Package Insert: Information for the User

Rigevidon 0.03 mg/0.15 mg Coated Tablets EFG

etinilestradiol and levonorgestrel

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rigevidon is a combined oral contraceptive, also known as the contraceptive pill. It contains two types of female hormones: an estrogen, ethinylestradiol, and a progestogen, levonorgestrel at a low dose.

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

1.Prevent the ovary from releasing an egg each month (ovulation),

2.Also thicken the fluid (in the cervix) making it more difficult for sperm to reach the egg.

3.Alter the lining of the uterus to make it less likely to accept a fertilized egg.

General information

If taken correctly, oral contraceptives are an effective reversible form of contraception. However, in certain circumstances, the effectiveness of the contraceptive may decrease or you may need to stop taking it (see below). In these cases, you should not have 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 like Rigevidon will not protect you against sexually transmitted infections (such as HIV). Only condoms can do this.

Before starting to take Rigevidon, read the information about blood clots in section 2. It is particularly important that you read 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 relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may perform some other tests.

In this prospectus, some situations are described in which you should stop taking Rigevidon or where the reliability of Rigevidon may decrease. In these situations, you should not have sexual intercourse or take 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 since 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 what other form of contraception would be more suitable.

Do not take Rigevidon:

• You are allergic to ethinylestradiol or levonorgestrel or to any of the other components of this medication (listed in section 6).
• You have (or have had at any time) a blood clot (thrombosis) in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs. If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• You need surgery or spend a lot of time without standing up (see section “Blood Clots”).
• You have had a heart attack or a stroke at any time.
• You have (or have had at any time) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• You have (or have had at any time) a type of migraine called “migraine with aura”.
• You have any of the following diseases that may increase the risk of arterial blood clots:
• • Severe diabetes with vascular damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.

• You have (or have had at any time) or suspect that you have breast cancer or cancer of the reproductive organs.
• You have (or have had at any time) liver disease and your liver function is not yet normal.
• You have (or have had at any time) a liver tumor.
• You have unexplained vaginal bleeding.

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

The St. John's Wort herb should not be used concurrently with Rigevidon because the contraceptive effect may be reduced.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rigevidon.

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

If the 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 known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).

• If you or a close relative have ever had heart problems or circulation problems such as high blood pressure.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• 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 chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have the hereditary form of deafness known as otosclerosis.
• If you have a depressed mood (depression or mood changes).
• If you have the movement disorder called Sydenham's chorea.
• If you have liver disease and/or gallbladder disease (jaundice – yellow skin –, gallstones).
• If you have the hereditary disease called porphyria.
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have hemolytic-uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have systemic lupus erythematosus (LES, a disease that affects your natural defense system).
• If you have the rash called herpes gestational (vesicular eruption of the skin during pregnancy).
• If you have brown spots on the face and body (melasma), which you can reduce by avoiding the sun and not using beds or UVA lamps.

Blood Clots

The use of a combined hormonal contraceptive like Rigevidon increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

How to recognize a blood clot

Seek immediate medical attentionif you notice any of the following signs or symptoms.

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 thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of 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 breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which a combined hormonal contraceptive is taken for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after an interruption of 4 weeks or more.

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

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

What is the risk of a blood clot?

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

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

-Of every 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.

-Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as Rigevidon, about 5-7 will develop a blood clot in a year.

-The risk of a blood clot will depend on your personal history (see below “Factors that increase your risk of a blood clot”).

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

The risk of having a blood clot with Rigevidon is small, but some conditions will increase the risk. Your risk is higher:

• If you have a lot of excess weight (body mass index or BMI greater than 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (e.g. before the age of about 50). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to interrupt the use of Rigevidon for several weeks before the surgical procedure or while you have less mobility. If you need to interrupt the use of Rigevidon, ask your doctor when you can start taking it again.
• As you get older (especially over the age of about 35).
• If you have given birth in the past few weeks.

The risk of a blood clot in a vein increases the more conditions you have.

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

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to interrupt the use of Rigevidon.

