Levobel Diario 0.10 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levobel Diario 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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 a blood clot in veins and arteries, especially during the first year of use 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 Diario is and what it is used for
2. What you need to know before taking Levobel Diario
3. How to take Levobel Diario
4. Possible side effects
5. How to store Levobel Diario

Contents of the pack and other information

1. What Levobel Diario is and what it is used for

Levobel Diario is a contraceptive tablet used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones: levonorgestrel, a progestogen, and ethinylestradiol, an oestrogen.

The white tablets do not contain any active substances and are called placebo tablets.

Contraceptives containing two hormones are known as "combined contraceptives". Levobel Diario is referred to as a "low-dose" contraceptive because it contains only a small amount of hormones.

2. What you need to know before starting to take Levobel Diario

General considerations Before starting to use Levobel Diario, 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 Levobel Diario, your doctor will ask you some questions about your own and your close family's medical history. Your doctor will also measure your blood pressure and, depending on your personal circumstances, may carry out other tests. This leaflet describes several situations in which you must stop taking Levobel Diario, or in which the reliability of Levobel Diario 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 method or the temperature method. These methods may not be reliable because Levobel Diario 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 or if they are taken incorrectly, if you have gastrointestinal disturbances, or when other medications or herbal preparations are taken. Levobel Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Levobel Diario

You should not use Levobel Diario 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 of the legs (deep vein thrombosis, DVT), in the 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 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 a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases 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 may 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 or ethinylestradiol, soy or peanuts, azo dyes, or any of the other components of this medicine (listed in section 6). This may present as itching, rash, or swelling.
• Do not take Levobel Diario 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 Diario”).

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 mean you are suffering from 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” below).

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

Inform your doctor if you have any of the following conditions

In certain situations, you need to be especially careful while using Levobel Diario or any other combined contraceptive, and your doctor may need to examine you regularly. If any of the following conditions develop or worsen while using Levobel Diario, 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 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 require surgery or remain 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 Diario after childbirth.
• If you have inflammation of 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 Diario”).
• If you have any condition that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin 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 rays.
  • 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. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive such as Levobel Diario increases your risk of developing a blood clot compared to not using it. 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 Diario 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 a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach 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 complete vision loss.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. 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 a 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 most 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 remains slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Levobel Diario, 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 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 Diario 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/ring and who are not pregnant.	About 2 out of 10,000 women
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women using Levobel Diario	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 Diario 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 have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). 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 a plaster cast on your leg. You may need to stop taking Levobel Diario several weeks before surgery or during periods of reduced mobility. If you need to stop taking Levobel Diario, 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 should stop taking Levobel Diario.

If any of the above conditions change while you are using Levobel Diario—for example, a close relative experiences a thrombosis without a 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 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 heart attack or stroke while using Levobel Diario is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Levobel Diario, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using 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 disorders, a 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 developing a blood clot may be further increased.

If any of the above conditions change while you are using Levobel Diario—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Levobel Diario and cancer

A slightly increased frequency of breast cancer has been observed 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 Diario have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Levobel Diario, you may experience unexpected bleeding (bleeding outside the placebo tablet 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 placebo week

If you have taken all the pink active tablets correctly, have not had vomiting or 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 cycle, 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 Diario

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

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

• 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
  • certain heart diseases, 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 (Hypericum perforatum)
• grapefruit juice.

Levobel Diario may influence the effect 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)
• theophylline (used to treat breathing problems)
• midazolam (for sedation and epilepsy)
• tizanidine (muscle relaxant).

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

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

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Taking Levobel Diario during breastfeeding is not recommended unless advised by your doctor. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and using machines

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

Levobel Diario contains lactose, soy, Allura red AC, indigo carmine

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

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

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

3. How to take Levobel Diario

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

If you were previously taking another contraceptive before starting Levobel Diario, you may be familiar with the fact that most contraceptives contain 21 tablets. With these contraceptives, one tablet is taken daily for 21 days, followed by a week without tablets (a "rest week").

The regimen for using Levobel Diario is different. After taking the 21 pink tablets, you must continue with the 7 placebo tablets, meaning there is no rest week, but rather a week of "placebo" (the week during which you take the placebo tablets from row 4). Since you take one tablet every day and there is no tablet-free interval between packs, tablet-taking becomes a routine, thereby reducing the risk of forgetting a dose.

The two differently colored tablets in Levobel Diario are arranged in order. One pack contains 28 tablets.

Take one Levobel Diario tablet daily, if necessary with a small amount of water. You must take the tablets at approximately the same time every day.

Do not confuse the tablets: take one pink tablet daily for the first 21 days, followed by one white tablet daily for the last 7 days. Then, immediately start a new blister pack (21 pink tablets and 7 white tablets). Therefore, there is no break between packs.

The blister contains 28 tablets. Taking one tablet daily for 28 consecutive days is important to maintain contraceptive effectiveness.

Adhesive labels with the days of the week are included with the blisters. Choose the label that starts with the day you begin taking the tablet. Place the strip on the blister over the words “START. Place adhesive label here.” Each day will align with a row of tablets. It is important to take your tablet every day. Take the first tablet from the first row, where the word “START” appears.

Follow the direction of the arrow on the packaging: first take the pink tablets for 21 days, then the white tablets for 7 days, until all 28 tablets are taken. Then, start a new blister pack immediately. This means there is no break between packs.

During the 7 days when you take the placebo tablets (called "placebo days"), you should experience bleeding (also known as withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last active pink tablet of Levobel Diario. Once you have taken the last white tablet, you must start the next blister pack, even if bleeding has not stopped. This means you should start the new pack on the same day of the week, and withdrawal bleeding should occur on the same days each month.

