Package Insert: Information for the User

Levonorgestrel/Ethinyl Estradiol pensa 0.1 mg/0.02 mg, Film-Coated Tablets

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

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

• Levonorgestrel/Ethinylestradiol 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 pills contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.

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

This leaflet describes some situations in which you should stop taking Levonorgestrel/Ethinylestradiol or where the reliability of Levonorgestrel/Ethinylestradiol may be reduced, with a risk of pregnancy. In these situations, you should not have sex or 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 because Levonorgestrel/Ethinylestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol pensa

• If you have or have had heart problems or blood vessel problems, particularly:
• • Heart attack (myocardial infarction), arrhythmia, or heart valve disorder.
  • Deep vein thrombosis, pulmonary embolism, or rupture of blood vessels in the brain (apoplexy), mini-apoplexy, or a tendency to form blood clots (venous or arterial thrombosis).
  • Chest pain caused by angina pectoris.
• If you have uncontrolled high blood pressure.
• If you have 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 medicines and Levonorgestrel/Ethinylestradiol pensa”).

If you have or have had a benign or malignant liver tumor, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol 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 any of these cancers.
• If you have unexplained vaginal bleeding.
• If you have high blood sugar (diabetes) associated with blood vessel problems.
• If you are pregnant or suspect that you may be.
• If you are allergic to the active ingredients (levonorgestrel or ethinylestradiol) or to any of the other components of this medicine (including those listed in section 6).

This medicine contains soy lecithin. Do not use it if you are allergic to peanuts or soy.

Warnings and precautions

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

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

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

Inform your doctor if:

• You have high blood pressure.
• You have high cholesterol levels or abnormal lipid levels in the blood (hyperlipidemia) – these levels are detected in a blood test.
• You are diabetic.
• You are obese.
• You have heart valve problems or arrhythmia (atrial fibrillation).
• You have a family history (parents, siblings, or children) of a disease that tends to develop blood clots (in the legs, lungs, or any other part of the body) or have had heart attacks or apoplexies.
• You have varicose veins or have had superficial venous inflammation in the legs.
• You experience sudden and inexplicable changes in vision.
• You have gallstones, bile duct disorders, or problems caused by bile duct blockage (cholestasis) – may cause intense itching.
• You develop migraine for the first time or worsen an existing migraine.
• You have or develop liver disease, jaundice, or pancreatitis or kidney disorder.
• You have depression.
• You have hearing loss due to a condition known as otosclerosis.
• You have had porphyria at any time.
• 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 disorder associated with kidney disease (hemolytic-uremic syndrome).
• You have a condition known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• You have a disorder that affects your immune system (systemic lupus erythematosus).
• You have had a skin problem during pregnancy or while taking another contraceptive pill that caused itching, red patches, or blisters (herpes gestationis).
• You have had during pregnancy brownish skin patches (melasma). The pill may cause this to recur, so you should avoid exposure to the sun or lying in the sun while taking Levonorgestrel/Ethinylestradiol.
• You have sickle cell disease.
• You experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Mental health disorders

Some women who use hormonal contraceptives like Levonorgestrel/Ethinylestradiol 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 can cause or worsen symptoms of angioedema. You should contact your doctor immediately if you experience symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing, or urticaria with possible difficulty breathing.

Levonorgestrel/Ethinylestradiol pensa and thrombosis (blood clots)

Deep vein thrombosis (blood clots)

The use of any combined pill, including Levonorgestrel/Ethinylestradiol, increases the risk in women of developing deep vein thrombosis (formation of blood clots in the veins) compared to women who do not take any contraceptive pill.

The risk of deep vein thrombosis in patients taking combined pills increases:

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

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 heart (heart attack) or brain (apoplexy).

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, 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 a close relative has had a heart attack or apoplexy at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have any heart problems (valve disorders or arrhythmias).

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

• Severe pain and/or inflammation of one of your legs.
• Severe and sudden chest pain that may spread to the left arm.
• Difficulty breathing, or sudden and unexpected coughing.
• Sudden and unusual coughing.
• Severe and unusual headache, or more frequent and severe migraines.
• Increased blood pressure.
• Changes in vision, partial or complete blindness, or double vision.
• Difficulty speaking, or inability to speak.
• Sudden and unusual changes in hearing, sense of smell, or taste.
• Dizziness or fainting.
• Severe and unusual stomach pain.