If any of the conditions listed above change while you are using Rigevidon, for example, a close relative experiences a blood clot without 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

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

• With age (over the age of about 35),
• If you smoke. When using a combined hormonal contraceptive like Rigevidon, you are advised to quit smoking. If you are unable to quit 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50). In this case, you may also be at higher risk of a 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 have migraines, especially migraines with aura,
• If you have a heart problem (valve disorder, 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, the risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using Rigevidon, for example, you start smoking, a close relative experiences a blood clot without 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 took oral contraceptives for extended periods. It is not clear whether this increased risk is caused by the contraceptives themselves or by the effects of sexual behavior and other factors.

There has been a slightly higher incidence of breast cancer in women who take oral contraceptives compared to women of the same age who do not take them. If women stop taking oral contraceptives, this reduces the risk so that 10 years after stopping the contraceptives, the risk of discovering breast cancer is the same as that of women who never took oral contraceptives. 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 that breast cancer is detected earlier.

There have been reports of malignant and benign liver tumors in women who took oral contraceptives. Liver tumors can cause life-threatening bleeding in the abdomen. Therefore, if you have severe stomach pain that does not improve quickly, inform your doctor.

Mental health disorders

Some women who use hormonal contraceptives like Rigevidon have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Regular reviews

Once you have started taking Rigevidon, your doctor will see you for regular reviews every year, or if you have any problems, you can see your doctor at any time.

Children and adolescents

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

Other medications and Rigevidon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are using Rigevidon. They may advise you 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 medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir as these medications can cause increases in liver function test results (elevated ALT levels).

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

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

Some medications:

• may affect the blood levels of Rigevidon
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

These include:

• Medications 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)
  • Increased pulmonary arterial pressure (bosentan)
  • Sleep disorders (modafinil)
  • A certain type of skin cancer (vemurafenib)
  • Arthritis treatment (etoricoxib)
  • Uterine fibroids (ulipristal).

If you already take or want to take a St. John's Wort preparation, ask your doctor for advice, as Rigevidon may not be suitable for you.

Rigevidon mayinfluence the effectof other medications, e.g.:

• ciclosporin (medication used to treat transplant rejection)
• the antiepileptic lamotrigine (may cause an increase in seizure frequency)

Effect on laboratory tests

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

When you are pregnant, you should not take Rigevidon. If you become pregnant or think you may be pregnant, stop taking Rigevidon and inform your doctor immediately.

Breastfeeding

Do not take Rigevidon during breastfeeding. If you are breastfeeding and want to take oral contraceptives, discuss this with your doctor.

Driving and operating machinery

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

Rigevidon contains lactose, sucrose, and sodium

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be taken as directed by your doctor.Consult your doctor or pharmacist if you are unsure.

The daily dose is one coated tablet.

Try to take the tablet at approximately the same time every day.It may be easier to take it before going to bed or as soon as you wake up.

Swallow the tablet whole, if necessary with water.

Each pack of Rigevidon contains 1 blister pack of 21 coated tablets or 3 blister packs of 21 coated tablets. The blister pack has been designed to help you remember to take the tablets.

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

After that, there are 7 days when you will not take any tablets. During these 7 days without tablets, on the 2nd or 3rd day, you will have a withdrawal bleed similar to menstruation, i.e., your period.

Start the next blister pack on the 8th day (after the 7 days without tablets) – even if the bleeding has not stopped yet. While taking Rigevidon correctly, you will always start each new blister pack on the same day of the week, and you will always have your period on the same day every 28 days.

Starting the first pack

If you have not used any previous oral contraceptives during the previous cycle.

Take the first tablet on the first day of your menstruation. This is the first day of your cycle – the day when bleeding starts. Take a tablet marked for that day of the week (for example, if your period starts on Tuesday, take the tablet marked as Tuesday in the blister pack). Follow the direction of the arrow and continue taking one tablet every day until the blister pack is empty.

If you start on the 2nd-5th day of your menstruation, you should also use another contraceptive method, such as a condom, during the first 7 days that you take contraceptives, but only in the first blister pack. You do not need to use another contraceptive method during the 7-day break as long as you have taken the 21 tablets correctly and start the next blister pack when due.

Switching to Rigevidon from another combined hormonal contraceptive

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

If you are unsure or have more doubts, consult your doctor or pharmacist.

