Patient Information Leaflet: Package Insert

Ibuprofen Pensa Pharma 400 mg Film-Coated Tablets

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

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

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

It is used in adults and adolescents over 12 years old (≥40 kg in weight). Ibuprofeno pensa pharma is used for:

• Symptomatic treatment of mild to moderate pain.
• Symptomatic treatment in primary dysmenorrhea.

Do not take Ibuprofeno pensa pharma

• If you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6). The symptoms that indicate an allergy could be: swelling of the eyelids, lips, tongue, or throat.
• If you have ever had an allergic reaction (such as bronchospasm [contraction of the muscles of the lungs that can cause asthma and difficulty breathing], asthma, nasal secretion, swelling of the nasal passages, skin reactions, or sudden swelling) after taking acetylsalicylic acid and other similar analgesics (NSAIDs).
• If you have unspecified blood-forming disorders.
• If you have or have had ulcerative colitis, Crohn's disease, recurrent stomach or duodenal bleeding (peptic ulcers), or bleeding (at least 2 different episodes of ulcers or bleeding diagnosed).
• If you have had gastrointestinal bleeding or perforation with previous treatments with NSAIDs.
• If you have active bleeding (even in the brain).
• If you have a severe liver or kidney disease or heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• if you have congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria).
• if you have chronic alcoholism (14 to 20 drinks/week or more).
• If you are a child or adolescent with a body weight below 40 kg and a child under 12 years of age.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

The adverse effects may be reduced by using the lowest effective dose necessary to control symptoms for the shortest possible period.

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

• you have high blood pressure.
• you have congestive heart failure.
• you have established ischemic heart disease.
• you have peripheral artery disease and/or cerebrovascular disease.
• you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases that affect the connective tissue).
• 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 diseases, as you have a higher risk of experiencing an allergic reaction. Allergic reactions may present as analgesic asthma attacks, rapid swelling (Quincke's edema), or urticaria.
• you are a child.
• you have an infection: see the heading "Infections" later.

Gastrointestinal effects

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

Bleeding of the gastrointestinal tract, ulcers, and perforation:

Bleeding of the gastrointestinal tract, ulcers, and perforations, sometimes with a fatal outcome, have been reported with all NSAIDs. They have occurred at any time during treatment, with or without previous warning symptoms or a history of severe gastrointestinal events.

The risk of suffering gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Ibuprofeno pensa pharma") and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require additional treatment with low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal disorders, consider treatment with protective medications (e.g., misoprostol or proton pump inhibitors).

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

Caution should be exercised 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 platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 "Other medications and Ibuprofeno pensa pharma").

Discontinue treatment and consult a doctor if you experience gastrointestinal bleeding or ulcers during treatment with ibuprofen.

Cardiovascular effects

Nonsteroidal anti-inflammatory drugs like ibuprofen may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

Discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary bypass surgery, peripheral artery disease, 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.

Renal effects

Ibuprofen should be used with caution when administered to patients with significant dehydration. There is a risk of renal insufficiency, especially in dehydrated children, adolescents, and elderly patients.

Like other NSAIDs, prolonged administration of ibuprofen has caused papillary necrosis and other renal pathological changes. Toxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, the administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which can cause renal insufficiency.

Patients at higher risk of experiencing this reaction are those with renal insufficiency, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment usually follows recovery to the pre-treatment state.

Dermatological reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis, have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno pensa pharma and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

During varicella infection, it is recommended to avoid the use of ibuprofen.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to varicella. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor as soon as possible.

Respiratory disorders and hypersensitivity reactions

In rare cases, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking/administering ibuprofen, treatment should be discontinued and a doctor consulted. The healthcare professional should initiate the necessary medical measures, depending on the symptoms.

Hematological effects

Ibuprofen may temporarily inhibit the function of blood platelets (platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored.

During prolonged use of ibuprofen, regular monitoring of liver function tests, renal function tests, and hemograms is required.

Before undergoing surgical procedures, ibuprofen should be taken under the guidance of a doctor or dentist.

Lupus erythematosus and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, there may be a higher risk of aseptic meningitis (see later and section 4.8).

Aseptic meningitis

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

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

Patients who report eye disorders during ibuprofen treatment should discontinue therapy and undergo ophthalmological examinations.

Severe allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Ibuprofeno pensa pharma immediately and contact your doctor or emergency medical services if you observe any of these symptoms.

Geriatric patients

Geriatric patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.Therefore, close medical supervision is required in geriatric patients.

Children and adolescents

There is a risk of renal insufficiency in dehydrated adolescents.

