LEVONORGESTREL/ETHINYLESTRADIOL PENSA 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levonorgestrel/Ethinylestradiol Daily pensa 0.1 mg/0.02 mg film-coated tablets EFG

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

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

Contents of the Package Leaflet:

1. What is Levonorgestrel/Ethinylestradiol Daily pensa and what is it used for
2. What you need to know before taking Levonorgestrel/Ethinylestradiol Daily pensa
3. How to take Levonorgestrel/Ethinylestradiol Daily pensa
4. Possible side effects
5. Storage of Levonorgestrel/Ethinylestradiol Daily pensa

Package Contents and Additional Information

1. What is Levonorgestrel/Ethinylestradiol Daily pensa and what is it used for

• Levonorgestrel/Ethinylestradiol Daily pensa is a combined oral contraceptive pill for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol.
• Each of the 21 pink tablets contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
• The package also includes 7 inactive white tablets (placebo).

2. What you need to know before starting to take Levonorgestrel/Ethinylestradiol Daily

Before you start taking Levonorgestrel/Ethinylestradiol Daily, your doctor will ask you some questions about your medical history and your personal relationships. Your doctor will also measure your blood pressure and may perform some other tests.

In this prospectus, some situations are described in which you should stop taking Levonorgestrel/Ethinylestradiol Daily or where the reliability of Levonorgestrel/Ethinylestradiol Daily may decrease, with a risk of pregnancy. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions (e.g., use condoms or another barrier method). Do not use the rhythm or temperature method. These methods may not be reliable since Levonorgestrel/Ethinylestradiol Daily alters the monthly changes in body temperature and cervical mucus.

Levonorgestrel/Ethinylestradiol Daily, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take Levonorgestrel/Ethinylestradiol Daily

• If you have or have had heart problems or blood vessel problems, in particular:
• • a heart attack (myocardial infarction), cardiac rhythm disturbances, or heart valve disorders
  • blood clots in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism), or rupture of blood vessels in the brain (stroke), mini-stroke, or a general tendency to form blood clots (thrombosis)
  • chest pain caused by angina pectoris.
• If you have uncontrolled high blood pressure.
• If you suffer from certain types of migraine (migraine with focal neurological symptoms).
• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Levonorgestrel/Ethinylestradiol Daily").
• If you have or have had a benign or malignant tumor in the liver, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol Daily until your liver has returned to normal.
• If you have breast cancer or uterine cancer, or a type of cancer that is sensitive to female hormones, or if you suspect that you may have one of these cancers.
• If you have vaginal bleeding of unknown cause.
• If you have high blood sugar levels (diabetes) associated with blood vessel problems.
• If you are pregnant or suspect that you may be pregnant.
• If you are allergic to the active ingredients (levonorgestrel or ethinylestradiol) or to any of the other components of this medication (listed in section 6).

This medication contains soy lecithin. It should not be used in case of peanut or soy allergy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Levonorgestrel/Ethinylestradiol Daily.

In some situations, special care may be needed when taking Levonorgestrel/Ethinylestradiol Daily or any combined oral contraceptive. Your doctor will check you regularly. Smoking cigarettes increases the risk of serious adverse reactions in the heart and blood vessels due to the use of oral contraceptives. This risk increases with age and the amount of tobacco and is quite significant in women over 35 years of age. Women who use oral contraceptives should not smoke. Women over 35 years of age and smokers should consider using other contraceptive methods.

If you have any of the following conditions, inform your doctor before starting to take Levonorgestrel/Ethinylestradiol Daily. If any of the following conditions develop or worsen while taking Levonorgestrel/Ethinylestradiol Daily, you should consult your doctor to decide if Levonorgestrel/Ethinylestradiol Daily is suitable for you.

