Levobel 0.10 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levobel 0.10 mg/0.02 mg film-coated tablets EFG

Levonorgestrel/Ethinylestradiol

Read the 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Important things 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 developing blood clots 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

1. What Levobel is and what it is used for
2. What you need to know before taking Levobel
3. How to take Levobel
4. Possible side effects
5. How to store Levobel

Pack contents and additional information

1. What Levobel is and what it is used for

Levobel is a contraceptive tablet used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.

Contraceptives that contain two hormones are known as "combined contraceptives".

2. What you need to know before taking Levobel

General considerations Before starting to use Levobel, you should 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 Levobel, your doctor will ask you some questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other tests. This leaflet describes several situations in which you should stop taking Levobel or in which the reliability of Levobel may be reduced. In these situations, you should not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, for example condoms or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since Levobel alters the monthly changes in body temperature and cervical mucus. When taken correctly, combined oral contraceptives have a failure rate of approximately 1% per year. The failure rate may increase if not all tablets are taken, if they are taken incorrectly, if you have gastrointestinal disturbances, or if you are taking other medications or herbal remedies. Levobel, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Levobel

You must not use Levobel 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 will be immobile for a long period (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 causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:
  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) severe liver disease and your liver function has not yet returned to normal.
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown cause.
• If you know, or suspect you are pregnant.
• If you are allergic to levonorgestrel, ethinylestradiol, soya, peanuts, azo dyes, or any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.

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

If any of the above conditions develop while you are using Levobel, stop taking the tablets immediately and consult your doctor.

Warnings and precautions

When should you consult your doctor? Seek urgent medical attention If you experience possible signs of a blood clot, which may indicate you are having 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 side effects, see “How to recognize a blood clot”.

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

In certain situations, you must take special care when using Levobel or any other combined contraceptive, and your doctor may need to examine you regularly. If any of the following conditions develop or worsen while you are using Levobel, you must also inform your doctor.

• 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 defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney damage).
• If you have sickle cell anemia (a hereditary red blood cell disorder).
• 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 require surgery or are immobile for long periods (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 Levobel after delivery.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close relative has or has ever had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see “Other medicines and Levobel”).
• If you have any condition that first occurred during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder causing involuntary movements (Sydenham’s chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face or neck, known as “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet radiation.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Levobel 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 veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “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 Levobel 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 noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. 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 most 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, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe 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 difficulty seeing in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. 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 stomach 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 events 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 of first-time use of a combined hormonal contraceptive. 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Levobel, 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 VTE and 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 Levobel is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot within one year.
• Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot in a vein” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/vaginal ring and who are not pregnant.	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use Levobel	About 5-7 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 Levobel is small, but certain conditions can increase this 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 a young 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 having a plaster cast on your leg. You may need to stop taking Levobel several weeks before surgery or while you are less mobile. If you need to stop taking Levobel, 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 (≥ 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

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 Levobel.

If any of the above conditions change while you are using Levobel—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 may 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 Levobel is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Levobel, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may recommend that you 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 a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has 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 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 is particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Levobel—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.

Levobel and cancer

Cervical cancer has been reported in long-term users, but it is unclear whether this is due to sexual behavior or other factors such as human papillomavirus (HPV).

Breast cancer has been observed at a slightly increased frequency in women using combined contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Benign (non-cancerous) liver tumors are rare, and in an even smaller number of cases, malignant (cancerous) liver tumors have been reported in users of combined contraceptives. Consult your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as Levobel have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Levobel, you may experience unexpected bleeding (bleeding outside the rest week). If this bleeding continues beyond a few months or starts after several months, your doctor should investigate the cause.

What to do if you do not have your period during the rest week

If you have taken all the tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

If this is not the case, or if you miss your period for a second consecutive time, you may be pregnant. Consult your doctor immediately, as pregnancy must be ruled out before continuing to take the pill. Start the next pack only if you are certain you are not pregnant.