Other medications and Ibuprofeno pensa pharma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Digoxin, phenytoin, and lithium. The combined use of Ibuprofeno pensa pharma with digoxin (used in the treatment of heart disorders), phenytoin (used in the treatment of epilepsy), or lithium (a medication used to treat depression) may increase the concentration of these medications in the blood. It is necessary to monitor serum levels of lithium. Serum levels of digoxin and phenytoin should also be monitored.
• Anticoagulants (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and medications for high blood pressure:
• • e.g., ACE inhibitors, beta-blockers, and angiotensin II receptor antagonists. The combined use of Ibuprofeno pensa pharma with diuretics that save potassium may increase the level of potassium in the blood. Therefore, serum potassium levels should be monitored.
  • Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, 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). Additionally, during combined use, there is a risk of renal insufficiency.

• Colestiramine (a medication used to treat high cholesterol) in combination with Ibuprofeno pensa pharma may reduce the absorption of Ibuprofeno pensa pharma in the gastrointestinal tract. However, the clinical significance is unknown.
• Other analgesics: The combined use of Ibuprofeno pensa pharma with other anti-inflammatory and analgesic medications in the NSAID group, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of ulcers and gastrointestinal bleeding.
• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Metotrexate: Administration of Ibuprofeno pensa pharma within 24 hours before or after administration of metotrexate (used to treat certain types of cancer or rheumatism) may cause an increase in metotrexate concentrations and an increase in its side effects.
• Ciclosporin and tacrolimus may damage the kidneys.
• Probenecid or sulfinpirazona: Medications containing probenecid or sulfinpirazona (used to treat gout) may delay the excretion of ibuprofen. This may cause ibuprofen to accumulate in the body, increasing its side effects.
• Sulfonilureas: During combined use of Ibuprofeno pensa pharma and sulfonilureas (medications used to treat diabetes), serum glucose levels should be monitored as a precaution.
• Zidovudine: There is evidence of a higher risk of hemarthrosis (accumulation of blood in the joints) and hematomas (hematoma) in HIV-infected patients taking zidovudine (an antiviral medication used to treat HIV) with ibuprofen.
• Quinolone antibiotics: The risk of seizures (attacks) may increase when taken simultaneously with quinolone antibiotics, such as ciprofloxacin, and ibuprofen.
• Aminoglucosides: The combined use of Ibuprofeno pensa pharma with aminoglucosides (a type of antibiotic) with NSAIDs may decrease the excretion of aminoglucosides.
• Voriconazol and fluconazol (CYP2C9 inhibitors) used to treat fungal infections, as the effect of ibuprofen may increase. Consider reducing the dose of ibuprofen, particularly when high doses of ibuprofen are administered with voriconazol or fluconazol.
• Ginkgo biloba (a herbal medication) may increase the risk of bleeding with NSAIDs.
• Mifepristone: The combined use of mifepristone with other anti-inflammatory and analgesic medications in the NSAID group (i.e., ibuprofen) may reduce the effect of mifepristone.
• Medications for inflammation (corticosteroids) due to the increased risk of gastrointestinal ulcers or bleeding.

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

Taking Ibuprofeno pensa pharma with food and alcohol

Alcohol may potentiate the adverse effects of Ibuprofeno pensa pharma, especially those affecting the central nervous system and the gastrointestinal tract. It is recommended not to drink alcohol while taking ibuprofen.

Pregnancy, lactation, and fertility

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

Pregnancy

Do not take Ibuprofeno pensa pharma 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 baby. It may increase the risk of bleeding in you and your baby during delivery, delay delivery, or cause it to be longer than expected. Do not take Ibuprofeno pensa pharma during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, Ibuprofeno pensa pharma may cause kidney problems in the fetus that may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Studies have suggested a higher risk of spontaneous abortion and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy.

Lactation

Ibuprofen is not recommended for use in women during lactation.

Fertility

There is evidence that substances that inhibit prostaglandin synthesis/cyclooxygenase may cause a decrease in female fertility due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

Driving and operating machinery

Generally, ibuprofen does not affect or affects the ability to drive and operate machinery. However, at higher doses, central nervous system side effects such as fatigue and dizziness may occur, affecting reaction time and the ability to drive and operate machinery, especially when combined with alcohol.

Ibuprofeno pensa pharma contains lactose

If your doctor has indicated that you have intolerance to certain sugars, consult your doctor before taking this medication.

Ibuprofeno pensa pharma contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult with your doctor or pharmacist.

The effective dose should be the lowest dose necessary to alleviate symptoms. If you have an infection, consult a doctor without delay if symptoms persist or worsen (see section 2).