Tell your doctor if:

• You have high blood pressure.
• You have high cholesterol or abnormal lipid levels in the blood (dyslipidemia) - these levels are detected in a blood test.
• You are obese.
• You are diabetic.
• You have heart valve problems or cardiac rhythm disturbances (atrial fibrillation).
• You have had or a close relative (parents, brothers, or sisters) has had a disease with a tendency to develop blood clots (in the legs, lungs, or any other part of the body) or has had a heart attack or stroke.
• You have varicose veins or have had inflammation in the superficial veins of the legs.
• You experience sudden and unexplained changes in vision.
• You have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) - this can cause intense itching.
• You develop migraine for the first time or worsening of existing migraine.
• You have or develop liver disease, jaundice, or inflammation of the pancreas or kidney disorder.
• You have depression.
• You have hearing loss due to a condition known as otosclerosis.
• You have had ulcerative colitis or Crohn's disease (inflammation of the intestine that causes abdominal pain, frequent diarrhea, and fatigue).
• You have had a blood disease associated with kidney disease (hemolytic uremic syndrome).
• You have a disorder that affects your immune system (systemic lupus erythematosus).
• You have had a blood disease called porphyria.
• You have had a skin problem during pregnancy or while taking the contraceptive pill that caused itching, red spots, or blisters (gestational herpes).
• You have a disease known as Sydenham's chorea. The symptoms include irregular, sudden, and involuntary movements.
• You have had brown spots on the skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid sun exposure or sunbathing while taking Levonorgestrel/Ethinylestradiol Daily.
• If you have a blood disease called sickle cell disease, also known as sickle cell anemia.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders

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

If you have hereditary angioedema, products containing estrogens may cause or worsen the symptoms of angioedema. You should see your doctor immediately if you experience symptoms such as swelling of the face, tongue, and/or pharynx, and/or difficulty swallowing, or urticaria along with breathing difficulties.

Levonorgestrel/Ethinylestradiol Daily and thrombosis (blood clots)

Venous thrombosis (blood clots)

The use of any combined pill, including Levonorgestrel/Ethinylestradiol Daily, increases the risk in women of developing a venous thrombosis (formation of a blood clot in the vessels) compared to women who do not take any contraceptive pill.

The risk of venous thrombosis in patients taking combined pills increases:

• with age,
• if they are overweight,
• if a close relative has had a disease with a tendency to develop blood clots in the blood vessels at a young age,
• with prolonged immobilization (e.g., with one leg in a cast or splint), major surgery, any type of surgery on the legs, significant trauma. In these situations, it is best to stop taking Levonorgestrel/Ethinylestradiol Daily (if surgery is planned, you should stop taking it at least four weeks in advance) and not start again until two weeks after you can stand up again,
• immediately after childbirth, women have an increased risk of forming blood clots, so you should consult your doctor when you can start taking the combined pill after childbirth.

Arterial thrombosis (blood clots)

The use of combined pills has been associated with an increased risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or brain (stroke).

The risk of arterial thrombosis in patients taking combined pills increases:

• If you smoke. It is strongly recommended to stop smoking when taking Levonorgestrel/Ethinylestradiol Daily, especially if you are over 35 years old.
• With age, even if you do not smoke.
• If you have high levels of fat in the blood (cholesterol or triglycerides).
• If you are overweight.
• If one of your close relatives has had a heart attack or stroke at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have any heart problems (valve disorders, cardiac rhythm disturbances).

Stop taking Levonorgestrel/Ethinylestradiol Daily and consult your doctor immediately or go to the emergency department of the nearest hospital if you experience signs of thrombosis, such as:

• Increased blood pressure.
• Severe pain and/or swelling of one of your legs.
• Sudden severe chest pain that may spread to the left arm.
• Difficulty breathing, sudden shortness of breath.
• Sudden unusual cough without an obvious cause.
• Unusual, severe, or prolonged headache, or more frequent or severe migraine attacks.
• Changes in vision, partial or complete blindness, or double vision.
• Difficulty speaking or inability to speak.
• Sudden changes in hearing, sense of smell, or taste.
• Dizziness or fainting.
• Weakness, unusual sensation, or numbness in any part of the body.
• Sudden severe stomach pain.

Levonorgestrel/Ethinylestradiol Daily and cancer

Breast cancer has been diagnosed slightly more frequently in women who use the combined pill, but it is unknown if the cancer is caused by the pill. It is possible that these women are simply examined more rigorously and frequently, so there is a greater likelihood that breast cancer will be detected earlier.

There have been studies in which cases of cervical cancer have been reported in women who take combined pills for a relatively long period. Currently, it is unknown if this fact may be caused by the pill or is related to sexual behavior (e.g., more frequent changes in partners) and other factors.

In rare cases, benign liver tumors, and even a few cases of malignant liver tumors, have been reported in patients taking the pill. Contact your doctor if you have severe unusual abdominal pain.

