Bemasive 0.15 mg/0.02 mg film-coated tablets: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

BEMASIVE 0.15 mg/0.02 mg film-coated tablets

desogestrel / ethinylestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

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

? Slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break 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 entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Bemasive is and what it is used for
What you need to know before taking Bemasive
How to take Bemasive
Possible adverse effects
How to store Bemasive
Contents of the pack and other information

1. What Bemasive is and what it is used for

Bemasive is a combined oral contraceptive, also known as a contraceptive pill. It contains two types of female hormones: a progestogen, desogestrel, and an oestrogen, ethinylestradiol, in a low dose. These hormones help prevent you from becoming pregnant in the same way as your natural hormones prevent conception when you are already pregnant.

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

prevent the ovary from releasing an egg each month (ovulation),
thicken the fluid (in the cervix), making it more difficult for sperm to reach the egg,
alter the lining of the uterus, making it less likely to accept a fertilised egg.

General information

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

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

2. What you need to know before starting Bemasive

General considerations

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

Before you can start taking 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 measure your blood pressure and, depending on your individual circumstances, may carry out additional tests.

Do not take Bemasive

You must 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 which 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), in your lungs (pulmonary embolism, PE), or in other organs.
if you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
if you require surgery or if you are going to be immobile for a long time (see section “Blood clots”).
if you have ever had a heart attack or a stroke.
if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
if you have any of the following conditions 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 hyperhomocysteinaemia.
if you have (or have ever had) a type of migraine called “migraine with aura”.
if you have liver disease or have ever had liver disease and your liver function is not normal.
if you have liver tumours or have ever had them.
if you have or may have breast cancer or another cancer, for example ovarian cancer, cervical cancer, or uterine (womb) cancer.
if you have unexplained vaginal bleeding.
if you are pregnant or think you might be pregnant.
if you have endometrial hyperplasia (a condition characterised by excessive growth of the lining of the uterus).
if you have or have ever had inflammation of the pancreas (pancreatitis).
if you are allergic to ethinylestradiol or desogestrel or to any of the other ingredients of this medicine (listed in section 6). This may be recognised by itching, rash, or swelling.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bemasive.

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

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots (thrombosis)” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Tell your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Bemasive, you should also inform your doctor:

if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen 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 affecting your body’s natural defence system).
if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
if you have sickle cell anaemia (a hereditary red blood cell disorder).
if you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
if you are due to have surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
if you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Bemasive after childbirth.
if you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
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 migraine.
if you have diabetes.
if you have the hereditary form of hearing loss known as otosclerosis.
if you have low mood (depression) or mood changes.
if you have the movement disorder called Sydenham’s chorea.
if you have liver and/or gallbladder disease (jaundice – yellowing of the skin – or gallstones).
if you have the inherited disease called porphyria.
if you have itching (pruritus).
if you have the skin rash known as herpes gestationis.
if you have brown patches on your face and body (chloasma), which may be minimized by avoiding sunlight and not using sunbeds or UV lamps.

BLOOD CLOTS

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

Blood clots can form:

in the veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
in the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

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

It is important 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.

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

BLOOD CLOTS IN A VEIN

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

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

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

The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also 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 somewhat higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

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

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

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, approximately 2 will develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, between 5 and 7 will develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as Bemasive, between 9 and 12 women will develop a blood clot within one year.
Your personal risk of developing a blood clot depends on your individual medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	Approximately 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	Approximately 5–7 out of 10,000 women
Women who use Bemasive	Approximately 9–12 out of 10,000 women

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

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

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

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

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

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

If any of the above conditions change while you are using Bemasive—for example, a close relative experiences a thrombosis without known cause or you gain significant 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 lead to a heart attack or stroke.

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

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

with age (especially over 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 of age, your doctor may advise you to use a different type of contraceptive.
if you are overweight.
if you have high blood pressure.
if a close relative has had a heart attack or stroke at an early age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
if you suffer from migraines, especially migraines with aura.
if you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation).
if you have diabetes.

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

If any of the above conditions change while you are using Bemasive—for example, you start smoking, a close relative suffers a thrombosis without known cause, or you gain significant 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 slightly more frequently in women who take oral contraceptives than in women of the same age who do not. If women stop taking oral contraceptives, this reduces the risk so that 10 years after stopping, the risk of developing breast cancer is the same as in women who have never taken 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 breast cancer is detected earlier.

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

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

Psychiatric disorders

Some women using hormonal contraceptives such as Bemasive have reported depression or 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 medical advice as soon as possible.

Children and adolescents

The safety and efficacy of Bemasive in adolescents under 18 years of age has not been established. No data are available.

Other medicines and Bemasive

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

Also inform any other doctor or dentist who prescribes you medication (or the pharmacist dispensing it) that you are taking Bemasive. They can advise you whether you need to take additional contraceptive precautions (e.g., use of condoms) and, if so, for how long.

Do not use Bemasive if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood tests measuring liver function (elevated liver enzyme ALT).

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

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

Some medicines may affect the levels of Bemasive in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

medicines used to treat:
epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
tuberculosis (e.g., rifampicin, rifabutin);
HIV infections (so-called reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, efavirenz, nevirapine, nelfinavir);
hepatitis C virus infections (boceprevir, telaprevir);
other infections (griseofulvin);
high blood pressure in the blood vessels of the lungs (bosentan);
the herbal remedy St. John's wort (Hypericum perforatum). If you wish to use herbal preparations containing St. John's wort while using Bemasive, you must first consult your doctor.

