BEMASIVE 0.15 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

BEMASIVE 0.15 mg/0.02 mg film-coated tablets

desogestrel / ethinylestradiol

Important things to know about combined hormonal contraceptives (CHCs):

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Bemasive and what is it used for
2. What you need to know before taking Bemasive
3. How to take Bemasive
4. Possible side effects
5. Storage of Bemasive
6. Package contents and additional information

1. What is Bemasive and what is it used for

Bemasive is a combined oral contraceptive, also known as the birth control pill. It contains two types of female hormones: a progestogen, desogestrel, and an estrogen, ethinylestradiol, at a low dose. These help prevent you from becoming pregnant, just like your natural hormones prevent you from conceiving again when you are already pregnant.

The combined birth control pill protects 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, in 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 spermicides) during sexual intercourse to ensure effective birth control.

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

2. What you need to know before taking Bemasive

General considerations

Before starting to use Bemasive, 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 Bemasive, your doctor will ask you a series of questions about your personal medical history and that of your close relatives. The doctor will also take your blood pressure, and depending on your personal circumstances, you may be given another test.

Do not take Bemasive

You should not use Bemasive 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.

• if you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or 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 are going to be immobile for a long time (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 the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• if you have any of the following diseases that may increase your risk of forming 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) a type of migraine called "migraine with aura".
• if you have liver disease or have ever had it and your liver function is not normal.

• if you have liver tumors or have ever had them.
• if you have or may have breast cancer or other cancer, such as ovarian cancer, cervical cancer, or uterine cancer (womb).
• if you have unexplained vaginal bleeding.
• if you are pregnant or think you may be pregnant.

• if you have endometrial hyperplasia (a condition characterized by excessive growth of the uterine lining).
• if you have or have ever had pancreatitis (inflammation of the pancreas).
• if you are allergic to ethinylestradiol or desogestrel or any of the other components of this medicine (listed in section 6). This may be recognized by itching, skin rash, or swelling.

Do not take Bemasive if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking Bemasive with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bemasive.

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

Tell your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while you are using Bemasive, you should also inform your doctor:

• if you suffer from symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• if you have sickle cell anemia (a hereditary disease of red blood cells).
• 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 need an operation or if you are going to be immobile for a long time (see section 2 "Blood clots").
• if you have recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Bemasive after childbirth.
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• if you have varicose veins.
• if you have high blood pressure.
• if you have a heart valve disorder or a heart rhythm disorder.
• if you have migraines.
• if you have diabetes.

• 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 a liver and/or bile duct disease (jaundice - yellow skin -, gallstones).
• if you have the hereditary disease called porphyria.
• if you have itching (pruritus).
• if you have the rash called gestational herpes.
• if you have brown spots on your face and body (chloasma), which can be reduced by avoiding the sun and not using sunbeds or UVA lamps.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Bemasive increases your risk of having 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 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 long-term effects or, very rarely, they can be life-threatening.

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

HOW TO RECOGNIZE 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 your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
• In very rare cases, a 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 having a blood clot in a vein is higher during the first year you take 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) 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 Bemasive, 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 Bemasive is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 of them will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, 5 to 7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains desogestrel, such as Bemasive, 9 to 12 will have a blood clot in a year.
• The risk of having a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

• if you are 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 (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• if you need an operation or if you are going to be immobile for a long time due to an injury or illness or if you have your leg in a cast. You may need to stop using Bemasive several weeks before surgery or while you are less mobile. If you need to stop using Bemasive, ask your doctor when you can start using it again.
• as you get older (especially above about 35 years).
• if you have recently given birth.

The risk of having a blood clot increases with the number of 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 essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Bemasive.

If any of the above conditions change while you are using Bemasive, 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 essential to note that the risk of a heart attack or stroke due to Bemasive is very small, but it can increase:

• with age (above about 35 years).
• if you smoke.When using a combined hormonal contraceptive like Bemasive, 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 be at higher 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 (heart 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, the risk of having a blood clot may be increased further.

If any of the above conditions change while you are using Bemasive, 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

All women have a risk of breast cancer, whether or not they take oral contraceptives. Breast cancer has been found to occur slightly more frequently in women who take oral contraceptives than in 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 oral contraceptives, the risk of finding breast cancer is the same as that of women who have never taken oral contraceptives. It is not clear whether oral contraceptives cause an increased risk of breast cancer. It is possible that women who take oral contraceptives are examined more frequently, so breast cancer is detected earlier.