Intermenstrual bleeding

During the first few months in which you are taking Levonorgestrel/Ethinylestradiol Daily, you may have unexpected bleeding (bleeding or spotting outside of the week in which you are taking the inactive tablets (placebo) of white color). If this bleeding lasts for more than a few months or starts after some months, your doctor should investigate the cause.

What to do if there is no bleeding in the last week of taking tablets (white tablets)

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

If your period does not appear for the second consecutive time, you may be pregnant. Consult your doctor immediately. Do not start with the next blister pack until you are sure you are not pregnant.

Other medications and Levonorgestrel/Ethinylestradiol Daily

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

There are medications that can interact with Levonorgestrel/Ethinylestradiol Daily.

Medications can sometimes interfere with each other. If you are receiving treatment from another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are taking Levonorgestrel/Ethinylestradiol Daily as a contraceptive. They may indicate that you need to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medications with Levonorgestrel/Ethinylestradiol Daily.

Some medications can make Levonorgestrel/Ethinylestradiol Daily less effective in preventing pregnancy or may cause unexpected bleeding. These include medications used to treat:

• epilepsy (e.g., phenobarbital, primidone, phenytoin, felbamate, carbamazepine, oxcarbazepine, or topiramate)
• infections (e.g., rifabutin, rifampicin, or griseofulvin)
• HIV infections (ritonavir, nevirapine)
• St. John's Wort (Hypericum perforatum) used to treat certain types of depression
• sleep disorders (modafinil)
• gout (phenylbutazone).

If you have been told to take additional contraceptive precautions while taking any of the medications mentioned above, follow your doctor's instructions carefully. If you need to continue taking the medication after finishing the active tablets of your current pack, do not take the inactive tablets (placebo) and start a new pack immediately.

In some cases, you may need to continue using an additional barrier contraceptive for several weeks after stopping the medication.

Levonorgestrel/Ethinylestradiol Daily may interfere with the following medications:

• cyclosporine (used to reduce the immune response)
• lamotrigine (used to treat epilepsy).

Taking an antibiotic called troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) during treatment with the combined pill.

Taking a medication called flunarizine used to prevent migraines may increase the risk of galactorrhea. This is a disorder in which the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not take Levonorgestrel/Ethinylestradiol Daily if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test parameters in the blood (increase in liver enzyme ALT).

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

Levonorgestrel/Ethinylestradiol Daily can be restarted approximately 2 weeks after completing this treatment. See section "Do not take Levonorgestrel/Ethinylestradiol Daily".

Pregnancy and breastfeeding

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

Do not take Levonorgestrel/Ethinylestradiol Daily if you are pregnant. If you think you may have become pregnant during treatment with Levonorgestrel/Ethinylestradiol Daily, consult your doctor immediately.

It is not recommended to take the combined pill while breastfeeding, as hormones may affect milk production. If you want to breastfeed, your doctor will advise you on alternative contraceptive methods.

Always consult your doctor, nurse, or healthcare professional before using any medication.

Driving and using machines

The effect of Levonorgestrel/Ethinylestradiol Daily on the ability to drive or use machines has not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or use machines until it has resolved.

Levonorgestrel/Ethinylestradiol Daily contains lactose and soy lecithin

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains soy lecithin. It should not be used in case of peanut or soy allergy.

3. How to take Levonorgestrel/Ethinylestradiol Daily pensa

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

Each Levonorgestrel/Ethinylestradiol Daily pensa blister pack contains 21 pink tablets and 7 white tablets. Taking one tablet daily for 28 consecutive days is important to maintain the contraceptive effect.

Along with the blister packs, adhesive labels with the days of the week are provided. Take the label for the day you start taking the pink tablet. Place the label on the blister pack over the words "Stick the label with the day here". Each day will align with a row of tablets. It is essential that you take your tablet every day and take the first tablet from the first row where the word "START" is indicated.

Follow the direction of the arrow indicated on the blister pack; you should take one pink tablet every day for 21 days, followed by the white tablets for 7 days. Take the tablets with water if necessary, and at the same time every day until the pack is finished. Once you finish the last tablet, start a new pack of tablets the next day. You should always start the next pack on the same day of the week.

During the week you are taking the white tablets, you will have a bleeding similar to your period. This bleeding usually starts after two or three days and may not have finished before you start the next pack of tablets.

