Rigevidon

Package leaflet: Information for the user

Rigevidon, 0.03 mg + 0.15 mg, coated tablets
Ethinylestradiolum + Levonorgestrelum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Important information about combined hormonal contraceptives:

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be alert and consult your doctor if you suspect symptoms of a blood clot (see section 2, "Blood clots").

Contents of the leaflet

1. What Rigevidon is and what it is used for
2. What you need to know before taking Rigevidon
3. How to take Rigevidon
4. Possible side effects
5. How to store Rigevidon
6. Contents of the pack and other information

1. What Rigevidon is and what it is used for

Rigevidon is a combined oral contraceptive, also known as a contraceptive pill. It contains two types of female hormones: an oestrogen – ethinylestradiol, and a progestogen – levonorgestrel, in low doses.
The combined contraceptive pill prevents pregnancy through three mechanisms. These hormones:

1. Inhibit each month the release of an egg from the ovaries (ovulation),
2. Thicken the cervical mucus, thereby making it more difficult for sperm to reach the egg,
3. Alter the lining of the uterus, reducing the likelihood of implantation of a fertilised egg.

When taken correctly, the contraceptive pill is an effective, reversible method of contraception.
However, in certain circumstances, its effectiveness may be reduced or its use should be discontinued (see below). In such situations, sexual intercourse should be avoided or an additional non-hormonal contraceptive method (such as a condom or another mechanical method) should be used during intercourse 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 particularly important to be aware of the symptoms of blood clots – see section 2 "Blood clots".
Before you can start taking Rigevidon, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some other tests.
This leaflet describes several situations in which you should stop taking Rigevidon or when the effectiveness of Rigevidon may be reduced. In such situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a condom or another mechanical method. Do not use fertility awareness-based methods. These methods may be unreliable because Rigevidon affects 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 infections.
Do not use Rigevidon if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable for you.

When not to use Rigevidon

• if you currently have (or have ever had) a blood clot in a deep vein of the leg (deep vein thrombosis), in the lungs (pulmonary embolism), or in another organ;
• if you know you have a disorder affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• heart valve disorders,
• very high blood pressure,
• very high levels of blood fats (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia;
• if you currently have (or have ever had) or are suspected to have breast cancer or cancer of the reproductive organs;
• if you currently have (or have ever had) pancreatitis;
• if you currently have (or have ever had) liver disease and liver function remains abnormal;
• if you currently have (or have ever had) liver tumours;
• if you have vaginal bleeding of unknown cause;
• if you are pregnant or suspect 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 intend to take herbal products containing St John's wort (Hypericum perforatum).

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

Warnings and precautions
Before starting to take Rigevidon, discuss this with your doctor or pharmacist.

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

You should immediately inform your doctor if any of the following conditions apply to you.
If any of these symptoms appear or worsen during treatment with Rigevidon, you should also inform your doctor:

• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you smoke;
• if you are significantly overweight;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have inflammation of the superficial veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you or your close family have ever had blood clotting problems;
• if you have migraine;
• if you have diabetes;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have a hereditary form of deafness called otosclerosis;
• if you have depression (depression or mood changes);
• if you have disorders of the central nervous system 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 inherited blood disorder);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have a blood disorder called haemolytic uraemic syndrome - HUS (in which kidney damage occurs due to blood clots);
• if you have systemic lupus erythematosus - SLE (a disease affecting the body's natural defence system);
• if you develop a rash called pemphigoid gestationis (blisters on the skin during pregnancy);
• if you develop brownish pigmented patches on the face and body (chloasma), which can be reduced by avoiding sunlight and not using sunbeds;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, which may cause breathing difficulties, you should contact your 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 not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious problems.
Blood clots may occur:

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Rigevidon is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, particularly if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, e.g. pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing;
• sudden coughing without an obvious cause, which may be associated with coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

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

• sudden loss of vision or
• painless visual disturbances, which may progress to vision loss.

BLOOD CLOTS IN VEINS
What could happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse effects are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to when not using combined hormonal contraceptives.
If a woman stops taking Rigevidon, the risk of developing blood clots returns to normal within a few weeks.

What does the risk of developing blood clots in veins depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with taking Rigevidon is small.

