Ibuprofen Pensa 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen pensa 600 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Ibuprofeno pensa contains the active substance ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen relieves pain and has an anti-inflammatory effect.

It is used in adults and adolescents over 14 years of age for:

• Symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and painful swelling and inflammation following soft tissue injuries.
• Symptomatic treatment of moderate pain.
• Symptomatic treatment of primary dysmenorrhea.

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

Do not take Ibuprofen pensa

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6). Symptoms of an allergic reaction may include swelling of the eyelids, lips, tongue, or throat.
• If you have ever had an allergic reaction (such as bronchospasm (contraction of the muscles in the lungs that may cause asthma and difficulty breathing), asthma attacks, runny nose, swelling of the nasal passages, skin reactions, or sudden swelling) after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• If you have or have had ulcerative colitis, Crohn's disease, recurrent stomach or duodenal bleeding (peptic ulcers), or bleeding (at least two separate episodes of ulcers or bleeding diagnosed by a doctor).
• If you have previously experienced gastrointestinal bleeding or perforation of the digestive tract while being treated with NSAIDs.
• If you currently have any active bleeding.
• If you suffer from severe liver or kidney disease or heart failure.
• If you are severely dehydrated (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you are in the third trimester of pregnancy.
• If you are a child or adolescent under 14 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

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

With prolonged use of any analgesic, headache may occur that should not be treated by increasing the drug dose.

When NSAIDs are used, adverse reactions, especially those affecting the gastrointestinal tract or central nervous system, may be enhanced by concomitant alcohol consumption.

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

• You have or have had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as these conditions may worsen.
• You have a hereditary blood disorder (e.g., acute intermittent porphyria).
• Your kidney or liver function is reduced.
• You have recently undergone major surgery.
• You are sensitive (allergic) to other substances.
• You suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of developing an allergic reaction. Allergic reactions may present as asthma attacks (analgesic-induced asthma), rapid swelling (Quincke's edema), or urticaria.
• You are dehydrated.
• You have an infection: see the section “Infections” below.

Effects on the gastrointestinal tract

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

Gastrointestinal bleeding, ulcers, and perforation:

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

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

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

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

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

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

Cardiovascular effects

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 ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of 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.

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Cardiac, renal, and hepatic impairment

NSAIDs should be used with caution in patients with cardiac, renal, or hepatic impairment because they may worsen renal function. The concomitant regular intake of several similar analgesics further increases this risk. For these patients, use the lowest effective dose for the shortest possible time and monitor renal function, especially in patients receiving long-term treatment (see also section 4.3).

Renal effects

Ibuprofen should be used with caution in patients with significant dehydration. There is a risk of renal failure, particularly in dehydrated children, adolescents, and elderly individuals.

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

Skin reactions

Serious skin reactions 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), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno pensa and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, potentially 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 your doctor as soon as possible.

Hematological effects

Ibuprofen, like other NSAIDs, may interfere with platelet aggregation and prolong bleeding time.

Aseptic meningitis

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

Signs of allergic reaction 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 pensa immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Elderly patients

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

Other medicines and Ibuprofeno pensa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Digoxin, phenytoin, and lithium. The combined use of ibuprofen with digoxin (used to strengthen the heart), phenytoin (used in the treatment of epilepsy), or lithium (a medicine used to treat depression) may increase blood levels of these medicines. Monitoring of serum lithium levels is necessary. Monitoring of serum digoxin and phenytoin levels is recommended.

• Anticoagulant medicines (e.g., to treat coagulation problems/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may enhance the effects of anticoagulants such as warfarin.

• Diuretics and medicines for treating high blood pressure:

  • E.g., ACE inhibitors, beta-blockers, and angiotensin-II receptor antagonists. The combined use of ibuprofen with potassium-sparing diuretics may increase blood potassium levels. Therefore, monitoring of serum potassium levels is recommended.
  • 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). Ibuprofen may reduce the effects of ACE inhibitors (used to treat heart failure and high blood pressure). In addition, there is a risk of renal impairment during concomitant use.

• Colestiramine (a medicine used to treat high cholesterol) in combination with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.

• Other analgesics: the combined use of ibuprofen with other anti-inflammatory and analgesic medicines of the NSAID group, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.

• Antiplatelet agents and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.

• Methotrexate: administration of ibuprofen within 24 hours before or after methotrexate (used to treat certain types of cancer or rheumatism) may lead to increased methotrexate concentrations and increased side effects.

• Cyclosporine and tacrolimus may damage the kidneys.

• Sulfonylureas: during concomitant use of ibuprofen and sulfonylureas (medicines used to treat diabetes), monitoring of blood sugar levels is recommended as a precaution.

• Zidovudine: evidence suggests an increased risk of hemarthrosis (blood accumulation in joints) and bruising (hematoma) in HIV-positive hemophiliacs taking zidovudine (an antiviral medicine used to treat HIV infections) together with ibuprofen.

• Quinolone antibiotics: the risk of seizures (fits) may increase when quinolone antibiotics such as ciprofloxacin are taken at the same time as ibuprofen.

• Aminoglycosides: the combined use of ibuprofen with aminoglycosides (a type of antibiotic) and NSAIDs may reduce the excretion of aminoglycosides.

• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may be increased. A reduction in the dose of ibuprofen should be considered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

• Ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs.

• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic medicines of the NSAID group (i.e., ibuprofen) may reduce the effect of mifepristone.

• Medicines for treating inflammation (corticosteroids) due to increased risk of gastrointestinal ulcers or bleeding.