If this is the first time you are starting with the pill or have not used any hormonal contraceptive in the previous month

Take the first tablet on the first day of your period.

If you start after the first day of your period (on days 2-7 of the cycle), you will need to use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If you are switching to the combined pill

If you are taking pills that contain 21 tablets in the pack

Finish the current pill pack, and start taking Levonorgestrel/Ethinylestradiol Daily pensa the next day, without a break.

If you are taking "daily" pills that contain 28 tablets in the pack

If your current pill pack contains inactive tablets (placebo), do not take these tablets, and start with Levonorgestrel/Ethinylestradiol Daily pensa immediately the next day.

If you are switching from a pill that containsonlyoneprogestogen,aninjectionor animplant

• If you are switching from a pill that only contains progestogen, you can start with Levonorgestrel/Ethinylestradiol Daily pensa at any time during your menstrual cycle, the day after you stop taking the progestogen-only pill.
• If you are switching from an implant, start using Levonorgestrel/Ethinylestradiol Daily pensa the day after the implant is removed.
• If you are switching from an injectable contraceptive, start with Levonorgestrel/Ethinylestradiol Daily pensa the day after you would have had your next injection.

In all cases, you must use a barrier contraceptive method during the first 7 days of taking the pill.

If you start withLevonorgestrel/Ethinylestradiol Daily pensa afteran abortionduring the first trimester (3 months) of pregnancy

You can start taking Levonorgestrel/Ethinylestradiol Daily pensa immediately, but you should follow your doctor's advice before doing so. No additional barrier contraceptive method is needed.

If you start with Levonorgestrel/Ethinylestradiol Daily pensa after having a baby or after an abortion during the second trimester

Like any other contraceptive pill, Levonorgestrel/Ethinylestradiol Daily pensa should not be started before 28 days after giving birth or after an abortion in the second trimester of pregnancy, as this increases the risk of blood clots. If you start later, it is recommended to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sexual intercourse before starting with Levonorgestrel/Ethinylestradiol Daily pensa, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you take more Levonorgestrel/Ethinylestradiol Daily pensa than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol Daily pensa than you should, you may experience symptoms including gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, numbness/fatigue, and vaginal bleeding. These symptoms will naturally decrease as your body handles the excess hormones.

If you are concerned, consult your doctor.

Consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Levonorgestrel/Ethinylestradiol Daily pensa

If you forget to take a pink tablet, there is a risk that you may become pregnant

• If you realize you have forgotten to take a pink tablet within12 hours of the usual time of intake,take the forgotten tablet immediately and continue normally, taking the following tablets at the usual times until the pack is finished.
• If you realize you have forgotten to take a pink tablet after12 hours of the usual time of intake,there is a risk that you may become pregnant. In this case:
• • Take the last forgotten tablet immediately, even if it means taking two tablets on the same day.
  • Continue taking the tablets until the end of the pack.
  • Also, use a barrier contraceptive method (e.g., condoms) for the next 7 days.
  • If this 7-day period extends beyond the last pink tablet of the pack, start the next pack immediately without taking any of the white inactive tablets. You may experience spotting or bleeding while taking the second pack, but you do not need to worry about this.

If you have forgotten one or more pink tablets in a pack and do not have any bleeding during the week you are taking the white tablets, you may be pregnant and should consult your doctor.

If you forget to take a white tablet, you do not need to take any other action, apart from starting the next pack on the usual day.

If you experience vomiting or diarrhea

If you vomit or experience severe diarrhea within 4 hours of taking the active pink tablet, it is as if you had forgotten to take a pink tablet. After vomiting or having diarrhea, you should take another pink tablet from the reserve pack as soon as possible. If possible, take it within the next 12 hours or when you normally takethe pill. If it is not possible or more than 12 hours have passed, you should follow the recommendations given in "If you realize you have forgotten to take a pink tablet after 12 hours of the usual time of intake".

If episodes of vomiting or severe diarrhea recur over several days, you should use a barrier contraceptive method (e.g., condoms) until the start of the next pack. Consult your doctor in case of doubt.

If you vomit or experience diarrhea while taking the white tablets, you do not need to take any action as long as the vomiting and diarrhea have disappeared by the time you start the next pack on the usual day.

