Ibuprofen Pensa Pharma 400 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ibuprofeno pensa pharma 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Ibuprofeno pensa pharma contains the active substance 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 of age (≥40 kg body weight). Ibuprofeno pensa pharma is used for:

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

2. What you need to know before starting to take Ibuprofeno pensa pharma

Do not take Ibuprofeno pensa pharma

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6). Symptoms indicating allergy 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, nasal discharge, nasal congestion, skin reactions or sudden swelling) after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• If you have nonspecific disorders in blood formation.
• If you have or have had recurrent ulcerative colitis, Crohn's disease, stomach or duodenal bleeding (peptic ulcers) or bleeding (at least two separate episodes of ulcers or bleeding diagnosed).
• If you have experienced gastrointestinal bleeding or perforation of the digestive tract during previous treatment with NSAIDs.
• If you have any active bleeding (including in the brain).
• If you suffer from severe liver or kidney disease or heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).
• if you suffer from congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria).
• if you suffer from chronic alcoholism (14 to 20 drinks/week or more).
• If you are a child or adolescent weighing less than 40 kg or 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.

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

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

• you have high blood pressure.
• you have congestive heart failure.
• you suffer from established ischemic heart disease.
• you suffer from peripheral arterial disease and/or cerebrovascular disease.
• you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disorder (autoimmune diseases affecting 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 disorders, as you have a higher risk of experiencing an allergic reaction. Allergic reactions may present as asthma attacks (analgesic-induced asthma), rapid swelling (Quincke's edema) or urticaria.
• you are a child.
• you have an infection: see the “Infections” section 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 with fatal outcomes, have been reported with all NSAIDs. These events may occur at any time during treatment, with or without previous warning symptoms or history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulcers and perforation increases with higher NSAID doses 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 pharma”) and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients 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 adverse gastrointestinal effects, especially if you are elderly, you should contact a doctor if you experience 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 platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 “Other medicines and Ibuprofeno pensa pharma”).

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

Cardiovascular effects

Anti-inflammatory/pain-relieving 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.

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 patients.

As with other NSAIDs, prolonged administration of ibuprofen has caused renal papillary necrosis and other pathological renal changes. Renal toxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, potentially leading to renal failure.

Patients at greatest risk of this reaction include those with renal impairment, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors, and the elderly. 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), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno pensa pharma and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

During varicella 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, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor as soon as possible.

Respiratory disorders and hypersensitivity reactions

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

Hematological effects

Ibuprofen may temporarily inhibit blood platelet function (platelet aggregation). Therefore, patients with blood coagulation disorders should be carefully monitored.

During prolonged use of ibuprofen, regular monitoring of liver function tests, kidney function tests and blood counts is required.

If ibuprofen is taken before surgical procedures, the doctor or dentist should be consulted/informed.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis (see below and section 4.8).

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 diseases, it has also been reported in patients without underlying chronic disease.

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

Patients who report ocular disorders during treatment with ibuprofen should discontinue therapy and undergo ophthalmic examinations.

Signs of allergic reaction to ibuprofen, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately stop using Ibuprofeno pensa pharma and contact your doctor or emergency medical services immediately if you observe 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.

Children and adolescents

There is a risk of renal failure in dehydrated adolescents.

Other medicines and Ibuprofeno pensa pharma

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

Ibuprofen may affect or be affected by other medicines. 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 medicine used to treat depression) may increase blood concentrations of these medicines. Serum lithium levels should be monitored. Monitoring of serum digoxin and phenytoin levels is recommended.

• Anticoagulant medicines (e.g., to treat or prevent clotting problems, 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 Ibuprofeno pensa pharma 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, during combined use, there is a risk of renal failure.

• Cholestyramine (a medicine 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 painkillers: the combined use of Ibuprofeno pensa pharma 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.

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

• Methotrexate: administration of Ibuprofeno pensa pharma 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.

• Probenecid or sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone (used to treat gout) may delay the excretion of ibuprofen. This may cause Ibuprofeno pensa pharma to accumulate in the body, increasing its side effects.

• Sulfonylureas: during combined use of Ibuprofeno pensa pharma and sulfonylureas (medicines used to treat diabetes), monitoring of blood sugar levels is recommended as a precautionary measure.

• Zidovudine: there is evidence suggesting an increased risk of hemarthrosis (blood accumulation in joints) and bruising (hematoma) in HIV-positive hemophiliacs who use zidovudine (an antiviral medicine used to treat HIV infection) together with ibuprofen.

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

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

• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. 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 Ibuprofeno pensa pharma treatment. Therefore, you should always seek advice from your doctor or pharmacist before using Ibuprofeno pensa pharma with other medicines.

