ELTROMBOPAG STADA 75 mg FILM-COATED TABLETS

2. What you need to know before you take Eltrombopag Stada

Do not takeEltrombopag Stada

• to eltrombopag or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take Eltrombopag Stada:

• . People who have a low platelet count and advanced chronic liver disease are at a higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of eltrombopag outweighs the risks, they will closely monitor you during treatment.
• in your veins or arteries, or if you know that blood clots are common in your family.

The risk of having a blood clot may be higherin the following circumstances:

If you are in any of these situations, tell your doctorbefore starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of having blood clots.

• (the lens of the eye becomes cloudy).
• , such as myelodysplastic syndrome (MDS). Before starting to take eltrombopag, your doctor will perform tests to check that you do not have this disease. If you have MDS and take eltrombopag, MDS may worsen.

Tell your doctorif you are in any of these situations.

Eye exams

Your doctor will recommend that you have an eye exam to check for cataracts. If you do not have regular eye exams, your doctor will ask you to have them. They will also examine your retina (the light-sensitive layer at the back of the eye) to see if there is any bleeding in the retina or around it.

You will need to have regular blood tests

Before you start taking eltrombopag, your doctor will perform a blood test to check your blood cells, including platelets. These tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, the basic treatment along with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting to take eltrombopag and frequently while taking it to check your liver function. You may need to stop taking eltrombopag if the levels of these markers increase too much or if you have any other sign of liver damage.

Read the information on “Liver problems” in section 4 of this leaflet.

Blood tests for platelet count

If you stop taking eltrombopag, it is likely that within a few days, you will have low platelet counts again (thrombocytopenia). Your platelet counts will be monitored, and your doctor will advise you on the precautions to take.

Very high platelet counts may increase the risk of blood clots. However, blood clots can also form with normal or even low platelet counts. Your doctor will adjust the dose of eltrombopag to ensure that your platelet count does not become too high.

Seek medical help immediatelyif you have any of these signs of a blood clot:

• swelling, painor tenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by sharp chest pain or rapid breathing
• abdominal pain(stomach), enlarged abdomen, blood in the stool

Tests to examine your bone marrow

In people with bone marrow disorders, medicines like eltrombopag may worsen the disorders. Signs of changes in the bone marrow may appear as abnormal results in your blood tests. Your doctor may also perform tests to directly check your bone marrow during treatment with eltrombopag.

Review of gastrointestinal bleeding

If you are taking interferon, the basic treatment along with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestine after you stop taking eltrombopag.

Heart monitoring

Your doctor may consider monitoring your heart while you are taking eltrombopag with an electrocardiogram, if necessary.

Elderly patients (65 years and over)

There is limited data on the use of eltrombopag in patients aged 65 years or over. If you are 65 or over, you should be cautious when using eltrombopag.

Children and adolescents

Eltrombopag is not recommended for use in children under 1 year of age with ITP. It is also not recommended for use in children under 18 years of age with low platelet counts due to hepatitis C.

Other medicines and Eltrombopag Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and vitamins.

Some common medicines may interact with eltrombopag(including prescription medicines, over-the-counter medicines, and minerals). These include:

• antacids for indigestion, heartburn, or stomach ulcers(see also section 3 “When to take it”).
• statins, to lower cholesterol
• certain medicines to treat HIV infection, such as lopinavir and/or ritonavir
• ciclosporin, used in transplantsor immune system diseases
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be present in vitamin and mineral supplements(see also section 3 “When to take it”).
• medicines such as methotrexate and topotecan, used to treat cancer

Consult your doctorif you are taking any of these medicines. Some should not be taken with eltrombopag; it may be necessary to adjust the dose or change the times when you take them. Your doctor will review the medicines you are taking and recommend alternatives if necessary.

If you are also taking medicines to prevent blood clots, there is a higher risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol,and/or azathioprinewith eltrombopag, it may be necessary to reduce the dose or stop treatment with these medicines.

Taking Eltrombopag Stada with food and drinks

Do not take eltrombopag with food or dairy products, as the calcium in dairy products affects the absorption of the medicine. For more information, see section 3, “When to take it”.

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnantunless your doctor specifically recommends it. The effect of eltrombopag during pregnancy is not known.

• Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Use a reliable contraceptive methodto prevent pregnancy while taking eltrombopag.
• If you become pregnant during treatmentwith eltrombopag, tell your doctor.

Do not breastfeed while taking eltrombopag. It is not known if eltrombopag passes into breast milk.

If you are breastfeedingor plan to breastfeed, tell your doctor.

Driving and using machines

Eltrombopag may cause dizzinessand have other side effects that may make you less alert.

