraine with aura";
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• heart valve disorders,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if you currently have (or have ever had) or suspect that you have breast or genital cancer;
• if you currently have (or have ever had) pancreatitis;
• if you have a liver disease and liver function is still impaired;
• if you have had liver tumors;
• if you have vaginal bleeding of unknown cause;
• if you are pregnant or think you may be pregnant;
• if you are allergic to ethinylestradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6);
• if you are taking or want to take herbal products containing St. John's Wort (Hypericum perforatum).

You should not use Rigevidon in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentaswir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Rigevidon and other medicines").

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to use Rigevidon

When to contact a doctor?

You should contact a doctor immediately
if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)").
To get a description of the serious side effects mentioned, see "How to recognize a blood clot".

You should tell your doctor immediately if any of the following conditions occur.

If these symptoms occur or worsen while using Rigevidon, you should also tell your doctor:

• if you have high levels of fats in the blood (hypertriglyceridemia) or a positive family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you smoke;
• if you are overweight;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you or a close relative have ever had problems with blood clotting;
• if you have migraines;
• if you have diabetes;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have a hereditary form of hearing loss called otosclerosis;
• if you have depression (depression or mood changes);
• if you have central nervous system disorders characterized by seizures and loss of consciousness (epilepsy);
• if you have movement disorders called Sydenham's chorea;
• if you have liver and/or gallbladder disorders (jaundice, gallstones);
• if you have a hereditary disease called porphyria (a rare hereditary blood disease);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have a blood disease called hemolytic-uremic syndrome (HUS) (in which the kidneys are damaged by blood clots);
• if you have systemic lupus erythematosus (SLE) (a disease that affects the body's natural defense system);
• if you have a rash called pemphigoid gestationis (appearance of blisters on the skin during pregnancy);
• if you have brown spots on the face and body (chloasma), which can be reduced if you avoid the sun and do not use a sunbed;
• - if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact a doctor immediately.Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Rigevidon, is associated with an increased risk of blood clots, compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• -in veins (called "venous thrombosis" or "venous thromboembolism"),
• -in arteries (called "arterial thrombosis" or "arterial thromboembolism").

Not everyone recovers fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of harmful blood clots caused by Rigevidon is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact a doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color in the leg, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should contact a doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions,
such as a respiratory infection (e.g. a cold).
Pulmonary embolism
Symptoms usually occur in one eye:
Retinal vein thrombosis (blood clot in the eye)

• immediate loss of vision or
• painless vision disturbances, which may lead to loss of vision.

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). Although these side effects are rare, they can occur. They most often occur in the first year of using combined hormonal contraceptives.
• -If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• -If a blood clot moves from the leg to the lungs, it can cause a pulmonary embolism.
• -In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to when combined hormonal contraceptives are not used.
If you stop using Rigevidon, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with Rigevidon is small.

• -In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• -In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel will develop blood clots.
• -The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Rigevidon is small, but some factors can increase this risk. The risk is higher:

• -if you are overweight (body mass index (BMI) over 30 kg/m);
• -if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, you may have hereditary coagulation disorders;
• -if you need to have surgery or will be immobilized for a long time, or have a leg in a cast. It may be necessary to discontinue Rigevidon for a few weeks before surgery or immobilization. If you need to discontinue Rigevidon, you should ask your doctor when you can resume taking the medicine;
• -with age (especially over 35 years old);
• -if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to tell your doctor if any of these factors apply to you, even if you are not sure. Your doctor may decide to discontinue Rigevidon.
You should inform your doctor if any of the above conditions change while using Rigevidon, e.g. if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is important to note that the risk of a heart attack or stroke associated with Rigevidon is very small, but it may increase:

• -with age (over about 35 years old);
• -if you smoke. While using a hormonal contraceptive like Rigevidon, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• -if you are overweight;
• -if you have high blood pressure;
• -if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• -if you or a close relative have had high levels of fats in the blood (cholesterol or triglycerides);
• -if you have migraines, especially migraines with aura;
• -if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• -if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of a blood clot may be even higher.
You should inform your doctor if any of the above conditions change while using Rigevidon, e.g. if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Contraceptive pill and cancer