Malignant and benign liver tumors have been reported in women taking oral contraceptives. Liver tumors can cause life-threatening intra-abdominal bleeding. Therefore, if you have pain in the upper abdomen that does not relieve soon, tell your doctor.

Some studies have found an increased risk of cervical cancer in women who take oral contraceptives for extended periods. It is not clear whether this increased risk is caused by oral contraceptives, as it may be due to the effects of sexual behavior and other factors.

Psychiatric disorders

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

Children and adolescents

The safety and efficacy of Bemasive in adolescents under 18 years of age have not been established. There are no data available.

Other medicines and Bemasive

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

Also, inform any other doctor or dentist who prescribes you a medicine (or pharmacist)

3. How to take Bemasive

Follow the administration instructions for this medication indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again.

Each package of Bemasive 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 every day for 21 days, following the direction of the arrow printed on the package, until the blister pack is empty.

Then come 7 days when you will not take any tablets. During the 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 Bemasive 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 of the week.

You should try to take the tablet at approximately the same time every day.It may be easiest to take it before going to bed or just after getting up.

Swallow each tablet whole, if necessary with water.

Starting the first package

If you have not used 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 a Tuesday, take the tablet marked as Tuesday on 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 days 2-5 of your menstruation, you should use another contraceptive method, such as a condom, during the first 7 days you take contraceptives, but only in the first blister pack.

It is not necessary 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 it is due.

Switching to Bemasive from another hormonal contraceptive

Start taking Bemasive the day after you take the last tablet from the previous contraceptive blister pack. If the previous contraceptive blister pack also contains inactive tablets, start taking Bemasive the day after you take the last active hormonal tablet, and no later than the day after the usual hormone-free interval of your previous hormonal contraceptive (or after taking the last inactive tablet from the previous blister pack).

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

Switching to Bemasive from a progestin-only contraceptive (POP or minipill)

You can stop taking progestin-only contraceptives at any time and start taking Bemasive the next day at the same time. However, make sure to use additional protection (such as condoms or spermicides) during sexual intercourse for the first 7 days while taking the tablets.

Switching to Bemasive from an injectable or implant contraceptive

If you have been given an injection or have had a progestin hormone implant, you can start taking Bemasive on the day you are due for your next injection or on the day the implant is removed. However, you should use another contraceptive method (such as condoms or spermicides) during sexual intercourse for the first 7 days while 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 can start taking Bemasive immediately after a spontaneous or induced abortion that occurs during the first trimester of pregnancy. In this case, it is not necessary to take other contraceptive measures.

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

If you forget to take Bemasive

If you forget to take a contraceptive tablet, follow these instructions.

If you are delayed by 12 hours or less in taking a tablet.

If you take the forgotten tablet as soon as you remember, and continue taking the following tablets at the usual time, you will still be 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 that your contraceptive protection will be reduced.

If you have forgotten more than one tablet, consult your doctor.

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

You should take the last forgotten tablet as soon as you remember, even if this means taking 2 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, e.g., a condom. If you have had sexual intercourse during the previous 7 days, the possibility of pregnancy should be considered. The more tablets you have forgotten and the closer you 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 forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Then, continue taking the tablets at the usual time of day. As long as the tablets have been taken correctly during the 7 days prior to the forgotten tablet, it is not necessary to take additional contraceptive precautions. However, if this is not the case, or if you have forgotten more than 1 tablet, you should take additional contraceptive precautions for 7 days.

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

The risk of contraceptive failure is imminent because the tablet-free interval follows. However, the reduction in contraceptive protection can be avoided by adjusting tablet intake. Therefore, following one of the two alternatives below, it is not necessary to take additional contraceptive precautions, as long as the tablets have been taken correctly during the 7 days prior to the first forgotten tablet. If you have not taken Bemasive correctly during the 7 days prior to the first forgotten 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 forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Then, continue taking the tablets at the usual time of day. You will then start taking the next blister pack immediately after taking the last tablet from the current blister pack, i.e., there will be no tablet-free interval 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 on 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 forgot to take the tablets, and then continue with the next blister pack.

