Levonorgestrel/ethinylestradiol diario Pensà 0.1 mg/0.02 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

What Levonorgestrel/Ethinylestradiol Diario pensa is and what it is used for
What you need to know before taking Levonorgestrel/Ethinylestradiol Diario pensa
How to take Levonorgestrel/Ethinylestradiol Diario pensa
Possible adverse effects
How to store Levonorgestrel/Ethinylestradiol Diario pensa

Pack contents and additional information

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

Levonorgestrel/Ethinylestradiol Diario pensa is a combined oral contraceptive tablet 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 taking Levonorgestrel/Ethinylestradiol Daily pensa

Before you start taking Levonorgestrel/Ethinylestradiol Daily, 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 additional tests.

This leaflet describes certain situations in which you should stop taking Levonorgestrel/Ethinylestradiol Daily or where the effectiveness of Levonorgestrel/Ethinylestradiol Daily may decrease, increasing the risk of pregnancy. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions (e.g., condoms or other barrier methods). Do not use rhythm or temperature methods. These methods may not be reliable because Levonorgestrel/Ethinylestradiol Daily alters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol Daily pensa

If you have or have had heart problems or blood vessel disorders, particularly:
- heart attack (myocardial infarction), heart rhythm disorders, or heart valve disorders
- blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or rupture of blood vessels in the brain (stroke), mini-stroke, or a general tendency to form blood clots (venous or arterial thrombosis)
- chest pain caused by angina pectoris.
If you have uncontrolled high blood pressure despite treatment.
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 section “Other medicines and Levonorgestrel/Ethinylestradiol Daily pensa”).
If you have or have had a benign or malignant liver tumor, or if you recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol Daily until your liver function returns to normal.
If you have breast cancer, uterine cancer, or any type of cancer sensitive to female hormones, or if you suspect you may have any 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 you might be.
If you are allergic to the active substances (levonorgestrel or ethinylestradiol) or to any of the other components of this medicine (listed in section 6).

This medicine contains soybean lecithin. It should not be used if you are allergic to peanuts or soy.

Warnings and precautions

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

Special care may be needed when taking Levonorgestrel/Ethinylestradiol Daily or any combined oral contraceptive. Your doctor will routinely monitor you. Smoking increases the risk of serious adverse effects on the heart and blood vessels associated with the use of oral contraceptives. This risk increases with age and the amount of tobacco smoked and is particularly relevant in women over 35 years of age. Women using oral contraceptives should not smoke. Women over 35 who smoke should consider using other contraceptive methods.

If you have any of the following conditions, inform your doctor before starting Levonorgestrel/Ethinylestradiol Daily. If any of the conditions listed below develop or worsen while taking Levonorgestrel/Ethinylestradiol Daily, you must consult your doctor to determine whether Levonorgestrel/Ethinylestradiol Daily is still suitable for you.

Inform your doctor if:

You have high blood pressure.
You have high cholesterol levels or abnormal blood lipid (fat) levels (dyslipidemia) – these are detected in a blood test.
You are obese.
You have diabetes.
You have heart valve problems or heart rhythm disorders (atrial fibrillation).
You or a close relative (parent, sibling) have had a condition predisposing to blood clots (in the legs, lungs, or elsewhere in the body), or have a history of heart attacks or strokes.
You have varicose veins or have had inflammation in the superficial veins of the legs (superficial thrombophlebitis).
You experience sudden, unexplained changes in vision.
You have gallstones, gallbladder disorders, or problems caused by blockage of bile ducts (cholestasis) – this may cause intense itching.
You develop migraine for the first time or experience worsening of existing migraines.
You have or develop liver disease, jaundice, pancreatitis, 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 (intestinal inflammation causing abdominal pain, frequent diarrhea, and fatigue).
You have ever had a blood disorder associated with kidney disease (hemolytic uremic syndrome).
You have a disorder affecting your immune system (systemic lupus erythematosus).
You have ever had a blood disorder called porphyria.
You experienced a skin condition during pregnancy or while taking oral contraceptives that caused itching, red spots, or blisters (herpes gestationis).
You have a condition known as Sydenham’s chorea. Symptoms include irregular, sudden, and involuntary movements.
You developed temporary brown patches on your skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid sun exposure or sunbathing while taking Levonorgestrel/Ethinylestradiol Daily.
You have a blood disorder called sickle cell disease (sickle cell anemia).
You experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders

Some women using hormonal contraceptives such as Levonorgestrel/Ethinylestradiol Daily have reported depression or 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.

If you have hereditary angioedema, products containing estrogens may cause or worsen angioedema symptoms. Seek immediate medical attention if you experience symptoms such as swelling of the face, tongue and/or pharynx, difficulty swallowing, or hives with breathing difficulties.

Levonorgestrel/Ethinylestradiol Daily pensa and thrombosis (blood clots)

Venous thrombosis (blood clots)

The use of any combined oral contraceptive, including Levonorgestrel/Ethinylestradiol Daily, increases the risk of venous thrombosis (formation of blood clots in blood vessels) in women compared to women not taking any contraceptive pill.

