Rigevidon 0.03 mg/0.15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rigevidon 0.03 mg/0.15 mg coated tablets EFG

ethinylestradiol and levonorgestrel

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

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 adverse 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 the contraceptive pill. It contains two types of female hormones: an oestrogen, ethinylestradiol, and a progestogen, levonorgestrel, in a low dose.

The combined oral contraceptive pill prevents pregnancy in three ways. These hormones:

1. Prevent the ovary from releasing an egg each month (ovulation),
2. Thicken the cervical fluid (in the cervix), making it more difficult for sperm to reach the egg,
3. Alter the lining of the uterus, making it less likely to accept a fertilised egg.

General information

When taken correctly, oral contraceptives are an effective form of reversible contraception. However, under certain circumstances, the effectiveness of the contraceptive may decrease, or you may need to stop taking it (see below). In such cases, either abstain from sexual intercourse or use other non-hormonal contraceptive precautions (such as condoms or another barrier method) during sexual intercourse to ensure effective contraception.

Remember that combined oral contraceptives such as Rigevidon do not protect you against sexually transmitted infections (such as AIDS). Only condoms can do this.

2. What you need to know before starting Rigevidon

Before starting Rigevidon, you should read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you can start taking Rigevidon, your doctor will ask you some questions about your medical history and that of your close family members. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out additional tests.

This leaflet describes certain situations in which you should stop using Rigevidon or where the reliability of Rigevidon may decrease. In these situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, for example, use condoms or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable, as Rigevidon alters the monthly changes in body temperature and cervical mucus.

Rigevidon, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to take Rigevidon

Do not take Rigevidon if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

Do not take Rigevidon:

• If you are allergic to ethinylestradiol or levonorgestrel or to any of the other ingredients of this medicine (listed in section 6).

• If you have (or have ever had) a blood clot (thrombosis) in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs. If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you require surgery or will be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or a 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 a transient ischaemic attack (TIA, 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 developing a clot in the arteries:

  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.

• If you have (or have ever had) or suspect you may have breast cancer or cancer of the genital organs.

• If you have (or have ever had) liver disease and your liver function is still not normal.

• If you have (or have ever had) a liver tumour.

• If you have unexplained vaginal bleeding.

Do not use Rigevidon if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/voxilaprevir (see also section “Other medicines and Rigevidon”).

St. John’s wort should not be used concomitantly with Rigevidon, as the contraceptive effect may be reduced.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rigevidon.

When should you consult your doctor? Seek urgent medical attention If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulty, contact a doctor immediately. Medicines containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema. If you notice possible signs of a blood clot which may indicate that you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

If you have any of the following conditions/situations, you may only take Rigevidon under strict medical supervision, as these conditions may worsen while you are taking the contraceptive.

If your condition develops or worsens while using Rigevidon, you must also inform your doctor.

• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you require surgery or are immobile for long periods (see section 2 “Blood clots”).

• If you or a close relative have ever had heart or circulatory problems such as high blood pressure.

• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If you or a close relative have ever had blood clotting disorders.

• If you have migraines.

• If you have diabetes.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases).

• If you have the hereditary form of hearing loss known as otosclerosis.

• If you have depressed mood (depression or mood changes).

• If you have the movement disorder called Sydenham's chorea.

• If you have liver and/or gallbladder disease (jaundice – yellowing of the skin – or gallstones).

• If you have the inherited disease called porphyria.

• If you have sickle cell anemia (a hereditary red blood cell disorder).

• If you have hemolytic uremic syndrome – HUS (a blood clotting disorder causing kidney failure).

• If you have systemic lupus erythematosus – SLE (a disease affecting your body's natural defense system).

• If you have the skin rash called herpes gestationis (blistering skin eruption during pregnancy).