Other medicines and Levobel

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine, including herbal preparations obtained without a prescription. Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are using Levobel. They can advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

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

• medicines used to treat:
  • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate or felbamate)
  • tuberculosis (e.g. rifampicin)
  • HIV infection and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nelfinavir, efavirenz)
  • fungal infections (e.g. griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin)
  • certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John’s wort
• grapefruit juice.

Levobel may affect the action of other medicines, for example:

• medicines containing cyclosporine (used to suppress the body’s immune response)
• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• melatonin (for insomnia)
• midazolam (for sedation and insomnia)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not take Levobel if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (increase in liver enzyme ALT).

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

Levobel can be restarted approximately 2 weeks after completion of such treatment. See the section “Do not take Levobel”.

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

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking the pill, as oral hormonal contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

Do not take Levobel if you are pregnant. If you become pregnant while taking Levobel, stop taking the tablets immediately and consult your doctor. If you intend to become pregnant, you may stop taking Levobel at any time (see also “If you stop taking Levobel”).

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Taking Levobel during breastfeeding is not recommended unless advised by your doctor. If you wish to use contraception while breastfeeding, you should consult your doctor.

Driving and use of machines

There is no information suggesting that the use of Levobel has any effect on the ability to drive or use machines.

Levobel contains lactose, soya, Allura red AC, indigo carmine

Levobel contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Levobel contains the azo dyes Allura red AC (E129) and indigo carmine (E132). These may cause allergic reactions.

Levobel contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.

3. How to take Levobel

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

Each blister contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if you start taking the tablets on a Tuesday, press the tablet through the aluminum foil in the position marked “TUE”. Take the tablets every day in the order indicated by the arrows.

Take one tablet of Levobel daily for 21 days, preferably with a small amount of water. You may take the tablets with or without food, but you should take them at approximately the same time each day.

The blister contains 21 tablets.

Adhesive labels with the days of the week are included with the blisters. Choose the label that starts with the day on which you take your first tablet. Place the strip on the blister, over the words “START. Place label here”. Each day will align with a row of tablets. It is important that you take your tablet every day. Take the first tablet from the first row where the word “START” appears. Follow the direction of the arrow indicated on the packaging until you have taken all 21 tablets.

After finishing the 21 tablets, you will not take any tablets for the next 7 days. Your period (withdrawal bleeding) will begin during these 7 days, usually 2 or 3 days after taking the last tablet of Levobel.

Start the next blister on the 8th day, even if your period continues. In this way, you will always start a new pack on the same day of the week, and withdrawal bleeding will occur approximately at the same time each month.

When to start the first pack

• If you have not taken any hormonal contraceptive in the previous month

Start taking Levobel on the first day of your cycle (i.e., the first day of your period). If you start taking Levobel on the first day of your menstruation, you will be protected immediately against pregnancy. You may also start on days 2–5 of the cycle, but then you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive, vaginal contraceptive ring, or patch

Start taking Levobel the day after taking the last active tablet of your previous contraceptive, or no later than the day after the rest week of your previous contraceptive or after taking the last placebo tablet of your previous contraceptive. In the case of a vaginal ring or patch, start taking Levobel on the day of removal of the last ring or patch of a cycle, or no later than when the next application would be due.

• Switching from a progestogen-only method (pill, injection, implant, or intrauterine delivery system (IUS))

You may switch from a progestogen-only pill to Levobel on any day (if it is an implant or IUS, on the same day of removal; if it is an injectable, when the next injection is due), but in all cases use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After a first-trimester abortion

Follow your doctor's recommendations.

• After childbirth or a second-trimester abortion

You may start taking Levobel between 21 and 28 days after childbirth or second-trimester abortion. If you start later than day 28, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Levobel.

If, after giving birth, you have already had sexual intercourse before starting to take Levobel (again), you must be sure you are not pregnant or wait until your next menstrual period before taking Levobel.

