Prospect: Information for the user

Ibudol 400 mg soft capsules

Ibuprofen

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

-Keep this prospect as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect (see section 4).

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

1.What is Ibudol and what it is used for.

2.What you need to know before starting to take Ibudol.

3.How to take Ibudol.

4.Possible side effects.

5.Storage of Ibudol.

6.Contents of the package and additional information.

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

It is indicated for adults and adolescents over 12 years old for symptomatic relief of occasional mild to moderate pain, such as headache, dental pain, menstrual pain, muscle pain (spasms) or back pain (lumbago), as well as in febrile states.

Consult a doctor if it worsens or does not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Do not take Ibudol:

• If you are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have a severe liver or kidney disease.
• If you have bleeding or clotting disorders or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibudol immediately and contact your doctor or emergency medical services if you observe any of these signs.

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

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense 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 disease, and in elderly patients.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart condition or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks.
• If you have symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.

In dehydrated adolescents, there is a risk of renal function deterioration.

• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or other NSAIDs. Also, inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-containing medications may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should monitor kidney function.
• If you have lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine or liver disease), so your doctor can assess the suitability of ibuprofen treatment.
• If you are receiving ibuprofen treatment, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• There may be allergic reactions to this medication.
• Your doctor will perform more stringent monitoring if you receive ibuprofen after major surgery.
• If you have an infection; see the "Infections" section below.
• It is recommended not to take this medication if you have chickenpox.
• It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Cardiovascular precautions

NSAIDs like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You must inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Skin reactions

Be particularly careful with Ibudol:

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 (PEGA), have been reported in association with ibuprofen treatment. Stop Ibudol treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

This medication may mask the signs of an infection, such as fever and pain. Consequently, it may delay or prolong the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Other medications and Ibudol

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

This medication may affect or be affected by other medications.

For example:

• Anticoagulant medications (e.g. to treat blood clotting problems, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

• Antiplatelet agents (prevent blood clots in blood vessels) like ticlopidine or aspirin (acetylsalicylic acid).
• Other NSAIDs like aspirin.
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (medications for depression).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and other cardiac glycosides (used in heart conditions).
• Hydantoins like phenytoin (in epilepsy treatment).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medications to increase urine production).

• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (for gout treatment).
• Sulfonylureas like tolbutamide (for diabetes).
• Insulin and oral hypoglycemic agents (used to lower blood glucose).
• Ciclosporin and tacrolimus (used to prevent organ transplant rejection)
• Antihypertensive medications (to lower high blood pressure).
• Thrombolytic medications (dissolve or break down blood clots).
• Zidovudine (medication for HIV/AIDS).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Baclofen (used to treat involuntary muscle contractions).
• Phenytoin (in epilepsy treatment).
• Ion exchange resins like cholestyramine (used to lower cholesterol in the blood).
• Tacrine (used in Alzheimer's disease treatment).
• CYP2C9 inhibitors like voriconazole and fluconazole.

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

Interaction with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking or have recently taken this medication, as it may alter the results.

Taking Ibudol with food, drink, and alcohol

You can take it alone or with food. Generally, it is recommended to take it with meals or with milk to reduce the possibility of stomach discomfort.

Do not take ibuprofen with alcohol to avoid damaging the stomach.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Do not take Ibudol 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 fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong delivery. Do not take Ibudol during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Ibudol may cause kidney problems in your fetus if taken for more than a few days, which 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.

Lactation

This medication passes into breast milk, but can be taken during breastfeeding if used at the recommended dose for the shortest time possible.

Fertility

For fertile women, consider that ibuprofen-containing medications have been associated with a decrease in the ability to conceive. Avoid taking this medication if you are trying to become pregnant.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

Ibudol contains sorbitol liquid (E-420) and Ponceau 4R (E-124)

This medication contains 110.4 mg of sorbitol liquid (E-420) in each capsule.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HF), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor or child's doctor before taking this medication.

This medication may cause allergic reactions because it contains Ponceau 4R (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 39 mg (1 mmol) of potassium per capsule, making it essentially "potassium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents over 12 years old: 1 capsule of 400 mg every 6-8 hours, if necessary.

Do not take more than 3 tablets (1200 mg) in 24 hours.

• Patients with kidney, liver, or heart diseaseconsult your doctorbecause you may need to reduce the dose.
• Patients over 65 years old: the dose to be taken should be established by your doctor, as there is a possibility that a reduction in the usual dose may be needed.