• If you have brown patches on your face and body (chloasma), which you can minimize by avoiding sunlight and not using sunbeds or UVA lamps.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Rigevidon increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Rigevidon is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking; increased warmth in the affected leg; change in skin color of the leg, e.g. if it becomes pale, red, or blue.	Deep vein thrombosis
sudden shortness of breath without known cause or rapid breathing; sudden cough without clear cause, possibly bringing up blood; sudden sharp chest pain that may worsen upon deep breathing; severe dizziness or lightheadedness; rapid or irregular heartbeat; severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g. common cold).	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision; painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
pain, discomfort, pressure, or heaviness in the chest; feeling of tightness or fullness in the chest, arm, or below the breastbone; feeling of fullness, indigestion, or suffocation; upper body discomfort spreading to the back, jaw, throat, arm, or stomach; sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.	Heart attack
sudden weakness or numbness of the face, arm, or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden vision problems in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache without known cause; loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical help as you may be at risk of another stroke.	Stroke
swelling and slight bluish discoloration of a limb; severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

After the first year, the risk decreases but remains somewhat higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Rigevidon is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as Rigevidon, about 5 to 7 will develop a blood clot in one year.
• Your individual risk of developing a blood clot will depend on your personal medical history (see below “Factors that increase your risk of a blood clot”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 in 10,000 women
Women who use a combined hormonal contraceptive containing levonorgestrel	About 5–7 in 10,000 women
Women who use Rigevidon	About 5–7 in 10,000 women

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

The risk of getting a blood clot with Rigevidon is small, but certain conditions can increase this risk. Your risk is higher:

• If you are very overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (e.g., before approximately 50 years of age). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury, illness, or having a leg in a cast. You may need to stop taking Rigevidon several weeks before surgery or while you are less mobile. If you need to stop taking Rigevidon, ask your doctor when you can start again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

Air travel (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you need to stop taking Rigevidon.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

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

• With age (especially over about 35 years),
• If you smoke. When using a combined hormonal contraceptive like Rigevidon, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive,
• If you are overweight,
• If you have high blood pressure,
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke,
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides),
• If you suffer from migraines, especially migraines with aura,
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation),
• If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

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

Oral contraceptives and cancer

Some studies have found an increased risk of cervical cancer in women who have taken oral contraceptives for long periods. It is unclear whether this increased risk is caused by oral contraceptives, as it could be due to the effects of sexual behavior and other factors.

Breast cancer has been found slightly more frequently in women who take oral contraceptives than in women of the same age who do not. If women stop taking oral contraceptives, this reduces the risk, so that 10 years after stopping oral contraceptives, the risk of developing breast cancer is the same as in women who have never taken them. It is not clear whether oral contraceptives increase the risk of breast cancer. It may be that women who take oral contraceptives are examined more frequently, so breast cancer is detected earlier.

Benign and malignant liver tumors have been reported in women taking oral contraceptives. Liver tumors can lead to life-threatening intra-abdominal bleeding (bleeding in the abdomen). Therefore, if you have pain in the upper part of your stomach that does not go away quickly, tell your doctor.

Psychiatric disorders

Some women using hormonal contraceptives such as Rigevidon have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

Regular check-ups

Once you have started taking Rigevidon, your doctor will see you for regular check-ups each year, or you can see your doctor at any time if you have any problems.

Children and adolescents

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

Other medicines and Rigevidon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are using Rigevidon. They may advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Do not use Rigevidon if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in blood test results for liver function (increase in liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

Rigevidon can be restarted approximately 2 weeks after completing this treatment. See the section “Do not take Rigevidon.”

Some medicines:

• May affect blood levels of Rigevidon
• May make it less effective in preventing pregnancy
• May cause unexpected bleeding

These include:

• Medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, rufinamide, perampanel)
  • tuberculosis (e.g., rifampicin)
  • HIV and Hepatitis C infections (also called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin)
  • pulmonary arterial hypertension (bosentan)
  • sleep disorders (modafinil)
  • certain types of skin cancer (vemurafenib)
  • symptomatic treatment of osteoarthritis (etoricoxib)
  • uterine fibroids (ulipristal).

If you are already taking or wish to take St. John’s wort, consult your doctor, as Rigevidon may not be suitable for you.

Rigevidon may affect the effect of other medicines, e.g.:

• cyclosporine (a medicine used to prevent tissue rejection after transplant surgery)
• the antiepileptic lamotrigine (which could lead to an increased frequency of seizures)

Effect on laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking oral contraceptives, as these medicines may affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must not take Rigevidon when you are pregnant. If you become pregnant or think you may be pregnant, stop taking Rigevidon and tell your doctor immediately.

