Package Insert: Information for the User

BEMASIVE 0.15 mg/0.02 mg Film-Coated Tablets

desogestrel / etinilestradiol

Important Information You Should Know About Combined Hormonal Contraceptives (CHCs):

?They are one of the most reliable reversible contraceptive methods if used correctly.

?They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.

?Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

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 should not be given to others, 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.

1. What is Bemasive and for what it is used

2. What you need to know before starting to take Bemasive

3. How to take Bemasive

4. Possible adverse effects

5. Storage of Bemasive

6. Contents of the package and additional information

Bemasive is a combined oral contraceptive, also known as the contraceptive pill. It contains two types of female hormones: a progestogen, desogestrel, and an estrogen, etinilestradiol at a low dose. These help you not get pregnant, just like your natural hormones prevent you from getting pregnant again when you are already pregnant.

The combined contraceptive pill protects you from getting 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 harder for sperm to reach the egg,
3. alter the internal 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 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 sex or use other non-hormonal contraceptive precautions (such as condoms or spermicides) during sex to ensure effective contraception.

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

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. Your doctor will also take your blood pressure, and depending on your personal circumstances, may perform some other tests.

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 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.
• If you need surgery or if you will be unable to stand for a long time (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you 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 symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular 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, for example 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 to any of the other components of this medication (including 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 medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Taking Bemasive with other medications”).

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.

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

If the condition develops or worsens while you are using Bemasive, you must 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. Estrogen-containing products can cause or worsen the symptoms of hereditary and acquired angioedema.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency).
• 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 surgery or if you will be unable to stand for a long time (see section “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Bemasive after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have high blood pressure.
• If you have a heart valve disorder or any 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 liver disease and/or gallbladder disease (jaundice, yellow skin, gallstones).
• If you have the hereditary disease called porphyria.
• If you have itching (pruritus).
• If you have the rash called herpes gestational.
• If you have brown spots on the face and body (chloasma), which may be reduced by avoiding the sun and not using beds or UVA lamps.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Bemasive increases your risk of developing 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 (which is called “deep vein thrombosis”, “venous thromboembolism”, or VTE).
• in the arteries (which is called “arterial thrombosis”, “arterial thromboembolism”, or ATE).

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

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 assistanceif 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 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 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 restart taking a combined hormonal contraceptive (the same medication 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 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 overall risk of a blood clot in the leg or lung (DVT or PE) with Bemasive is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, approximately 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing desogestrel like Bemasive, 9-12 will develop a blood clot in a year.
• The risk of 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 a blood clot with Bemasive is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index (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 (i.e., before about 50 years). In this case, you may have a hereditary disorder of blood clotting.
• if you need surgery or if you will be unable to stand for a long time due to an injury or illness or if you have a leg cast. You may need to stop taking Bemasive for several weeks before the operation or while you have reduced mobility. If you need to stop taking Bemasive, ask your doctor when you can start taking it again.
• with increasing age (especially above about 35 years).
• if you have given birth recently.

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

Long 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 conditions above, even if you are unsure. Your doctor may decide that you should stop taking Bemasive.

If any of the conditions above change while you are using Bemasive, for example, a close relative experiences a clot 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 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 Bemasive is very small, but it may increase:

• with age (above about 35 years).
• if you smoke.When using a combined hormonal contraceptive like Bemasive, 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 close relative has 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 close relative has 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 or heart rhythm disorder called atrial fibrillation).
• if you have diabetes.

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

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

Contraceptives and Cancer

All women have a risk of breast cancer whether they take contraceptives or not. 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 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 is possible 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 taking oral contraceptives. Liver tumors can cause life-threatening intra-abdominal bleeding. Therefore, if you have abdominal pain that does not improve quickly, inform your doctor.

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, as it may be due to the effects of sexual behavior and other factors.

Mental Health Disorders

Some women who use hormonal contraceptives like Bemasive 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.

Children and Adolescents

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

Other Medications and Bemasive

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

Also, inform any other doctor or dentist who prescribes a medication (or the pharmacist who dispenses it) that you are taking Bemasive. They can advise you on whether you need to take additional contraceptive precautions (for example, use condoms) and for how long.