Levonorgestrel/Ethinylestradiol pensa and cancer

Cancer of the breast has been diagnosed at a slightly higher frequency in women who use the combined pill, but it is unknown whether the cancer is caused by the pill. It is possible that these women are simply examined more rigorously and more frequently, so there would be a greater chance of detecting breast cancer before it becomes apparent. There have been studies in which cases of cervical cancer have been reported in women who take combined pills for a relatively long period. It is currently unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent changes of partner) 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 and unusual abdominal pain.

Intermenstrual bleeding

During the first few months of taking Levonorgestrel/Ethinylestradiol, you may experience unexpected bleeding (bleeding or spotting outside of the pill-free week). If this bleeding lasts more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if there is no bleeding during the pill-free week

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

If your period does not appear for the second time in a row, you may be pregnant. Consult your doctor immediately. Do not start a new pack until you are sure you are not pregnant.

Other medicines and Levonorgestrel/Ethinylestradiol pensa

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

There are medicines that can interact with Levonorgestrel/Ethinylestradiol.

Medicines 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 as a contraceptive. They may advise you to take additional precautions (e.g., use condoms or other barrier methods) while taking other medicines with Levonorgestrel/Ethinylestradiol.

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

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

If you have been told to take additional contraceptive precautions while taking one of the above medicines, follow your doctor's instructions carefully. If you need to continue taking the medicine after completing your current pack, do not skip the pill-free week 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 medicine.

Levonorgestrel/Ethinylestradiol can interfere with the following medicines:

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

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

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

Do not take Levonorgestrel/Ethinylestradiol if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in liver function parameters in the blood (elevated ALT levels).

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

Levonorgestrel/Ethinylestradiol can be restarted approximately 2 weeks after completing this treatment. See the section “Do not take Levonorgestrel/Ethinylestradiol pensa”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

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

Driving and operating machinery

No studies have been conducted on the effect of Levonorgestrel/Ethinylestradiol on the ability to drive or operate machinery. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machinery until it has resolved.

Levonorgestrel/Ethinylestradiol pensa contains lactose and soy lecithin

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

Levonorgestrel/Ethinylestradiol pensa contains soy lecithin. Do not use it if you are allergic to peanuts or soy.

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

Each blister pack ofLevonorgestrel/Ethinylestradiol contains 21 tablets. Take the first tablet from the blister pack where the correct day of the week appears. You should take one tabletevery day, with water if necessary, and at the same time every day until the packaging is finished. You will then have a week of no tablet intake before starting the next packaging of tablets. You should always start the next packaging on the same day of the week.

During the week of no tablet intake, you will have a bleeding similar to your period.This bleeding usually starts after two or three days, and may not have finished before starting the next packaging of tablets.

If it is the first time you start taking a pill or have not used any hormonal contraceptive the previous month

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

If you are changing from a combined oral contraceptive

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

Finish the packaging of the current pill, and start taking Levonorgestrel/Ethinylestradiol pensa the next day, without interruption.

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

If your current packaging of pills contains inactive tablets (placebo), do not take these tablets and start with Levonorgestrel/Ethinylestradiol pensa immediately the next day, without leaving any gap.

If you are changing from a pill that only contains a progestogen, an injection, or an implant

• If you change from a pill that only contains progestogens, you can start taking Levonorgestrel/Ethinylestradiol pensa at any time of the menstrual cycle, the day after stopping the pill that only contains progestogen.
• If you change from an implant, start using Levonorgestrel/Ethinylestradiol pensa the day after the implant is removed.
• If you change from an injectable contraceptive, start taking Levonorgestrel/Ethinylestradiol pensa the day after the next injection would have been due.

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

If you start taking Levonorgestrel/Ethinylestradiol pensa after a first-trimester abortion (3 months) of pregnancy

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

If you start taking Levonorgestrel/Ethinylestradiol pensa after having a baby or after a second-trimester abortion

Like any other combined oral contraceptive,Levonorgestrel/Ethinylestradiol pensa should not be initiated before 28 days after giving birth, or after a second-trimester abortion, as the risk of blood clots increases. If you start later, it is recommended to use a barrier contraceptive method for the first 7 days after starting the pill. If you have had sex before starting Levonorgestrel/Ethinylestradiol pensamake sure you are not pregnant or wait until your next period.

In case of doubt, consult your doctor always.

If you take more Levonorgestrel/Ethinylestradiol pensa than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol pensa than you should, you may experience symptoms that include 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.

Consult your doctor if you are concerned.

