IBUDOL 400 MG SOFT GEL CAPSULES

2. What you need to know before taking Ibudol

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 medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• If you have had a stomach or duodenal ulcer 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 disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibudol immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by 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 treatments, in patients with a history of peptic ulcer and in elderly patients.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart disorder or high blood pressure.
• If you have a kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks.
• If you have symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this case could 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 coagulation, such as oral anticoagulants, antiplatelet agents of the type acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen medications can worsen these diseases.
• If you are being treated with diuretics (medicines to increase urine production), as your doctor should monitor kidney function.
• If you have lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it can cause aseptic meningitis.
• If you have acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine color or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you are receiving treatment with ibuprofen, as it can mask fever, which is an important sign of infection, making diagnosis difficult.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• If you have an infection; see the "Infections" section below.
• It is advisable not to take this medicine if you have chickenpox.
• It is important to use the smallest dose that relieves-controls the pain and not to take this medicine for longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medications 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 should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Be 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop taking Ibudol and seek medical attention immediately if you notice any of these symptoms related to severe skin reactions described in section 4.

Infections

This medicine may hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other medicines and Ibudol

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

This medicine may affect or be affected by other medicines.

For example:

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

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

• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Insulin and oral hypoglycemic agents (used to decrease blood glucose levels).
• Cyclosporine and tacrolimus (used to prevent organ rejection in transplants)
• Antihypertensive agents (to decrease high blood pressure).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (medicine against the AIDS virus).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Phenytoin (in the treatment of epilepsy).
• Ion exchange resins like cholestyramine (used to decrease cholesterol levels in blood).
• Tacrine (used in the treatment of Alzheimer's disease).
• CYP2C9 inhibitors like voriconazole and fluconazole.

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

Interaction with analytical tests:

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

Taking Ibudol with food, drink, and alcohol

You can take it alone or with food. It is generally recommended to take it during meals or with milk to reduce the possibility of stomach upset.

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

Taking ibuprofen by patients who habitually 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 tendency to bleed and delay or prolong labor more than expected. You should 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 possible time. From the 20th week of pregnancy, Ibudol may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid 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 checks.

Breastfeeding

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

Fertility

For female patients of childbearing age, it should be noted that ibuprofen medications have been associated with a decrease in fertility. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you feel dizzy, vertigo, vision changes, or other symptoms while taking this medicine, do not drive or use hazardous machinery.

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

This medicine 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 an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, consult your doctor before taking this medicine.

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

This medicine contains less than 39 mg (1 mmol) of potassium per capsule, so it is considered "essentially potassium-free".

3. How to take Ibudol

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

• Patient with kidney, liver, or heart disease should consult their doctor, as they may need to reduce the dose.
• Patient over 65 years: the amount to take should be established by the doctor, as it may be necessary to reduce the usual dose.

The lowest effective dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult your doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children and adolescents under 12 years

Children under 12 years should not take this medicine due to the 400mg dose of ibuprofen. There are other presentations more suitable for this population.

How to take:

This medicine is taken orally.

Swallow the medicine with a little water.

Take the medicine with meals or with milk, especially if you experience digestive discomfort.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, the medication should be discontinued.

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

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

If you take more Ibudol than you should

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

The symptoms of an overdose may include stomach pain, nausea, vomiting (which may contain bloody sputum), headache, involuntary eye movements, ringing in the ears. At high doses, intestinal bleeding, hypotension, metabolic acidosis, coma, somnolence, chest pain, palpitations, loss of consciousness, convulsions (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 large amounts, activated charcoal should be administered. Gastric lavage will be considered if large amounts have been ingested and within 60 minutes after ingestion.

4. Possible Adverse Effects

Like all medications, this medication can have adverse effects, although not all people suffer from them.

Adverse effects are more common in people over 65 years of age. The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

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

• Reddish, non-raised, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• Signs of intestinal bleeding,such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble ground coffee beans.
• Signs of a very rare but serious allergic reaction,such as worsening asthma, wheezing, or unexplained breathing difficulties, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure that causes shock. These can occur even with the first use of this medication.

Inform your doctor if you experience the following adverse effects:

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

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

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

• Gastrointestinal ulcers, perforation, or bleeding, inflammation of the mucous membrane of the mouth with ulcers, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis.
• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, and fatigue.
• Visual disturbances.
• Various skin rashes.
• Hypersensitivity reactions with hives and itching.

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

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

Very Rare:(in less than 1 in 10,000 patients)

• Esophagitis, pancreatitis, and formation of intestinal stenosis of the diaphragm type.
• Heart failure, heart attack, and swelling of the face and hands (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 above symptoms or have a feeling of sadness, stop taking this medication and consult your doctor immediately, as it may be the first signs 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 failure, acute liver inflammation (acute hepatitis).
• Problems with blood cell production. The first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding and bruising of unknown origin. In these cases, you should immediately stop treatment and consult your doctor. Do not self-medicate with pain relievers or antipyretic medications.
• Severe skin infections and soft tissue complications during chickenpox infection.
• A worsening of inflammation associated with an infection (e.g., necrotizing fasciitis) has been described with the use of some pain relievers (NSAIDs). If signs of infection appear or worsen, you should see a doctor immediately. It should be evaluated whether antibiotic therapy is necessary.
• Symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed during treatment with ibuprofen. It is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this happens, contact your doctor immediately.
• Severe skin reactions such as skin rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell syndrome) and hair loss (alopecia).

Frequency Not Known:(cannot be estimated from available data)

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

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

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibudol

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears 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 thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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, partially dehydrated liquid sorbitol (E-420), Ponceau 4R (E124), white ink (propylene glycol (E-1520), titanium dioxide (E171), polyvinyl acetate phthalate, macrogol, ammonium hydroxide), medium-chain triglycerides, and lecithin.

Appearance of Ibudol and Package Contents:

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

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

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus:July 2024

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