IBUPROFEN PENSA PHARMA 400 mg FILM-COATED TABLETS

1. What is Ibuprofen Pensa Pharma and what is it used for

Ibuprofen Pensa Pharma contains the active ingredient ibuprofen. Ibuprofen belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen Pensa Pharma relieves pain and has an anti-inflammatory effect.

It is used in adults and adolescents over 12 years old (≥40 kg body weight). Ibuprofen Pensa Pharma is used for:

• Symptomatic treatment of mild to moderate pain.
• Symptomatic treatment of primary dysmenorrhea.

2. What you need to know before taking Ibuprofeno pensa pharma

Do not take Ibuprofeno pensa pharma

• If you are allergic to the active substance or to any of the other components of this medicine (included in section 6). The symptoms that indicate allergy could be: swelling of the eyelids, lips, tongue, or throat.
• If you have ever had an allergic reaction (such as bronchospasm [contraction of the muscles of the lungs that can cause asthma and difficulty breathing], asthma, nasal discharge, swelling of the nasal passages, skin reactions, or sudden swelling) after taking acetylsalicylic acid and other similar analgesics (NSAIDs).
• If you have nonspecific disorders in blood formation.
• If you have or have had ulcerative colitis, Crohn's disease, recurrent stomach or duodenal bleeding (peptic ulcers), or bleeding (at least 2 different episodes of ulcers or bleeding diagnosed).
• If you have had gastrointestinal bleeding or perforation of the digestive tract with previous treatments with NSAIDs.
• If you have any active bleeding (even in the brain).
• If you have severe liver or kidney disease or heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you have congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria).
• If you have chronic alcoholism (14 to 20 drinks/week or more).
• If you are a child or adolescent with a body weight below 40 kg and a child under 12 years of age.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

Adverse effects can be reduced by using the lowest effective dose necessary to control symptoms for the shortest possible time.

Consult your doctor or pharmacist before starting to take ibuprofen if:

• you have high blood pressure.
• you have congestive heart failure.
• you have established ischemic heart disease.
• you have peripheral arterial disease and/or cerebrovascular disease.
• you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases that affect connective tissue).
• your kidney or liver function is reduced.
• you have recently undergone major surgery.
• you are sensitive (allergic) to other substances.
• you suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of suffering an allergic reaction. Allergic reactions can present as asthma attacks (anaphylactic asthma), rapid swelling (Quincke's edema), or hives.
• you are a child.
• you have an infection: see the "Infections" section later.

Effects on the gastrointestinal tract

The combined use of ibuprofen with other non-steroidal anti-inflammatory medicines (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Gastrointestinal bleeding, ulcers, and perforation:

Gastrointestinal bleeding, ulcers, and perforations have been reported with all NSAIDs. They have occurred at any time during treatment, with or without previous warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Ibuprofeno pensa pharma") and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require additional treatment with low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal disorders, combination treatment with protective medications (e.g., misoprostol or proton pump inhibitors) should be considered.

If you have a history of adverse effects that affect the gastrointestinal tract, especially if you are an elderly person, you should contact a doctor in case of unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of treatment.

Cautiousness is recommended if you are also taking other medications that may increase the risk of ulcers or bleeding, e.g., oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 "Other medicines and Ibuprofeno pensa pharma").

Treatment should be discontinued and a doctor consulted if you experience gastrointestinal bleeding or ulcers during treatment with ibuprofen.

Cardiovascular effects

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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 if you are a smoker.

Renal effects

Ibuprofen should be used with caution when administered to patients with a considerable level of dehydration. There is a risk of renal failure, especially in children, adolescents, and elderly patients who are dehydrated.

As with other NSAIDs, prolonged administration of ibuprofen has caused renal papillary necrosis and other renal pathological changes. Renal toxicity has also been observed in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. In these patients, the administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which can cause renal failure.

Patients at higher risk of this reaction are those with renal failure, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment is usually followed by recovery to the pre-treatment state.