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).

Use in children and adolescents under 12 years old

Children under 12 years old cannot take this medication due to the 400mg dose of ibuprofen. There are other presentations more suitable for this population.

How to take:

This medication is taken orally.

Swallow the medication with a little water.

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

The use of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

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

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

If you take more Ibudol than you should

If you take or accidentally administer more medication than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or call the toxicology information service, phone 915620420, indicating the medication and the amount used, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The symptoms of an overdose may include stomach pain, nausea, vomiting (which may contain blood-stained mucus), headache, involuntary eye movements, buzzing in the ears. At high doses, intestinal bleeding, hypotension, metabolic acidosis, coma, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low potassium levels in the blood, chills, and breathing problems have been reported.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if significant amounts have been ingested and within the 60 minutes following ingestion.

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

Side effects are more common in people over 65 years old. The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Stop taking Ibudol and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).
• Signs of intestinal bleeding,such as: severe abdominal pain, black or tar-like stools, vomiting with blood or dark particles that resemble ground coffee.
• Signs of a very rare but severe allergic reaction,such as worsening of asthma, wheezing, or unknown respiratory problems, facial, tongue, or throat swelling, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These can occur even with the first use of this medication.

Inform your doctor if you experience the following side effects:

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

• Stomach problems, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, gas, constipation, and mild bleeding in the stomach and/or intestines that can cause anemia in exceptional cases.

Rare:(can 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 headaches, dizziness, insomnia, agitation, irritability, and fatigue
• Visual disturbances
• Diverse skin eruptions
• Hypersensitivity reactions with urticaria and itching.

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

• Tinnitus (ringing in the ears)
• Increased urea concentration in the blood, side pain and/or abdomen, blood in the urine, and fever, which can be signs of kidney damage (papillary necrosis)
• Decreased hemoglobin levels

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

• Esophagitis, pancreatitis, and formation of diaphragmatic intestinal stenosis
• Heart failure, myocardial infarction, and facial and hand swelling (edema)
• Decreased urine output, swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that can lead to acute kidney failure. If you experience any of the mentioned symptoms or feel sad, stop taking this medication and consult your doctor immediately, as it may be the first sign of kidney damage or failure.
• Psychotic reactions, depression
• High blood pressure, vasculitis
• Palpitations
• Liver dysfunction (the first symptoms may be skin discoloration), liver damage, especially with prolonged treatment, liver insufficiency, acute hepatitis
• Blood cell production problems. The first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding, and unknown hematomas. In these cases, stop treatment immediately and consult your doctor. Do not self-medicate with painkillers or antipyretic medications.
• Severe skin infections and complications of soft tissue during varicella infection
• Worsening of inflammation associated with infection (e.g., necrotizing fasciitis) associated with the use of some analgesics (NSAIDs). If you experience signs of infection or worsening, seek medical attention immediately. Antibiotic therapy may be necessary.
• Asymptomatic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation during ibuprofen treatment. It is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately.
• Severe skin reactions, such as skin eruptions with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell syndrome) and hair loss (alopecia).

Unknown frequency:(cannot be estimated from available data)

• Respiratory tract reactivity, including asthma, bronchospasm, or dyspnea.
• A severe skin reaction known as DRESS syndrome can occur. DRESS symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medication if you experience these symptoms and seek medical attention immediately. See section 2.
• The skin becomes sensitive to light.

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

Based on experience with NSAIDs, it cannot be ruled out that cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) may occur.

Reporting of side effects

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

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe deterioration of the capsules.

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

Composition of Ibudol

Each soft capsule contains 400 mg of ibuprofen as the active ingredient.

The other components are:

• Core: macrogol, potassium hydroxide, and purified water.
• Capsule: gelatin, liquid sorbitol, partially dehydrated (E-420), Ponceau 4R (E124), white ink (propylene glycol (E-1520), titanium dioxide (E171), phthalate of polyvinyl acetate, macrogol, ammonium hydroxide), medium-chain triglycerides, and lecithin.

Appearance of Ibudol and content of the container:

Oval-shaped capsules (approximately 15 mm in length and 10 mm in width) with a transparent and red gelatin coating. The capsule has a white logo printed on one of its faces.

It is presented in containers containing 10 or 20 soft capsules conditioned in blisters of PVC/PVdC/Al (transparent or opaque) or PVC/PE/PVdC/Al (transparent or opaque).

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:July 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/