How to delay your period

You can delay your period by starting another pack of Levonorgestrel/Ethinylestradiol Daily pensa immediately without taking any of the white tablets. You may experience some spotting or bleeding while taking the second pack, but you do not need to worry about this. You should have a normal bleeding after finishing the pink tablets of the second pack.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

If you experience any of the following serious side effects, consult your doctor immediately:

• A severe allergic reaction: frequency not known.

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat, skin rash, hives.

• A blood clot in the eye: frequency not known.

Symptoms include loss of vision, pain, and swelling of the eye, especially if they are sudden.

• Hemolytic uremic syndrome (a condition that affects the blood and kidneys): frequency not known.

Symptoms include vomiting, diarrhea (which may be bloody), fever, feeling of weakness, decreased urine output.

• Pancreatitis: frequency not known.

Symptoms include severe pain in the upper abdomen, which may radiate to the back.

• ERYTHEMA MULTIFORME: frequency not known.

Symptoms include a skin rash with pink-red spots, especially on the palms or soles of the feet, which may blister. You may also have ulcers in the mouth, eyes, or genitals and may have a fever.

Other side effects include:

• Very common (may affect more than 1 in 10 people)
• • headache, including migraines
  • nausea
  • abdominal pain
  • bleeding and spotting outside of period
  • painful periods

• Common (may affect up to 1 in 10 people)
• • vaginal irritation and infection, including candidiasis
  • mood changes, including depression
  • decreased sexual desire
  • feeling nervous
  • feeling dizzy
  • vomiting
  • diarrhea
  • feeling bloated in the abdomen
  • acne (pimples)
  • skin rash
  • absence of period (amenorrhea)
  • changes in the amount of blood loss and duration of periods
  • breast pain/tenderness, enlargement, or discharge
  • changes in the cervix that can be seen in the cytology
  • fluid retention (e.g., swollen ankles)
  • weight increase or decrease
  • changes in blood lipid levels (observed through blood tests)

• Uncommon (may affect up to 1 in 100 people)
• • increased appetite
  • decreased appetite
  • hives (urticaria)
  • abnormal hair growth (hirsutism)
  • hair loss
  • dark spots on the skin (which may be from a previous pregnancy)
  • increased blood pressure
  • gallstones
  • intolerance to a sugar called glucose
  • worsening of varicose veins

• Rare (may affect up to 1 in 1,000 people)
• • painful red lumps under the skin (erythema nodosum)
  • yellowing of the skin and eyes (jaundice caused by abnormal bile flow in the liver)

• Frequency not known (cannot be estimated from the available data)
• • benign or malignant liver tumor
  • worsening of an autoimmune disease called systemic lupus erythematosus
  • worsening of a hereditary blood disease called porphyria
  • worsening of uncontrolled or spasmodic body movements (chorea)
  • inflammation of the optic nerve: symptoms include blurred vision and can lead to total or partial loss of vision
  • intolerance to contact lenses
  • gallbladder disease or worsening of this condition
  • inflammatory or ischemic intestinal disease: symptoms include abdominal pain and cramps, diarrhea (which may be bloody), weight loss
  • stomach cramps
  • vaginal discharge
  • decreased blood folate levels

• Serious side 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 the section "Warnings and precautions").

If you are concerned about new symptoms or other aspects related to your health while taking Levonorgestrel/Ethinylestradiol, consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levonorgestrel/Ethinylestradiol Daily pensa

Keep this medication out of sight and reach of children.

Do not store above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Levonorgestrel/Ethinylestradiol Daily pensa

• The active ingredients are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Daily pensa film-coated tablets contain tablets of 2 colors:

• Each pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other components (excipients) are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572), and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, aluminum lake red (E129), soy lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].
• Each white tablet (inactive or placebo tablet) contains only excipients (without active ingredients), which are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572), and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), and polyethylene glycol 3350].

Appearance and packaging of the product

Each active film-coated tablet is round and pink.

Each placebo film-coated tablet is round and white.

Levonorgestrel/Ethinylestradiol Daily pensa is marketed in packs (blisters) of 28 tablets: 21 active pink tablets and 7 white placebo tablets.

Package sizes are 1, 3, or 6 blisters, and each blister contains 28 tablets. Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina, s/n

24193 Villaquilambre (León)

Spain

Date of last revision of this leaflet: September 2022

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/