Leaflet: information for the user

Ibuprofen pensavital 400 mg film-coated tablets

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

- 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 or pharmacist, even if they are not listed in this leaflet (see section 4).

- You should consult a doctor if you get worse or do not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

1. What is Ibuprofen pensavital and what it is used for

2. What you need to know before starting to take Ibuprofen pensavital

3. How to take Ibuprofen pensavital

4. Possible side effects

5. Storage of Ibuprofen pensavital

6. Contents of the pack and additional information

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents over 12 years old for symptomatic relief of occasional mild or moderate pain, such as headache, toothache, menstrual pain, muscle cramps, or back pain (lumbago), as well as in febrile states.

Consult a doctor if it worsens or does not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.).

Do not take Ibuprofeno pensavital

• If you are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have severe heart failure.
• If you have a severe liver or kidney disease.
• 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 are in the third trimester of pregnancy.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before starting this medication:

• 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 have kidney or liver disease, are over 60 years old, or need to take this medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case may cause kidney failure as a result of dehydration. In dehydrated adolescents, there is a risk of renal function deterioration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients.
• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents (e.g. acetylsalicylic acid), or if you are taking corticosteroids and selective serotonin reuptake inhibitors (SSRIs). You should inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and SSRIs.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications 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 meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), as your doctor should assess the suitability of ibuprofen treatment.
• Inform your doctor if you are receiving ibuprofen treatment, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• 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 closer monitoring if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" heading 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 Ibuprofeno pensavital immediately and contact your doctor or emergency medical services if you observe any of these signs.
• 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 ibuprofen treatment. Discontinue Ibuprofeno pensavital treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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.

Infections

Ibuprofeno pensavital may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing 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.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration. Consult your doctor or pharmacist before taking this medication 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 narrowed or blocked 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.

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

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Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking this medication and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Taking Ibuprofeno pensavital with other medications:

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

• Other NSAIDs like aspirin.Antiplatelet agents (prevent blood clots or platelet aggregation in blood vessels) like ticlopidine or aspirin (acetylsalicylic acid).
• Anticoagulants (e.g. for treating coagulation problems/preventing coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (used to treat depression).
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and others (cardiotonic glucosides) (used in heart disorders).
• Hydantoins like phenytoin (used in epilepsy treatment).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medications used to increase urine production).
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (SSRIs) (used for depression).
• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Ion exchange resins like cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used to treat gout).
• Insulin and oral hypoglycemic agents (used to lower blood glucose levels).
• Tacrine (used in Alzheimer's disease treatment).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve or break down blood clots).
• Aminoglycoside antibiotics like neomycin.
• CYP2C9 inhibitors like voriconazole or fluconazole.
• Herbal extracts: from the Ginkgo biloba tree.

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

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Ibuprofeno pensavital with food, drink, and alcohol

You can take it alone or with food. Generally, it is recommended to take it before meals to reduce the likelihood of stomach discomfort.

Do not take ibuprofen with alcohol to avoid damaging the stomach.

Taking ibuprofen by patients who regularly consume alcohol (3 or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Do not take ibuprofen 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 ibuprofen 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 time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Fertility

For fertile women, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive. Avoid taking this medication if you are trying to become pregnant.

Lactation

This medication passes into breast milk, but it can be taken during breastfeeding if used at the recommended dose for the shortest possible period.

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.

This applies to a greater extent when combined with alcohol.

Ibuprofeno pensavital contains lactose.If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Ibuprofeno pensavital contains sodium.This medication contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".

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

The recommended dose is:

Adults and adolescents over 12 years:

1 tablet of 400 mg every 6-8 hours, if necessary.

Do not take more than 3 tablets (1200 mg of ibuprofen) in 24 hours.

Patients with kidney, liver, or heart diseases:consult your doctor because you may need to reduce the dose..

Patients over 65 years:the amount to be taken must be established by your doctor, as there is a possibility that a dose reduction may be needed.

It is important that you use the lowest effective dose to relieve/control your symptoms and do not take this medication for longer than necessary to control your symptoms.

You should use the lowest effective dose for the shortest duration necessary to relieve your symptoms. If you have an infection, consult your doctor as soon as possible if your symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

Children (under 12 years) cannot take this medication due to the 400 mg ibuprofen dose. There are other presentations more suitable for this population.

Administration form:

This medication is administered orally.

Swallow the medication with a little water.

Take the medication with meals or with milk, especially if digestive discomfort is noted.

The use of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

In adolescents from 12 to 18 years, if the use of this medication is required for more than 3 days or if symptoms worsen, a doctor should be consulted.

In adults, if symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, a doctor should be consulted.