Cutaneous reactions

Severe cutaneous reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno pensa pharma treatment and seek immediate medical attention if you notice any of the symptoms related to these severe cutaneous reactions described in section 4.

During chickenpox infection, the use of ibuprofen is not recommended.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor as soon as possible.

Respiratory disorders and hypersensitivity reactions

Acute severe hypersensitivity reactions (e.g., anaphylactic shock) have been rarely observed. At the first signs of a hypersensitivity reaction after taking/administering ibuprofen, treatment should be discontinued and a doctor consulted. The healthcare professional should initiate the necessary medical measures, depending on the symptoms.

Hematological effects

Ibuprofen may temporarily inhibit the function of blood platelets (platelet aggregation). Therefore, patients with blood coagulation disorders should be carefully monitored.

During prolonged use of ibuprofen, regular monitoring of liver function tests, renal function, and blood counts is required.

If you take ibuprofen before surgical procedures, you should consult/inform your doctor or dentist.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be a higher risk of aseptic meningitis (see below and section 4.8).

Aseptic meningitis

Aseptic meningitis has been rarely observed in patients treated with ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in patients without underlying chronic disease.

When using NSAIDs, adverse reactions, particularly those affecting the gastrointestinal tract or central nervous system, may be potentiated by concomitant alcohol consumption.

Patients who report eye disorders during treatment with ibuprofeno should discontinue therapy and undergo eye examinations.

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno pensa pharma immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal. For this reason, close medical monitoring is required in elderly patients.

Children and adolescents

There is a risk of renal failure in dehydrated adolescents.

Other medicines and Ibuprofeno pensa pharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

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

• Digoxin, phenytoin, and lithium. The combined use of Ibuprofeno pensa pharma with digoxin (used to treat heart disorders), phenytoin (used to treat epilepsy), or lithium (a medication used to treat depression) may increase the concentration of these medications in the blood. It is necessary to monitor lithium serum levels. Monitoring of digoxin and phenytoin serum levels is recommended.
• Anticoagulant medications (e.g., to treat coagulation problems/avoid coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and medications for treating high blood pressure:
• • e.g., ACE inhibitors, beta-blockers, and angiotensin-II receptor antagonists. The combined use of Ibuprofeno pensa pharma with potassium-sparing diuretics may increase the potassium level in the blood. Therefore, monitoring of serum potassium levels is recommended.
  • Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan). Ibuprofen may reduce the effects of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, during combined use, there is a risk of renal failure.

• Cholestyramine (a medication used to treat high cholesterol) in combination with Ibuprofeno pensa pharma may reduce the absorption of Ibuprofeno pensa pharma in the gastrointestinal tract. However, the clinical significance is unknown.
• Other analgesics: the combined use of Ibuprofeno pensa pharma with other anti-inflammatory and analgesic medications of the NSAID group, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Methotrexate: the administration of Ibuprofeno pensa pharma in the 24 hours before or after the administration of methotrexate (used to treat certain types of cancer or rheumatism) may cause an increase in methotrexate concentrations and an increase in its adverse effects.
• Cyclosporine and tacrolimus may cause kidney damage.
• Probenecid or sulfinpyrazone: medications containing probenecid or sulfinpyrazone (used to treat gout) may delay the excretion of ibuprofen. This may cause Ibuprofeno pensa pharma to accumulate in the body, with an increase in its adverse effects.
• Sulfonylureas: during the combined use of Ibuprofeno pensa pharma and sulfonylureas (medications used to treat diabetes), monitoring of blood sugar levels is recommended as a precautionary measure.
• Zidovudine: there is evidence suggesting a higher risk of hemarthrosis (blood accumulation in the joints) and hematomas (hematoma) in patients with hemophilia and HIV who use zidovudine (an antiviral medication used to treat HIV infections) along with ibuprofen.
• Quinolone antibiotics: the risk of convulsions (seizures) may increase when taking quinolone antibiotics, such as ciprofloxacin, and ibuprofen at the same time.
• Aminoglycosides: the combined use of Ibuprofeno pensa pharma with aminoglycosides (a type of antibiotic) and NSAIDs may decrease the excretion of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medication) may increase the risk of bleeding with NSAIDs.
• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic medications of the NSAID group (i.e., ibuprofen) may decrease the effect of mifepristone.
• Medications for treating inflammation (corticosteroids) due to the increased risk of gastrointestinal ulcers or bleeding.

