IBUPROFEN PENSAVITAL 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Pensavital 400 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet (see section 4).
• You should consult a doctor if your symptoms worsen 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.

Package Leaflet Contents:

1. What is Ibuprofen Pensavital and what is it used for
2. What you need to know before taking Ibuprofen Pensavital
3. How to take Ibuprofen Pensavital
4. Possible side effects
5. Storage of Ibuprofen Pensavital
6. Package Contents and Additional Information

1. What is Ibuprofeno Pensavital and what is it used for

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

This medication is used in adults and adolescents over 12 years of age for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, menstrual, muscular (cramps) or back (lumbago) pain, as well as in febrile conditions.

You should consult a doctor if your symptoms worsen 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.

2. What you need to know before taking Ibuprofen Pensavital

Do not take Ibuprofen 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, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have had a stomach or duodenal ulcer 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 severe liver or kidney disease.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have edema (fluid retention)
• if you have or have had heart problems or high blood pressure.
• if you have asthma or any other respiratory disorder.
• 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.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure due to dehydration in this specific case. In dehydrated adolescents, there is a risk of renal function deterioration.
• if you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients.
• if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these diseases.
• If you are being treated with diuretics (medications to increase urine production) because your doctor should monitor your kidney function.
• if you have systemic lupus erythematosus (a chronic disease 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.
• if you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• inform your doctor if you are receiving treatment with ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• if you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofen Pensavital immediately and contact your doctor or medical emergency service immediately if you observe any of these signs.
• Severe skin reactions have been reported, associated with ibuprofen treatment, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with Ibuprofen Pensavital and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

Infections

Ibuprofen Pensavital may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Pensavital may delay the 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 infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

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 this medication 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.

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

.

Skin Reactions

Severe skin reactions have been reported, associated with ibuprofen treatment. Stop taking this medication and consult 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.

Taking Ibuprofen Pensavital withother medications:

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

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

• Other NSAIDs like aspirin. Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine or aspirin (acetylsalicylic acid).
• Anticoagulant medications (e.g., to treat coagulation problems/prevent 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).
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and others (cardiac glycosides) (used in heart disorders).
• Hydantoins like phenytoin (in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medications used to increase urine production).
• Corticosteroids like cortisol and prednisolone.
• Selective serotonin reuptake inhibitors (medications for depression).
• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Ion exchange resins like cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout treatment).
• Insulin and oral hypoglycemics (used to decrease blood glucose levels).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Thrombolytics (medications that dissolve or break down blood clots).
• Aminoglycoside antibiotics like neomycin.
• CYP2C9 inhibitors like voriconazole or fluconazole.
• Herbal extracts: Ginkgo biloba tree.

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

Interference with Laboratory Tests:

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

Taking Ibuprofen Pensavital with Food, Drink, and Alcohol

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

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

Taking ibuprofen by patients who habitually 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.

Because taking medications with ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should 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 possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Fertility

For female patients of childbearing age, it should be noted that medications of the ibuprofen type have been associated with a decrease in fertility. Avoid taking this medication if you are trying to become pregnant.

Breastfeeding

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

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

This applies to a greater extent to the combination with alcohol.

Ibuprofen Pensavital contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Ibuprofeno pensavital

Follow the administration instructions of the medication contained in this prospectus or as 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.

No more than 3 tablets (1200 mg of ibuprofen) should be taken in 24 hours

Patients with kidney, liver, or heart disease: consult your doctor because it may be necessary to reduce the dose.

Patients over 65 years: the amount to be taken must be established by the doctor, as it may be necessary to reduce the usual dose

It is essential to use the lowest dose that relieves/controls the symptoms and should not take this medication for longer than necessary to control symptoms.

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if 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 dose of ibuprofen. There are other presentations more suitable for this population.

Method of administration:

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 noticed.

Taking this medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

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 a doctor or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount used, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and prospectus of the medication to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody stools), headache, rapid involuntary eye movements, ringing in the ears, and confusion. At high doses, intestinal bleeding, hypotension, low potassium levels in the blood, metabolic acidosis, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), coma, weakness, and dizziness, blood in urine, chills, and breathing difficulties have been reported.

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

If you forget to take Ibuprofeno pensavital

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is near, skip the forgotten dose and take the next dose at the usual time

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.

Adverse effects of medications like ibuprofen are more common in people over 65 years.

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

STOP taking this medication and seek medical help immediately if you present:

• signs of intestinal bleeding, such as: intense abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble ground coffee
• signs of a very rare but severe allergic reaction, such as worsening of asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure that causes shock. These can occur even with the first use of this medication
• severe skin reactions such as rashes that cover the entire body, exfoliation, blisters, or peeling of the skin.
  • Chest painthat can be a sign of a potentially severe allergic reaction called Kounis syndrome.
  • red patches, target-like or circular on the trunk, 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 rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
  • Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you present these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Tell your doctor if you present the following adverse effects:

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

stomach problems, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and slight blood loss in the stomach and/or intestine that can cause anemia in exceptional cases.

Uncommon:(may 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 rashes

hypersensitivity reactions with hives and itching.

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

tinnitus (ringing in the ears)

increased urea concentration in the blood, pain in the sides and/or abdomen, blood in the urine, and fever, may be signs of kidney damage (papillary necrosis)

decrease in hemoglobin levels.

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

esophagitis, pancreatitis, and formation of intestinal stenosis of the diaphragm type

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 above symptoms or have a feeling of sadness, stop taking ibuprofen and consult your doctor immediately, as it may be the first signs of kidney damage or failure

psychotic reactions, depression

high blood pressure, vasculitis

palpitations

liver dysfunction (the first symptoms may be skin discoloration), liver damage, especially with prolonged treatment, liver failure, acute liver inflammation (acute hepatitis)

• blood cell production problems. The first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding and bruising of unknown origin. In these cases, treatment should be stopped immediately and a doctor consulted. Do not self-medicate with pain relievers or antipyretic medications

severe skin infections and soft tissue complications during chickenpox infection

it has been described that the worsening of inflammation associated with an infection (e.g., necrotizing fasciitis) is associated with the use of some pain relievers (NSAIDs). If signs of infection or worsening appear, a doctor should be consulted immediately. It should be evaluated if antibiotic therapy is necessary

symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation during ibuprofen treatment have been observed. 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 rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lell's syndrome) and hair loss (alopecia).

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

respiratory tract reactivity including asthma, bronchospasm, or dyspnea.

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

Widespread, red, scaly rash, with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you present these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Medications of this type may be associated with a slight increase in the risk of heart attack or stroke (myocardial infarction or stroke). Prolongation of bleeding time, edema (fluid retention), high blood pressure, and heart failure have also been observed with treatments with medications like ibuprofen.

Based on experience with NSAIDs, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and kidney failure (sudden loss of kidney function) cannot be excluded.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno pensavital

Keep this medication out of sight and reach of children.

Store below 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno pensavital:

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components (excipients) are: sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, 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 package contents

Oval, biconvex, white tablets.

They are presented in packages of 20 tablets in PVC/PVdC/Al blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Farmalider, S.A.

C/Aragoneses 2, 28108

Alcobendas (Madrid)

Spain

Toll Manufacturing Services, S.L.

C/Argoneses, 2

28108-Alcobendas

Madrid

Spain

Date of the last revision of this prospectus:March 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (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