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

What to do if you have stomach upset

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. In this case, follow the advice described above regarding forgotten tablets. In case of vomiting or diarrhea, use additional contraceptive precautions, such as a condom, during all sexual intercourse while your stomach upset lasts and for the next 7 days.

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 Bemasive blister pack after taking the last tablet from the current blister pack, without taking the tablet-free interval. 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 Bemasive is resumed after the normal 7-day tablet-free period.

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

If you take Bemasive correctly, you will always have your period on the same day of the week. If you want to change your period to another day of the week, different from the usual one according to the current tablet intake, you should shorten (but never lengthen) the next tablet-free interval 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 Bemasive blister pack three days earlier. The shorter the tablet-free interval, the greater the likelihood that you will have a withdrawal bleed, and that you will have hormonal 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 Bemasive, especially during the first few months. This bleeding should not normally be a cause for concern, and it will stop within 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 is prolonged, consult your doctor.

If you do not have a period

If you have taken all the tablets correctly and have not had stomach upset or used other medications, it is unlikely that you are pregnant. Continue taking Bemasive as usual.

If you have not had two periods in a row, you may be pregnant and should see your doctor immediately. You are only allowed to continue taking the contraceptive after having a pregnancy test and if your doctor advises it.

If you take more Bemasive than you should

If you take more Bemasive than you should, it is unlikely to cause you any harm, but you may have nausea, vomiting, or vaginal bleeding. If you have any of these symptoms, you should tell your doctor, who can advise you on what to do, if necessary.

If you stop taking Bemasive

You can stop taking Bemasive at any time. If you stop taking Bemasive 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.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Bemasive can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any health change that you think may be due to Bemasive, consult your doctor.

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 also the section "Warnings and Precautions").

All women who take 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 Bemasive".

Very common (may affect more than 1 in 10 people):irregular bleeding.

Common (may affect up to 1 in 10 people):depression, mood alterations, nervousness, headache, dizziness, nausea, abdominal pain, acne, breast tenderness, breast pain, absence of menstruation, painful menstruations, pre-menstrual syndrome (physical and emotional problems before starting menstruation), weight gain.

Uncommon (may affect up to 1 in 100 people):fluid retention, decreased sexual desire, migraine, hearing impairment (otosclerosis), high blood pressure, diarrhea, vomiting, skin rash (urticaria), breast enlargement.

Rare (may affect up to 1 in 1,000 people):hypersensitivity, increased sexual desire, eye irritation due to contact lenses, skin disorders (erythema nodosum - a skin disease associated with joint pain, fever, hypersensitivity, or infections, and characterized by small, painful nodules, pink or blue in color, under the skin and on the shins, which tend to recur, erythema multiforme - a skin disease characterized by solid, raised patches on the skin or lesions like fluid-filled blisters and redness or discoloration of the skin, often in concentric areas around the lesions), chloasma (skin patches, also known as "pregnancy patches"), vaginal discharge, breast discharge, and weight loss.

Harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., DVT),
• in a lung (i.e., PE),
• heart attack,
• stroke,
• mild stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and their symptoms).

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 this 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 Bemasive

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bemasive

The active ingredients are desogestrel and ethinylestradiol. One coated tablet contains 0.15 mg of desogestrel and 0.02 mg of ethinylestradiol.

The other components are:

Tablet core: potato starch; stearic acid; alpha-tocopherol; lactose monohydrate; magnesium stearate; anhydrous colloidal silica; povidone K30; quinoline yellow E 104.

Tablet coating: hypromellose; Macrogol 6000; propylene glycol.

Appearance of the Product and Package Contents

Light yellow, biconvex, round tablet with " (Grünenthal logo) engraved on one side and "P9" on the other.

Each box contains 1, 3 calendar blister(s) of 21 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Gedeon Richter Plc.

Gyömroi ut 19-21

H-1103, Budapest,

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2ª

08028 Barcelona, Spain

+34 93 2034300

This medicine is authorized in the Member States of the European Economic Area with the following names:

Denmark: Igixon 150 micrograms/20 micrograms film-coated tablet

Spain: Bemasive 0.15 mg/0.02 mg film-coated tablets

Italy and Portugal: Novynette 150 micrograms/20 micrograms film-coated tablet.

Date of the last revision of this prospectus:January 2023

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/