Some other medications may also affect or be affected by Ibuprofeno pensa pharma treatment. Therefore, you should always seek the advice of your doctor or pharmacist before using Ibuprofeno pensa pharma with other medications.

Taking Ibuprofeno pensa pharma with food and alcohol

Alcohol may potentiate the adverse effects of Ibuprofeno pensa pharma, especially those affecting the central nervous system and gastrointestinal tract. It is preferable not to drink alcohol while using ibuprofen.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

Pregnancy

Do not take Ibuprofeno pensa pharma 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 baby. It may increase the risk of bleeding for you and your baby during delivery, delay delivery, or prolong it more than expected. You should not take Ibuprofeno pensa pharma during the first 6 months of pregnancy unless it is absolutely necessary and prescribed by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Ibuprofeno pensa pharma may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Epidemiological study data suggest a higher risk of spontaneous abortion and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy.

Breastfeeding

The use of ibuprofen is not recommended in women during breastfeeding.

Fertility

There is evidence that substances that inhibit prostaglandin synthesis/cyclooxygenase may cause a decrease in female fertility due to an effect on ovulation. This effect is reversible with the discontinuation of treatment.

Driving and using machines

Generally, ibuprofen does not influence or slightly influences the ability to drive and use machines. However, as higher doses may cause central nervous system side effects such as fatigue and dizziness, the ability to react and the ability to drive and operate machinery may be affected in individual cases. This is especially important when combined with alcohol.

Ibuprofeno pensa pharma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Ibuprofeno pensa pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

3. How to take Ibuprofeno pensa pharma

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

The effective lowest dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult your doctor without delay if symptoms persist or worsen (see section 2).

The recommended dose is:

Pain

Adults and adolescents with a body weight over 40 kg (over 12 years old)

One whole 400 mg tablet as a single dose. If necessary, additional doses of 400 mg of ibuprofen may be taken. The respective dosing interval should be chosen based on observed symptoms and the maximum recommended daily dose. It should not be less than 6 hours. Do not take more than 1200 mg of ibuprofeno in 24 hours.

Special populations

If you have severe liver and kidney disease or are an elderly person, your doctor will indicate the correct dose to take, which will be the lowest possible dose.

Use in children and adolescents

Ibuprofeno pensa pharma is not indicated in children or adolescents with a body weight under 40 kg or under 12 years of age.

Method of administration

Ibuprofeno pensa pharma is for oral use.

Take the tablets with a glass of water.

The tablets should not be crushed, chewed, or sucked to avoid stomach or throat irritation. The score line should not be used to divide the tablet.

It is recommended that patients with sensitive stomachs take ibuprofeno with food.

Duration of treatment

The doctor will decide the duration of treatment.

If you take more Ibuprofeno pensa pharma than you should

If you take more ibuprofeno than you should, or if children have taken this medication by accident, always contact a doctor or the nearest hospital to obtain an opinion on the risk and advice on the measures to take.

Symptoms may include nausea, stomach pain, and vomiting (which may contain blood), or less frequently, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, and eye tremor, and exacerbation of asthma in asthmatics. At high doses, somnolence, excitement, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), dizziness, weakness, and fainting, blood in the urine, low blood pressure, increased potassium levels in the blood, increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling of cold body, and respiratory problems have been reported.

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 medication and the amount ingested.

If you forget to take Ibuprofeno pensa pharma

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The pattern of adverse effects reported for ibuprofeno is similar to that of other NSAIDs.

