RIGEVIDON 0.03 mg/0.15 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Rigevidon 0.03 mg/0.15 mg coated tablets EFG

ethinylestradiol and levonorgestrel

Read this leaflet carefully before starting to take this medicine, as 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 to you only, 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 side effects, consult your doctor or pharmacist, even if they are side 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 side effects
5. Storage of Rigevidon
6. Package contents and additional information

1. What Rigevidon is and what it is used for

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

The combined birth control pill prevents you from becoming pregnant 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 form of reversible birth control. However, under certain circumstances, the effectiveness of the contraceptive may decrease, or you may need to stop taking it (see below). In these cases, either do not have sexual intercourse or use other non-hormonal birth control precautions (such as condoms or another barrier method) during sexual intercourse to ensure effective birth control.

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

2. What you need to know before taking Rigevidon

Before starting to take Rigevidon, you should 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.

This leaflet describes some situations in which you should stop using Rigevidon or where the reliability of Rigevidon may be decreased. In these situations, you should not have sex or should take extra non-hormonal contraceptive precautions, such as using a condom or some other 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 infection (AIDS) or any other sexually transmitted disease.

When not to take Rigevidon

You should 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:

• If you are allergic to ethinylestradiol or levonorgestrel or any of the other components 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a long time immobile (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of an impending 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 diseases that may increase the risk of forming a blood 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 hyperhomocysteinaemia.

• If you have (or have ever had) or if you suspect you 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 medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/voxilaprevir (see also section "Other medicines and Rigevidon").

St John's Wort should not be taken at the same time as 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 should also inform your doctor.

• If you have high levels of fat in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• If you need an operation or spend a long time immobile (see section 2 "Blood clots").

• If you or a close relative have ever had heart or circulation problems, such as high blood pressure.
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you or a close relative have ever had problems with blood clotting.
• If you have migraines.

• If you have diabetes.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases).
• If you have the hereditary form of deafness known as otosclerosis.
• If you have a depressed mood (depression or mood changes).
• If you have a movement disorder called Sydenham's chorea.
• If you have liver or biliary disease (jaundice - yellow skin - or gallstones).
• If you have the hereditary disease called porphyria.
• If you have sickle-cell anaemia (a hereditary disease of the red blood cells).
• If you have haemolytic uraemic syndrome (HUS - a blood clotting disorder that causes kidney failure).
• If you have systemic lupus erythematosus (SLE - a disease that affects your natural defence system).
• If you have the rash called gestational herpes (blistering rash during pregnancy).
• If you have brown patches on the face and body (chloasma), which you may be able to reduce by avoiding the sun and not using sunbeds or UVA lamps.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

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

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if 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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of having 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 higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) again after a break 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 having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

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

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

• Out of 10,000 women who are not taking any combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who take a combined hormonal contraceptive that contains levonorgestrel, such as Rigevidon, about 5-7 will have a blood clot in a year.
• The risk of having 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 are seriously overweight (body mass index or BMI over 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. below the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or if you spend a long time immobile due to injury or illness or if you have a leg in a plaster cast. You may need to stop taking Rigevidon several weeks before the operation or while you are less mobile. If you need to stop taking Rigevidon, ask your doctor when you can start taking it again.
• As you get older (especially above the age of about 35).
• If you gave birth less than a few weeks ago.

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

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

It is important to tell your doctor if you have any of the conditions listed above, even if you are not sure. Your doctor may decide that you should stop taking Rigevidon.

If any of the conditions listed above change while you are taking Rigevidon, for example, if you become pregnant or start smoking, a close relative has a thrombosis without any apparent reason, or you gain a lot of weight, tell 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 a stroke.

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

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

• with age (above about 35 years),
• if you smoke. When you use 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also have an increased risk of having 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 (valvular heart disease, heart rhythm disturbance 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 having a blood clot may be increased even further.

If any of the conditions listed above change while you are taking Rigevidon, for example, if you start smoking, a close relative has a thrombosis without any apparent reason, or you gain a lot of weight, tell your doctor.

Oral contraceptives and cancer

Some studies have found an increased risk of cervical cancer in women who have taken oral contraceptives for a long time. It is not clear whether this increased risk is caused by the oral contraceptives, as it may be due to sexual behaviour and other factors.

Breast cancer has been found to occur slightly more often in women who take oral contraceptives than in women of the same age who do not take them. If women stop taking oral contraceptives, the risk decreases, so that 10 years after stopping oral contraceptives, the risk of finding breast cancer is the same as for women who have never taken oral contraceptives. It is not clear whether oral contraceptives cause an increased risk of breast cancer. It may be that women who take oral contraceptives are examined more frequently, so that breast cancer is detected earlier.