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

If you forget to take Levonorgestrel/Ethinylestradiol pensa

If you forget to take a tablet, there is a risk of becoming pregnant

• If you realize you have forgotten to take a tabletwithin 12 hours of the usual time of taking,take the missed tablet immediately and continue as normal, taking the next tablets at the usual time until the packaging is finished.
• If you realize you have forgotten to take a tablet more than12 hours after the usual time of taking,there is a risk of becoming pregnant. In this case:
• • Take the last missed tablet immediately, even if this means taking two tablets on the same day.
  • Continue taking the tablets until the packaging is finished.
  • Also use a barrier contraceptive method (e.g., condoms) for the next 7 days.
  • If this 7-day period extends beyond the last tablet of the packaging, start the next packaging immediately without interruption. You may experience spotting or bleeding while taking the second packaging, but you do not need to worry about this.

If you have forgotten one or more tablets in a packaging and have no bleeding during the week of no tablet intake, you may be pregnant and should consult your doctor.

If you experience vomiting or diarrhea

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

If the episodes of vomiting or severe diarrhea are repeated over several days, a barrier contraceptive method (e.g., condoms) should be used until the start of the next packaging. Consult your doctor if you are unsure.

How to delay your period

You can delay your period by starting another packaging ofLevonorgestrel/Ethinylestradiol pensa immediately without interruption. You may experience spotting or bleeding while taking the second packaging, but you do not need to worry about this. You should have a normal bleeding after finishing the second packaging.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

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

• A severe allergic reaction:frequency unknown.

The symptoms consist of sudden sneezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat, skin rash, hives.

• Blood clot in the eye:frequency unknown

The symptoms consist of loss of vision, eye pain and swelling, especially if they are sudden.

• Haemolytic uraemic syndrome (a condition that affects the blood and kidneys):frequency unknown

The symptoms consist of vomiting, diarrhea (which may be bloody), fever, feeling weak, urinating less than usual.

• Pancreatitis:frequency unknown

The symptoms consist of intense pain in the upper abdomen, which may radiate to the back.

• Erythema multiforme:frequency unknown

The symptoms consist of a skin rash with pink-red patches, especially on the palms or soles of the feet, which may have blisters. It may also have ulcers in the mouth, eyes, or genitals, and may have 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
  • Changes in mood, including depression
  • Decreased libido
  • Feeling nervous
  • Dizziness
  • Vomiting
  • Diarrhea
  • Feeling bloated in the abdomen
  • Acne (pimples)
  • Skin rash
  • Absence of period (amenorrhea)
  • Changes in the amount of bleeding and duration of periods
  • Pain/sensitivity in the breasts, enlargement or discharge from the breasts
  • Changes in the cervix that can be observed in cytology
  • Fluid retention (e.g. swollen ankles)
  • Weight gain or loss
  • 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 (may have been present 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)
• • Boils under the skin that are painful and red (erythema nodosum)
  • Yellowing of the skin and eyes (jaundice caused by an abnormal flow of bile in the liver)

• Frequency not known(cannot be estimated from available data)
• • Benign or malignant liver tumor
  • Worsening of an autoimmune disease called systemic lupus erythematosus
  • Worsening of a hereditary blood disorder called porphyria
  • Worsening of uncontrolled or spasmodic body movements (chorea)
  • Inflammation of the optic nerve: symptoms consist of blurred vision and may lead to total or partial loss of vision
  • Intolerance to contact lenses
  • Biliary tract disease or worsening of this condition
  • Inflammatory or ischemic intestinal disease: symptoms consist of abdominal pain and cramps, diarrhea (which may be bloody), weight loss
  • Stomach cramps
  • Vaginal discharge
  • Decreased levels of folate in the blood

• Severe 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 "Warnings and precautions" section).

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

Reporting side effects

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

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

Do not store at a temperature above 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat thepharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel/Ethinylestradiol pensa

• The active principles are levonorgestrel and ethinylestradiol.
• Each 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, red aluminium lake (E129), soy lecithin (E322), red iron oxide (E172) and blue aluminium lake (E1329)].

Appearance of the product and contents of the packaging

Each film-coated tablet is round and pink in color.

Levonorgestrel/Ethinylestradiol pensais marketed in packs (blister packs) of 21 tablets.

The pack sizes are 1, 3 or 6 blister packs and each blister pack contains 21 tablets.Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate

La Vallina, s/n

24193 Villaquilambre (León)

Spain

Last review date of this leaflet: September 2022

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