If you take more Ibuprofeno pensavital than you should

If you have taken more medication than you should, or if a child has accidentally ingested the medication, consult your doctor immediately or call theToxicological Information Service, phone: 91 5620420, indicating the medication and the amount used or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, rapid involuntary eye movements, buzzing in the ears, and confusion. At high doses, intestinal hemorrhage, hypotension, low potassium levels in the blood, metabolic acidosis, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), coma, weakness, and dizziness, blood in urine, chills, and breathing problems have been reported.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno pensavital

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 time for the next dose is near, skip the missed dose and take the next dose at your usual time.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of medicines such as ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

STOP taking this medicine and seek medical help immediately if you experience:

• signs of intestinal bleeding,such as: severe abdominal pain, black or tar-like stools, vomiting with blood or dark particles that resemble ground coffee

• signs of a very rare but severe allergic reaction,such as worsening of asthma, wheezing or unknown respiratory distress, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These can occur even with the first use of this medicine

• severe skin reactionssuch as widespread hives, exfoliation, blisters or skin peeling.

• Chest pain,which can be a sign of a potentially severe allergic reaction called Kounis syndrome.
• flat, red, non-elevated patches, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption, with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Inform your doctor if you experience the following side effects:

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

?stomach problems, such as burning, stomach pain, and nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and mild bleeding in the stomach and/or intestine that can cause anemia in exceptional cases.

Rare:(can affect up to 1 in 100 people)

?gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis

?central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, and fatigue

?visual disturbances

?various skin eruptions

?hypersensitivity reactions with urticaria and itching.

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

?tinnitus (ringing in the ears)

?increased urea concentration in the blood, side pain and/or abdomen, blood in the urine, and fever, which can be signs of kidney damage (papillary necrosis)

?decreased hemoglobin levels.

Very rare:(in less than 1 in 10,000 patients)

?esophagitis, pancreatitis, and formation of diaphragmatic intestinal stenosis

?heart failure, heart attack, and swelling of the face and hands (edema)

?decreased urine output, swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that can lead to acute kidney failure. If you experience any of the symptoms mentioned above or feel sad, stop taking ibuprofen and consult your doctor immediately, as it may be the first sign of kidney damage or failure

?psychotic reactions, depression

?high blood pressure, vasculitis

?palpitations

?liver dysfunction (the first symptoms can be skin discoloration), liver damage, especially with prolonged treatment, liver insufficiency, acute hepatitis.

• problems in blood cell production. The first symptoms can be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding, and unknown origin hematomas. In these cases, you should stop treatment immediately and consult your doctor. Do not self-medicate with analgesics or antipyretics.

?severe skin infections and complications of soft tissue during varicella infection

?there has been a description of the worsening of inflammation associated with an infection (e.g. necrotizing fasciitis) associated with the use of some analgesics (NSAIDs). If you experience signs of infection or they worsen, seek medical attention immediately. You should be evaluated to see if antibiotic therapy is necessary.

?asymptomatic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation during treatment with ibuprofen. It is more likely to affect patients with autoimmune disorders (e.g. SLE, mixed connective tissue disease). If this happens, contact your doctor immediately

?severe skin reactions such as skin eruptions with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lell's syndrome) and hair loss (alopecia).

Unknown frequency:(cannot be estimated from available data)

?reactivity of the respiratory tract, including asthma, bronchospasm, or dyspnea.

?a severe skin reaction known as DRESS syndrome. The symptoms of DRESS syndrome include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

?generalized, red, scaly eruption, with subcutaneous nodules and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See section 2. The skin becomes sensitive to light.

The medicines of this type may be associated with a slight increase in the risk of heart attack or stroke (myocardial infarction or cerebral infarction). There has also been an observation of prolonged bleeding time, edema (fluid retention), high blood pressure, and heart failure in association with treatments with medicines like ibuprofen.

Based on the experience with NSAIDs, it cannot be ruled out that there may be cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling) and renal insufficiency (sudden loss of kidney function).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is 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 medicine.

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

Store below 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Ibuprofeno pensavital:

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components (excipients) are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, and purified water. Coating: hypromellose, titanium dioxide (E-171), talc, purified water, and propylene glycol.

Appearance of the product and contents of the packaging

Oval, biconvex tablets, white in color.

Presented in packs of 20 tablets in PVC/PVdC/Al blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Farmalider, S.A,

C/Aragoneses 2, 28108

Alcobendas (Madrid)

Spain

Toll Manufacturing Services, S.L.

C/Argoneses, 2

28108-Alcobendas

Madrid

Spain

Last review date of this leaflet: March 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the carton with your smartphone. You can also access this information at the following URL: https://www.pensapharma.es/info/pensavital-ibuprofeno-400mg-comprimidos and at the following internet address: https://cima.aemps.es/cima/dochtml/p/82815/P_82815.html