In several studies, an increased risk of cervical cancer has been found in women who have been using contraceptive pills for a long time. It is not clear whether this increased risk is due to the effect of oral contraceptives or to sexual behavior and other factors.
Women who use contraceptive pills have a slightly higher risk of breast cancer than women of the same age who do not use this type of contraception. After stopping the use of contraceptive pills, the risk of breast cancer decreases, and after 10 years from the end of the use of contraceptive pills, the risk of breast cancer is the same as in women who have never used contraceptive pills. It is not certain whether the use of contraceptive pills causes an increased risk of breast cancer. It is possible that breast cancer is detected earlier in women who use oral contraceptives, as they are more frequently examined.
There have been reports of malignant and benign liver tumors in women who use contraceptive pills. Liver tumors can lead to life-threatening bleeding into the abdominal cavity. Therefore, if you experience abdominal pain of unknown origin, you should inform your doctor.
Psychological disorders
Some women who use hormonal contraceptives, including Rigevidon, have reported depression or mood changes. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Regular examinations

After starting to use Rigevidon, you will need to visit your doctor for regular medical check-ups once a year. If you have any doubts, you should consult your doctor.

Children and adolescents

Rigevidon is not indicated for use before the first menstrual period (menarche).

Rigevidon and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also inform other doctors or your dentist who prescribe other medicines (or pharmacist) that you are using Rigevidon. Your doctor will tell you if there is a need to use additional contraception (e.g. a condom) and if so, for how long, and whether there is a need to change the use of certain medicines.
Rigevidon should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentaswir, and sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased liver enzyme activity ALT).
Before starting to take these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Rigevidon again about 2 weeks after the end of the above-mentioned treatment. See section "When not to use Rigevidon".
Certain medicines:

• -may affect the level of Rigevidon in the blood,
• -may reduce the effectiveness of Rigevidon in preventing pregnancy,
• -may cause unexpected bleeding.

These include:

• -medicines used to treat:
• -epilepsy (e.g. phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, perampanel, rufinamide, eslicarbazepine),
• -tuberculosis (e.g. rifampicin),
• -HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir, boceprevir, telaprevir, and the so-called integrase inhibitor elvitegravir),
• -nausea and vomiting caused by chemotherapy or surgery (aprepitant),
• -fungal infections (e.g. griseofulvin),
• -high blood pressure in the blood vessels in the lungs (bosentan),
• -sleep disorders (modafinil),
• -a certain type of cancer (dabrafenib, enzalutamide, vemurafenib);
• -herbal products containing St. John's Wort (Hypericum perforatum). If you want to use herbal products containing St. John's Wort while using Rigevidon, you should first consult your doctor.

Rigevidon may affect the action of other medicines, such as:

• -lamotrigine (an antiepileptic medicine).

The following medicine may reduce the tolerance of Rigevidon:

• -etoricoxib (used to treat arthritis, osteoarthritis).

You should also avoid concomitant use of emergency contraception containing ulipristal with combined oral contraceptives,

Using Rigevidon with food and drink

Swallow the tablet whole, with water if necessary.

Pregnancy and breastfeeding

Pregnancy
You should not use Rigevidon if you are pregnant. If you become pregnant or think you may be pregnant, you should stop taking Rigevidon and contact your doctor immediately.
Breastfeeding
You should not use Rigevidon during breastfeeding. If you are breastfeeding and plan to use contraceptive pills, you should discuss this with your doctor.

Driving and using machines

There is no data to suggest that Rigevidon affects the ability to drive and use machines.

Lab tests

You should inform your doctor or laboratory staff that you are taking contraceptive pills, as oral contraceptives may affect the results of some tests.

Rigevidon contains lactose, sucrose, and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Rigevidon

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor.
You should take one coated tablet per day.
The tablet should be taken every day at about the same time. It may be helpful to take the tablet in the evening as the last thing you do before bed or in the morning as the first thing you do.
Tablets should be swallowed whole, with water if necessary.

Tablets should be swallowed whole, with water if necessary.

Each pack of Rigevidon contains 1 blister pack of 21 coated tablets.
The special marking on the blister pack is designed to help you take the tablets regularly.

The blister pack is marked with the days of the week on which you should take a tablet.

You should take 1 tablet per day for 21 consecutive days, following the direction of the arrows on the packaging, until the blister pack is empty.

After this time, there is a 7-day break in taking tablets. During this 7-day break, you will probably have bleeding similar to a menstrual period, i.e. menstruation.

Taking tablets from the next pack should start on the 8th day (after the 7-day break in taking tablets), even if bleeding has not stopped. If Rigevidon is used correctly, taking tablets from a new pack will always start on the same day of the week, and menstrual bleeding will start on the same day every month.