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

Taking Ibuprofen Pensa with food and alcohol

Patients with a sensitive stomach are advised to take ibuprofen with food. Alcohol may enhance the adverse effects of ibuprofen, particularly those affecting the central nervous system and the gastrointestinal tract. It is preferable not to drink alcohol while taking ibuprofen.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your baby. It may also increase the risk of bleeding for you and your baby during childbirth, delay labor, or prolong it beyond the expected duration. You should not take ibuprofen during the first six months of pregnancy unless absolutely necessary and specifically advised by your doctor. If treatment is required during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If ibuprofen is taken for more than a few days starting from week 20 of pregnancy, it may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasting longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

The use of ibuprofen is not recommended for women who are breastfeeding.

Fertility

Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you are experiencing difficulties in conceiving.

Driving and operating machinery

During treatment with ibuprofen, reaction ability, as well as the ability to drive and operate machinery, may be impaired in individual cases. This is especially important when combined with alcohol.

Ibuprofen Pensa contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

Ibuprofen Pensa contains sodium

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

3. How to take Ibuprofen pensa

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The lowest effective dose should be used for the shortest duration 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).

The recommended dose is:

Adults and adolescents over 14 years of age

The single dose is 300–600 mg of ibuprofen. The recommended daily dose is 1,200–1,800 mg in divided doses. There should be an interval of at least 6 hours between doses. Some patients may be maintained on 600–1,200 mg daily. In severe or acute conditions, it may be beneficial to increase the dose to control the acute phase, provided that the daily dose does not exceed 2,400 mg in divided doses.

Special populations

If you have severe liver or kidney disease, or if you are elderly, your doctor will advise you on the correct dose to take, which will be the lowest possible dose.

Use in children and adolescents

Ibuprofen 600 mg film-coated tablets are not indicated for use in children or adolescents under 14 years of age.

Method of administration

Ibuprofen is for oral use.

Take the tablets with a glass of water.

The tablets must not be crushed, chewed, or sucked, to avoid irritation of the stomach or throat.

Patients with a sensitive stomach are advised to take ibuprofen with food.

Duration of treatment

Your doctor will decide the duration of treatment.

In rheumatic diseases, the use of ibuprofen may be required for a longer period.

If you take more Ibuprofen pensa than you should

If you take more ibuprofen than you should, or if children have accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and measures to take.

Symptoms of overdose may include nausea, stomach pain, and vomiting (which may contain blood-stained sputum). In addition, headache, gastrointestinal bleeding, tinnitus, confusion, and involuntary eye movements may occur. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, acute kidney failure, liver damage, chills, and respiratory problems have been reported.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ibuprofen pensa

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

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.

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

Stop taking ibuprofen and contact a doctor immediately if you experience any of the following adverse effects:

• Angioedema (an uncommon adverse effect) with symptoms such as:

  • swelling of the face, tongue, or throat,
  • difficulty swallowing,
  • hives, and difficulty breathing.

• An infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems.

Ibuprofen may cause a reduction in the number of white blood cells (agranulocytosis), leading to decreased resistance to infections (a rare adverse effect). It is important that you inform your doctor about your medication.

• Red, flat, target-like or circular skin rashes on the trunk, often with blisters in the center, skin peeling, and mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, high 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)².

Other side effects that may occur:

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

• Headache, dizziness
• Gastrointestinal side effects (dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, bleeding in the stomach and intestines, vomiting blood)
• Rash
• Fatigue

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

• Rhinitis
• Hypersensitivity
• Insomnia, anxiety
• Tingling sensation
• Somnolence
• Visual disturbances, hearing impairment
• Dizziness
• Tinnitus (ringing in the ears)
• Bronchospasm, asthma
• Dyspnea
• Oral ulceration
• Stomach ulcer, intestinal ulcer, stomach ulcer perforation, inflammation of the stomach mucosa
• Hepatitis, jaundice, abnormal liver function
• Pruritus, small bruises on skin and mucous membranes
• Skin becomes sensitive to light
• Worsening of renal function

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

• Aseptic meningitis
• Changes in blood count
• Anemia (a reduction in red blood cells or hemoglobin, which may cause paleness of the skin and weakness)
• Anaphylactic reaction
• Depression, confusion
• Optic neuritis
• Toxic optic neuropathy
• Edema

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

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

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

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

Please note that ibuprofen may prolong bleeding time.

Exceptionally, serious skin infections may occur in cases of chickenpox. When using an NSAID, a skin inflammation related to an infection may develop or worsen (for example, a condition such as necrotizing fasciitis, characterized by intense pain, high fever, swollen and hot skin, blisters, necrosis). If signs of a skin infection appear or worsen during ibuprofen use, you are advised to consult your doctor immediately.

Medicines such as ibuprofen may involve a slightly increased risk of heart attack or stroke.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects 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 pensa

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Ibuprofeno pensa

The active substance is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.

The other components (excipients) are:

Tablet core: hypromellose, sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and contents of the container

Film-coated tablets, oval, biconvex, and white in colour.

Ibuprofeno pensa 600 mg film-coated tablets are available in aluminium-PVC/PVDC blisters in pack sizes of 20, 30, 40 or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense 140,

28805 Alcalá de Henares (Madrid)

Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Ibuprofeno pensa 600 mg film-coated tablets EFG

Italy: Ibuprofene Pensa

Portugal: Ibuprofeno Pensa

Date of the most recent review of this leaflet: August 2025

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