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Rigevidon is small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited tendency to form blood clots;
• if the patient requires surgery, is immobilised for a prolonged period due to injury, illness or has a leg in plaster. It may be necessary to stop taking Rigevidon several weeks before surgery or immobilisation. If the patient has to stop taking Rigevidon, ask the doctor when it is safe to restart;
• with increasing age (particularly over 35 years of age);
• if the patient has recently given birth (within the last few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots, especially if the patient has another risk factor present.
It is important to inform the doctor if any of these risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Rigevidon.
Inform the doctor if any of the above conditions change during treatment with Rigevidon, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with the use of Rigevidon is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes cigarettes. While using a hormonal contraceptive such as Rigevidon, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Rigevidon, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Oral contraceptive and cancer
Several studies have shown an increased risk of cervical cancer in women who have used oral contraceptives for a long time. It has not been definitively established whether this increased risk is due to the effect of oral contraceptives or to sexual behaviour or other factors.
Breast cancer has been reported slightly more frequently in women using oral contraceptives than in women of the same age who do not use this type of contraception. After stopping oral contraceptives, the risk of breast cancer decreases, and after 10 years from stopping, the risk is the same as in women who have never used oral contraceptives. It is not certain whether the use of oral contraceptives causes an increased risk of breast cancer. It is possible that breast cancer is detected earlier in women using oral contraceptives because they undergo medical examinations more frequently.
Malignant or benign liver tumours have been reported in women using oral contraceptives. Liver tumours may lead to life-threatening intra-abdominal haemorrhage. Therefore, if the patient experiences unexplained abdominal pain in the upper abdomen, medical advice should be sought immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Rigevidon, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Regular examinations
After starting Rigevidon, follow-up visits to the doctor are necessary to perform regular medical check-ups once a year. If any concerns arise, consult the doctor.

Children and adolescents
Rigevidon is not indicated for use before the onset of first menstruation (first menstrual bleeding).

Rigevidon and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The patient should also inform other doctors or dentists (or pharmacist) prescribing other medicines about the use of Rigevidon. The doctor will advise whether additional contraception (e.g. condoms) is needed, for how long, and whether any changes to current medication are required.
Do not use Rigevidon in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased liver enzyme ALT activity).
Before starting these medicines, the doctor will prescribe another type of contraception.
Rigevidon may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to take Rigevidon".

Some medicines:

• may affect the blood concentration of Rigevidon,
• may cause reduced 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 infection and hepatitis C virus infection (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 following chemotherapy or surgery (aprepitant),
• fungal infections (e.g. griseofulvin),
• high blood pressure in the pulmonary arteries (bosentan),
• sleep disorders (modafinil),
• certain types of cancer (dabrafenib, enzalutamide, vemurafenib);
• herbal products containing St John's wort (Hypericum perforatum). If the patient wishes to use herbal products containing St John's wort while taking Rigevidon, she should first consult her doctor.

Rigevidon may affect the action of other medicines, for example:

• lamotrigine (an antiepileptic medicine).

The following medicine may reduce tolerance to Rigevidon:

• etoricoxib (used to treat arthritis and osteoarthritis).

Concomitant use of emergency contraception containing ulipristal with combined oral contraceptives should also be avoided.

Taking Rigevidon with food and drink
Swallow the tablet whole with water, if necessary.

Pregnancy and breast-feeding
Pregnancy
Do not take Rigevidon during pregnancy. If the patient becomes pregnant or suspects she may be pregnant, she should stop taking Rigevidon and contact her doctor immediately.

Breast-feeding
Rigevidon should not be used during breast-feeding. If a woman is breast-feeding and considering using oral contraceptives, she should discuss this with her doctor.

Driving and operating machinery
There are no data indicating that Rigevidon affects the ability to drive or operate machinery.

Laboratory tests
Inform the doctor or laboratory staff that the patient is taking oral contraceptives, as oral contraceptives may influence the results of certain laboratory tests.

Rigevidon contains lactose, sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before starting this medicine.
The medicine contains less than 1 mmol 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 in doubt, consult your doctor.
Take one coated tablet daily.
The tablet should be taken every day at approximately the same time of day.
Taking the tablet in the evening as the last activity of the day or in the morning as the first activity may help with adherence.
Tablets should be swallowed whole, with water if necessary.
Each Rigevidon pack contains 1 blister strip with 21 coated tablets.
The blister is specially marked to help ensure regular tablet intake.
The blister is labelled with the days of the week on which each tablet should be taken.
Take 1 tablet daily for 21 consecutive days, following the direction of the arrow on the packaging, until the blister is completely empty.
After this, there is a 7-day break from taking tablets. During this 7-day break, withdrawal bleeding, similar to menstrual bleeding (i.e. a period), will most likely occur on the 2nd or 3rd day.
The next blister pack should be started on the 8th day (after the 7-day break), even if bleeding has not yet stopped. If Rigevidon is taken correctly, starting a new pack will always occur on the same day of the week, and menstrual bleeding will begin on the same day each month.