The risk of venous thrombosis in women taking combined oral contraceptives increases:

with age,
if you are overweight,
if a close relative had a condition predisposing to blood clots at a young age,
during prolonged immobility (e.g., with one leg in a cast or splint), major surgery, leg surgery, or major trauma. In these cases, it is advisable to stop taking Levonorgestrel/Ethinylestradiol Daily (if surgery is planned, stop at least four weeks before) and not restart until two weeks after you are able to walk again,
immediately after childbirth, when women have an increased risk of blood clots; consult your doctor about when you can start taking the combined pill again.

Arterial thrombosis (blood clots)

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

The risk of arterial thrombosis in women taking combined oral contraceptives increases:

If you smoke. You are strongly advised to stop smoking while taking Levonorgestrel/Ethinylestradiol Daily, especially if you are over 35 years old.
With age, even if you do not smoke.
If you have elevated fat levels in the blood (cholesterol or triglycerides).
If you are overweight.
If a close relative had a heart attack or stroke at a young age.
If you have high blood pressure.
If you have migraines.
If you have heart problems (valve disorders, heart rhythm disorders).

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

Increased blood pressure.
Severe and/or swelling in one of your legs.
Sudden severe chest pain that may spread to the left arm.
Difficulty breathing, sudden breathlessness.
Sudden unexplained cough.
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 numbness, or tingling in any part of the body.
Sudden severe stomach pain.

Levonorgestrel/Ethinylestradiol Daily pensa and cancer

Breast cancer has been diagnosed slightly more frequently in women using combined oral contraceptives, but it is unknown whether the pill causes cancer. It is possible that these women were simply examined more thoroughly and frequently, increasing the likelihood of earlier detection.

Studies have reported cases of cervical cancer in women taking combined oral contraceptives for a relatively long time. It is currently unknown whether this is caused by the pill or related to sexual behavior (e.g., more frequent partner changes) and other factors.

Rarely, benign liver tumors and even a few cases of malignant liver tumors have been reported in patients taking oral contraceptives. Contact your doctor if you experience unusual, severe abdominal pain.

Breakthrough bleeding

During the first few months of taking Levonorgestrel/Ethinylestradiol Daily, you may experience unexpected bleeding (bleeding or spotting outside the week when you are taking the inactive (placebo) white tablets). If this bleeding lasts longer than a few months, or if it starts after several months, your doctor should investigate the cause.

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

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

If you miss your period for a second consecutive time, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and Levonorgestrel/Ethinylestradiol Daily pensa

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

Some medicines may interact with Levonorgestrel/Ethinylestradiol Daily.

Medicines can sometimes interfere with each other. If you are being treated by another doctor, nurse, or qualified healthcare professional, ensure they know you are taking Levonorgestrel/Ethinylestradiol Daily as a contraceptive. They may advise you to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medicines with Levonorgestrel/Ethinylestradiol Daily.

Some medicines may reduce the effectiveness of Levonorgestrel/Ethinylestradiol Daily in preventing pregnancy or may cause unexpected bleeding. These include medicines 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 are advised to use additional contraceptive precautions while taking any of the medicines listed above, follow your doctor’s instructions carefully. If you need to continue taking the medicine after finishing the pink tablets in your current pack, do not take the white tablets 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 interacting medicine.

Levonorgestrel/Ethinylestradiol Daily may interfere with the following medicines:

cyclosporine (used to reduce 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 medicine called flunarizine, used to prevent migraines, may increase the risk of galactorrhea. This is a condition in which the breasts secrete milk spontaneously without breastfeeding or recent childbirth.

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 medicines may cause increases in blood markers of liver function (elevated liver enzyme ALT).

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

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

Pregnancy and breastfeeding

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

Do not take Levonorgestrel/Ethinylestradiol Daily if you are pregnant. If you suspect you may have become pregnant while taking Levonorgestrel/Ethinylestradiol Daily, consult your doctor immediately.

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

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

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 symptoms resolve.

Levonorgestrel/Ethinylestradiol Daily contains lactose and soybean lecithin

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

This medicine contains soybean lecithin. It should not be used if you are allergic to peanuts or soy.

3. How to take Levonorgestrel/Ethinylestradiol Daily pensa

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

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

Attached to the blisters are adhesive labels with the days of the week. Select the label corresponding to the day you start taking the pink tablet. Place the label on the blister over the words "Apply label with day here". Each day will then align with a row of tablets. It is important that you take your tablet every day. Take the first tablet from the first row where the word "START" is indicated.

Follow the direction of the arrow shown on the blister. You must take one pink tablet daily for 21 days, followed by the white tablets for 7 days. Take the tablets with water if necessary, at the same time each day, until the pack is finished. Once you have taken the last tablet, start a new pack the next day. You must always start the next pack on the same day of the week.