Do not drive or use machinesunless you are sure that eltrombopag does not affect you.

Eltrombopag Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Eltrombopag Stada

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again. Do not change the dose or treatment schedule with eltrombopag unless your doctor or pharmacist advises you to do so. While you are taking eltrombopag, you will be under the supervision of a specialist doctor with experience in treating your disease.

How much to take

For ITP

Adults and children(6 to 17 years) - the usual starting dose for ITP is one 50mgeltrombopag tablet per day. If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25mg.

Children(1 to 5 years) - the usual starting dose for ITP is one 25mgeltrombopag tablet per day.

For Hepatitis C

Adults- the usual starting dose for hepatitis C is one 25mgeltrombopag tablet per day. If you are of East or Southeast Asian descent, start treatment with the same dose of 25mg.

Eltrombopag may take 1 to 2 weeks to work. Depending on your response to eltrombopag, your doctor may recommend changing your daily dose.

How to take the tablets

Swallow the tablet whole, with water.

Eltrombopag Stada 25 mg and Eltrombopag Stada 50 mg:

The tablet can be broken into equal doses.

When to take it

Make sure that -

• in the 4hours beforetaking eltrombopag
• and in the 2hours aftertaking eltrombopag

do notconsume any of the following:

• dairy productssuch as cheese, butter, yogurt, or ice cream
• milk or milkshakes, drinks made with milk, yogurt, or cream
• antacids, a type of medicine for indigestion and heartburn
• certain vitamin and mineral supplements, including iron, calcium, magnesium, aluminum, selenium, and zinc

If you do, your body may not absorb the medicine properly.

For more information on what foods and drinks are suitable, consult your doctor.

If you take more Eltrombopag Stada than you should

Consult your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for signs or symptoms of side effects and will receive immediate treatment if necessary.

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

If you forget to take Eltrombopag Stada

Take the next dose at the usual time. Do not take more than one dose of eltrombopag per day.

If you stop taking Eltrombopag Stada

Do not stop taking eltrombopag without first consulting your doctor. If your doctor advises you to stop treatment, your platelet counts will be monitored every week for four weeks. See also “Bleeding or bruising after stopping treatment” in section 4.

If you have any other questions about the use of this medicine, 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.

Symptoms to which you need to pay attention: consult your doctor

People taking eltrombopag for both ITP and low platelet counts associated with hepatitis C may exhibit signs related to potential serious adverse effects. It is essential that you inform your doctor if you develop symptoms.

Increased Risk of Thrombosis

Some people may have a higher risk of having a thrombus, and medications like eltrombopag can worsen this problem. The sudden blockage of a blood vessel by a thrombus is a rare adverse effect that can affect up to 1 in 100 people.

Seek immediate medical attention if you experience signs or symptoms of thrombosis, such as:

• swelling, pain, heat, redness, orsensitivity in one leg
• sudden difficulty breathing, exceptionally accompanied by acute chest pain or agitated breathing
• abdominal pain (stomach), enlarged abdomen, blood in your stool.

Liver Problems

Eltrombopag may cause changes that appear in blood tests, which can be signs of liver damage. Liver problems (elevated liver enzymes in blood tests) are common and can affect up to 1 in 10 people. Other liver problems are rare and can affect up to 1 in 100 people.

If you have any signs of liver problems:

• yellowish coloron the skin or in the white area of the eyes (jaundice)
• dark-colored urinethat is unusual

contact your doctor immediately.

Bleeding or Hematoma after Treatment Interruption

Two weeks after interrupting treatment with eltrombopag, your platelet levels will normally drop to levels similar to those before starting eltrombopag. A decrease in platelet levels can increase the risk of bleeding or hematoma. Your doctor will check your platelet levels for at least 4 weeks after interrupting treatment with eltrombopag.

Contact your doctorif you experience bleeding or hematoma when stopping eltrombopag.

Some people have bleeding in thedigestive systemafter stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tar-like stools (stool discoloration is a rare adverse effect that can affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or something that looks like coffee grounds

Contact your doctor immediatelyif you experience any of these symptoms.

