DROSURELLE 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drosurelle 0.02 mg/3 mg film-coated tablets EFG

Etinilestradiol/Drospirenone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

1. What is Drosurelle and what is it used for
2. What you need to know before you start taking Drosurelle
3. How to take Drosurelle
4. Possible side effects
5. Storage of Drosurelle
6. Package contents and further information

1. What is Drosurelle and what is it used for

• Drosurelle is a contraceptive and is used to prevent pregnancy.
• Each film-coated tablet contains a small amount of two different female hormones, called drospirenone and etinilestradiol.
• Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Drosurelle

General considerations

Before starting to use Drosurelle, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take Drosurelle, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your state of health, may perform other tests.

This prospectus describes several situations in which you should interrupt the use of Drosurelle, or in which the effect of Drosurelle may decrease.

In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use the rhythm method or the temperature method. These methods may not be reliable since Drosurelle alters the monthly changes in body temperature and cervical mucus.

Drosurelle, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Drosurelle

You should not use Drosurelle if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected of having breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (see section 6). This may cause itching, rash or inflammation.
• Do not take Drosurelle if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medicines and Drosurelle").

Additional information on special populations

Children and adolescents

Drosurelle is not indicated for use in women who have not yet had their first menstrual period.

Older women

Drosurelle is not indicated for use after menopause.

Women with liver insufficiency

Do not take Drosurelle if you suffer from liver disease. See sections "Do not take Drosurelle" and "Warnings and precautions".

Women with renal insufficiency

Do not take Drosurelle if you are suffering from kidney malfunction or acute renal failure. See sections "Do not take Drosurelle" and "Warnings and precautions".

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section "Blood clot" below).

To obtain a description of the symptoms of these serious side effects, see

"How to recognize a blood clot".

Tell your doctor if you suffer from any of the following conditions

In some situations, you will need to be particularly careful while using Drosurelle or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Drosurelle, you should also inform your doctor.

• If a close relative has or has had breast cancer in the past.
• If you have any liver or gallbladder disease (such as gallstones)
• If you have diabetes
• If you have depression. Some women who use hormonal contraceptives like Drosurelle have reported depression or a depressed mood. Depression can be severe and sometimes can 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 Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Drosurelle after delivery.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Other medicines and Drosurelle").
• If you have any disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face and neck, known as "pregnancy spots"). In this case, you should avoid direct exposure to the sun or ultraviolet rays while taking this medicine.
• Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, difficulty swallowing or urticaria potentially with difficulty breathing. Medicines that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drosurelle increases your risk of having a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Drosurelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drosurelle, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Drosurelle is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Drosurelle, between 9 and 12 women will have a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot in a vein" below).

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Drosurelle is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to interrupt the use of Drosurelle several weeks before the operation or while you have less mobility. If you need to interrupt the use of Drosurelle, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

The risk of a blood clot increases the more conditions you have.

Long-distance flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you need to interrupt the use of Drosurelle.

If any of the above conditions change while you are using Drosurelle, for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase the risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Drosurelle is very small, but it can increase:

• With age (above about 35 years).
• If you smoke. When you use a combined hormonal contraceptive like Drosurelle, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased further.

If any of the above conditions change while you are using Drosurelle, for example, you start smoking, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

Drosurelle and cancer

It has been observed that breast cancer occurs slightly more frequently in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you suffer from unusually severe abdominal pain.

Bleeding between periods

3. How to take Drosurelle

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

Take one Drosurelle tablet every day, with some water if necessary. You can take the tablets with or without food, but always at approximately the same time every day.

The pack (blister) contains 21 tablets. Next to each tablet is printed the day of the week on which it should be taken. If, for example, you start on a Wednesday, take a tablet with "WED" next to it. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

After that, you should not take any tablets for 7 days. During these 7 days when you are not taking tablets (called the rest week), you should have your period. The period, which can also be called "withdrawal bleeding", usually starts on the 2nd or 3rd day of the rest week.

On the 8th day after taking the last Drosurelle tablet (i.e., after the 7-day rest period), you should start the next pack, even if you have not yet had your period. This means that you should start each pack on the same day of the week, and your period should occur during the same days each month.

If you use Drosurelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking tablets.

When can you start with the first pack?

• If you have not used any hormonal contraceptive in the previous month

Start taking Drosurelle on the first day of your usual cycle (i.e., the first day of your period). If you start Drosurelle on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Switching from a combined hormonal contraceptive, vaginal ring, or patch

You can start taking Drosurelle preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

• Switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine device)

You can switch from the progestin-only pill at any time (if it's an implant or intrauterine device, on the same day it is removed; if it's an injection, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

You can start taking Drosurelle between 21 and 28 days after having a child. If you start later, use a barrier method (e.g., a condom) during the first 7 days of Drosurelle use.