The recommended dose is:

Pain

Adults and adolescents with a body weight of more than 40 kg (over 12 years old)

A single 400 mg tablet. If necessary, additional doses of 400 mg of ibuprofen can be taken. The respective dosing interval should be chosen based on observed symptoms and the maximum recommended daily dose. It should not be less than 6 hours. Do not take more than 1200 mg of ibuprofen in 24 hours.

Special populations

If you have severe liver and kidney disease or are an elderly person, your doctor will indicate the correct dose for you, which will be the lowest possible dose.

Use in children and adolescents

Ibuprofen pensa pharma is not indicated for children or adolescents with a body weight of less than 40 kg or under 12 years of age.

Method of administration

Ibuprofen pensa pharma is for oral use.

Take the tablets with a glass of water.

The tablets should not be crushed, chewed, or sucked to avoid stomach or throat irritation. The groove should not be used to break the tablet.

Patients with sensitive stomachs are recommended to take ibuprofen with food.

Treatment duration

Your doctor will decide the treatment duration.

If you take more Ibuprofen pensa pharma than you should

If you take more ibuprofen than you should, or if children have taken this medication by accident, always contact a doctor or the nearest hospital to obtain an opinion on the risk and advice on the measures to be taken.

The symptoms may include nausea, stomach pain, and vomiting (which may contain blood spots), or more rarely diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and tremor, and exacerbation of asthma in asthmatics. At high doses, somnolence, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), vertigo, weakness, and dizziness, blood in the urine, low blood pressure, increased potassium levels in the blood, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of cold body, and respiratory problems have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ibuprofen pensa pharma

Do not take a double dose to compensate for the missed doses.

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

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

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

Gastrointestinal disorders: The most commonly observed side effects affect the digestive tract. They may cause stomach/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, especially in elderly patients (see section 2: "Warnings and precautions"). After use, nausea, vomiting, diarrhea, flatulence, constipation, digestive discomfort, abdominal pain, black stools, vomiting blood, mouth and throat ulcers (stomatitis ulcerosa), worsening of colitis and Crohn's disease (see section 2: "Warnings and precautions") have been reported. Less frequently, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose and duration of treatment.

Immune system disorders:Allergic reactions have been reported after treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity including asthma, exacerbated asthma, bronchospasm or dyspnea, or (c) various skin disorders, including various types of rashes, pruritus, urticaria, purpura, angioedema, and very rarely, erythema multiforme, bullous dermatosis (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Infections and infestations:Rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever, or disorientation (see section 4.4).

Exacerbation of inflammation related to infections has been described coinciding with the use of NSAIDs. Therefore, if signs of infection or worsening appear during the use of ibuprofen, the patient is recommended to consult the doctor without delay.

Skin and subcutaneous tissue disorders:In exceptional cases, severe skin infections and complications of soft tissues may occur during a varicella infection (see also "Infections and infestations").

Cardiovascular and vascular disorders:Edema, hypertension, and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2,400 mg/day), may be associated with a small increase in the risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4).

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

Other side effects that may occur:

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

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

Less frequent (may affect up to 1 in 100 people):

• Rhinitis
• Hypersensitivity
• Insomnia, anxiety
• Paresthesia
• Somnolence
• Visual disturbances, hearing impairment.
• Dizziness
• Tinnitus
• Bronchospasm, asthma
• Dyspnea
• Mouth ulcers
• Stomach ulcers, intestinal ulcers, perforated ulcers, stomach lining inflammation
• Hepatitis, jaundice, abnormal liver function
• Pruritus, small skin and mucous membrane hemorrhages
• Photosensitivity
• Nephrotoxicity in various forms, for example, tubulointerstitial nephritis, nephrotic syndrome, and renal insufficiency

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

• Aseptic meningitis
• Leucopenia
• Thrombocytopenia
• Aplastic anemia
• Neutropenia
• Agranulocytosis
• Hemolytic anemia
• 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
• Hypertension
• Pancreatitis, liver insufficiency
• 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 pustular psoriasis (PEAG)
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30 °C.

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

Composition of Ibuprofeno pensa pharma

The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components (excipients) are:

Tablet core:hypromellose, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, 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 packaging

Coated tablets, oblong, biconvex, and white in color, scored on both faces.

Ibuprofeno pensa pharma 400 mg coated tablets are available in aluminum-PVC/PVDC blisters in packs containing 20, 30, or 60 coated tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense 140,

E-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 medicine is authorized in the EEA member states with the following names:

Spain:Ibuprofeno pensa pharma 400 mg coated tablets

Italy: TowaDol

Portugal: Ibuprofeno Pensa

Date of the last review of this leaflet:January 2024

Other sources of information

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