Taking Ibuprofeno pensa pharma with food and alcohol

Alcohol may enhance the adverse effects of Ibuprofeno pensa pharma, especially those affecting the central nervous system and gastrointestinal tract. It is preferable not to drink alcohol while using 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 Ibuprofeno pensa pharma 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 baby. It may increase the risk of bleeding in you and your baby during childbirth, delay or prolong labor beyond expected duration. Do not take Ibuprofeno pensa pharma during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest dose should be used for the shortest possible time. If taken for more than a few days from 20 weeks of pregnancy, Ibuprofeno pensa pharma 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 is needed for more than a few days, your doctor may recommend additional monitoring.

Epidemiological study data suggest an increased risk of spontaneous abortion and cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy.

Breastfeeding

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

Fertility

Evidence suggests that substances inhibiting prostaglandin/cyclooxygenase synthesis may cause a reversible reduction in female fertility due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

Driving and use of machines

Generally, ibuprofen does not affect or has minimal effect on the ability to drive and use machines. However, since central nervous system side effects such as fatigue and dizziness may occur at higher doses, reaction ability and the ability to drive and operate machinery may be impaired in individual cases. This is especially important when combined with alcohol.

Ibuprofeno pensa pharma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Ibuprofeno pensa pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Ibuprofen pensa pharma

Follow exactly the administration instructions for this medicine provided by your doctor. In case of 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 persist or worsen (see section 2).

The recommended dose is:

Pain

Adults and adolescents with a body weight above 40 kg (over 12 years of age):

One whole 400 mg tablet as a single dose. If necessary, additional doses of 400 mg ibuprofen may be taken. The respective dosing interval should be chosen according to observed symptoms and the recommended maximum daily dose. It must not be less than 6 hours. Do not exceed 1200 mg of ibuprofen in 24 hours.

Special populations

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

Use in children and adolescents

Ibuprofen pensa pharma is not indicated for children or adolescents with a body weight below 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 must not be crushed, chewed, or sucked to avoid irritation of the stomach or throat. The score line should not be used to split the tablet.

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

Duration of treatment

Your doctor will decide the duration of treatment.

If you take more Ibuprofen pensa pharma 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 be taken.

Symptoms of overdose may include nausea, stomach pain, and vomiting (which may contain blood), or more rarely diarrhea. In addition, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and tremulous eye movements, and worsening of asthma in asthmatic patients. At high doses, somnolence, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), dizziness, weakness, and vertigo, blood in urine, low blood pressure, low blood potassium levels, increased blood potassium levels, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold sensation, and breathing difficulties 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 pharma

Do not take a double dose to make up for forgotten 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 produce adverse effects, although not everyone experiences them.

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

Gastrointestinal disorders: The most commonly observed side effects affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation, or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2: "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, vomiting of blood, ulceration in the mouth and throat area (ulcerative stomatitis), and worsening of colitis and Crohn's disease have been reported after use (see section 2: "Warnings and precautions"). Less frequently, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.

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

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

Exacerbation of inflammation associated with infections has been described in connection with the use of NSAIDs. Therefore, if signs of infection appear or worsen during ibuprofen use, patients are advised to seek medical attention without delay.

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

Cardiac and vascular disorders: Oedema, 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 increased risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4).

Discontinue ibuprofen treatment and seek immediate medical attention if you experience any of the following symptoms:

• Flat, non-elevated, target-shaped or circular red 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, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, 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).

Other side effects that may occur:

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

• Headache, dizziness
• Gastrointestinal side effects (indigestion, diarrhoea, 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
• Paresthesia
• Somnolence
• Visual disturbances, hearing impairment
• Dizziness
• Tinnitus
• Bronchospasm, asthma
• Dyspnoea
• Oral ulceration
• Stomach ulcer, intestinal ulcer, gastric ulcer perforation, inflammation of the stomach mucosa
• Hepatitis, jaundice, abnormal liver function
• Pruritus, small bruises on skin and mucous membranes
• Photosensitivity
• Nephrotoxicity in various forms, e.g., tubulointerstitial nephritis, nephrotic syndrome, and renal failure

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

• Aseptic meningitis
• Leukopenia
• Thrombocytopenia
• Aplastic anaemia
• Neutropenia
• Agranulocytosis
• Haemolytic anaemia
• Anaphylactic reaction
• Depression, confusion
• Optic neuritis
• Toxic optic neuropathy
• Oedema

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

• Heart failure, myocardial infarction
• Hypertension
• Pancreatitis, liver failure
• Severe forms of skin reactions (e.g., erythema multiforme, bullous 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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they 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 pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP" or "CAD". 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno pensa pharma

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

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

Film-coated, oblong, biconvex white tablets, scored on both sides.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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,
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 medicinal product is authorized in EEA Member States under the following names:

Spain: Ibuprofeno pensa pharma 400 mg film-coated tablets EFG
Italy: TowaDol
Portugal: Ibuprofeno Pensa

Date of the latest revision of this leaflet: September 2025

Other sources of information

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