During the week you are taking the white tablets, you will experience a withdrawal bleed 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 the pill or you 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 cycle days 2–7), you must use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If switching from a combined oral contraceptive pill

If you are currently taking 21-tablet packs

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

If you are currently taking "daily" 28-tablet packs

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

If switching from a progestogen-only pill, an injection, or an implant

If switching from a progestogen-only pill, you may start Levonorgestrel/Ethinylestradiol Daily pensa at any point in your menstrual cycle, the day after stopping the progestogen-only pill.
If switching from an implant, start using Levonorgestrel/Ethinylestradiol Daily pensa the day after removal of the implant.
If switching from a contraceptive injection, start Levonorgestrel/Ethinylestradiol Daily pensa the day after the next scheduled injection would have been due.

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

If starting Levonorgestrel/Ethinylestradiol Daily pensa after a first-trimester abortion (within 3 months of pregnancy)*

You may 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 starting Levonorgestrel/Ethinylestradiol Daily pensa after childbirth or after a second-trimester abortion

Like any other oral contraceptive, Levonorgestrel/Ethinylestradiol Daily pensa should not be started earlier than 28 days after childbirth or after a second-trimester abortion, as the risk of blood clots is increased. If you start later, a barrier contraceptive method is recommended for the first 7 days of taking the pill. If you have had sexual intercourse before starting Levonorgestrel/Ethinylestradiol Daily pensa, make sure you are not pregnant or wait until your next period.

If in 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 disturbances (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, numbness/fatigue, and vaginal bleeding. These symptoms will naturally subside as your body processes the excess hormones.

If you are concerned, consult your doctor.

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levonorgestrel/Ethinylestradiol Daily pensa

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

If you remember you missed a pink tablet within 12 hours of your usual time, take the missed tablet immediately and continue as normal, taking the following tablets at your usual times until the end of the pack.
If you remember you missed a pink tablet more than 12 hours after your usual time, there is a risk you may become pregnant. In this case:
- Take the most recently missed tablet immediately, even if this means taking two tablets in one day.
- Continue taking the tablets until the end of the pack.
- In addition, use a barrier contraceptive method (e.g., condoms) for the next 7 days.
- If this 7-day period extends beyond the last pink tablet in the pack, start the next pack immediately without taking any of the inactive white tablets. You may experience spotting or bleeding while taking the second pack, but this is not a cause for concern.

If you have missed 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, no further action is needed other than starting the next pack on the usual day.

If you experience vomiting or diarrhoea

If you vomit or have severe diarrhoea within 4 hours of taking the active pink tablet, this is equivalent to missing a pink tablet. After vomiting or having diarrhoea, take another pink tablet from your reserve pack as soon as possible. If possible, take it within the next 12 hours or at your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given under "If you remember you missed a pink tablet more than 12 hours after your usual time".

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

If you vomit or have diarrhoea while taking the white tablets, no action is required provided the vomiting and diarrhoea have stopped by the time you start the next pack, allowing you to begin it 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 this is not a cause for concern. You should have a normal bleed after finishing the pink tablets in the second blister.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

If you experience any of the following serious adverse effects, seek immediate medical advice:

A severe allergic reaction: frequency unknown.

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 unknown.

Symptoms include sudden vision loss, eye pain and swelling, especially if sudden.

Haemolytic uraemic syndrome (a condition affecting blood and kidneys): frequency unknown.

Symptoms include vomiting, diarrhoea (which may be bloody), fever, feeling weak, reduced urine output.

Pancreatitis: frequency unknown.

Symptoms include severe upper abdominal pain, which may spread to the back.

Erythema multiforme: frequency unknown.

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

Other adverse effects include:

Very common (may affect more than 1 in 10 people)
- headache, including migraines
- nausea
- abdominal pain
- bleeding and spotting between periods
- 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
- dizziness
- vomiting
- diarrhoea
- bloating sensation in the abdomen
- acne (spots)
- skin rash
- absence of periods (amenorrhoea)
- changes in the amount of menstrual blood loss and duration of periods
- breast pain/tenderness, breast enlargement or breast discharge
- changes in the cervix that may be seen on a smear test
- fluid retention (e.g. swollen ankles)
- weight gain or loss
- changes in blood fat levels (seen 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 patches on the skin (may have occurred during 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 due to abnormal bile flow in the liver)
Frequency not known (cannot be estimated from available data)
- benign or malignant liver tumour
- 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)
- optic nerve inflammation: symptoms include blurred vision and may lead to partial or complete vision loss
- intolerance to contact lenses
- gallbladder disease or worsening of this condition
- inflammatory or ischaemic bowel disease: symptoms include abdominal pain and cramps, diarrhoea (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 breathing difficulty (see also section “Warnings and precautions”).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel/Ethinylestradiol Daily Pensa

Keep this medicine out of sight and reach of children.

Do not store at temperatures above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel/Ethinylestradiol Diario pensa

The active substances are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Diario pensa film-coated tablets contain 2 types of tablets in different colours:

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, red aluminium lake (E129), soya lecithin (E322), iron oxide red (E172) and blue aluminium lake (E1329)].
Each white tablet (inactive tablets or placebo tablets) contains only excipients (no active substances), which are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and Opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Appearance of the product and contents of the pack

Each active film-coated tablet is round and pink in colour.

Each placebo film-coated tablet is round and white in colour.

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

Pack sizes are 1, 3 or 6 blisters, and each blister contains 28 tablets. Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: September 2022

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