Ibudol 400 Mg 20 Envelopes Oral Suspension 10 ml

Ibudol is presented in the form of an oral suspension to be taken directly from the sachet or dissolved in water.

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

It is indicated for adults and adolescents from 12 years of age and weighing more than 40 kg for the symptomatic relief of occasional mild or moderate pains, such as headaches, dental pain, menstrual pain, muscle pain (contractures) or back pain (lumbago), as well as in febrile states.

Do not take Ibudol:

• If you suffer from a serious liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If he vomits blood.
• If you have black stools or bloody diarrhea.
• If you have a bleeding or blood clotting disorder, or are taking anticoagulants (medications used to "thin" the blood), your doctor will perform blood clotting tests if you need to use anticoagulant medication at the same time.
• If you suffer from severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking this medicine.

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

Inform your doctor:

- If you have edema (fluid retention).

- If you suffer or have suffered from any heart disorder or have high blood pressure.

- If you suffer from asthma or any other respiratory disorder.

- If you have an infection; see the heading "Infections" below.

If you have kidney or liver disease, are over 60, or need to take the medication for an extended period (more than 1 to 2 weeks), your doctor may need to monitor you regularly. Your doctor will tell you how often these checkups will be.

- If you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could cause kidney failure as a result of dehydration.

- If you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, which may manifest as intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider prescribing a stomach-protective medication.

- If you are simultaneously taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet drugs like aspirin, you should also inform your doctor if you are using other medications that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

- If you suffer from Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, then medications of this type can worsen these pathologies.

- If you are being treated with diuretics (medications to make you urinate) because your doctor needs to monitor your kidney function.

- If you suffer from systemic 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 aseptic meningitis may occur.

- If you suffer from acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, blood in the urine, or liver disease), so that you can assess whether or not treatment with ibuprofen is appropriate.

- If you experience headaches after prolonged treatment, you should not take higher doses of the medication.

- Allergic reactions are possible with this medication.

- The doctor will carry out stricter monitoring if you receive ibuprofen after undergoing major surgery.

- It is advisable not to take this medicine if you have chickenpox.

It is important that you use the smallest dose that relieves/controls your pain and you should not take this medicine for longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibudol:

Severe skin reactions, including 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. Stop taking Ibudol and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Anti-inflammatory/pain-relieving medications 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:

• has heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (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”).
• has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or is a smoker.

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

Infections

Ibudol can mask the signs of an infection, such as fever and pain. Consequently, Ibudol may delay appropriate treatment of the infection, which can increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Children and adolescents

There is a risk of kidney damage in dehydrated adolescents.

Using Ibudol with other medications

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Ibudol can affect or be affected by other medications. For example:

• Anticoagulant medications (e.g. to treat clotting problems/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (are used in the treatment of some bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine elimination).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or in conjunction with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medicine against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Voriconazole or fluconazole, used for fungal infections.
• Herbal extracts: from the Ginkgo biloba tree.

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

Interference with analytical tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may last for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen concentrations and serum concentrations of creatinine and potassium (may increase)
• Liver function tests showed elevated transaminase levels.

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), tell the doctor that you are taking this medicine, as it may alter the results.

Taking Ibudol with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Precautions during pregnancy and in women of childbearing age

Because this type of medication has been associated with an increased risk of birth defects/miscarriage, it is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In these cases, the dose and duration of treatment will be kept to a minimum. It can cause kidney and heart problems in your fetus. It can affect your and your baby's predisposition to bleeding and delay or prolong labor. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to conceive, you should take the lowest dose for the shortest possible time. From week 20 of pregnancy onwards, ibuprofen can cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you require treatment for a period longer than a few days, your doctor may recommend additional check-ups.

The administration of this medication is contraindicated in the third trimester.

For patients of childbearing age, it should be noted that medications of this type have been associated with a decreased ability to conceive.

Lactation:

Although drug levels in breast milk are negligible, it is recommended to consult a doctor for long-term treatments or high doses during breastfeeding.

Driving and operating machinery

If you experience dizziness, vertigo, blurred vision, or other symptoms while taking this medicine, you should not drive or operate machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take any special precautions.

Ibudol contains liquid maltitol and sodium

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Patients on low-sodium diets should be aware that this medicine contains 58 mg of sodium per 400 mg sachet.

Follow the instructions for administering this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.

The lowest effective dose should be used for the shortest time 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).

The recommended dose is:

Adults and adolescents (weighing over 40 kg) from 12 years of age:

Take one 400 mg sachet every 6-8 hours, if necessary. Do not take more than 3 sachets (1200 mg) in any 24-hour period.

Children and adolescents :

This medicine is not recommended for use in children or adolescents weighing less than 40 kg, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Elderly patients (> 65 years):

The dosage should be determined by your doctor, as a reduction from the usual dose may be necessary. Elderly people are more prone to side effects, so the dose may sometimes need to be reduced. Consult your doctor.