Breastfeeding

Rigevidon must not be taken during breastfeeding. If you are breastfeeding and wish to take oral contraceptives, discuss this with your doctor.

Driving and use of machines

There is no information suggesting that the use of Rigevidon coated tablets has any effect on the ability to drive or operate machinery.

Rigevidon contains lactose, sucrose, and sodium

If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Rigevidon

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The daily dose is one coated tablet.

You should try to take the tablet at approximately the same time each day. You may find it easiest to take it either before going to bed or just after waking up.

Swallow the tablet whole, with water if necessary.

Each pack of Rigevidon contains either 1 reminder blister of 21 coated tablets or 3 reminder blisters of 21 coated tablets. The reminder blister is designed to help you remember to take your tablets.

The blister is marked with the day of the week on which you should take each tablet. You must take one tablet daily for 21 days, following the direction of the arrow printed on the pack, until the blister is empty.

Then comes a 7-day period during which you take no tablets. During these 7 tablet-free days, on day 2 or 3, you will have a withdrawal bleed similar to menstruation—this is your period.

Start the next blister on the 8th day (after the 7 tablet-free days)—even if bleeding has not yet stopped. Provided you take Rigevidon correctly, you will always start each new blister on the same day of the week, and you will always have your period every 28 days on the same day.

Starting the first pack

If you have not used any hormonal contraceptives in the previous cycle.

Take the first tablet on the first day of your menstrual period. This is day 1 of your cycle—the day bleeding starts. Take a tablet marked for that day of the week (for example, if your period begins on a Tuesday, take the tablet marked Tuesday on the blister). Follow the direction of the arrow and continue taking one tablet daily until the blister is empty.

If you start on day 2–5 of your period, you must use an additional contraceptive method, such as a condom, during the first 7 days of taking the contraceptive, but only during the first blister. It is not necessary to use another contraceptive method during the 7-day break, provided you have taken all 21 tablets correctly and start the next blister on time.

Switching to Rigevidon from another combined hormonal contraceptive

Start taking Rigevidon the day after taking the last active tablet of your previous contraceptive pack. Do not leave a gap between packs. If your previous contraceptive pack contains inactive (placebo) tablets, you should start taking Rigevidon the day after taking the last active tablet, and no later than the day after the usual hormone-free interval of your previous combined hormonal contraceptive (or after taking the last inactive tablet of the previous pack). When switching from a combined hormonal contraceptive of the vaginal ring or patch type, follow your doctor's advice.

If you are unsure or have further questions, consult your doctor or pharmacist.

Switching to Rigevidon from a progestogen-only contraceptive (POP or mini-pill)

You may stop taking the progestogen-only contraceptive at any time and start taking Rigevidon the following day at the same time. However, ensure you use additional contraception (such as a condom) during sexual intercourse in the first 7 days of taking the tablets.

Switching to Rigevidon from a contraceptive injection or implant

If you have received a progestogen-only hormonal injection or have an implant, you may start taking Rigevidon on the day your next injection is due or on the day your implant is removed. However, you must use another contraceptive method (such as a condom) during sexual intercourse in the first 7 days of taking the tablets.

Starting after childbirth or abortion (spontaneous or induced)

Your doctor should advise you on taking contraceptives after childbirth or abortion (spontaneous or induced).

You may start taking Rigevidon immediately after an abortion occurring during the first trimester of pregnancy. In this case, no additional contraceptive measures are necessary.

If you have given birth or had an abortion during the second trimester of pregnancy, your doctor will advise you on when to start taking contraceptives.

The duration of treatment has no fixed limit, but regular check-ups are recommended.

If you take more Rigevidon than you should

Taking more Rigevidon than prescribed is unlikely to cause harm, but you may experience nausea, vomiting, abdominal pain, chest pain, dizziness, numbness/fatigue, and in younger girls, small amounts of vaginal bleeding. If you experience any of these symptoms, inform your doctor, who will advise you on what to do, if anything.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rigevidon

If you forget to take your contraceptive, follow these instructions. Be aware that contraceptive effectiveness may be reduced if you miss a dose, especially if this increases the time between the last tablet of the current pack and the first tablet of the next pack.