Gastrointestinal disorders: The most commonly observed side effects affect the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforation, or bleeding may occur, sometimes fatal, especially in elderly patients (see section 2: "Warnings and precautions"). After its use, nausea, vomiting, diarrhea, flatulence, constipation, digestive discomfort, abdominal pain, black stools, vomiting blood, and mouth and throat ulcers (stomatitis) have been reported. Less frequently, stomach mucosa inflammation (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose and duration of treatment.

Immune system disorders: Hypersensitivity reactions have been reported after treatment with NSAIDs. These can consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity including asthma, worsened asthma, bronchospasm, or dyspnea, or (c) various skin disorders, including rashes of various types, itching, urticaria, purpura, angioedema, and very rarely, erythema multiforme, bullous dermatosis (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever, or disorientation (see section 4.4).

Worsening of inflammation-related infections has been described coinciding with the use of NSAIDs. Therefore, if signs of infection or worsening appear during the use of ibuprofeno, it is recommended that the patient consult a doctor without delay.

Skin and subcutaneous tissue disorders: In exceptional cases, severe skin infections and soft tissue complications may occur during a chickenpox infection (see also "Infections and infestations").

Cardiac and vascular disorders: Edema, hypertension, and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofeno, particularly at high doses (2400 mg/day), may be associated with a small increase in the risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4).

Stop treatment with ibuprofeno and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated, target-like or circular patches on the torso, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Other side effects that may occur:

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

• Headache, dizziness
• Gastrointestinal side effects (indigestion, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, gastrointestinal bleeding, vomiting blood)
• Rash
• Fatigue

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

• Rhinitis
• Hypersensitivity
• Insomnia, anxiety
• Paresthesia
• Somnolence
• Visual disturbances, hearing impairment
• Dizziness
• Tinnitus
• Bronchospasm, asthma
• Dyspnea
• Mouth ulcers
• Stomach ulcers, intestinal ulcers, perforation, stomach inflammation
• Hepatitis, jaundice, abnormal liver function
• Itching, small bruises on skin and mucous membranes
• Photosensitivity
• Nephrotoxicity in various forms, such as tubulointerstitial nephritis, nephrotic syndrome, and kidney failure

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

• Non-bacterial meningitis
• Leukopenia
• Thrombocytopenia
• Aplastic anemia
• Neutropenia
• Agranulocytosis
• Hemolytic anemia
• Anaphylactic reaction
• Depression, confusion
• Optic neuritis
• Toxic optic neuropathy
• Edema

Very rare (may affect up to 1 in 10,000 people):

• Heart failure, myocardial infarction
• Hypertension
• Pancreatitis, liver failure
• Severe forms of skin reactions (e.g., erythema multiforme, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis)

Frequency not known (frequency cannot be estimated from available data):

• Worsening of ulcers in the large intestine (colitis) and Crohn's disease (intestinal disease)
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
• Acute generalized exanthematous pustulosis (AGEP)
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any 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 Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno pensa pharma

Keep this medication out of sight and reach of children.

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

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno pensa pharma

The active ingredient is ibuprofeno. Each tablet contains 400 mg of ibuprofeno.

The other ingredients (excipients) are:

Core of the tablet:hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Coating material:hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and package contents

White, oblong, biconvex, film-coated tablets with a score line on both sides.

Ibuprofeno pensa pharma 400 mg film-coated tablets are available in aluminum-PVC/PVDC blisters in packs of 20, 30, or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense 140,

E-28805 Alcalá de Henares (Madrid) Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses, 2

28108 (Alcobendas-Madrid) Spain

or

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid) Spain

This medication is authorized in EEA member states under the following names:

Spain: Ibuprofeno pensa pharma 400 mg film-coated tablets EFG

Italy: TowaDol

Portugal: Ibuprofeno Pensa

Date of last revision of this leaflet:January 2024

Other sources of information

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