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

Introduction

Package Leaflet: Information for the User

Levonorgestrel/Ethinylestradiol 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 not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

• Levonorgestrel/Ethinylestradiol pensa is a combined 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.

2. What you need to know before taking Levonorgestrel/Ethinylestradiol pensa

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

This package leaflet describes some situations where 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 sexual intercourse 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 alters the monthly changes in body temperature and cervical mucus.

Levonorgestrel/Ethinylestradiol pensa, 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 or blood vessel problems, in particular:
• • Heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders.
  • Blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism) or rupture of blood vessels in the brain (stroke), mini-stroke, or general tendency to form blood clots (venous or arterial 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 pensa").

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 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 are suspected of having 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 think 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.

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 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 who smoke should consider using other contraceptive methods.

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

Tell your doctor if:

• You have high blood pressure.
• You have high cholesterol or abnormal lipid levels in the blood (dislipidemia) - these levels are detected in a blood test.
• You are diabetic.
• You are obese.
• You have heart valve problems or irregular heartbeat (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) - it can cause intense itching.
• You develop migraine for the first time or worsen an 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 a blood disease called porphyria.
• 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 disease known as Sydenham's chorea. The 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 when taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
• 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.
• 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 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 difficulty breathing.

Levonorgestrel/Ethinylestradiol pensa and thrombosis (blood clots)

Venous thrombosis (blood clots)

The use of any combined pill, including Levonorgestrel/Ethinylestradiol, increases the risk in women of developing venous thrombosis (formation of blood clots 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 you are overweight,
• if a close relative has had a disease with a tendency to develop blood clots at a young age,
• with prolonged immobilization (e.g., with one or both 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 (if surgery is planned, you should stop taking it at least four weeks before) and not start again until two weeks after you can get up again,
• immediately after childbirth, women have an increased risk of forming blood clots, so you should consult your doctor about when you can start taking the combined pill after childbirth.

Arterial thrombosis (or 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, 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 or irregular heartbeat).

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

• Severe pain and/or swelling of one of your legs.
• Sudden severe chest pain that may spread to the left arm.
• Difficulty breathing or sudden shortness of breath.
• Sudden unusual cough without an obvious cause.
• Unusual, severe, or prolonged headache, or more frequent or severe migraine attacks.
• Increased blood pressure.
• Changes in vision, 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 abdominal pain.

Levonorgestrel/Ethinylestradiol pensa and cancer

Breast cancer has been diagnosed slightly more frequently in women who use the combined pill, but it is not known 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 not known if this is 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 you are taking Levonorgestrel/Ethinylestradiol, you may have unexpected bleeding (bleeding or spotting outside of the pill-free week). 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 during the pill-free week

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 the next blister pack until you are sure you are not pregnant.

Other medications and Levonorgestrel/Ethinylestradiol pensa

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

There are medications that can interact with Levonorgestrel/Ethinylestradiol.

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 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.

Some medications can make Levonorgestrel/Ethinylestradiol 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., rifampicin, rifabutin, or griseofulvin)
• HIV infections (ritonavir, nevirapine)
• 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 any of the medications mentioned above, follow your doctor's instructions carefully. If you need to continue taking the medication after finishing your current pack, do not leave 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 medication.

Levonorgestrel/Ethinylestradiol 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 condition 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 medications may cause increases in liver function 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 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Levonorgestrel/Ethinylestradiol if you are pregnant. If you think you may have become pregnant during treatment with Levonorgestrel/Ethinylestradiol, 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 appropriate alternative contraceptive methods.

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

Driving and using machines

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

Levonorgestrel/Ethinylestradiol pensa 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 pensa

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

Each Levonorgestrel/Ethinylestradiol pensa blister pack contains 21 tablets. Take the first tablet from the blister pack where the correct day of the week appears. You should take one tablet every day, with water if necessary, and at the same time every day until the pack is finished. Then you will have a week without taking tablets before starting the next pack of tablets. You should always start the next pack on the same day of the week.

During the week without taking 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 a 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 method (e.g., condoms) for the first 7 days.

If you are changing from a combined contraceptive pill

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

Finish the current pill pack and start taking Levonorgestrel/Ethinylestradiol 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 pensa immediately the next day, without leaving any break.

If you are changing from a progestogen-only pill, injection, or implant

• If you change from a progestogen-only pill, you can start Levonorgestrel/Ethinylestradiol pensa at any time during your menstrual cycle, the day after you stop taking the progestogen-only pill.
• 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 with Levonorgestrel/Ethinylestradiol pensa the day after you would have had your next injection.

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

If you start Levonorgestrel/Ethinylestradiol pensa after an abortion during the first trimester (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 contraceptive method is needed.

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

Like any other contraceptive pill,Levonorgestrel/Ethinylestradiol 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 of taking the pill. If you have had sexual intercourse before starting Levonorgestrel/Ethinylestradiol 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 pensa than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol 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 manages 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 ingested.

If you forget to take Levonorgestrel/Ethinylestradiol pensa

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

• If you realize you have forgotten to take a tabletwithin 12 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 tabletmore than 12 hours after 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., condom) for the next 7 days.
  • If this 7-day period extends beyond the last tablet of the pack, start the next pack immediately without a break. 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 tablets in a pack and do not have any bleeding during the week of rest, you may be pregnant and should consult your doctor.

If you have 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 pack as soon as possible. If possible, take it within the next 12 hoursor when you normally take the pill. If it is 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 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.

How to delay your period

You can delay your period by starting another pack of Levonorgestrel/Ethinylestradiol pensa immediately without a break. 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 second pack.

4. Possible side effects

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

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

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

• A severe allergic reaction: the frequency is unknown.

The 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: the frequency is unknown.

The 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): the frequency is unknown.

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

• Pancreatitis: the frequency is unknown.

The symptoms include severe pain in the upper abdomen, which may spread to the back.

• Erythema multiforme: the frequency is unknown.

The symptoms include a skin rash with pink-red spots, especially on the palms or soles of the feet, which may have blisters. 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 sex drive
  • 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 or tenderness, enlargement, or discharge
  • changes in the cervix that can be seen in the cytology
  • 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 spots on the skin (which may have been present 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 caused by abnormal bile flow 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 disease called porphyria
  • worsening of uncontrolled or spasmodic body movements (chorea)
  • optic nerve inflammation: 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 that does not appear in this prospectus. 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 pensa

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 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 medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Levonorgestrel/Ethinylestradiol pensa

• The active ingredients 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, aluminum lake red (E129), soy lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

Appearance of the product and package contents

Each film-coated tablet is pink and round.

Levonorgestrel/Ethinylestradiol pensa is marketed in packs (blisters) of 21 tablets.

The package sizes are 1, 3, or 6 blisters, and each blister contains 21 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 the last revision of this prospectus: September 2022

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