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

You can stop taking progestogen-only contraceptives at any time and start taking Rigevidon the next day at the same time. However, make sure to use additional protection (such as a condom) during the first 7 days that you take the tablets.

Switching to Rigevidon from an injectable or implantable contraceptive

If you have received an injection or an implant of progestogen hormones, you can start taking Rigevidon on the day you are due for the next injection, or on the day the implant is removed. However, you should use another contraceptive method (such as a condom) during the first 7 days that you take the tablets.

Starting after childbirth or abortion (spontaneous or induced)

Your doctor should advise you on taking contraceptives after childbirth or abortion.

You can start taking Rigevidon immediately after a first-trimester abortion. In this case, you do not need to take any additional measures.

If you have given birth or had an abortion in the second trimester, your doctor will advise you on taking contraceptives.

The duration of treatment is not limited, but frequent reviews are recommended.

If you take more Rigevidon than you should

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

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

If you forget to take Rigevidon

If you forget to take your contraceptive, follow these instructions. Note that the contraceptive efficacy may be reduced if you forget 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 delayed by 12 hours or less in taking a tablet

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

If you are delayed by more than 12 hours in taking a tablet

If you are delayed by more than 12 hours in taking a tablet, your protection against pregnancy may be reduced, so you should take additional contraceptive precautions. The more tablets you have forgotten, the greater the risk of reduced contraceptive protection.

If you have forgotten more than one tablet, ask your doctor for advice

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

You should take the last tablet that you forgot as soon as you remember, even if this means taking 2 tablets at the same time. From then on, continue taking the tablets at the usual time of the day. During the next 7 days, use an additional barrier method, e.g., a condom. If you have had sex in the previous 7 days, the risk of pregnancy should be considered. The more tablets you have forgotten and the closer you are to the usual hormone-free interval, the greater the risk of pregnancy.

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

You should take the last tablet that you forgot as soon as you remember, even if this means taking 2 tablets at the same time. From then on, continue taking the tablets at the usual time of the day. As long as the tablets have been taken correctly during the 7 days before the forgotten tablet, no additional contraceptive precautions are necessary. However, if this is not the case, or if more than 1 tablet has been forgotten, you should take additional contraceptive precautions for 7 days.

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

The risk of reduced reliability is imminent due to the proximity of the hormone-free interval. However, the reduction in contraceptive protection can be avoided by adjusting the tablet-taking schedule. Therefore, following one of the two alternatives below, no additional contraceptive precautions are necessary, as long as the tablets have been taken correctly during the 7 days before the first forgotten tablet.However, if you have not taken Rigevidon correctly during the 7 days before the first forgotten tablet, you should follow the first of the two alternatives. In addition, you should use an additional barrier method (such as a condom) simultaneously for the next 7 days.

1.You should take the last tablet that you forgot as soon as you remember, even if this means taking 2 tablets at the same time. From then on, continue taking the tablets at the usual time of the day. Then, start taking the next pack immediately after taking the last tablet of the current pack, i.e., there will be no hormone-free interval between packs. It is unlikely that you will have a withdrawal bleed before the end of the second pack, but you may experience spotting (light bleeding) or hormonal disruption during the days you take the tablets.

2.You can also stop taking the tablets from the current pack. In that case, you should wait for a period of up to 7 days without taking tablets, including the days when you forgot to take the tablets, and then continue with the next pack.

If you have forgotten tablets and then do not have a withdrawal bleed in the first hormone-free interval, you should consider the possibility of pregnancy.

If you want to stop taking Rigevidon

You can stop taking Rigevidon at any time. If you stop taking Rigevidon to become pregnant, use another contraceptive method until you have had a real period. This will make it easier for your doctor to tell you when your baby will be born.

What to do if you experience digestive discomfort

If you have vomited or had diarrhea in the 3-4 hours after taking the tablet, the active ingredients of the tablet may not have been fully absorbed by your body. The situation is similar to forgetting a tablet. After vomiting or diarrhea, take another tablet from another pack as soon as possible. If possible, take it within 12 hours of the usual time you take your tablet. If this is not possible or more than 12 hours have passed, follow the instructions in the section "If you forget to take Rigevidon".

What to do if you want to delay or change your menstrual period

If you want to delay or change your menstrual period, consult your doctor for advice.