Malignant and benign liver tumours have been reported in women who take oral contraceptives. Liver tumours can cause life-threatening internal bleeding. Therefore, if you have severe pain in the upper abdomen that does not disappear within a short time, you should tell your doctor.

Psychiatric disorders

Some women who use hormonal contraceptives like 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 regularly, usually every year, or if you have any problems, you can see your doctor at any time.

Children and adolescents

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

3. How to take Rigevidon

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 every day.It may be easiest to take it either before going to bed or just after getting up.

Swallow the tablet whole, if necessary with water.

Each pack of Rigevidon contains 1 reminder blister pack of 21 coated tablets or 3 reminder blister packs of 21 coated tablets. The reminder 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. You should take one tablet each day for 21 days, following the direction of the arrow printed on the pack, until the blister pack is empty.

Then come 7 days when you take no tablets. During the 7 days without tablets, on day 2 or 3, you will have a withdrawal bleed similar to a period, 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 finished 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 did not use oral contraceptives during the previous cycle.

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

If you start on days 2-5 of your period, you should also use another contraceptive method, such as a condom, for the first 7 days of taking the tablets, but only during the first blister pack. You do not need to use another method of contraception during the 7-day break, provided you have taken the 21 tablets correctly and start the next blister pack on time.

Switching to Rigevidon from another hormonal contraceptive

Start taking Rigevidon the day after taking the last tablet from the previous contraceptive blister pack. Do not leave a gap between packs. If the previous contraceptive blister pack contains inactive tablets as well, start taking Rigevidon the day after taking the last active tablet (and not more than one day after taking the last inactive tablet from the previous pack). When switching from a combined contraceptive vaginal ring or patch, follow your doctor's advice.

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

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

You can stop taking the progestogen-only contraceptive at any time and start taking Rigevidon the next day, at the same time. However, make sure to use additional contraception (such as a condom) for the first 7 days of taking the tablets.

Switching to Rigevidon from an injectable or implant contraceptive

If you have been given an injection or an implant of progestogen hormones, you can start taking Rigevidon on the day you would have your next injection or on the day your implant is removed. However, you should use another contraceptive method (such as a condom) for the first 7 days of taking the tablets.

Starting after childbirth or abortion (spontaneous or induced)

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

You can start taking Rigevidon immediately after an abortion that occurs during the first trimester of pregnancy. In this case, you do not need to take additional contraceptive measures.

If you have had a child or have had an abortion during the second trimester of pregnancy, your doctor will advise you about taking contraceptives.

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

If you take more Rigevidon than you should

If you take more Rigevidon than you should, it is unlikely to harm you, but you may feel nauseous, vomit, have 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 can tell you what to do, if necessary.

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 medicine and the amount taken.

If you forget to take Rigevidon

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

If you are less than 12 hours late taking a tablet

If you take the last tablet as soon as you remember, and continue taking the following tablets at the 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 taking a tablet

If you are more than 12 hours late taking a tablet, your protection against pregnancy may be reduced, so you should take extra contraceptive precautions. The more tablets you have missed, the greater the risk that your contraceptive protection will be reduced.

If you have missed 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 you missed as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time of day. During the next 7 days, you should also use a barrier method, such as a condom. If you have had sex in the 7 days before missing the tablet, the possibility of pregnancy should be considered. The more tablets you have missed and the closer they are to the usual tablet-free period, the greater the risk of pregnancy.

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

You should take the last tablet you missed as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time of day. If you have taken the tablets correctly during the 7 days before missing the tablet, you do not need to take extra contraceptive precautions. However, if this is not the case, or if you have missed more than one tablet, you should take extra 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 tablet-free period. However, the reduction in contraceptive protection can be avoided by adjusting the tablet intake. Therefore, following one of the two alternatives below, you do not need to take extra contraceptive precautions, provided you have taken the tablets correctly during the 7 days before missing the first tablet. If you have not taken Rigevidon correctly during the 7 days before missing the first tablet, you should follow the first of the two alternatives. Additionally, you should use a barrier method (such as a condom) simultaneously for the next 7 days.

1. You should take the last tablet you missed as soon as you remember, even if it means taking two tablets at the same time. Then, continue taking the tablets at the usual time of day. You will then start the next blister pack immediately after taking the last tablet of the current blister pack, i.e., there will be no tablet-free period between the blister packs. It is unlikely that you will have a withdrawal bleed before the end of the second blister pack, but you may have spotting or breakthrough bleeding during the days you are taking the tablets.
2. You can also stop taking the tablets from the current blister pack. In this case, you should wait for a period of up to 7 days without taking tablets, including the days you missed tablets, and then continue with the next blister pack.

