Ibudol 400 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibudol 400 mg soft capsules

Ibuprofen

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet (see section 4).
• You should consult a doctor if you worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Contents of the leaflet

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

1. What Ibudol is and what it is used for

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

It is indicated in adults and adolescents over 12 years of age for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (muscle strains), or back pain (lumbago), as well as for feverish conditions.

You should consult a doctor if your symptoms worsen or do not improve, if fever persists for more than 3 days, or if pain lasts more than 3 days in adolescents or 5 days in adults.

2. What you need to know before taking Ibudol

Do not take Ibudol:

• If you are allergic to ibuprofen, to other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.), or to any of the other components of this medicine (listed in section 6). Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you suffer from severe liver or kidney disease.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulants is necessary, 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

Allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibudol immediately and contact your doctor or emergency medical services right away if you experience any of these symptoms.

Consult your doctor or pharmacist before starting this medicine:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms. This risk is higher when high doses or prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients.
• If you have oedema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you have or have had heart problems or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen under these conditions could lead to kidney failure due to dehydration.

In dehydrated adolescents, there is a risk of impaired kidney function.

• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as ibuprofen-containing medicines may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine output), because your doctor should monitor kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
• If you are receiving treatment with ibuprofen, as it may mask fever—a key sign of infection—making diagnosis more difficult.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions to this medicine may occur.
• Your doctor will perform closer monitoring if you receive ibuprofen after 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 lowest effective dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a “mini-stroke” or transient ischaemic attack “TIA”).

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

In addition, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Take special care 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 syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibudol and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

This medicine may mask signs of infection such as fever and pain. Therefore, it may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Other medicines and Ibudol

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

This medicine may interact with or be affected by other medicines.

For example:

• Anticoagulant medicines (e.g. to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).

• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).

• Antiplatelet agents (prevent blood clots in blood vessels), such as ticlopidine or aspirin (acetylsalicylic acid).

• Other NSAIDs such as aspirin.

• Corticosteroids such as 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 (used to induce abortion).

• Digoxin and other cardiac glycosides (used for heart disorders).

• Hydantoins such as phenytoin (used in epilepsy treatment).

• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used for bacterial infections).

• Diuretics (medicines used to increase urine output).

• Pentoxifylline (used for circulatory disorders).

• Probenecid (used in gout patients or with penicillin for infections).

• Quinolone antibiotics such as norfloxacin.

• Sulfinpyrazone (used to treat gout).

• Sulfonylureas such as tolbutamide (used for diabetes).

• Insulin and oral hypoglycaemics (used to lower blood glucose).

• Cyclosporine and tacrolimus (used to prevent organ transplant rejection).

• Antihypertensives (to lower high blood pressure).

• Thrombolytics (medicines that dissolve or break down blood clots).

• Zidovudine (an anti-HIV medicine).

• Aminoglycoside antibiotics such as neomycin.

• Herbal extracts: Ginkgo biloba.

• Baclofen (used to treat involuntary and persistent muscle contractions).

• Phenytoin (used in epilepsy treatment).

• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).

• Tacrine (used in the treatment of Alzheimer’s disease).

• CYP2C9 inhibitors such as voriconazole and fluconazole.

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

Interaction with diagnostic tests:

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

Taking Ibudol with food, drink, and alcohol

You may take it with or without food. It is generally recommended to take it with meals or milk to reduce the risk of stomach discomfort.

Do not take ibuprofen with alcohol to avoid stomach damage.

Taking ibuprofen in patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, spirits—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 during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labour. Do not take Ibudol during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibudol may cause kidney problems in your fetus if taken for more than a few days, 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 longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

This medicine passes into breast milk, but may be taken during breastfeeding if used at the recommended dose and for the shortest duration possible.

Fertility

For women of childbearing age, it should be noted that ibuprofen-containing medicines have been associated with reduced fertility. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or operate machinery.

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

This medicine contains 110.4 mg of sorbitol liquid (E-420) per capsule.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which fructose cannot be broken down, consult your doctor (or your child’s doctor) before taking this medicine.

