HARMONET 0.075 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Harmonet 0.075 mg/0.02 mg coated tablets

gestodene and ethinylestradiol

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

• Keep this package 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. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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 see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

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

1. What is Harmonet and what it is used for

Harmonet is a combined oral contraceptive.

Harmonet is prescribed for the following indications: hormonal oral contraception, menstrual cycle disorders, and ovarian rest.

In addition, the use of hormonal contraceptives may have beneficial effects on conditions such as dysmenorrhea (menstrual pain) and to reduce the incidence of some breast and reproductive organ disorders.

2. What you need to know before you start taking Harmonet

General considerations

Before you start using Harmonet, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

When you should not use Harmonet

You should not use Harmonet 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 for you.

Do not take Harmonet

• If you are allergic to gestodene, ethinylestradiol, or any of the other components of this medication (listed in section 6).
• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or 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 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 symptoms of stroke).
• If you have coronary artery disease or heart valve disease (valvulopathy with the possibility of clot formation).
• If you have heart rhythm disorders (arrhythmias) with the possibility of clot formation.
• 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 and/or uncontrolled 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 are pregnant or think you may be pregnant.
• If you have severe liver disease. If you have or are suspected of having liver tumors.
• If you have (or have ever had) or are suspected of having malignant diseases of the genital organs or breasts.
• If you have vaginal bleeding of unknown cause.
• If you have pancreatitis (inflammation of the pancreas) due to a severe increase in triglycerides.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medications and Harmonet").

Warnings and precautions

When you should be extra careful with Harmonet

Before taking Harmonet, you will need to see your doctor for a physical examination. It is essential that you inform your doctor if you have or have had any of the risk situations listed below. If so, your doctor must weigh the benefits of using Harmonet against the possible risks and discuss them with you before you decide to start using it.

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

If the condition develops or worsens while you are using Harmonet, you should also inform your doctor.

• 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 recently given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Harmonet after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have any heart disease (chest pain, certain types of heart rhythm disorders, heart disease).
• If you have high blood pressure, particularly if it worsens or does not improve with anti-hypertensive medications.
• If you have severe and recurrent headaches (migraines).
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or recur when using hormonal contraceptives.
• If you have certain types of jaundice (yellowing of the eyes and/or skin) or liver function disorders.
• If you have itching, especially if it occurred during a previous pregnancy.
• If you have brown patches on the skin of your face, especially if you had them during a previous pregnancy. If so, avoid sun exposure and ultraviolet radiation (e.g., sunlamp).
• 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.
• If you have angioedema (inflammation similar to hives, but which occurs under the skin instead of on the surface), particularly in women with hereditary angioedema (an immune system problem that is passed from parents to children).

Psychiatric disorders:

Some women who use hormonal contraceptives like Harmonet 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Harmonet increases your risk of blood clots 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 (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (which 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 Harmonet 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 breaks loose 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 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 medication 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 Harmonet, 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 Harmonet is small.

• Out of 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.
• Out of 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.
• Out of 10,000 women who use a combined hormonal contraceptive that contains gestodene, like Harmonet, about 9-12 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" below).

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

The risk of a blood clot with Harmonet 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 50).
• 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 stop using Harmonet several weeks before surgery or while you have reduced mobility. If you need to stop using Harmonet, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of 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 unsure. Your doctor may decide that you should stop using Harmonet.

If any of the above conditions change while you are using Harmonet, 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 clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

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

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

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like Harmonet, you are advised to stop smoking. If you are unable to stop 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 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 disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more 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 Harmonet, 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.

Tumors

There have been reports of breast cancer cases with a slightly higher frequency in women who use oral contraceptives, but it is not known if this is due to the treatment. For example, it could be that more tumors are detected in women who use oral contraceptives because they visit their doctor more frequently. This increased frequency decreases gradually after stopping treatment. After ten years, the chances of having breast cancer will be the same as for women who have never used oral contraceptives.

Similarly, cervical cancer (cervix) occurs more frequently in women who use oral contraceptives. However, the occurrence of this tumor is associated with increased sexual activity and sexually transmitted diseases, so it is not clear if oral contraceptives play a direct role in this risk.

Rarely, cases of liver tumors have been reported in women who use oral contraceptives. In these cases, internal bleeding can occur, leading to severe abdominal pain. If this happens, you should contact your doctor immediately. Some studies suggest that the use of hormonal contraceptives may be associated with an increased risk of cervical intraepithelial neoplasia or invasive cervical cancer in some groups of women.

Other conditions

Blood pressure:

If you have hypertension (high blood pressure) or suffer from

3. How to take Harmonet

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

This medication is for oral administration.

Remember to take your medication, as forgetting Harmonet can decrease the effectiveness of the preparation.

