Ibuprofen, the medicines active substance, works by reducing pain and fever.

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

You must talk to a doctor if you do not feel better or if you feel worse, if the fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Do not take Ibuprofen pensavital:

• if you are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other ingredients of this medicine (listed in section 6). The reactions that indicate allergy could be: itchy rash, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma.
• if you have had an ulcer or bleeding of the stomach or duodenum or have suffered a perforation of the digestive tract.
• if you vomit blood.
• if you have black stools or bloody diarrhoea.
• if you suffer from severe heart failure.
• if you have severe liver or kidney disease.
• if you have bleeding or blood clotting disorders or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medication must be used at the same time, the doctor will have blood clotting tests performed.
• if you are in the third trimester of pregnancy.
• if you are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen pensavital:

• if you have oedema (fluid retention).
• if you have or have ever had a heart condition or high blood pressure.
• if you suffer from asthma or any other respiratory disorder.
• if you have kidney or liver disease, are over 60 years old or need to take the medicine for a long time (more than 1 to 2 weeks), your doctor may need to check you regularly.
• if you develop symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this particular case could lead to kidney failure as a result of dehydration. Dehydrated adolescents are at risk of impaired kidney function.
• if you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, which may appear as severe 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 and in elderly patients.
• if you are simultaneously taking medicines that alter blood clotting, such as oral anticoagulants, antiplatelet agents such as 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 inhibitor antidepressants.
• if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea) or ulcerative colitis, as ibuprofen-type medicines can make these diseases worse.
• if you are being treated with diuretics (medicines for urination) because your doctor will need to monitor your kidney function.
• if you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur.
• if you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, blood in urine or liver disease), to assess whether or not you should be treated with ibuprofen.
• Tell your doctor if you are being treated with ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have varicella (chickenpox).
• If you have an infection; see the heading "Infections" below.
• Signs of an allergic reaction to ibuprofen have been reported with this medicinal product, such as breathing problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Ibuprofen pensavital immediately and contact your doctor or the emergency medical service right away if you notice any of these signs.
• Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen pensavital and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

Infections

Ibuprofen pensavital may hide signs of infection, such as fever and pain. It is therefore possible that Ibuprofen pensavital may delay appropriate treatment of the infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly 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), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if you are a smoker.

Furthermore, this type of medicine can 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. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Other medicines and Ibuprofen pensavital

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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

• other NSAIDs such as aspirin, Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine or aspirin (acetylsalicylic acid).
• anticoagulant drugs (e.g. to treat clotting problems/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol medicines, and angiotensin II receptor antagonists such as losartan).
• baclofen (used to treat persistent involuntary muscle contractions).
• lithium (used to treat depression).
• methotrexate (used to treat cancer and auto-immune diseases). Your doctor might adjust the dose of this medicine for you.
• mifepristone (abortion inducer).
• digoxin and others (cardiotonic glycosides) (used in heart disorders).
• hydantoins such as phenytoin (in the treatment of epilepsy).
• sulphamides such as sulfamethoxazole and co-trimoxazole (used for bacterial infections).
• diuretics (medicines used to increase the elimination of urine).
• corticosteroids such as cortisone and prednisolone.
• selective serotonin reuptake inhibitors (medicines for depression).
• pentoxifylline (used in circulatory problems).
• probenecid (used in patients with gout or together with penicillin in infections).
• quinolone antibiotics such as norfloxacin.
• ion exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• sulfinpyrazone (for treating gout).
• insulin and oral hypoglycaemic agents (used to lower blood glucose).
• tacrine (used in the treatment of Alzheimer's disease).
• tacrolimus or ciclosporin (used in organ transplants to prevent rejection).
• zidovudine (anti-AIDS medicine).
• thrombolytics (medicines that dissolve or disintegrate clots in the blood).
• aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors such as voriconazole or fluconazole.
• herbal extracts: from the Ginkgo biloba tree.

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

Interferences with analytical tests:

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

Ibuprofen pensavital with food, drink and alcohol

It can be taken on its own or with food. It is generally recommended to be taken before meals to reduce the chance of stomach upset.

Ibuprofen should not be taken with alcohol to avoid damaging the stomach.

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

Pregnancy, breast-feeding and fertility

Pregnancy

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

Because taking ibuprofen medicines has been associated with an increased risk of congenital abnormalities/miscarriage, the administration of ibuprofen is not recommended during the first and second trimester of pregnancy unless it is considered strictly necessary. In these cases the dose and duration should be limited to the minimum possible.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it could harm your unborn child or cause problems during delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for as short a time as possible. If taken for more than a few days after the 20th week of pregnancy, ibuprofen can cause kidney problems in your unborn baby, which can lead to low levels of the amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Fertility

For patients of childbearing age, it should be noted that ibuprofen-type drugs have been associated with a decreased ability to conceive. Avoid taking this medicine if you are trying to become pregnant.

Breast-feeding

 This medicine passes into breast milk but can be taken during breast-feeding if used at the recommended dose for the shortest possible period of time.

Driving and using machines

If you experience dizziness, light-headedness, impaired vision or other symptoms while taking this medicine, you should not drive or use dangerous machinery.