If you use Levobel Diario as directed, you are also protected against pregnancy during the 7 days when you take the placebo tablets.

When to start the first pack

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

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

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

Start taking Levobel Diario the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous hormonal contraceptive (or after taking the last placebo tablet of your previous contraceptive). For a vaginal ring or patch, start taking Levobel Diario the day after removing the last ring or patch of a cycle, or no later than when the next application would normally occur.

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

You may switch from a progestogen-only pill to Levobel Diario on any day (if using an implant or IUS, on the same day of removal; if using an injectable, at the time the next injection would be due), but in all cases, use additional contraceptive measures (e.g., a condom) for the first 7 days of tablet-taking.

• After a first-trimester abortion

Follow your doctor’s recommendations.

• After childbirth or a second-trimester abortion

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

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

• If you are breastfeeding and wish to start (or restart) Levobel Diario 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 Diario before menstruation has started.

Use in elderly patients

Do not take Levobel Diario after menopause.

Use in patients with liver problems

Do not take Levobel Diario if you have severe liver problems.

Use in patients with kidney problems

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

If you take more Levobel Diario than you should

No serious harm has been reported from overdosing on Levobel Diario. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may have 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 Diario tablets, or if you discover that a child has taken them, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levobel Diario

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, this will not affect the effectiveness of Levobel Diario. Discard the forgotten tablet.

If you forget to take an active pink tablet (tablets from rows 1, 2, and 3), do the following:

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

• If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The more tablets you forget, the higher the risk of pregnancy.

The risk of incomplete contraceptive protection is greatest if you forget a pink tablet at the beginning (row 1) or at the end of the pack (row 3).

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

• Never interrupt tablet-taking for more than 7 days.

• The effectiveness of Levobel Diario depends on taking tablets for 7 consecutive days.

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

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking tablets at your 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 forgetting the tablet, consider the possibility of pregnancy. The more tablets you have forgotten, and the closer to the rest week, the higher the risk of pregnancy. Consult your doctor.

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

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking tablets at your usual time. If you took all tablets correctly in the 7 days before the first forgotten tablet, no additional precautions are needed. If you did not take tablets correctly, or if you forgot more than one tablet, use additional contraceptive measures for the next 7 days.

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

The risk of pregnancy increases as you get closer to the rest week. However, pregnancy can be avoided by adjusting the dosing.

If you follow the advice below, no additional contraceptive precautions are necessary, provided you took all tablets correctly in the 7 days before the first forgotten tablet. If not, follow the first of these two options and use additional contraceptive precautions for the next 7 days.

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. Instead of taking the placebo tablets, discard them and start the next pack immediately (your starting day will be different).

   Withdrawal bleeding will probably not occur until the end of the second pack (while taking the white placebo tablets), but you may experience light bleeding or breakthrough bleeding during the second pack.

2. Alternatively, you may stop taking the active pink tablets and immediately start the 7 white placebo tablets (before starting the placebo tablets, note the day you forgot the tablet). Then start the next pack. If you wish to start a new pack on the same day as usual, take fewer than 7 days of placebo tablets.

• If you have forgotten several tablets in a pack and do not have withdrawal bleeding during the placebo week, you may be pregnant.

What to do in case of vomiting or severe diarrhea

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

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

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 Diario instead of taking the white placebo tablets and completing it. You may experience light bleeding or breakthrough bleeding while using the second pack. Complete the second pack by taking the 7 white tablets in row 4. Then 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 placebo days. If you wish to change that day, reduce the number of placebo days – when you take the white tablets – (but never increase them – maximum is 7 days!). For example, if you usually start placebo tablets on Fridays and wish to change to Tuesdays (3 days earlier), you should start the new pack 3 days earlier than usual. Bleeding may not occur during these days. You may later experience light or breakthrough bleeding.

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

If you stop treatment with Levobel Diario

You may stop taking Levobel Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Levobel Diario and wait until your period before trying to conceive. This will allow you to calculate your estimated due date more easily.

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 Diario, 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 starting to take Levobel Diario”.

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

• 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 rashes
  • 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 combined oral contraceptives (see also sections “Do not take Levobel Diario”, “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) may have an increased risk of pancreatitis (inflammation of the pancreas) when using combined oral contraceptives.
• High blood pressure
• Onset or worsening of diseases whose relationship with combined oral contraceptives is not fully established: 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)
• In women with hereditary angioedema (symptoms include sudden swelling of, for example, the eyes, mouth, throat, etc.), medicines containing oestrogens may induce or worsen angioedema symptoms
• 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 Diario
• 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 Diario”.

The following conditions may occur or worsen with combined oral contraceptives:

Crohn's disease, ulcerative colitis, migraine, cervical cancer, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (the body attacks and damages 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 disorders 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 Diario

Keep this medicine out of 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. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levobel Diario

• The active substances are levonorgestrel and ethinylestradiol. Levobel Diario contains tablets of two different colours:

• Each pink 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)].

• Each white tablet (inactive tablets or placebo tablets) contains only the following excipients (no active substances): lactose, povidone K30 (E1201), magnesium stearate (E572) and Opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Presentation of the product and contents of the pack

The active tablets are film-coated, pink, round tablets.

The placebo tablets are film-coated, white, round tablets.

Levobel Diario is available in blister packs of 28 tablets: 21 pink active tablets and 7 white placebo tablets.

Pack sizes of 1, 3 or 6 blisters are available, each blister containing 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation 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

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

Austria Melleva

Slovakia Levonille

Spain Levobel Diario

Hungary Missee 0.10 mg/0.02 mg filmtabletta

Poland Orlifique

Portugal Gesffiset

Czech Republic Asumate

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 Medical Devices (AEMPS) (http://www.aemps.gob.es/).