Leaflet: information for the user

Ibufén Infantil 20 mg/ml oral suspension

ibuprofen

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days or 24 hours in children aged 3 to 5 months.

1. What isIbufén Infantiland what it is used for

2. What you need to know before starting to takeIbufén Infantil

3. How to takeIbufén Infantil

4. Possible side effects

5. Storage ofIbufén Infantil

6. Contents of the pack and additional information

Ibufén Infantil contains ibuprofen as the active ingredient and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in infants over 3 months and children up to 12 years for the symptomatic relief of occasional mild or moderate pain, as well as in febrile states.

Do not take Ibufén Infantil

- if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include skin rash with itching, facial, lip, or tongue swelling, nasal discharge, difficulty breathing, or asthma.

- if you have a severe liver or kidney disease.

- if you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive system.

- if you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.

- if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).

- if you have severe heart failure.

- if you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are already receiving treatment with this medication, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood), such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea), or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• Do not take this medication if you have an infection; see the "Infections" section below.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufén Infantil immediately and contact your doctor or emergency medical services if you observe any of these signs.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with treatment with Ibufén Infantil.Stop treatment with Ibufén Infantil and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking Ibufén Infantil and see your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Cardiovascular precautions

Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibufén Infantil if:

- you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

- you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Pregnancy and lactation

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Infections

Ibufén Infantil may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibufén Infantil may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Taking Ibufén Infantil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Ibufén Infantil may affect or be affected by other medications.For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants, e.g., to treat blood clotting problems or prevent clotting (e.g., aspirin, warfarin, ticlopidine).
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used to treat depression).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by treatment with Ibufén Infantil. Therefore, always consult your doctor or pharmacist before using Ibufén Infantil with other medications.

Ibufén Infantil may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase)
• With liver function tests: increased values of transaminases

Inform your doctor if you are to undergo a clinical analysis and are taking or have taken ibuprofen recently.

Taking Ibufén Infantil with food, drinks, and alcohol

It is recommended to take Ibufén Infantil with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, lactation, and fertility

The use of this medication is not recommended for women trying to become pregnant. If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Ibufén Infantil if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take Ibufén Infantil during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Ibufén Infantil may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Pregnancy

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of Ibufén Infantil is contraindicated.

Fertility

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Lactation

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during lactation

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibufén Infantil contains maltitol liquid, sodium, sodium benzoate, benzyl alcohol, and ethanol

This medication contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may have a mild laxative effect. Caloric value: 2.3 kcal/g of maltitol.

This medication contains 3.60 mg of sodium (main component of table salt/for cooking) in each milliliter. This is equivalent to 0.18% of the recommended daily maximum sodium intake for an adult.

This medication contains 1 mg of sodium benzoate (E-211) in each milliliter.

Sodium benzoate (E-211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains 0.00021 mg of benzyl alcohol in each milliliter. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with a risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless recommended by your doctor.

This product should not be used for more than a week in children under 3 years old unless recommended by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medication contains less than 0.00007 mg of ethanol per milliliter. The amount of alcohol in this medication is much less than 1 ml of beer. The small amount of alcohol in this medication has no perceptible effect.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Only for occasional use and for limited periods.

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the age and weight of the child.

Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight depending on the intensity of symptoms and is divided into three doses.

The use of this medication in children under 2 years will always be by medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a 4-dose daily regimen. In this case, the daily maximum doses (see last column of the table above) should not be exceeded. The dose to be administered in each dose, every 6 hours, will be recalculated/reduced proportionally.

This medication is not recommended for children under 3 months or weighing less than 5 kg.

Patients with kidney, liver, or heart diseases

They should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe heart, renal, or hepatic failure.

If this medication needs to be used for more than 3 days or if symptoms worsen in children from 6 months to 12 years, a doctor should be consulted.

In children aged 3 to 5 months, a doctor should be consulted if symptoms worsen or persist after 24 hours.

Administration form

Ibufén Infantil is a suspension for oral administration. It can be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the perforated cap
3. Invert the bottle and remove the required dose
4. Administer the syringe contents directly into the mouth or on a spoon.
5. The syringe should be washed after each dose and can be sterilized by boiling it in water or immersing it in the sterilizing solution used for bottles.

A burning sensation in the mouth or throat may occur when taking the oral suspension of ibuprofen; ensure that you have shaken the bottle well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals. The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

If you take more Ibufén Infantil than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement and muscle coordination problems. It may also cause agitation or disorientation. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing problems may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. In rare cases, cases of metabolic acidosis, hypothermia, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central and respiratory system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forget to take Ibufén Infantil

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medications, Ibufén Infantil may cause side effects, although not everyone will experience them. The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple spots on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or buzzing in the ears), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, tachycardia, hypotension), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decreased red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas.

Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of these symptoms occur during ibuprofen use, it is recommended to consult a doctor as soon as possible.

Unknown frequency(cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

A generalized red, scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibufén Infantil if you experience these symptoms and seek medical attention immediately. See section 2.

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Stop treatment and consult a doctor immediately if any of the following side effects occur:

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blistering or peeling of the skin.
• Severe headache or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the extremities or fluid accumulation in the arms or legs.
• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

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 not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication requires special conditions for conservation.

Once the container is opened, store below 25°C for a maximum of 6 months.

Do not use this medication after the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibufén Infantil

-The active ingredient is ibuprofen. Each ml of suspension contains 20 mg of ibuprofen.

-The other components are: Sodium benzoate (E-211), citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), strawberry flavor (contains benzyl alcohol and ethanol) and purified water.

Appearance of the product and contents of the packaging

Ibufén Infantil is an oral, viscous suspension, white or almost white in color, and strawberry-scented.

It contains a 5 ml graduated syringe with a polipropylene cylinder and a polyethylene piston.

It is presented in 100, 150, and 200 ml packaging. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes

Madrid

Spain

“o”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191 Spain

“o”

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

“o”

FARMALIDER, S.A.

C/ Aragoneses 2

28108- Alcobendas

Madrid

Spain

“o”

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10.

Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: November 2024

Other sources of information

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