Starting the first pack
If no oral contraceptives were used in the previous cycle
Take the first tablet on the first day of menstrual bleeding. The first day of bleeding is considered the first day of the cycle. Take the tablet designated for that day of the week (e.g. if bleeding started on Tuesday, take the tablet marked "Tu" on the blister). Then continue taking one tablet daily, following the arrow, until the blister 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
Start taking Rigevidon the day after taking the last active tablet from the previously used contraceptive. Do not leave a gap between packs. If the previous contraceptive pack also included placebo tablets (without hormones), start Rigevidon the day after taking the last active tablet, but no later than the day after the usual tablet-free break of the previous combined contraceptive (or after taking the last placebo tablet from the previous pack). If switching from a combined contraceptive in the form of a vaginal ring or transdermal patch, follow your doctor’s advice.
If you have further doubts or questions, consult your doctor.

Switching from progestogen-only contraceptive tablets to Rigevidon
Progestogen-only tablets can be stopped on any chosen day, and Rigevidon should be started the next day at the same time. However, remember to use an additional contraceptive method (such as a condom) during the first 7 days of taking Rigevidon if having sexual intercourse.

Switching from injectable or implant contraceptives to Rigevidon
If using injectable or implant contraceptives containing only progestogen, start taking Rigevidon on the day the next injection would have been due or on the day the implant is removed. However, remember to use an additional contraceptive method (such as a condom) during the first 7 days of taking the contraceptive tablets.

Taking Rigevidon after childbirth or miscarriage
If starting the contraceptive tablet after childbirth or miscarriage, follow your doctor’s advice.
Rigevidon can be started immediately after a miscarriage in the first three months of pregnancy. In this case, additional contraceptive methods are not necessary.
After childbirth or miscarriage in the second trimester of pregnancy (4–6 months), follow your doctor’s advice.
There are no restrictions on when to start taking the contraceptive tablet, but regular medical check-ups are recommended.

Taking more Rigevidon than recommended
If an overdose of Rigevidon occurs, serious health problems are unlikely, although symptoms such as nausea, vomiting, breast tenderness, numbness, drowsiness and/or fatigue may occur, and in young girls, vaginal bleeding. If such symptoms occur, contact your doctor for advice.

Missed dose of Rigevidon
If a tablet is missed, follow the rules below.

If the tablet is taken less than 12 hours late
Contraceptive protection is not reduced, provided the missed tablet is taken as soon as remembered, and subsequent tablets are taken at the usual time. This may mean taking two tablets on the same day.

If the tablet is taken more than 12 hours late
If the tablet is taken more than 12 hours late, contraceptive protection may be reduced, and an additional contraceptive method may be necessary. The more tablets missed, the greater the risk of reduced contraceptive protection.
If more than 1 tablet is missed, consult your doctor.

• Missed tablet in the first week
  Take the last missed tablet as soon as remembered, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. Additionally, use a mechanical contraceptive method (e.g. condom) for the next 7 days. If sexual intercourse occurred in the previous 7 days, consider the possibility of pregnancy. The greater the number of missed tablets and the shorter the interval between the missed tablet and the tablet-free break, the higher the risk of pregnancy.

• Missed tablet in the second week
  Take the last missed tablet as soon as remembered, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. An additional contraceptive method is not necessary, provided that contraceptive tablets were taken correctly in the 7 days before the missed tablet. However, if tablets were taken incorrectly or more than one tablet was missed, use an additional contraceptive method for 7 days.

• Missed tablet in the third week
  There is a high risk of contraceptive failure due to the approaching tablet-free break. However, reduced contraceptive protection can be prevented by adjusting the tablet-taking schedule. If the patient follows one of the rules below, additional contraceptive methods are not necessary, provided all tablets were taken correctly in the 7 days before the first missed tablet. If Rigevidon tablets were not taken correctly during the 7 days before the first missed tablet, the first method listed below should be used. Additionally, a mechanical contraceptive method (e.g. condom) should be used for the next 7 days.

  1. Take the last missed tablet as soon as remembered, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. Start the next pack immediately after taking the last tablet from the current pack, i.e. without the usual 7-day tablet-free break between packs. Withdrawal bleeding will most likely not occur until after finishing the tablets in the second pack, although spotting or breakthrough bleeding may occur during tablet intake.
  2. Alternatively, stop taking tablets from the current pack. In this case, observe a 7-day break from tablets, including the days when tablets were missed, and then continue with the next pack. If tablets were missed and no withdrawal bleeding occurred during the first, usual tablet-free break, consider the possibility of pregnancy.

Stopping Rigevidon
Rigevidon can be stopped at any time. If a woman stops taking Rigevidon in order to become pregnant, she should use another contraceptive method until the first natural menstrual period. This will help the doctor determine the due date.

What to do in case of gastrointestinal disturbances
If vomiting or diarrhoea occurs within 3–4 hours of taking the tablet, the active ingredient may not be fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a different pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section "Missed dose of Rigevidon".

How to delay or shift the timing of withdrawal bleeding
If a woman wishes to delay the onset of withdrawal bleeding or shift it to another day of the week, she should follow the rules below and consult her doctor.