Do not use Bemasive if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can increase liver function parameters in the blood (elevated ALT enzyme).

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

Bemasive can be taken again 2 weeks after completing this treatment. See the section “Do not take Bemasive”.

Some medications may affect the levels of Bemasive in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. This includes:

• medications used to treat:

• epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, efavirenz, nevirapine, nelfinavir);
• hepatitis C infections (boceprevir, telaprevir);
• other infections (griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• the medicinal herb St. John's Wort (Hypericum perforatum). If you want to use preparations with medicinal herbs containing St. John's Wort while taking Bemasive, you should first consult your doctor.

The interaction of Bemasive with other medications may lead to a greater or more pronounced occurrence of side effects.

The following medications may affect the tolerability of Bemasive:

• itraconazole, ketoconazole, fluconazole (used to treat fungal infections);
• calcium channel blockers, such as diltiazem (used to treat certain heart and high blood pressure conditions);
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
• etoricoxib (used to treat arthritis and osteoarthritis).

Bemasive may influence the effect of other medications administered concomitantly, such as medications containing the following active principles:

• ciclosporin (a medication used to treat tissue rejection after a transplant),
• lamotrigine (an antiepileptic medication; concomitant use with Bemasive may increase the frequency of seizures),
• theophylline (a medication for respiratory problems),
• tizanidine (a medication for muscle spasticity),
• levothyroxine (a medication for hormonal deficiency).

Consult your doctor or pharmacist before taking any medication.

Before any laboratory tests

Inform your doctor or laboratory personnel that you are taking the pill, as oral contraceptives can affect the results of some tests.

Pregnancy and Breastfeeding

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

If you are pregnant, do not take Bemasive. If you become pregnant or think you may be pregnant, stop taking Bemasive and consult your doctor immediately.

It is not recommended to take Bemasive during breastfeeding. If you are breastfeeding and want to take oral contraceptives, discuss this with your doctor.

Driving and Operating Machines

Bemasive has no or insignificant effect on your ability to drive and operate machines.

Bemasive contains lactose

If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

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

Each package of Bemasive 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 when 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.

After that, you will have 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 bleeding similar to menstruation, that is, 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 approximately at the same time every day.You may find it easier to take it before going to bed or just after waking up.

Swallow each tablet whole, if necessary with water.

Starting the first package

If you did not use 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 use an additional 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 an additional 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 Bemasive from another combined hormonal contraceptive

Start taking Bemasive the day after taking the last tablet of the previous contraceptive blister pack. If the previous contraceptive blister pack also contains tablets without active ingredients, start taking Bemasive the day after taking the last tablet with active hormonal ingredients, 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 blister pack).

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

Switching to Bemasive from a progestin-only contraceptive (PPO or mini-pill)

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 contraception (such as condoms or spermicides) during the first 7 days that you take the tablets.

Switching to Bemasive from an injectable or implantable contraceptive

If you have been given an injection or had an implantable hormone inserted, you can start taking Bemasive on the day you are due for the next injection, or the day the implant is removed. However, you should use an additional contraceptive method (such as condoms or spermicides) 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 (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, you do not need to take any additional measures.

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

What to do if you forget to take Bemasive

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

What to do if you are delayed by 12 hours or less in taking a tablet.

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

What to do 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 missed, the greater the risk of reduced protection.

What to do if you have forgotten more than one tablet, consult your doctor.

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

You should take the last missed tablet 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, you should use an additional barrier method, e.g., a condom. If you have had sex during the previous 7 days, you should consider the possibility of pregnancy. The more tablets you have missed and the closer to the usual hormone-free interval, the greater the risk of pregnancy.

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

You should take the last missed tablet 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 missed tablet, you do not need to take any additional contraceptive precautions. However, if this is not the case, or if you have missed more than 1 tablet, you should take additional contraceptive precautions for 7 days..

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

The risk of contraceptive failure is imminent because the hormone-free interval is approaching. However, the reduction in contraceptive protection can be avoided by adjusting the tablet-taking schedule. Therefore, following one of the two alternatives below, you do not need to take any additional contraceptive precautions, as long as the tablets have been taken correctly during the 7 days before the first missed tablet.If you have not taken Bemasive correctly during the 7 days before the first missed tablet, you should follow the first of the two alternatives. Additionally, you should use an additional barrier method (such as a condom) simultaneously for the next 7 days.