Patients with kidney, liver, or heart disease:

In patients with mild or moderate disease, the initial dose should be reduced. Ibuprofen should not be used in patients with severe renal, hepatic, or cardiac impairment.

Form of administration

This medication is administered orally.

Ibudol is a suspension. It should be homogenized before use by pressing the top and bottom of the sachet several times with your fingers. It can be taken directly from the sachet or diluted in water. In case of gastrointestinal discomfort, it is recommended to take the medication with food.

Always use the lowest effective dose. This medication should only be administered if pain or fever occurs. Once these symptoms subside, the medication should be discontinued.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days (3 days in adolescents), you should consult a doctor.

If you take more Ibudol than you should

If you have taken more Ibudol than you should, or if a child has accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, contact the National Poison Control Center (telephone: 91 562 04 20), or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken, indicating the medication and the amount ingested. It is recommended that you take the packaging and leaflet of the medication with you to the healthcare professional.

Symptoms of an overdose may include stomach pain, nausea, vomiting (which may contain blood), lethargy, drowsiness, headache, involuntary eye movements, ringing in the ears, confusion, and muscle incoordination. More serious symptoms such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney failure, and coma are rare. Adult respiratory distress and transient respiratory arrest in children (after ingesting large quantities) have been reported. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and difficulty breathing have been reported.

If severe poisoning has occurred, the doctor will take the necessary measures.

If you forgot to take Ibudol

Do not take a double dose to make up for forgotten doses.

If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Ibudol can cause side effects, although not everyone experiences them.

The adverse effects of medications like Ibudol 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.

Frequencies have been defined as follows: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients) and frequency not known (cannot be estimated from the available data).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects associated with ibuprofen medications are gastrointestinal: peptic ulcers, gastrointestinal bleeding, and perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in the stool, mouth ulcers, and exacerbation of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Other adverse effects include:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stenosis), exacerbation of intestinal diverticula disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Ibuprofen medications may be associated with a moderately increased risk of heart attack (“myocardial infarction”) or stroke.

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with ibuprofen-type drug treatments.

Cutaneous:

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

• Non-raised, reddish, target-shaped or circular patches on the trunk, often with central blisters, peeling skin, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema polymorphus, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• A widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Ibuprofen medications can, in very rare cases, be associated with very serious blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions). preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Other adverse effects include:

Common: skin rash.

Uncommon: skin reddening, itching or swelling of the skin, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the blood vessels of the skin.

In rare cases, severe skin infections and soft tissue complications can occur during chickenpox.

Frequency not known: Widespread red, scaly rash with bumps under the skin and blisters, mainly in skin folds, on the trunk, and on the upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibudol if you experience these symptoms and seek immediate medical attention. See also section 2.

Of the immune system:

Uncommon: transient edema in areas of the skin, mucous membranes or sometimes in viscera (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi that prevents the passage of air to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of a severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock may occur.

Very rare: joint pain and fever (lupus erythematosus).

Of the central nervous system:

Common: fatigue or drowsiness, headache, and dizziness or a feeling of unsteadiness.

Rare: paresthesia (a sensation of numbness, tingling, prickling, etc. most frequently in the hands, feet, arms or legs).

Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms of aseptic meningitis observed included stiff neck, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Hearing:

Common: vertigo. Uncommon: ringing or buzzing in the ears.

Rare: hearing impairment.

Eyepieces:

Uncommon : vision impairment.

Rare : abnormal or blurred vision.

Sanguine:

Rare side effects include: decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that can predispose individuals to infections), pancytopenia (a deficiency of red blood cells, white blood cells, and platelets), agranulocytosis (a very large decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). Early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, and nosebleeds and bleeding under the skin.

Very rare: prolonged bleeding time.

Renal:

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

Liver:

Medications containing ibuprofen can, in rare cases, be associated with liver damage.

Other rare adverse effects include: hepatitis (inflammation of the liver), abnormal liver function, and jaundice (yellowing of the skin and eyes).

Frequency unknown: liver failure (severe liver impairment).

General:

Worsening of inflammations during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If you experience any of the following side effects, stop treatment and consult your doctor immediately:

Reporting of adverse effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

Keep in the original packaging.

Do not use this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of down the drain or in the trash. Take any unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of unused medicines and their packaging. By doing so, you will help protect the environment.

Ibudol Composition

• The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen.
• The excipients are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, thaumatin (E-957), strawberry flavor, glycerol and purified water.

Product appearance and package contents

Ibudol 400 mg is presented as an oral suspension. It comes in heat-sealed sachets made of an aluminum complex (polyester, aluminum, polyethylene, polyester, and polyethylene). Each pack contains 20 sachets.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, SL

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: January 2024.

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