Delaying withdrawal bleeding
To delay bleeding, continue taking tablets from the next Rigevidon pack immediately after the last tablet of the current pack, without taking the usual break. Tablet-taking can be continued as long as needed, until the second blister is finished. Breakthrough bleeding or spotting may occur during the second blister. Regular use of Rigevidon can be resumed after the usual 7-day break.

Shifting the timing of withdrawal bleeding to another day of the week
If Rigevidon is taken correctly, bleeding will always occur on the same day of the month. If a woman wishes to shift the bleeding to a different day of the week than the one in the current dosing schedule, she should shorten (but never extend) the upcoming tablet-free break by any number of days. For example, if bleeding usually starts on Friday and the woman wants it to start on Tuesday (3 days earlier), she should start the next pack 3 days earlier than usual. The shorter the tablet-free break, the greater the likelihood that bleeding will not occur. However, breakthrough bleeding or spotting may occur during the second pack.

Managing breakthrough bleeding
A small number of women may experience light breakthrough bleeding or spotting while taking Rigevidon, especially during the first few months of use. Such bleeding is usually not a cause for concern and stops within one or two days. Continue taking tablets as usual, and bleeding typically resolves after taking the first few packs.
If bleeding recurs, is bothersome, or persists for a longer time, consult your doctor.

What to do if withdrawal bleeding does not occur
If tablets were taken correctly, there were no gastrointestinal disturbances, and no other medicines were taken, the likelihood of pregnancy is low. Continue taking Rigevidon as usual.
If two consecutive withdrawal bleeds do not occur, there is a possibility that the woman is pregnant. Contact your doctor immediately. Continue taking tablets only after a pregnancy test has been performed and with your doctor’s approval.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact a doctor immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, which may cause difficulty breathing (see also section "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of venous thromboembolic events (venous thromboembolic disease) or arterial thromboembolic events (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Rigevidon".
Common adverse reactions (may occur in more than 1 in 10 people):
Vaginitis, including vaginal candidiasis, mood changes, including depression, changes in libido, nervousness, dizziness, nausea, vomiting, abdominal pain, acne, breast pain, breast tenderness, breast enlargement and breast discharge, painful menstruation, irregular menstrual bleeding, cervical abnormalities (cervical ectopy) and changes in vaginal discharge, absence or scanty menstrual bleeding, fluid retention and/or oedema, changes in body weight.
Uncommon adverse reactions (may occur in not more than 1 in 100 people):
Changes in appetite, hypertension, diarrhoea, abdominal cramps, bloating, rash, chloasma (yellow-brown patches on the skin), which may persist, excessive hair growth, hair loss, changes in serum lipid levels, including hypertriglyceridaemia.
Rare adverse reactions (may occur in not more than 1 in 1000 people):
Severe allergic reaction (anaphylactic reaction with very rare cases of urticaria, facial swelling, tongue swelling, severe circulatory and respiratory disturbances), glucose intolerance, eye irritation while wearing contact lenses, yellowing of the skin (jaundice), a skin condition called nodular erythema (characterized by the presence of painful red skin nodules).
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 ischaemic attack (TIA),
• blood clots in the liver, stomach, intestine, kidneys or eye.
  The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
  Very rare adverse reactions (may occur in not more than 1 in 10,000 people):
  Benign or malignant liver tumours, exacerbation of systemic lupus erythematosus (an autoimmune disease), exacerbation of porphyria, exacerbation of chorea (involuntary movement disorders), optic neuritis, blood clots in ocular blood vessels, worsening of varicose veins, inflammation of the colon (ischaemic colitis), pancreatitis, gallbladder disease (including gallstones), erythema multiforme (characterized by rash with target-shaped redness or ulcerations), a blood disorder called haemolytic-uraemic syndrome (HUS) (a condition in which blood clots may lead to kidney failure), decreased plasma folate concentration.
  Unknown (frequency cannot be estimated from available data):
  Inflammatory bowel disease (Crohn's disease, ulcerative colitis), liver cell damage (e.g. hepatitis, liver function disorders).
  Reporting of adverse reactions
  If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  Al. Jerozolimskie 181C
  PL-02 222 Warsaw
  Phone: +48 22 49 21 301
  Fax: +48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  Adverse reactions can also be reported to the marketing authorisation holder.
  Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rigevidon

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Rigevidon contains

• The active substances are ethinylestradiol (30 micrograms) and levonorgestrel (150 micrograms).

• The other ingredients are:
  Tablet core:

  • colloidal anhydrous silica
  • magnesium stearate
  • talc
  • maize starch
  • lactose monohydrate

  Coating:

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

What Rigevidon looks like and contents of the pack
White, biconvex, round coated tablets.
21 tablets in an AL/PVC/PVDC blister pack, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest, Hungary

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ks. J. Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki, Poland
Tel. +48 (22) 755 96 48
[email protected]