Ibuprofen Pensavital 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen pensavital 400 mg film-coated tablets EFG

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

Always follow exactly the instructions for administration of the medicine contained in this leaflet or as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet (see section 4).
• You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain lasts for more than 3 days in adolescents or 5 days in adults.

Contents of the leaflet:

1. What Ibuprofen pensavital is and what it is used for
2. What you need to know before taking Ibuprofen pensavital
3. How to take Ibuprofen pensavital
4. Possible side effects
5. How to store Ibuprofen pensavital
6. Contents of the pack and other information

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

Ibuprofen, the active ingredient in this medicine, works by reducing pain and fever.

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

You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain lasts more than 3 days in adolescents or 5 days in adults.

2. What you need to know before taking Ibuprofeno pensavital

Do not take Ibuprofeno pensavital

• if you are allergic to ibuprofen, to other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.), or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• if you are vomiting blood.
• if you have black stools or bloody diarrhoea.
• if you have severe heart failure.
• if you suffer from severe liver or kidney disease.
• if you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy.
• if you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Warnings and precautions

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

• if you have oedema (fluid retention).
• if you suffer from, or have previously suffered from, heart disorders or have 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 medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring.
• if you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration. In dehydrated adolescents, there is a risk of impaired kidney function.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when using high doses or prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients.
• if you are taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• if you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as ibuprofen-type medicines can worsen these conditions.
• if you are being treated with diuretics (medications to increase urine output), because your doctor must monitor your kidney function.
• if you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.
• if you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• inform your doctor if you are being treated with ibuprofen, as it may mask fever, an important sign of infection, thereby complicating diagnosis.
• if you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• allergic reactions to this medicine may occur.
• your doctor will carry out stricter monitoring if you are receiving ibuprofen after major surgery.
• it is advisable not to take this medicine if you have chickenpox.
• if you have an infection; see the section titled «Infections» below.
• allergic reactions to this medicine, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno pensavital immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
• serious skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno pensavital and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

It is important that you use the lowest effective dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.

Infections

Ibuprofeno pensavital may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno pensavital may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), a previous heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

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

Skin reactions

Serious skin reactions have been reported in association with ibuprofen treatment. Stop taking this medicine and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Taking Ibuprofeno pensavital with other medicines:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Ibuprofen may interact with or be affected by other medicines. For example:

• Other NSAIDs such as aspirin. Antiplatelet agents (which prevent blood clots or thrombi in blood vessels), such as ticlopidine or aspirin (acetylsalicylic acid).
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion-inducing agent).
• Digoxin and other cardiac glycosides (used in heart disorders).
• Hydantoins such as phenytoin (used in epilepsy treatment).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medicines used to increase urine output).
• Corticosteroids such as cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (medicines for depression).
• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (used to treat gout).
• Insulin and oral hypoglycaemics (used to lower blood glucose).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medication).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors such as voriconazole or fluconazole.
• Herbal extracts: Ginkgo biloba.

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

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Ibuprofeno pensavital with food, drink, and alcohol

You may 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 stomach damage.

Taking ibuprofen in patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, spirits—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 medicine.

Because the use of ibuprofen-containing medicines has been associated with an increased risk of congenital malformations or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Do not take ibuprofen during 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 may delay or prolong labour beyond expected duration. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Fertility

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with reduced fertility. Avoid taking this medicine if you are trying to become pregnant.

Breastfeeding

This medicine passes into breast milk, but may be taken during breastfeeding if used at the recommended dose and for the shortest possible duration.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

This is especially important when combined with alcohol.

Ibuprofeno pensavital contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Ibuprofen pensavital

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years of age:

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 disease: consult your doctor, as a dose reduction may be necessary.

Patients over 65 years of age: the dose should be determined by the doctor, as a reduction from the usual dose may be required.

It is important to use the lowest dose that relieves/controls symptoms and not to take this medicine longer than necessary to control your symptoms.

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

Use in children

Children (under 12 years of age) must not take this medicine due to the 400 mg ibuprofen dose. Other formulations more suitable for this population are available.

Method of administration:

This medicine is taken orally.

Swallow the tablet with some water.

Take the medicine with food or milk, especially if you experience gastrointestinal discomfort.

This medicine should only be taken when pain or fever occurs. As symptoms subside, treatment should be discontinued.

In adolescents aged 12 to 18 years, if this medicine is required for more than 3 days or if symptoms worsen, consult a doctor.

In adults, if symptoms worsen, if fever persists for more than 3 days, or if pain lasts longer than 5 days, consult a doctor.

If you take more Ibuprofen pensavital than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or call the Toxicology Information Service at telephone: 91 5620420, indicating the medicine and amount taken, or go to the nearest hospital to assess the risk and receive advice on necessary measures. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained material), headache, rapid involuntary eye movements, tinnitus, and confusion. At high doses, intestinal bleeding, hypotension, low blood potassium levels, metabolic acidosis, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), coma, weakness, dizziness, blood in urine, chills, and breathing difficulties have been reported.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofen pensavital

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

If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time.

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

4. Possible adverse effects

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

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

• signs of gastrointestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee
• signs of a very rare but serious allergic reaction, such as worsening asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or decreased blood pressure leading to shock. These may occur even with the first use of this medicine
• severe skin reactions such as rashes affecting the entire body, skin exfoliation, blisters or peeling skin.
  • Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
  • non-elevated red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
  • Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
  • Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Tell your doctor if you experience 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 minor blood loss in the stomach and/or intestine, which may exceptionally lead to anemia.

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 bowel disease (ulcerative colitis or Crohn's disease), gastritis

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

? visual disturbances

? various skin rashes

? hypersensitivity reactions with urticaria and itching.

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

? tinnitus (ringing in the ears)

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

? decreased hemoglobin levels.

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

? esophagitis, pancreatitis, and development of diaphragm-type intestinal strictures

? 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) which may lead to acute kidney failure. If you experience any of the symptoms listed above, or if you feel sadness, stop taking ibuprofen and consult your doctor immediately, as these may be early signs of kidney damage or failure

? psychotic-type reactions, depression

? high blood pressure, vasculitis

? palpitations

? hepatic dysfunction (early symptoms may include skin discoloration), liver damage especially with prolonged treatment, liver failure, acute inflammation of the liver (acute hepatitis)

• problems in the production of blood cells. Early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Do not self-medicate with analgesic medicines or medicines to reduce fever (antipyretic medicines)

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

? worsening of inflammation associated with infection (e.g., necrotizing fasciitis) has been described in association with the use of some analgesics (NSAIDs). If signs of infection appear or worsen, seek medical attention immediately. Antibiotic therapy should be evaluated as necessary

? symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed during treatment with ibuprofen. This is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately

? severe forms of 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. Symptoms of DRESS syndrome include: skin rash, lymph node swelling, and elevated eosinophils (a type of white blood cell).

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

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

Based on experience with NSAIDs, cases of interstitial nephritis (a kidney disorder), nephrotic syndrome (a disorder characterized by protein in the urine and body swelling), and renal 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen pensavital

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

Store below 30º C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ibuprofeno pensavital:

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components (excipients) are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, colloidal anhydrous 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 pack

White, oval-shaped, biconvex tablets.

Packaged in blisters of PVC/PVdC/Al containing 20 tablets.

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 most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the carton. You may 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