Delaying your period, continue with the next pack of Rigevidon after taking the last tablet of the current pack, without taking the hormone-free interval. You can take as many tablets as you want from this second pack until it is finished. While taking this second pack, you may experience spotting (light bleeding) or hormonal disruption during the days you take the tablets. The usual Rigevidon-taking schedule resumes after the usual 7-day hormone-free interval.

Changing the day of your period

If you take Rigevidon correctly, you will always have your period on the same day every 28 days. If you want to change the day of your period to a different day of the week, you can shorten (but not lengthen) the next hormone-free interval by as many days as you want. For example, if your period usually starts on Friday and you want it to start on Tuesday (i.e., 3 days earlier), start the next pack of Rigevidon 3 days earlier. The shorter the hormone-free interval, the greater the likelihood that you will not have a withdrawal bleed, and the greater the likelihood that you will experience hormonal disruption or spotting during the second pack.

If you experience bleeding between periods

A small number of women may experience spotting (light bleeding) or hormonal disruption while taking Rigevidon, especially during the first few months. Normally, this bleeding should not cause concern, and it will stop within a day or two. Continue taking the tablets as usual, and the problem will resolve after the first few packs.

If the bleeding continues, is bothersome, or is prolonged, tell your doctor.

If you do not have a period

If you have taken all the tablets correctly, and have not experienced gastrointestinal discomfort, and have not taken other medications, it is unlikely that you are pregnant. Continue taking Rigevidon as usual.

If you have not had two consecutive periods, you may be pregnant and should see your doctor immediately. You will only be allowed to continue taking the contraceptive after a pregnancy test and if your doctor advises you to do so.

If you have any doubts about the use of this medication, consult your doctor.

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

Severe side effects

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

• All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 "What you need to know before starting to use Rigevidon".

These side effects have been reported in women taking oral contraceptives and may appear in the first few months after starting Rigevidon, but usually disappear once the body has adjusted to the contraceptive.

Frequent (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 secretion, painful periods, changes in the cervix (change in cervical ectropion) and vaginal discharge, absence or decrease in bleeding, fluid retention/edema, weight changes.

Infrequent (may affect up to 1 in 100 people): Changes in appetite, high blood pressure, abdominal cramps, swelling, rash, melasma (brownish-yellow 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 rare cases of urticaria, facial swelling, circulatory and respiratory disorders), glucose intolerance, eye irritation when wearing contact lenses, yellow skin (jaundice), skin erythema nodosum (characterized by painful red skin nodules).

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

Liver benign or malignant tumor, worsening of autoimmune disorder (lupus), worsening of porphyria, worsening of chorea (an involuntary movement disorder), optic nerve inflammation, blood clots in the eye vessels, worsening of varicose veins, inflammatory bowel disease (ischemic colitis), pancreatitis, gallbladder disorder (including gallstones), erythema multiforme (characterized by skin rash with target-shaped redness or ulcers), a blood disorder called hemolytic-uremic syndrome (HUS) (a blood clotting disorder that causes kidney failure).

Unknown (frequency cannot be estimated from available data):

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in the leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rigevidon

The active principles are etinilestradiol and levonorgestrel. A coated tablet contains 0.03 mg of etinilestradiol and 0.15 mg of levonorgestrel.

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

Appearance of the product and contents of the package

White, biconvex, and circular coated tablets.

Each box contains 1, 3, 6, or 13 calendar blister packs of 21 coated tablets. It is possible that not all package sizes will be marketed.

Marketing Authorization Holder:

Gedeon Richter Ibérica, S.A.

Sabino Arana 28, 4th 2nd

08028 Barcelona

Spain

Responsible for manufacturing:

Gedeon Richter Plc.

Gyömroi út 19-21.

Budapest

H-1103

Hungary

This medicinal product is authorized in the Member States of the EEA with the following names:

Danish:Rigevidon 30 mikrogram/150 mikrogram 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:Ovreena30 micrograms/150 micrograms coated tablets

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

Norway:Rigevidon30 mikrogram/150 mikrogram tabletter, drasjerte

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

United Kingdom:Rigevidon 150 micrograms/30 micrograms coated tablets

Last review date of this leaflet: September 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/