• If you are breastfeeding and wish to start taking Levobel (again) after childbirth

Read the section “Breastfeeding”.

Ask your doctor if you are unsure when to start.

Use in children and adolescents

Do not take Levobel before starting menstruation.

Use in elderly patients

Do not take Levobel after menopause.

Use in patients with liver problems

Do not take Levobel if you have severe liver problems.

Use in patients with kidney problems

Consult your doctor before starting to take Levobel if you have kidney problems.

If you take more Levobel than you should

No cases of serious harm due to overdose of Levobel have been reported. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may experience vaginal bleeding. Even girls who have not yet started menstruating but have accidentally taken this medicine may experience such bleeding.

If you have taken too many Levobel tablets, or if you discover that a child has taken them, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levobel

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and continue taking the following tablets at the usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of becoming pregnant.

Therefore, you should follow the recommendations below (see also the diagram below):

• If you are more than 12 hours late during week 1 (see also the diagram)

Take the last missed tablet as soon as you remember, even if this means taking two tablets at once. Then continue taking the tablets at the usual time. In addition, you must use a barrier method, such as a condom, for the next 7 days. If you had sexual intercourse in the 7 days before missing the tablet, you may be pregnant. The more tablets you have missed, and the closer to the rest week, the greater the risk of pregnancy. Consult your doctor if this has happened to you.

• If you are more than 12 hours late during week 2 (see also the diagram)

Take the last missed tablet as soon as you remember, even if this means taking two tablets at once. Then continue taking the tablets at the usual time. If you have taken the tablets correctly in the 7 days prior to the first missed tablet, no additional contraceptive precautions are necessary. If you have not taken the tablets correctly or have missed more than one tablet, you must use additional contraceptive precautions for the next 7 days.

• If you are more than 12 hours late during week 3 (see also the diagram)

The risk of pregnancy increases the closer you are to the rest week. However, pregnancy can still be prevented by adjusting the dosage.

If you follow the advice below, no additional contraceptive precautions are necessary, provided all tablets were taken correctly in the 7 days prior to the first missed tablet. If this is not the case, you must follow the first of these two options and also use additional contraceptive precautions for the next 7 days.

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at once. Then continue taking the remaining tablets at the usual time. Instead of the rest week, immediately start the next pack of 21 tablets. Withdrawal bleeding will probably not occur until the end of the second pack, but you may experience spotting or intermenstrual bleeding during the tablet-taking days.
2. You may stop taking tablets from the current pack and take a 7-day break without taking tablets, including the days on which you did not take them, and then continue with the next pack.

• If you have missed several tablets from a blister and do not have withdrawal bleeding during the first week of the rest period, pregnancy should be considered.

What to do in case of vomiting or severe diarrhea

Vomiting or diarrhea may reduce the effectiveness of Levobel in preventing pregnancy.

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by the body. The situation is almost the same as when you miss taking a tablet. After vomiting or having diarrhea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Levobel”.

If you do not wish to change your usual tablet-taking routine, you may take the extra tablet from another pack.

If vomiting or diarrhea continues, consult your doctor. You should use additional contraceptive measures.

Delaying your period: what you should know

Although not recommended, you may delay your period by starting a new pack of Levobel instead of continuing with the rest week and completing it. You may experience light bleeding or bleeding similar to menstruation while using the second pack. After the usual 7-day rest period, start the next pack.

It is advisable to consult your doctor before deciding to delay your menstrual period.

Changing the first day of your period: what you should know

If you take the tablets as instructed, your period will begin during the rest week. If you need to change that day, reduce the number of rest days (but never increase them – the maximum is 7!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or less), bleeding may not occur during these days. You may experience light bleeding or bleeding similar to menstruation.

If you are unsure how to proceed, consult your doctor.

If you stop treatment with Levobel

You may stop taking Levobel whenever you wish. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Levobel and wait until your period before trying to conceive. This will make it easier to calculate the estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to Levobel, consult your doctor.

Serious adverse effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible difficulty breathing (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 you start taking Levobel”.