If, after having a child, you have already had sexual intercourse before starting to take Drosurelle again, you must be sure you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking Drosurelle again after having a child.

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take more Drosurelle than you should

No cases have been reported in which an overdose of Drosurelle has caused serious harm.

The symptoms that may appear if you take many tablets at once are feeling unwell or having vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first period, if they accidentally take this medication.

If you have taken too many Drosurelle tablets, or discover that a child has taken them, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Drosurelle

• If you are less than 12 hourslate in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget to take a tablet at the beginning or end of the pack. Therefore, you should follow these recommendations (see also the diagram below):

• Forget to take more than one tablet from the pack

Consult your doctor.

• Forget to take a tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In this case, consult your doctor.

• Forget to take a tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Forget to take a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time. Instead of starting the rest week, start the next pack.

You will probably have your period at the end of the second pack, although you may experience light bleeding or spotting during the second pack.

1. You can also stop taking tablets and go directly to the rest week (noting the day you forgot to take the tablet). If you want to start a new pack on the day you always start, your rest week should last less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten to take a tablet and do not have your period during the first rest week, you may be pregnant. Contact your doctor before starting the next pack.

The following diagram shows you what to do if you forget to take a tablet:

What to do in case of vomiting or severe diarrhea?

If you vomit within 3-4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take a tablet from a reserve pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the "If you forget to take Drosurelle" section.

Delaying your period: what you should know

Although it is not recommended, you can delay your period if you start taking a new pack of Drosurelle instead of continuing with the rest week and finish it. You may experience light bleeding or spotting during the second pack. After finishing the second pack, take the usual rest week and startthe next pack.

You should ask your doctor for advice before deciding to delay your period.

Changing the first day of your period: what you should know

If you take the tablets according to the instructions, your period will start during the rest week. If you need to change the day, reduce the number of rest days (but never increase them - 7 days maximum!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest week very short (e.g., 3 days or less), you may not have bleeding during these days. Then you may experience light bleeding or spotting.

If you are unsure how to proceed, consult your doctor.

If you interrupt treatment with Drosurelle

You can stop taking Drosurelle whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods.

If you want to become pregnant, stop taking Drosurelle and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated due date.

If you have any additional questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Drosurelle, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before you start using Drosurelle".

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 urticaria potentially with difficulty breathing (see also the section "Warnings and Precautions").

The following list of adverse effects has been associated with the use of Drosurelle.

Frequent Adverse Effects(may affect up to 1 in 10 people):

• mood changes,
• headache,
• abdominal pain (stomach pain),
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular periods,
• weight gain.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• candidiasis (a fungal infection),
• cold sores (herpes simplex),
• allergic reactions
• increased appetite,
• depression, nervousness, sleep disorders
• tingling and numbness, dizziness,
• vision problems,
• irregular or unusually rapid heart rate,
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, stomach and/or intestinal inflammation, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or urticaria along with difficulty breathing (angioedema),
• hair loss (alopecia), eczema, itching, skin rash, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• bladder infection,
• breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, pain in the lower abdominal region (pelvic), abnormal cervical smears (Pap smear or Papanicolaou staining), decreased libido,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• asthma
• hearing problems
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (skin rash with target-like redness or ulcers)
• harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT)
• In a lung (i.e., PE)
• Heart attack
• Stroke
• Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Drosurelle

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiration date stated on the packaging after "CAD:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Drosurelle

The active ingredients are 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the Product and Package Contents

The tablets are film-coated, round, pink, with a diameter of approximately 5.7 mm.

Drosurelle is available in packs of 1, 2, 3, 6, and 13 units (blisters), each containing 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina, s/n,

Polígono Industrial Navatejera,

Villaquilambre

24193 León, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Jangee 0.02 mg/3 mg ????????? ????????

Greece: Estrofix 0.02 mg/3 mg ?????????? ????????? ??? ?????????

Spain: Drosurelle 0.02 mg/3 mg film-coated tablets EFG

Ireland: Ethinylestradiol/Drospirenone Leon Farma 0.02 mg/3 mg film-coated tablets

Portugal: Drospirenone + Ethinylestradiol Generis 3 mg + 0.02 mg film-coated tablets

Date of the Last Revision of this Prospectus: November 2022

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