Starting the first pack

If you did not use oral contraceptives in the previous cycle
The first tablet should be taken on the first day of menstrual bleeding. The first day on which menstrual bleeding starts is the first day of the cycle. You should take the tablet for the given day of the week (e.g. if menstrual bleeding starts on a Tuesday, you should take the tablet marked "Tue" on the blister pack). Then, you should take the next tablet every day, following the direction of the arrows, until the blister pack is empty.
There is no need to use another contraceptive method during the 7-day break, provided that all 21 tablets from the previous pack were taken correctly and the next pack is started on time.
Switching from another combined hormonal contraceptive to Rigevidon
You should start using Rigevidon the day after taking the last tablet from the pack of the previously used contraceptive. Do not take a break between packs. If the pack of the previously used contraceptive contained tablets that were inactive (placebo), you should start using Rigevidon the day after taking the last active tablet, but no later than the day after the usual break in taking tablets from the previous combined hormonal contraceptive (or after taking the last placebo tablet from the previous pack).
In case of switching from another combined hormonal contraceptive, you should follow your doctor's advice.
If you have any further doubts or questions, you should consult your doctor.
Switching from progestogen-only tablets to Rigevidon
You can stop taking progestogen-only tablets at any time and start using Rigevidon the next day at the same time. You should remember to use an additional contraceptive method (such as a condom) during the first 7 days of taking Rigevidon, if you have sexual intercourse.
Switching from injectable or implant contraceptives to Rigevidon
If you are using injectable or implant contraceptives containing only progestogen, you should start using Rigevidon on the day the next injection is due or on the day the implant is removed. However, you should remember to use an additional contraceptive method (such as a condom) during the first 7 days of taking Rigevidon.

Using Rigevidon after childbirth or miscarriage

In case of starting to take the contraceptive pill after childbirth or miscarriage, you should follow your doctor's advice.
You can start taking Rigevidon immediately after a miscarriage in the first three months of pregnancy. In this case, there is no need to use additional contraceptive methods.
After childbirth or miscarriage in the second trimester of pregnancy (4-6 months of pregnancy), you should follow your doctor's advice.
There are no restrictions on the duration of use of the contraceptive pill, but it is recommended to have regular medical check-ups.

Overdose of Rigevidon

If you have taken more than the prescribed dose of Rigevidon, it is unlikely that this will cause serious health problems, although you may experience nausea, vomiting, breast pain, numbness, drowsiness, and/or fatigue, and in young girls, bleeding from the genital tract. If such symptoms occur, you should contact your doctor, who will tell you what to do.

Missed dose of Rigevidon

If you have forgotten to take a tablet, you should follow the rules below.

If the tablet is delayed by less than 12 hours

Contraceptive protection is not reduced, provided that the missed tablet is taken as soon as possible and subsequent tablets are taken at the usual time. This may mean taking two tablets on the same day.

If the tablet is delayed by more than 12 hours

If the tablet is delayed by more than 12 hours, contraceptive protection is reduced, and additional contraceptive methods may be necessary. The more tablets that are missed, the higher the risk that contraceptive protection is reduced.

In case of missing more than 1 tablet, you should consult your doctor.

• Procedure in case of missing a tablet in the first weekYou should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, you should continue taking the tablets at the usual time of day. Additionally, for the next 7 days, you should use a mechanical contraceptive method, such as a condom. If you had sexual intercourse during the 7 days before missing the first tablet, you should consider the possibility of pregnancy. The more tablets that are missed and the shorter the interval between missing a tablet and the break in taking tablets, the higher the risk of pregnancy.
• Procedure in case of missing a tablet in the second weekYou should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, you should continue taking the tablets at the usual time of day. There is no need to use additional contraceptive methods, provided that the tablets were taken correctly during the 7 days preceding the missed tablet. However, if the tablets were not taken correctly or more than 1 tablet was missed, you should use an additional contraceptive method for 7 days.
• Procedure in case of missing a tablet in the third weekThere is a high risk of contraceptive failure due to the upcoming break in taking tablets. However, reduced contraceptive protection can be prevented by adjusting the tablet-taking schedule. If you follow one of the rules below, there is no need to use additional contraceptive methods, provided that all tablets were taken correctly during the 7 days preceding the missed tablet. If you did not take Rigevidon correctly during the 7 days preceding the missed tablet, you should follow the first of the rules below. Additionally, for the next 7 days, you should use a mechanical contraceptive method (such as a condom).
• 1. You should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, you should continue taking the tablets at the usual time of day. You should start taking the tablets from the next pack immediately after taking the last tablet from the current pack, i.e. without the usual 7-day break between packs. You will probably not have withdrawal bleeding until you finish taking the tablets from the second pack, but you may experience spotting or breakthrough bleeding during tablet-taking.
• 2. You can also stop taking the tablets from the current pack. In this case, you should have a break of 7 days, including the days you forgot to take the tablets, and then continue taking the tablets from the next pack. If you forgot to take a tablet and did not have withdrawal bleeding during the first usual break in taking tablets, you should consider the possibility of pregnancy.