This is particularly true when combined with alcohol.

Ibuprofen pensavital contains lactose. If you have been told by your doctor that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 ibuprofen) in 24 hours.

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

Patients over 65 years of age: the amount to be taken should be established by the doctor, as a reduction of the usual dose may be necessary.

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

The lowest effective dose should be used for the shortest time necessary 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) cannot take this medicine because of the 400 mg dose of ibuprofen. There are other presentations more suitable for this population.

Method of administration:

This medicine is taken orally.

Swallow the medicine with a little water.

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

The use of this medicine is subject to the onset of pain or fever. As soon as the pain or fever disappears, the medicine should be discontinued.

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

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

If you take more Ibuprofen pensavital than you should

If you have taken more medicine than you should, or if a child has accidentally swallowed the medicine, seek medical advice immediately or call the Toxicological Information Service, telephone: 91 5620420, stating the medicine and the quantity used or go to the nearest hospital for information about the risk and advice on what action to take. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, rapid involuntary eye movements, ringing in the ears and confusion. At high doses, intestinal bleeding, hypotension, 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 problems have been reported.

If large amounts are ingested, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and during the first 60 minutes following ingestion.

If you forget to take Ibuprofen pensavital

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

If you miss a dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the missed dose and take the next dose at your usual time.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The incidence of side effects is lower in short courses of treatment and if the daily dose is below the maximum recommended dose.

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

• signs of intestinal bleeding, such as: severe pain in the abdomen, black or tarry stools, vomit with blood or dark particles that look like coffee grounds.
• very rare but serious signs of allergic reaction, such as worsening asthma, wheezing or altered breathing of unknown origin, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These may occur even on the first use of this medicine.
• severe skin reactions, such as full-body rashes, peeling, blistering or flaking of the skin.
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• non raised reddish, bull's-eye or circular spots on the trunk, often with blisters in the centre, peeling of the skin, ulcers of the mouth, throat, nose, genitalia and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Extensive skin rash, elevated body temperature and enlarged lymph nodes (DRESS syndrome).
• Extensive, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalised exanthematous pustulosis).

Tell your doctor if you experience any of the following side effects:

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

• Stomach problems, such as heartburn, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence (gas), constipation and slight blood loss in the stomach and/or intestine which may cause anaemia in rare 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 tiredness.
• Visual disturbances.
• various rashes on the skin.
• 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 side and/or abdomen, blood in the
• urine and fever may be signs of kidney damage (papillary necrosis), decreased haemoglobin levels.

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

• oesophagitis, pancreatitis and the formation of diaphragm-type small bowel strictures
• heart failure, heart attack, and swelling of the face and hands (oedema)
• decreased urine output, swelling (oedema) 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 if you have a feeling of sadness, stop taking ibuprofen and consult your doctor immediately as these may be early signs of kidney damage or failure.
• psychotic-like reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction (first symptoms may be discolouration of the skin), liver damage especially with prolonged treatment, liver failure, acute inflammation of the liver (acute hepatitis).
• problems with blood cell production. Early symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, skin and nosebleeds, and bruising of unknown origin. In these cases you should stop treatment immediately and consult your doctor. Do not self-medicate with painkillers or fever-reducing medicines (antipyretic medicines)
• severe skin infections and soft tissue complications during varicella infection
• the worsening of inflammation associated with infection (e.g. necrotising fasciitis) has been reported in association with the use of some analgesics (NSAIDs). If signs of infection appear or worsen, a doctor should be consulted immediately. An assessment should be made as to whether antibiotic therapy is necessary.
• symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or disorientation have been observed 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 forms of skin reactions such as skin rashes with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell's syndrome) and hair loss (alopecia).

Not known: (frequency cannot be estimated from the available data)

• reactivity of the airways including asthma, bronchospasm or dyspnoea.
• a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).
• Generalised red scaly rash with bumps under the skin and blisters located mainly in skin folds, trunk and upper extremities, accompanied by fever at the start of treatment (acute generalised exanthematous pustulosis). If you experience these symptoms, stop taking this medicine and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

These medicines may be associated with a slightly increased risk of heart attack or stroke (myocardial infarction or stroke). Prolonged bleeding time, oedema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment with medicines such as ibuprofen.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

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

Store below 30 °C

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Dispose of containers and medicines that you do not need at the SIGRE Point in the pharmacy. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ibuprofen pensavital contains:

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other ingredients (excipients) are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, silica; colloidal anhydrous, magnesium stearate and purified water. Film coating: hypromellose, titanium dioxide (E-171), talc, purified water and propylene glycol.

What Ibuprofen pensavital look like and contents of the pack

White, oval, biconvex tablets.

They are available in PVC/PVdC/Al blister packs containing 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

This leaflet was last revised in: November 2023

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

Detailed and updated information on this product is available by scanning the QR code included in the outer carton with a smartphone. The same information is also available on the following URL: https://www.pensapharma.es/info/pensavital-ibuprofeno-400mg-comprimidos and the AEMPS website: https://cima.aemps.es/cima/dochtml/p/82815/P_82815.html