The following adverse effects have been reported in relation to treatment with eltrombopag in adult patients with ITP:

Very Common Adverse Effects

May affect more than 1 in 10people:

• cold
• feeling of nausea
• diarrhea
• cough
• infection of the nose, nasal sinuses, throat, and respiratory tract (upper respiratory tract infection)
• back pain

Very Common Adverse Effects that may appear in Blood Tests:

• increase in liver enzymes (alanine aminotransferase (ALT))

Common Adverse Effects

May affect up to 1 in 10people:

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstruation
• irritation of the throat and difficulty swallowing
• eye problems including anomaly in eye tests, dry eye, eye pain, and blurred vision
• vomiting
• flu
• cold sore
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection in the tonsils
• infection of the lungs, sinuses, nose, and throat
• inflammation of the gums
• loss of appetite
• feeling of tingling, itching, or numbness
• decreased sensitivity in the skin
• drowsiness
• ear pain
• pain, swelling, and sensitivity in one leg (generally the calf) with hot skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood due to a rupture of a blood vessel (hematoma)
• hot flashes
• alterations in the mouth including dryness or irritation in the mouth, sensitivity in the tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, rash with itching, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in the urine)
• high temperature, feeling of heat
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• feeling that everything is spinning (vertigo)
• gas

Common Adverse Effects that may appear in Blood Tests:

• decrease in the number of red blood cells (anemia)
• decrease in the number of platelets (thrombocytopenia)
• decrease in the number of white blood cells
• decrease in hemoglobin levels
• increase in the number of eosinophils
• increase in the number of white blood cells (leukocytosis)
• increase in the level of uric acid
• decrease in potassium levels
• increase in creatinine levels
• increase in alkaline phosphatase levels
• increase in liver enzymes (aspartate aminotransferase (AST))
• increase in blood bilirubin (a substance produced by the liver)
• increase in some protein levels

Rare Adverse Effects

May affect up to 1 in 100people:

• allergic reaction
• interruption of blood supply to parts of the heart

• sudden difficulty breathing, especially when accompanied by acute chest pain and/or agitated breathing, which could be signs of a pulmonary thrombus (see “Increased Risk of Thrombosis” above in section 4)

• partial loss of lung function caused by a blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein that could be signs of thrombosis in a vein
• yellowish skin and/or abdominal pain that could be signs of a bile duct obstruction, liver injury, liver damage due to inflammation (see “Liver Problems” above in section 4)
• liver damage due to medication
• rapid or irregular heartbeat, discoloration of the skin, alterations in heart rhythm (prolonged QT interval) that could be a sign of a heart and blood vessel disorder.
• blood clots
• hot flashes
• joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrolled crying or crying unexpectedly
• balance problems, speech and nervous system alterations, tremors
• pain or abnormal sensations in the skin
• paralysis of one side of the body
• migraine with aura
• nerve pain
• expansion or swelling of blood vessels that cause headaches
• eye problems, including increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eye
• nose, throat, and sinus problems, breathing problems while sleeping
• blisters/pain in the mouth and throat
• loss of appetite
• digestive system problems, including frequent bowel movements, food poisoning, blood in stool, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• alterations in the mouth, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth ulcers
• sunburn
• feeling hot, feeling anxious
• redness or inflammation around wounds
• bleeding around a catheter (if you have one) in the skin
• feeling of a foreign body
• kidney problems, including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine
• cold sweat
• feeling of general discomfort

• skin infection
• skin changes, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Rare Adverse Effects that may appear in Blood Tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that may be indicative of certain diseases
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in the number of myelocytes
• increase in neutrophils
• increase in blood urea
• increase in protein in urine
• increase in albumin levels in blood
• increase in total protein levels
• decrease in albumin levels in blood
• increase in urine pH
• increase in hemoglobin levels

The following adverse effects have been reported in relation to treatment with eltrombopag in children (1 to 17 years) with ITP:

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10children:

• infection of the nose, nasal sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• high temperature
• feeling of nausea

Common Adverse Effects

May affect up to 1 in 10children:

• difficulty sleeping (insomnia)
• toothache
• sore throat and nose
• itching, runny nose, or stuffiness
• irritation of the throat, runny nose, nasal congestion, and sneezing
• alterations in the mouth, including dryness, irritation in the mouth, sensitivity in the tongue, gum bleeding, mouth ulcers

The following adverse effects have been reported in relation to treatment with eltrombopag in combination with peginterferon and ribavirin in patients with HCV:

Very Common Adverse Effects

May affect more than 1 in 10people:

• headache
• loss of appetite
• cough
• feeling of nausea, diarrhea
• muscle pain, muscle weakness
• itching
• feeling of fatigue
• fever
• hair loss
• feeling of weakness
• flu-like discomfort
• swelling of hands or feet
• chills

Very Common Adverse Effects that may appear in Blood Tests:

• decrease in the number of red blood cells (anemia)

Common Adverse Effects

May affect up to 1 in 10people:

• urinary tract infection
• inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation, or inflammation of the mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes
• decrease in brain function due to liver damage
• tingling or numbness in hands and feet
• fever, headache
• eye problems, including clouding of the eye lens (cataracts), dry eye, small yellow deposits in the retina, yellowish color in the white area of the eyes
• retinal bleeding
• feeling that everything is spinning
• rapid or irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sore, throat irritation, and difficulty swallowing
• digestive system alterations, including vomiting, stomach pain, indigestion, constipation, bloating, changes in taste, hemorrhoids (piles), abdominal pain/discomfort, stomach swelling, gas/bloating, changes in stool color
• toothache
• liver problems, including liver tumor, yellowish color in the white area of the eyes or skin (jaundice), liver damage due to medication (see “Liver Problems” above in section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, pain in the limbs (arms, legs, hands, and feet), muscle spasms
• irritability, feeling of general discomfort, skin reactions such as redness or swelling and pain at the injection site, chest pain, and discomfort, fluid retention in the body or limbs that causes swelling

• infection of the nose, nasal sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi

• depression, anxiety, sleep problems, nervousness

Common Adverse Effects that may appear in Blood Tests:

• increase in blood sugar (glucose)
• decrease in the number of white blood cells
• decrease in the number of neutrophils
• decrease in blood albumin
• decrease in hemoglobin levels
• increase in blood bilirubin (a substance produced by the liver)
• changes in the enzymes that control blood coagulation

Rare Adverse Effects

May affect up to 1 in 100people:

• pain when urinating
• alterations in heart rhythm (prolonged QT interval)

• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes, including changes in color, peeling, redness, itching, and sweating at night

• blood clots in the liver veins (possible liver damage and/or digestive system damage)
• poor blood clotting in small blood vessels with kidney failure
• itching and bruising at the injection site, chest discomfort
• decrease in the number of red blood cells (anemia) caused by massive destruction of red blood cells (hemolytic anemia)

• confusion, agitation
• liver failure

The following adverse effects have been observed in relation to treatment with eltrombopag in patients with severe aplastic anemia (SAA):

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very Common Adverse Effects

May affect more than 1 in 10people:

• cough
• headache
• pain in the mouth and throat
• diarrhea
• nausea, dizziness
• joint pain (arthralgia)
• pain in the limbs (arms, legs, hands, and feet)
• dizziness
• feeling very tired
• fever
• chills
• eye itching
• blisters in the mouth
• gum bleeding
• abdominal pain
• muscle spasms

Very Common Adverse Effects that may appear in a Blood Test

• abnormal changes in bone marrow cells
• increase in liver enzymes (aspartate aminotransferase (AST))

Common Adverse Effects

May affect up to 1 in 10people:

• anxiety
• depression
• feeling cold
• feeling of general discomfort
• eye problems, including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eye, eye itching, yellowish color in the white area of the eyes or skin
• nosebleeds
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, stomach swelling, gas/bloating, changes in intestinal motility that can cause constipation, bloating, diarrhea, and/or the aforementioned symptoms, changes in stool color
• passing out
• skin problems, including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood circulation to the spleen (splenic infarction)
• runny nose

Common Adverse Effects that may appear in a Blood Test

• increase in some enzymes due to muscle breakdown (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decrease in blood sugar levels (hypoglycemia)
• increase in blood bilirubin (a substance produced by the liver)
• decrease in the number of white blood cells

Adverse Effects of Unknown Frequency

Cannot be estimated from the available data

• skin discoloration

• skin darkening

• liver damage

5. Storage of Eltrombopag Stada

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

Do not use this medicine after the expiration date that appears on the box and on the blister after "CAD".

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Eltrombopag Stada

The active ingredient is eltrombopag (in the form of eltrombopag olamine)

25 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

50 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

Eltrombopag Stada 25 mg film-coated tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (potato), magnesium stearate

Tablet coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc

Eltrombopag Stada 50 mg film-coated tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (potato), magnesium stearate

Tablet coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172)

Eltrombopag Stada 75 mg film-coated tablets EFG

Tablet core

Microcrystalline cellulose, mannitol, povidone K90, sodium carboxymethyl starch type A (potato), magnesium stearate

Tablet coating

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172)

Appearance of the product and package contents

Eltrombopag Stada 25 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, white to pale yellow in color, with a dark red to brown score line on one side.

Eltrombopag Stada 50 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, brown in color, with a dark red to brown score line on one side.

Eltrombopag Stada 75 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, pink in color.

Eltrombopag Stada is available in blisters containing 14, 28, or 84 film-coated tablets or unit-dose blisters containing 14x1, 28x1, or 84x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrase 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Limited

Waterford Road,

Clonmel, Co. Tipperary, E91 D768,

Ireland

or

Centrafarm Services B.V.

Van De Reijtstraat 31 E,

Breda, 4814 NE,

Netherlands

Date of the last revision of this prospectus:December 2024

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