Before starting treatment with Harmonet, your doctor should perform a detailed medical history and a thorough medical examination, including blood pressure, and rule out the existence of pregnancy. They should also perform a breast examination, liver, limbs, and pelvic organs (urinary bladder, vagina, uterus, and rectum). Your doctor may also need to perform a cervical cytology (a gentle, painless scraping of the cervix to take cells from the area for analysis). Your doctor will repeat this review 3 months after starting treatment and then annually.

See section 2 "What you need to know before starting to take Harmonet".

Instructions for the correct administration of the medication

You should take the tablets orally, in the order indicated on the blister pack, approximately at the same time, every day, with some liquid if necessary. You should take one tablet daily for 21 consecutive days and then be without tablets for 7 days. Each subsequent pack will start after the 7-day interval without tablets, during which a bleeding usually occurs. This bleeding, similar to menstruation, usually starts between days 2 and 3 after taking the last tablet, and may not have finished before starting the next pack.

Your doctor will indicate the duration of your treatment with this medication.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Start of the first pack of Harmonet

• When no hormonal contraceptive has been used the previous month

Treatment starts on the first day of the menstrual cycle (i.e., the first day of bleeding).

For example, if bleeding appears on a Monday, you should start taking the first tablet of this medication on the same day, with the coated tablet marked "Monday", and follow the arrow indicator for the next tablets.

It is also allowed to start on days 2-7 of the menstrual cycle, in this case, a non-hormonal contraceptive method (e.g. condoms or spermicide) is recommended for birth control during the first 7 days of tablet taking.

• When you are taking another contraceptive and switch to Harmonet

You can start taking Harmonet the day after taking the last active tablet of your current pack of pills (this means there is no break in tablets). If your current pack of pills also contains inactive tablets, you can start taking Harmonet the day after taking the last activetablet. You should never delay more than the day after finishing the usual interval without tablets or the interval of inactive tablets of your previous contraceptive.

• When you switch from a progestin-only method (minipill, implant, intrauterine device (IUD), or injection)

You can stop taking the progestin pill (minipill) any day and start taking Harmonet the next day, at the same time.

Start using this medication when your next injection is due or the day your implant or intrauterine device (IUD) is removed.

In all these situations, make sure to also use a barrier method (e.g. condoms, spermicides) when having sex during the first 7 days of tablet taking.

• After an abortion in the first trimester

You can start taking the tablets immediately. If you do so, you do not need to take other contraceptive measures.

• Postpartum

If you are breastfeeding, you should not take this medication (see "Pregnancy, breastfeeding, and fertility").

Use of the tablets starts 28 days after delivery in women who are not breastfeeding or after an abortion in the second trimester. If you start later, you should use a barrier method during the first 7 days of tablet taking. However, if you have already had sex, you should rule out pregnancy before taking the contraceptive or wait for your next menstrual period.

Subsequent cycles

After the 7-day break, a new pack of Harmonet is continued, starting on the same day of the week as the first pack.

What to do if bleeding occurs during the 21 days of taking the coated tablets

The appearance of bleeding during the 3 weeks of taking the coated tablets is not a reason to discontinue treatment. A light bleeding usually disappears on its own. If the bleeding reaches an intensity similar to that of normal menstruation and lasts more than 3 cycles, you should consult your doctor.

Absence of bleeding

If vaginal bleeding does not appear during the break, it is advisable to consult your doctor immediately to rule out the possibility of pregnancy if the coated tablets have not been taken regularly or if there have been vomiting or diarrhea during the cycle.

If you forgot to take Harmonet

The protection of the contraceptive may be reduced if you forget to take tablets. In particular, if the forgetfulness is in the first week of treatment and you had sex in the previous week, there may be a possibility of becoming pregnant.

• If you have delayed less than 12 hoursin taking a tablet, the efficacy of the pill is maintained. Take it as soon as you remember and take the next tablets at the usual time.
• If you have delayed more than 12 hoursin taking a tablet, the efficacy of the contraceptive may be reduced.
• • Always take the last forgotten tablet as soon as you remember, even if it means taking two tablets in one day. Continue taking the next tablets at the usual time, but use a barrier method (such as condoms or spermicides) during the next 7 days.
  • If you take the last tablet before the 7 days that require the use of an additional contraceptive method, start another pack immediately without leaving an interval between them. You will not have menstruation until the end of the new pack, although you may experience spotting or bleeding on the days you take the tablets.
  • If you do not have menstruation at the end of the new pack, contact your doctor, who should check that you are not pregnant before starting the next pack.

Advice in case of vomiting and/or diarrhea

If vomiting or diarrhea occur within 4 hours after taking a tablet, you should follow the advice regarding forgetting to take a tablet. If you do not want to change your usual tablet-taking schedule, you should take the additional tablets needed from another pack.