The following list of adverse effects has been associated with the use of Levobel:

• Common (may affect up to 1 in 10 people)

  • Mood changes, depression
  • Headache
  • Nausea, abdominal pain
  • Breast pain or tenderness
  • Weight gain

• Uncommon (may affect up to 1 in 100 people)

  • Decreased interest in sex
  • Skin rash
  • Migraine
  • Vomiting, diarrhoea
  • Itching or hives on the skin
  • Breast swelling
  • Fluid retention

• Rare (may affect up to 1 in 1,000 people)

  • Intolerance to contact lenses
  • Allergic reactions
  • Increased interest in sex
  • Breast or vaginal discharge
  • Red skin lesions or nodules
  • Redness or skin spots
  • Weight loss
  • Harmful blood clots in a vein or artery, for example:
  • in a leg or foot (e.g., DVT)
  • in a lung (e.g., PE)
  • myocardial infarction
  • stroke
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eyes

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

Description of selected adverse reactions

Listed below are adverse reactions with very low frequency or delayed onset of symptoms considered related to the group of combined oral contraceptives (see also sections “Do not take Levobel”, “Warnings and precautions”):

Tumours

• Breast cancer has been observed to be slightly more frequent in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, more tumours may be detected in women taking combined oral contraceptives because they are examined more frequently by their doctor. As breast cancer is rare in women under 40 years of age, the excess number of cases is small in relation to the overall risk of breast cancer.
• Liver tumours (benign and malignant).

Other conditions

• Women with increased levels of fats in the blood (hypertriglyceridaemia), which increases the risk of inflammation of the pancreas (pancreatitis) when using combined oral contraceptives.
• High blood pressure.
• Onset or worsening of diseases whose relationship with combined oral contraceptives is not definitive: jaundice and/or itching related to obstruction of bile flow (cholestasis); gallstone formation; a blood disorder called porphyria; systemic lupus erythematosus (a disease affecting your natural defence system); haemolytic uraemic syndrome (a blood clotting disorder); a nervous system disorder called Sydenham's chorea; a type of skin condition occurring during pregnancy (herpes gestationis); hearing loss (related to otosclerosis).
• Impaired liver function.
• If you are diabetic, your blood glucose control may be affected. Generally, it is not necessary to change your diabetes treatment while using Levobel.
• Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• Chloasma (skin discolouration, especially on the face/neck, known as “pregnancy mask”).

Interactions

Unexpected bleeding and/or contraceptive failure may occur due to interactions between other medicines and oral contraceptives (for example, St. John’s wort, or medicines for epilepsy, tuberculosis, HIV infections, and other infections). See section “Other medicines and Levobel”.

The following conditions may appear or worsen with combined oral contraceptives: Crohn’s disease, ulcerative colitis, epilepsy, migraine, cervical cancer, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks its own organs and tissues), herpes at the end of pregnancy, Sydenham's chorea (rapid, involuntary spasmodic movements), haemolytic uraemic syndrome (a disorder occurring after diarrhoea caused by E. coli), liver problems with jaundice, gallbladder disorders or gallstone formation, hearing loss.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Levobel

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

This medicine does not require any special storage conditions.

Expiry date

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levobel

• The active substances are levonorgestrel and ethinylestradiol. Each tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
• The other components (excipients) are: lactose, povidone K30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, allura red AC (E129), soy lecithin (E322), iron oxide red (E172), indigo carmine (E132)].

Appearance of the product and contents of the pack

Film-coated, round, pink tablets.

Levobel is available in blisters of 21 tablets.

Pack sizes are 1, 3 or 6 blisters, each blister containing 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193 Villaquilambre, León

Spain

or

Hormosan Pharma GmbH

Hanauer Landstraße 139-143

60314 Frankfurt am Main

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria Madonella mite

Portugal Effilevo

Spain Levobel

Germany Maexeni

Date of the most recent review of this leaflet: April 2023

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