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

The following medicines 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 conditions and hypertension);
macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
etoricoxib (for the treatment of arthritis and osteoarthritis).

Bemasive may influence the effect of other concomitantly administered medicines, such as those containing the following active substances:

cyclosporine (a medicine used to prevent tissue rejection after transplantation),
lamotrigine (an antiepileptic medicine; concomitant use with Bemasive may increase the frequency of seizures),
theophylline (a medicine used to treat respiratory problems),
tizanidine (a medicine used to treat muscle spasticity),
levothyroxine (a medicine used to treat hormonal deficiency).

Consult your doctor or pharmacist before taking any medicine.

Before undergoing any laboratory tests

Inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding

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

You must not take Bemasive if you are pregnant. If you become pregnant or think you might be pregnant, stop taking Bemasive and consult your doctor immediately.

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

Driving and use of machines

Bemasive has no or negligible effect on the ability to drive and use machines.

Bemasive contains lactose

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

3. How to take Bemasive

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

Each pack of Bemasive contains 1 reminder blister of 21 coated tablets or 3 reminder blisters of 21 coated tablets. The reminder blister has been designed to help you remember to take your tablets.

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

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

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

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

Swallow each tablet whole, with water if necessary.

Starting the first pack

If you have not used oral contraceptives in the previous cycle

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

If you start on day 2–5 of your period, you must use another contraceptive method, such as a condom, during the first 7 days of taking the contraceptive, but only during the first blister.

You do not need to use another contraceptive method during the 7-day break, provided you have taken all 21 tablets correctly and start the next blister on time.

Switching to Bemasive from another combined hormonal contraceptive

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

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

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

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

Switching to Bemasive from a contraceptive injection or implant

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

Starting after childbirth or abortion (spontaneous or induced)

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

You may start taking Bemasive immediately after a spontaneous or induced abortion occurring during the first trimester of pregnancy. In this case, no additional contraceptive measures are necessary.

If you have given birth or had an abortion during the second trimester of pregnancy, your doctor will advise you on using 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 missed 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 miss, the greater the risk that contraceptive protection will be reduced.

If you miss more than one tablet, consult your doctor.

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

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Thereafter, continue taking the tablets at your usual daily time. For the next 7 days, you must also use a barrier method, e.g., a condom. If you had sexual intercourse during the previous 7 days, consider the possibility of pregnancy. The more tablets you have missed and the closer to the usual tablet-free interval, the greater the risk of pregnancy.

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

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Thereafter, continue taking the tablets at your usual daily time. If you have taken all tablets correctly during the 7 days before the missed tablet, no additional contraceptive precautions are necessary. However, if this is not the case, or if you have missed more than one tablet, you must use additional contraceptive precautions for 7 days.

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

The risk of contraceptive failure is imminent because the tablet-free interval follows. However, the reduction in contraceptive protection can be avoided by adjusting tablet intake. Therefore, by following one of the two alternatives below, no additional contraceptive precautions are necessary, provided that the tablets were 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, follow the first of the two alternatives below. Additionally, you must use a barrier method (such as a condom) simultaneously for the next 7 days.

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

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

What to do if you have stomach upset

If you vomit or have diarrhea within 3–4 hours after taking a tablet, the active ingredients may not have been fully absorbed into your body. In this case, follow the advice given above for missed tablets. In case of vomiting or diarrhea, use additional contraceptive precautions, such as condoms, for all sexual intercourse while your stomach upset lasts and for the following 7 days.

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

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

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

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

If you take Bemasive correctly, your period will always occur on the same day of the week. If you wish to shift your period to a different day of the week than your current schedule, shorten (but never extend) the next tablet-free interval by as many days as desired. For example, if your period usually begins on Friday and you want it to start on Tuesday (i.e., three days earlier), start the next blister of Bemasive three days earlier. The shorter the tablet-free interval, the greater the likelihood of experiencing a withdrawal bleed and breakthrough bleeding or spotting during the second blister.

If you experience bleeding between periods

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

If the bleeding continues, is bothersome, or lasts a long time, consult your doctor.

If you do not have a period

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

If you miss two consecutive periods, 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

Taking more Bemasive than prescribed is unlikely to cause harm, but you may experience nausea, vomiting, or vaginal bleeding. If you have any of these symptoms, inform your doctor, who can advise you on what to do, if anything.

If you stop taking Bemasive

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Bemasive may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health 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 hives with possible breathing difficulty (see also section “Warnings and precautions”).

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

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

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

Uncommon (may affect up to 1 in 100 people): fluid retention, decreased sexual desire, migraine, hearing disorders (otosclerosis), elevated blood pressure, diarrhoea, vomiting, skin rashes (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 (nodular erythema – a skin disease associated with joint pain, fever, hypersensitivity or infections, and characterized by small painful pink or blue nodules under the skin and over the shins, which tend to recur; erythema multiforme – a skin disease characterized by raised solid spots on the skin or blister-like lesions filled with fluid, and redness or discoloration of the skin, often in concentric rings around the lesions), chloasma (skin patches, so-called “pregnancy mask”), 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,
mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),
blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bemasive

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

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bemasive

The active substances 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 contents of the pack

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

Each box contains 1 or 3 calendar blisters 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

More information about this medicinal product is available upon request to 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 medicinal product is authorized in the Member States of the European Economic Area under 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 most recent review of this leaflet: January 2023

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