If you have missed tablets and do not have a withdrawal bleed in the first normal tablet-free period, the possibility of pregnancy should be considered.

If you want to stop taking Rigevidon

You can stop taking Rigevidon at any time. If you stop taking Rigevidon to have a baby, 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 have gastrointestinal problems

If you have vomited or had diarrhea within 3-4 hours after taking the tablet, the active ingredients of the tablet may not have been fully absorbed into your body. The situation is almost the same as 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 the usual time you take your tablet. 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 want to delay or change your menstrual period

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

If you want to delay your period, you should continue with the next blister pack of Rigevidon after taking the last tablet of the current blister pack, without taking the usual tablet-free period. You can take as many tablets as you want from this second blister pack until it is finished. While taking this second blister pack, you may have breakthrough bleeding or spotting. The usual intake of Rigevidon will resume after the normal 7-day tablet-free period.

If you want to change your period to another day of the week

If you take Rigevidon correctly, you will always have your period on the same day every 28 days. If you want to change your period to another day of the week, different from the usual one according to your current tablet intake, you can shorten (but never lengthen) the next tablet-free period by as many days as you want. For example, if your period usually starts on a Friday and you want it to start on a Tuesday (i.e., three days earlier), you should start the next blister pack of Rigevidon three days earlier. The shorter the tablet-free period, the greater the likelihood that you will not have a withdrawal bleed, and that you will have breakthrough bleeding or spotting during the second blister pack.

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. This bleeding usually does not need to cause concern, and it will stop after a day or two. Continue taking the tablets as usual, and the problem will disappear after the first few blister packs.

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

If you do not have a period

If you have taken all the tablets correctly and have not had any gastrointestinal problems or used other medicines, it is unlikely that you are pregnant. Continue taking Rigevidon as usual.

If you have not had two periods in a row, 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 it.

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

4. Possible Adverse Effects

Like all medicines, Rigevidon can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

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

• 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 taking Rigevidon".

In women taking oral contraceptives, these side effects have been reported, which may appear in the first few months after starting to take Rigevidon, but usually disappear once the body has become accustomed 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 tension, 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.

Uncommon (may affect up to 1 in 100 people): Changes in appetite, high blood pressure, abdominal cramps, swelling, rash, chloasma (brownish-yellow spots on the skin), 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, circulatory and respiratory disorders), glucose intolerance, eye irritation when wearing contact lenses, yellowish skin (jaundice), skin affection erythema nodosum (characterized by painful red cutaneous nodules).

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

Benign or malignant liver tumor, worsening of immune system disorder (lupus), worsening of porphyria, worsening of chorea (an involuntary movement disorder), optic nerve inflammation, blood clots in the blood vessels of the eye, worsening of varices, inflammation of the large intestine (ischemic colitis), pancreatitis, gallbladder disorder (including gallstones), erythema multiforme (characterized by skin rash with target-like redness or ulcers), a blood disorder called hemolytic uremic syndrome (HUS) (a blood clotting disorder that causes kidney failure).

Unknown frequency (frequency cannot be estimated from available data):

Inflammatory bowel disease (Crohn's disease, ulcerative colitis), hepatocellular damage (e.g., hepatitis, altered 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 that is not listed in the prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Rigevidon Composition

The active ingredients 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, cornstarch, lactose monohydrate (33 mg), sucrose, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, povidone, sodium carboxymethylcellulose.

Product Appearance and Package Contents

White, biconvex, and circular coated tablets.

Each box 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 medicine is authorized in the Member States of the EEA under the following names:

Denmark: Rigevidon 30 mikrogram/150mikrogram film-coated tablets

Germany: Florentia 30,30 Mikrogramm/150 Mikrogramm film-coated tablets

Austria: Rigevidon 30 Mikrogramm/150 Mikrogramm film-coated tablets

Belgium: Levorichter 30,30 microgrammes/150 microgrammes coated tablets

Spain: Rigevidon 0,03 mg/0,15 mg coated tablets EFG

Ireland: Ovreena 30 micrograms/150 micrograms coated tablets

Luxembourg: Levorichter 30,30 microgrammes /150 microgrammes coated tablets

Norway: Rigevidon 30 mikrogram/150 mikrogram coated tablets

Portugal: Ethinylestradiol + Levonorgestrel Rigevidon 30 micrograms/150 micrograms coated tablets

United Kingdom: Rigevidon 150 micrograms/30 micrograms coated tablets

Date of the last revision of this prospectus: September 2022

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