Stopping Rigevidon

You can stop using Rigevidon at any time. If you stop using Rigevidon to become pregnant, you should use another contraceptive method until you have your first natural menstrual period. This will help your doctor determine the expected date of delivery.

4. Possible side effects

Like all medications, this medication can cause side effects, although they may not occur in everyone. The patient should immediately consult a doctor if any of the following symptoms of angioedema occur: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing (see also "Warnings and precautions"). In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before taking Rigevidon". Common side effects(may occur more frequently than in 1 in 10 people): Vaginitis, including vaginal candidiasis, mood swings, including depression, changes in libido, nervousness, dizziness, nausea, vomiting, abdominal pain, acne, breast pain, breast tenderness, breast enlargement and discharge, painful menstruation, irregular menstrual bleeding, cervical abnormalities (cervical ectropion) and changes in vaginal discharge, absence or scanty menstrual bleeding, fluid retention and/or edema, weight changes. Uncommon side effects(may occur no more frequently than in 1 in 100 people): Changes in appetite, hypertension, diarrhea, abdominal cramps, bloating, rash, chloasma (yellow-brown spots on the skin) that may persist, excessive hair growth, hair loss, changes in lipid levels in the serum, including hypertriglyceridemia. Rare side effects(may occur no more frequently than in 1 in 1000 people): Severe allergic reaction (anaphylactic reaction with very rare cases of hives, facial swelling, tongue swelling, severe circulatory and respiratory disorders), glucose intolerance, eye irritation when wearing contact lenses, jaundice, a skin disease called erythema multiforme (characterized by the occurrence of painful red bumps on the skin). Harmful blood clots in a vein or artery, for example:

• -in the leg or foot (e.g., deep vein thrombosis),
• -in the lungs (e.g., pulmonary embolism),
• -heart attack,
• -stroke,
• -mini-stroke or transient stroke symptoms, known as a transient ischemic attack,
• -blood clots in the liver, stomach, intestine, kidneys, or eye. The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors and symptoms of blood clots).

Very rare side effects(may occur no more frequently than in 1 in 10,000 people): Benign or malignant liver tumors, exacerbation of systemic lupus erythematosus (an immune system disease), exacerbation of porphyria, exacerbation of chorea (involuntary movement disorders), optic neuritis, blood clots in the blood vessels of the eye, exacerbation of varicose veins, ischemic colitis (ischemic inflammation of the colon), pancreatitis, gallbladder disease (including gallstones), erythema multiforme (characterized by a rash with redness in the shape of a target or ulcers), a blood disorder called hemolytic-uremic syndrome (HUS) (a disorder in which blood clots can cause kidney failure), decreased folic acid levels in the blood. Unknown(frequency cannot be determined based on available data): Inflammatory bowel disease (Crohn's disease, ulcerative colitis), liver cell damage (e.g., hepatitis, liver function disorders).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medication.

5. How to store Rigevidon

The medication should be stored out of sight and out of reach of children. Store at a temperature below 25°C. Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medications should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Rigevidon contains

• The active substances of the medication are ethinylestradiol (30 micrograms) and levonorgestrel (150 micrograms).
• Other ingredients are: Tablet core:
• colloidal anhydrous silica
• magnesium stearate
• talc
• cornstarch
• lactose monohydrate

Coating:

• sucrose
• talc
• calcium carbonate
• titanium dioxide (E171)
• copovidone
• macrogol 6000
• colloidal anhydrous silica
• polyvidone K30
• sodium carmellose

What Rigevidon looks like and what the package contains

White, biconvex, round film-coated tablets. 21 tablets in an AL/PVC/PVDC blister pack, in a cardboard box.

Marketing authorization holder and manufacturer

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more detailed information, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, lekalert@grodzisk.rgnet.org.

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