If you are less than 12 hours late in taking a tablet

If you take the missed tablet as soon as you remember and continue taking the following tablets at your usual time, you are still protected against pregnancy. This may mean taking two tablets in one day.

If you are more than 12 hours late in taking a tablet

If you are more than 12 hours late in taking a tablet, your protection against pregnancy may be reduced, and you should use additional contraceptive precautions. The more tablets you miss, the greater the risk of reduced contraceptive protection.

If you have missed more than one tablet, consult your doctor for advice.

What to do if you miss a tablet in the first week

You should take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. For the next 7 days, you must also use a barrier method, e.g., a condom. If you had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets you have missed and the closer they are to the usual tablet-free interval, the greater the risk of pregnancy.

What to do if you miss a tablet in the second week

You should take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. If you have taken all tablets correctly in the 7 days before the missed tablet, no additional contraceptive precautions are necessary. However, if this is not the case, or if you have missed more than one tablet, you must use additional contraceptive precautions for 7 days.

What to do if you miss a tablet in the third week

The risk of reduced contraceptive reliability is imminent due to the proximity of the tablet-free interval. However, decreased contraceptive protection can be avoided by adjusting tablet intake. Therefore, by following one of the two alternatives below, additional contraceptive precautions are not necessary, provided all tablets were taken correctly during the 7 days before the first missed tablet. If you have not taken Rigevidon correctly during the 7 days before the first missed tablet, follow the first of the two alternatives below. Additionally, you must use a barrier method (such as a condom) simultaneously for the next 7 days.

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. Then, immediately start the next blister after finishing the last tablet of the current blister—i.e., there will be no tablet-free interval between blisters. It is unlikely you will experience a withdrawal bleed before the end of the second blister, but you may experience spotting or breakthrough bleeding during tablet intake.
2. Alternatively, you may stop taking tablets from the current blister. In this case, wait up to 7 days without taking tablets, including the days when you missed tablets, and then continue with the next blister.

If you have missed tablets and do not experience a withdrawal bleed during the first usual tablet-free interval, consider the possibility of pregnancy.

If you wish to stop taking Rigevidon

You may stop taking Rigevidon at any time. If you stop taking Rigevidon to become pregnant, use another contraceptive method until you have had a true menstrual period. This will make it easier for your doctor to determine your due date.

What to do if you have gastrointestinal disturbances

If you vomit or have diarrhea within 3–4 hours after taking a tablet, the active ingredients may not have been fully absorbed into your body. This situation is similar to missing a tablet. After vomiting or diarrhea, take another tablet from another pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Rigevidon.”

What to do if you wish to delay or shift your menstrual period

If you wish to delay or shift your menstrual period, consult your doctor for advice.

To delay your period, continue with the next blister of Rigevidon immediately after taking the last tablet of the current blister, without taking the usual 7-day break. You may take as many tablets as desired from this second blister until it is finished. While taking this second blister, you may experience breakthrough bleeding or spotting. Resume your usual Rigevidon schedule after the normal 7-day tablet-free interval.

To shift your period to another day of the week

If you take Rigevidon correctly, your period will always occur on the same day every 28 days. If you wish to shift your period to a different day of the week than your current schedule allows, you may shorten (but never extend) the next tablet-free interval by as many days as desired. For example, if your period usually starts on Friday and you want it to start on Tuesday (i.e., three days earlier), you should start the next blister of Rigevidon three days earlier. The shorter the tablet-free interval, the greater the chance that you will not have a withdrawal bleed and that you may experience hormonal breakthrough bleeding or spotting during the second blister.

If you experience bleeding between periods

A small number of women may experience breakthrough bleeding or light spotting while taking Rigevidon, especially during the first few months. Usually, this bleeding is not a cause for concern and will stop within a day or two. Continue taking the tablets as usual, and the problem should resolve after the first few blisters.

If bleeding continues, is bothersome, or persists for a long time, inform your doctor.

If you do not have a period

If you have taken all tablets correctly, have had no gastrointestinal disturbances, and have not taken other medications, it is unlikely that you are pregnant. Continue taking Rigevidon as usual.

