Package Insert: Information for the User

Levonorgestrel/Ethinyl Estradiol Daily 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.

Contents of the package and additional information

• Levonorgestrel/Ethinylestradiol Dailythoughtis 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.
• The package also includes 7inactive white pills (placebo).

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

In this leaflet, some situations are described in which you should stop taking Levonorgestrel/Ethinylestradiol Daily or where the reliability of Levonorgestrel/Ethinylestradiol Daily 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 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 (AIDS) infection or other sexually transmitted diseases.

Do not take Levonorgestrel/Ethinylestradiol Daily

• If you have or have had heart problems or blood vessel problems, particularly:
• • heart attack (myocardial infarction) arrhythmias or heart valve disorders
  • blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or brain (stroke), mini-stroke, or a tendency to form blood clots (arterial thrombosis)
  • chest pain caused by angina pectoris.
• If you have uncontrolled high blood pressure.
• If you have certain types of migraines (migraines 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 Daily”)
• 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 takingLevonorgetrel/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 any of these cancers.
• If you have unexplained vaginal bleeding.
• If you have high blood sugar levels (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 Daily.

In some situations, special care may be needed when taking Levonorgestrel/Ethinylestradiol Daily 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 Daily. If any of the following situations develop or worsen while taking Levonorgestrel/Ethinylestradiol Daily, you should consult your doctor to decide if Levonorgestrel/Ethinylestradiol Daily 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 obese.
• You are diabetic.
• You have heart valve problems or arrhythmias (atrial fibrillation).
• You have a family history of blood clotting disorders (in the legs, lungs, or any other part of the body) or have had heart attacks or strokes at a young age.
• You have varicose veins or have had superficial vein inflammation in the legs.
• You experience sudden and inexplicable changes in vision.
• You have gallstones, bile duct problems, or liver problems (cholestasis) - may cause intense itching.
• You develop migraines for the first time or worsen an existing migraine.
• You have liver disease, jaundice, or pancreatitis or kidney problems.
• 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 disorder associated with kidney disease (hemolytic-uremic syndrome).
• You have a condition that affects your immune system (systemic lupus erythematosus).
• You have had porphyria.
• You have had a skin problem during pregnancy or while taking the contraceptive pill that caused itching, red spots, or blisters (herpes gestationalis).
• You have a condition known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• You have had melasma during pregnancy. The pill may cause this to recur, so you should avoid exposure to the sun or lying in the sun while taking Levonorgestrel/Ethinylestradiol Daily.
• 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 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 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 Daily and thrombosis (blood clots)

Deep vein thrombosis (blood clots)

The use of any combined pill, including Levonorgestrel/Ethinylestradiol Daily, 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 blood clotting disorder,
• with prolonged immobilization (e.g., with one of your legs 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 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 (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 a close relative 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, arrhythmias).

Stop taking Levonorgestrel/Ethinylestradiol Daily and consult 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 swollen leg pain
• Severe and/or sudden chest pain that may spread to the left arm.
• Difficulty breathing, sudden shortness of breath.
• Sudden and unusual coughing.
• Severe and/or prolonged headache, or more frequent and severe migraines.
• 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.
• Severe stomach pain.

Levonorgestrel/Ethinylestradiol Daily and cancer

Cervical cancer 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 frequently, so there would be a greater chance of detecting cervical cancer before.

There have been studies in which cases of cervical cancer have been reported in women taking combined pills for a relatively long period. Currently, it is unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent partner changes) 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 Daily, you may experience unexpected bleeding (bleeding or spotting outside the week in which you take the inactive pills (placebo) of white color).If this bleeding lasts more than a few months, or if it starts after some months, your doctor should investigate the cause.

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

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, then you may be pregnant.Consult your doctor immediately.Do not start a newblisteruntil you are sure you are not pregnant.

Other medicines and Levonorgestrel/Ethinylestradiol Daily

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

There are medicines that may interact withLevonorgestrel/Ethinylestradiol Daily.

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

Some medicines may make Levonorgestrel/Ethinylestradiol Daily less effective 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 infection (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 one of the above medicines, follow your doctor's instructions carefully. If you need to continue taking the medicine after completing the white pills in your current pack, do not take the white pills 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 Daily may interact 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 a condition 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 parameters in the blood (elevated ALT levels).