1. You should take the last missed tablet 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 blister pack immediately after taking the last tablet of the current blister pack, that is, there will be no hormone-free interval between the blister packs. It is unlikely that you will experience withdrawal bleeding before the end of the second blister pack, but you may experience spotting (light bleeding) or hormonal disruption bleeding during the days you take the tablets.
2. You can also stop taking the tablets from the current blister 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 blister pack.

If you have forgotten tablets and then do not experience withdrawal bleeding on the first usual hormone-free interval, you should consider the possibility of pregnancy.

What to do if you have stomach 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. In this case, follow the advice described above regarding missed tablets. In case of vomiting or diarrhea, use additional contraceptive precautions, such as condoms, for all your sexual encounters while your stomach discomfort lasts and for the next 7 days.

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

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

What to do if you want to delay your period, you should continue with the next blister pack of Bemasive after taking the last tablet of the current blister pack, without taking the usual hormone-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 experience spotting (light bleeding) or hormonal disruption bleeding. The usual Bemasive-taking schedule resumes after the usual 7-day hormone-free interval.

What to do if you want to displace 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 displace your period to another day of the week different from the usual one according to the current tablet-taking schedule, you should shorten (but never 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), you should start the next blister pack of Bemasive 3 days earlier. The more you shorten the hormone-free interval, the greater the probability of experiencing withdrawal bleeding, and the greater the probability of experiencing hormonal disruption bleeding or spotting during the second blister pack.

What to do if you experience bleeding between periods

A small number of women may experience spotting (light bleeding) or mild bleeding while taking Bemasive, especially during the first few months. Normally, this bleeding should not be a concern, and it will stop in 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.

What to do if you do not have a period

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

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

What to do if you take more Bemasive than you should

If you take more Bemasive than you should, it is unlikely that this will cause any harm, but you may experience 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 anything.

What to do if you stop taking Bemasive

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

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

Like all medications, Bemasive may cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Bemasive, consult your doctor.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the "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 Bemasive".

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

Common (may affect up to 1 in 10 people):depression, mood changes, nervousness, headaches, dizziness, nausea, abdominal pain, acne, breast tenderness, breast pain, absence of menstruation, painful menstruation, premenstrual syndrome (physical and emotional problems before menstruation), weight gain.

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

Rare (may affect up to 1 in 1,000 people):hypersensitivity, increased libido, eye irritation due to contact lenses, skin changes (erythema nodosum - a skin disease associated with joint pain, fever, hypersensitivity, or infections, and characterized by painful, pink or blue nodules under the skin and over the pimples, which tend to recur, erythema multiforme - a skin disease characterized by solid, elevated patches on the skin or lesions like fluid-filled blisters and redness or discoloration of the skin often in concentric zones around the lesions), melasma (skin patches, also known as "pregnancy spots"), vaginal discharge, nipple discharge, and weight loss.

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

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 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 this 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 medication.

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

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

Unused medications should not be disposed of through drains or in the trash. Ask your pharmacist how to properly dispose of the packaging and unused medications. By doing so, you will help protect the environment..

Composition of Bemasive

The active principles are desogestrel and etinilestradiol. A coated tablet contains 0.15 mg of desogestrel and 0.02 mg of etinilestradiol.

The other components are:

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

Coating of the tablet: hypromellose; Macrogol 6000; propylene glycol.

Appearance of the product and contents of the packaging

Yellowish clear biconvex round tablet and ” (Grünenthal logo) engraved on one side and “P9” on the other.

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

It is possible that not all packaging sizes will be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Gedeon Richter Plc.

Gyömr oi ut 19-21

H-1103, Budapest ,

Hungary

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

Gedeon Richter Ib é rica S.A.

Sabino Arana, 28 4 º 2 ª

08028 Barcelona , Spain

+34 93 2034300

This medication 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 coated tablets with film

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

Date of the last review of this leaflet: January 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/