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

This medicine contains less than 39 mg (1 mmol) of potassium per capsule and is therefore considered essentially “potassium-free”.

3. How to take Ibudol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

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

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

• Patients with kidney, liver, or heart disease should consult their doctor, as the dose may need to be reduced.
• Patients over 65 years of age: the dose must be determined by the doctor, as a reduction from the usual dose may be necessary.

The lowest effective dose for the shortest possible duration needed to relieve symptoms should be used. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children and adolescents under 12 years of age

Children under 12 years of age must not take this medicine due to the 400 mg dose of ibuprofen. Other formulations more suitable for this population are available.

How to take:

This medicine is taken orally.

Swallow the medicine with a little water.

Take the medicine with food or milk, especially if gastrointestinal discomfort occurs.

This medicine should only be taken when pain or fever occurs. As symptoms subside, treatment should be discontinued.

In adolescents aged 12 to 18 years, if use of this medicine is required for more than 3 days or if symptoms worsen, consult a doctor.

In adults, if symptoms worsen, if fever persists for more than 3 days, or if pain lasts longer than 5 days, consult a doctor.

If you take more Ibudol than you should

If you or someone else has accidentally taken more than the prescribed dose, or if a child has accidentally ingested the medicine, contact a doctor immediately or call the Toxicology Information Service at 915620420, stating the name of the medicine and the amount taken, or go to the nearest hospital to assess the risk and obtain advice on necessary measures. It is recommended to bring the medicine packaging and leaflet to show the healthcare professional.

Symptoms of an overdose may include stomach pain, nausea, vomiting (which may contain blood-stained sputum), headache, involuntary eye movements, tinnitus (ringing in the ears). At high doses, gastrointestinal bleeding, hypotension, metabolic acidosis, coma, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness and dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties have been reported.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes of ingestion.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone will experience them.

Adverse effects are more common in people over 65 years of age. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

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

• Non-elevated reddish spots, target-shaped or circular rashes 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).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• signs of gastrointestinal bleeding, such as severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee
• 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, or drop in blood pressure leading to shock. These may occur even with the first use of this medicine.

Inform your doctor if you experience any of the following adverse effects:

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

• stomach problems, such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestine, which may exceptionally lead to anemia.

Uncommon: (may 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 bowel disease (ulcerative colitis or Crohn's disease), gastritis
• disorders of the central nervous system, 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 blood urea concentration, pain in the sides and/or abdomen, blood in the urine and fever, which may be signs of kidney damage (papillary necrosis)
• decrease in hemoglobin levels.

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

• esophagitis, pancreatitis, and development of diaphragm-type intestinal strictures
• heart failure, heart attack, and swelling of the face and hands (edema)
• reduced urine output, swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If you experience any of the symptoms listed above or feel depressed, stop taking this medicine and consult your doctor immediately, as these may be early signs of kidney damage or failure
• psychotic-type reactions, depression
• elevated blood pressure, vasculitis
• palpitations
• liver dysfunction (early symptoms may include skin discoloration), liver damage especially with prolonged treatment, liver failure, acute inflammation of the liver (acute hepatitis)
• problems in blood cell production. Early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and a doctor consulted. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammation associated with infection (e.g., necrotizing fasciitis) has been reported in association with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen, seek medical attention immediately. The need for antibiotic therapy should be evaluated
• symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, or disorientation, have been observed during treatment with ibuprofen. This is more likely to occur in patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
• severe forms of 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 serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, lymph node swelling, and elevated eosinophils (a type of white blood cell).
• Widespread red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See also section 2.
• 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 cerebrovascular accident). Prolongation of bleeding time, edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments containing ibuprofen.

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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibudol

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any deterioration of the capsules.

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 dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibudol

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

The other components are:

• Core: macrogol, potassium hydroxide, and purified water.
• Capsule shell: gelatin, liquid sorbitol, partially dehydrated (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 pack contents:

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

Available in packs containing 10 or 20 soft capsules, presented 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 most recent review of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/