How to delay a period

To delay a period, you should start a new pack immediately after finishing the current pack, without any break. Periods can be delayed as long as you want, but not beyond the end of the second pack. During this time, you may experience bleeding or spotting. Afterward, the regular taking of this medication is resumed after the usual 7-day interval without taking tablets.

If you take more Harmonet than you should

You may experience nausea, vomiting, drowsiness, breast pain, dizziness, and vaginal bleeding; treatment will consist of discontinuing the administration of this medication. Contact your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you have any other 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 Harmonet, 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 taking Harmonet".

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

The use of hormonal contraceptives has also been associated with an increased risk of:

• Cervical intraepithelial neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (cancer of the cervix).
• Diagnosis of breast cancer (see "Be especially careful with Harmonet").
• Benign hepatic tumors (e.g., focal nodular hyperplasia, hepatic adenomas).

Adverse effects are listed below, classified according to their frequency, based on the following criteria:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Frequency not known: cannot be estimated from the available data.

Infections and Infestations

Common: Vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Benign or Malignant Neoplasms or Unspecified

Very rare: Hepatic carcinomas (malignant liver tumors).

Immune System Disorders

Rare: Allergic reactions such as urticaria (itching), angioedema (swelling of the face, lips, mouth, and in very rare cases, accompanied by difficulty breathing, dizziness, and even loss of consciousness).

Very rare: Worsening of systemic lupus erythematosus (autoimmune disease).

Metabolic and Nutritional Disorders

Uncommon: Changes in appetite (increased or decreased).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (familial metabolic disorder).

Psychiatric Disorders

Common: Mood changes, including depression; changes in libido (sexual desire).

Nervous System Disorders

Very common: Headache, including migraines (severe headaches).

Common: Nervousness, vertigo.

Very rare: Worsening of chorea (involuntary movements).

Eye Disorders

Rare: Intolerance to contact lenses.

Very rare: Eye anomalies and visual disturbances.

Vascular Disorders

Uncommon: Increased blood pressure.

Rare: Formation of harmful blood clots in a vein or artery, such as:

• 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).

Very rare: Worsening of varices.

Gastrointestinal Disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Colic, feeling of bloating.

Very rare: Pancreatitis (inflammation of the pancreas); ischemic colitis (certain types of colon inflammation).

Frequency not known: Inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Hepatobiliary Disorders (Liver and Gallbladder)

Rare: Cholestatic jaundice (yellowing of the whites of the eyes and skin due to bile stasis).

Very rare: Cholecystopathy (gallbladder disorders) including gallstones.

Frequency not known: Liver damage (e.g., hepatitis, abnormal liver function).

Skin and Subcutaneous Tissue Disorders

Common: Acne.

Uncommon: Rash (eruption), chloasma (skin patches) that may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: Erythema nodosum (a type of skin inflammation with nodules on the legs).

Very rare: Erythema multiforme (a type of skin inflammation).

Renal and Urinary Disorders

Very rare: Hemolytic uremic syndrome (kidney disease with blood abnormalities).

Reproductive System and Breast Disorders

Very common: Unexpected vaginal bleeding or spotting.

Common: Breast pain or tenderness, breast swelling, nipple discharge, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal discharge, and cervical ectopia (alteration of the cervical mucosa), amenorrhea (absence of menstruation).

General Disorders

Common: Fluid retention, edema (swelling).

Others

Common: Changes in weight (increase or decrease).

Uncommon: Increased blood pressure, changes in blood lipid levels, including hypertriglyceridemia (high levels of fatty acids in the blood).

Rare: Decreased folate levels in the blood.

Do not be alarmed by these adverse effects, as it is very likely that none of them will appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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 Harmonet

Keep the blister pack in the outer packaging to protect it from light.

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

Do not use this medicine after the expiration date stated on the packaging. 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 medicines that are no longer needed at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Harmonet

The active ingredients of Harmonet are: 0.075 mg of gestodene and 0.02 mg of ethinylestradiol.

The other components (excipients) are: sucrose, lactose, cornstarch, povidone K-25, magnesium stearate, povidone K-90, macrogol 6,000, calcium carbonate, talc, and montan wax glycolate.

Appearance of the Product and Package Contents

It is presented in calendar packs containing 1 or 3 blisters with 21 film-coated tablets per blister.

The blisters are packaged in an aluminum bag containing a sachet with desiccant (silica gel).

After opening the aluminum bag, the desiccant can be removed.

Marketing Authorization Holder

Wyeth Farma, S.A.

Ctra. Burgos, Km 23. Desvío Algete, Km 1.

San Sebastián de los Reyes – Madrid

Spain

Manufacturer

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge

Co. Kildare

W12 HX57

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Spain

Date of the Last Revision of this Leaflet: November 2022

Detailed and 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/