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 the section “Do not take Levonorgestrel/Ethinylestradiol Daily”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect that you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 the hormones may affect the milk. If you want 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 Daily 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 Daily contains lactose and soy lecithin

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

This medicine 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 of Levonorgestrel/Ethinylestradiol Daily contains 21 pink tablets and 7 white tablets.The daily intake for 28 consecutive days is important to maintain the contraceptive effect.

Along with the blisters, adhesive labels with the days of the week are attached.Take the label of the day when you start taking the pink pill.Put the label on the blister over the words “Stick the label with the day here”.Each day will align with a row of pills.It is essential to take your pill every day.And take the first tablet of the first row where the word “BEGINNING” is indicated.

Follow the direction of the arrow indicated inthe blister, you should take a 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 package is finished. Once you have finished the last tablet, start the next day with a new package of tablets. You must always start the next package 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 starting the next package of tablets.

If it is the first time you start with the pill or you 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 (in 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 changing the combined oral contraceptive pill

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

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

If you are taking “daily” pills that contain 28 tablets in the package

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

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

• If you change from a pill that only contains progestogen, you can start with Levonorgestrel/Ethinylestradiol Daily 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 Daily the day after the implant is removed.
• If you change from an injectable contraceptive, start with Levonorgestrel/Ethinylestradiol Daily the day after when you would have had the next injection.

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

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

You can start taking Levonorgestrel/Ethinylestradiol Daily 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 after having a baby or after an abortion in the second trimester

Like any other oral contraceptive, Levonorgestrel/Ethinylestradiol Daily should not be initiated before 28 days after giving birth, or after an abortion in the second trimester of pregnancy, as the risk of blood clots increases. If you start later, you are recommended to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sex before starting Levonorgestrel/Ethinylestradiol Daily, make 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 Daily than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol Daily than you should, you may experience symptoms such as 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 Daily

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

• If you realize you have forgotten to take a pink tablet within the12 hours following the usual time of taking,take the forgotten tablet immediately and continue normally, taking the next tablets at the usual times until the package is finished.
• If you realize you have forgotten to take a pink tablet after the12 hours following the usual time of taking,there is a risk of becoming pregnant.In this case:
• • Take the last forgotten tablet immediately, even if this means taking two tablets on the same day.
  • Continue taking the tablets until the end of the package.
  • Additionally, 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 package, start with the next package immediately without taking any of the white inactive tablets. You may have spotting or bleeding while taking the second package, but you do not need to worry about this.

If you have forgotten one or more pink tablets in a package 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, apart from starting the next package on the usual day.

If you experience vomiting or diarrhea

If you vomit or have 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 package as soon as possible.If possible, take itwithin the next 12 hours or when you normally take the pill.If 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 the 12 hours following the usual time of taking”.

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

If you vomit or have diarrhea while taking the white tablets, no action is needed as long as the vomiting and diarrhea have stopped by the time you start the next package.

How to delay your period

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

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:

• 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 blister. It may also present with 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
  • Abdominal bloating
  • Acne (pimples)
  • Skin rash
  • Amenorrhea (absence of period)
  • Changes in the amount of bleeding and duration of periods
  • Pain or tenderness 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 skin patches (may have been present from a previous pregnancy)
  • Increased blood pressure
  • Gallstones
  • Glucose intolerance
  • Worsening of varicose veins

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

• Unknown frequency(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)
  • Optic neuritis: symptoms consist of blurred vision and may lead to total or partial loss of vision
  • Lens intolerance
  • Biliary tract disease or worsening of this condition
  • Inflammatory or ischemic bowel disease: symptoms consist of abdominal pain and cramps, diarrhea (which may be bloody), weight loss
  • Abdominal cramps
  • Vaginal discharge
  • Decreased folate levels in the blood

• Severe side effects: contact your 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 related to 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 above 86°F (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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levonorgestrel/Ethinylestradiol Daily pensa

• The active principles are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Daily pensa 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, red aluminum lake (E129), soy lecithin (E322), red iron oxide (E172) and blue aluminum lake (E1329)].
• Each white tablet (inactive tablets or placebo tablets) contains only excipients (without active principles), 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 content of the container

Each active coated tablet is a round pink tablet.

Each placebo coated tablet is a round white tablet.

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

The sizes of the container are 1, 3 or 6 blister packs and eachblister pack contains 28 tablets. Some container sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

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