If you miss two consecutive periods, you may be pregnant and should see your doctor immediately. You should only continue taking the contraceptive after a pregnancy test and if your doctor advises it.

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

4. Possible adverse effects

Like all medicines, Rigevidon can cause adverse effects, although not everyone will experience them.

Serious adverse effects

• Contact a doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties (see section “Warnings and precautions”).

• All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Rigevidon”.

The following side effects have been reported in women taking oral contraceptives. These may occur during the first few months after starting Rigevidon, but usually disappear once the body has adapted to the contraceptive.

Common (may affect up to 1 in 10 people): Vaginitis, including vaginal candidiasis, mood changes including depression, changes in sexual desire, nervousness, dizziness, nausea, vomiting, abdominal pain, acne, breast tenderness, breast pain, breast enlargement or discharge, painful periods, changes in the cervix (change in cervical ectropion) and vaginal discharge, absence or reduction of bleeding, fluid retention/edema, changes in weight.

Uncommon (may affect up to 1 in 100 people): Changes in appetite, elevated blood pressure, abdominal cramps, bloating, rash, chloasma (yellowish-brown skin patches), which may persist, excessive hair growth, hair loss, changes in serum lipid levels, including hypertriglyceridemia.

Rare (may affect up to 1 in 1,000 people): Severe allergic reactions (anaphylactic reaction with very rare cases of urticaria, facial swelling, tongue swelling, severe circulatory and respiratory disorders), glucose intolerance, eye irritation when wearing contact lenses, yellowish skin (jaundice), skin condition erythema nodosum (characterized by painful reddish skin nodules).

Very rare (may affect up to 1 in 10,000 people):

Benign or malignant liver tumour, worsening of immune system disorder (lupus), worsening of porphyria, worsening of chorea (a disorder of involuntary movement), inflammation of the optic nerve, blood clots in blood vessels of the eye, worsening of varicose veins, inflammation of the large intestine (ischaemic colitis), inflammation of the pancreas, gallbladder disorder (including gallstones), erythema multiforme (characterized by skin rash with target-like red spots or ulcers), a blood disorder called haemolytic uraemic syndrome - HUS (a blood coagulation disorder causing kidney failure).

Frequency not known (frequency cannot be estimated from available data):

Inflammatory bowel disease (Crohn's disease, ulcerative colitis), hepatocellular damage (e.g. hepatitis, impaired liver function).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rigevidon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following the word "EXP". The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rigevidon

The active substances are ethinylestradiol and levonorgestrel. One coated tablet contains 0.03 mg of ethinylestradiol and 0.15 mg of levonorgestrel.

The other components are: anhydrous colloidal silica, magnesium stearate, talc, maize starch, monohydrate lactose (33 mg), sucrose, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, povidone, sodium carboxymethylcellulose.

Appearance of the product and contents of the pack

White, biconvex, round coated tablets.

Each pack contains 1, 3, 6 or 13 calendar blister packs of 21 coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder:

Gedeon Richter Ibérica, S.A.

Sabino Arana 28, 4º 2ª

08028 Barcelona

Spain

Manufacturer:

Gedeon Richter Plc.

Gyömroi út 19-21.

Budapest

H-1103

Hungary

This medicinal product is authorised in the EEA Member States under the following names:

Denmark: Rigevidon 30 mikrogram/150mikrogram overtrukne tabletter

Germany: Florentia 30,30 Mikrogramm/150 Mikrogramm überzogene Tabletten

Austria: Rigevidon 30 Mikrogramm/150 Mikrogramm überzogene Tabletten

Belgium: Levorichter 30,30 microgrammes/150 microgrammes comprimés enrobés

Spain: Rigevidon 0,03 mg/0,15 mg comprimidos recubiertos EFG

Ireland: Ovreena 30 micrograms/150 micrograms coated tablets

Luxembourg: Levorichter 30,30 microgrammes /150 microgrammes comprimés enrobés

Norway: Rigevidon 30 mikrogram/150 mikrogram tabletter, drasjerte

Portugal: Etinilestradiol + Levonorgestrel Rigevidon 30 microgramas/150microgramas comprimidos revestidos.

United Kingdom: Rigevidon 150 micrograms/30 micrograms coated tablets

Date of the most recent revision of this leaflet: September 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/