Ibudol 400 mg oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibudol 400 mg oral suspension

Ibuprofen

Read all of this 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 provided by your doctor, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or more information, consult your pharmacist.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
You should consult a doctor if your condition worsens or if you do not improve after 3 days in case of fever or 5 days (3 days for children and adolescents) in case of pain.

Contents of the leaflet:

What Ibudol is and what it is used for
What you need to know before taking Ibudol
How to take Ibudol
Possible adverse effects
Storage of Ibudol
Contents of the pack and other information

1. What Ibudol is and what it is used for

Ibudol is presented as 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 aged 12 years and older, weighing more than 40 kg, for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscular pain (muscle strains), or back pain (lumbago), as well as for febrile conditions.

2. What you need to know before taking Ibudol

Do not take Ibudol:

If you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
If you are vomiting blood.
If you have black stools or bloody diarrhea.
If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulant medicines 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

Consult your doctor or pharmacist or nurse before starting to take this medicine.

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

Tell your doctor:

If you have edema (fluid retention).
If you have or have had heart problems or high blood pressure.
If you have asthma or any other respiratory disorder.
If you have an infection; see the section “Infections” below.
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 carry out regular monitoring. Your doctor will advise you on how often these checks should be done.
If you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case could lead to kidney failure due to dehydration.
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, or even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could 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 that usually leads to bloody diarrhea) or ulcerative colitis, as this type of medicine may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect 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, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions may occur with this medicine.
Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.

It is important that you use the lowest effective dose to relieve/control pain and that you do not take this medicine longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibudol:

Serious skin reactions have been reported with ibuprofen, 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). Discontinue treatment with Ibudol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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 ibuprofen 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 ischemic 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 medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Infections

Ibudol may mask signs of infection, such as fever and pain. Therefore, Ibudol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

Children and adolescents

There is a risk of kidney damage in dehydrated adolescents.

Use of Ibudol with other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Ibudol 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, and angiotensin II receptor antagonists such as losartan).
Baclofen (used to treat involuntary and persistent muscle contractions).
Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
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 to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output).
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in patients with gout or together with penicillin for 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 (an anti-HIV medicine).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Voriconazole or fluconazole (used for fungal infections).
Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Hematocrit or hemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
Liver function tests: increased transaminase values

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

Taking Ibudol with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Precautions during pregnancy and in women of childbearing age

Because the use of this type of medicine has been associated with an increased risk of congenital abnormalities and miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be kept to a minimum. Ibuprofen may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s ability to clot blood and may 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 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, ibuprofen may cause kidney problems in your unborn baby 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 for longer than a few days is needed, your doctor may recommend additional monitoring.

Administration of this medicine is contraindicated during the third trimester.

For women of childbearing age, it should be noted that this type of medicine has been associated with reduced fertility.

Breastfeeding:

Although levels of the medicine in breast milk are negligible, it is recommended to consult your doctor if long-term treatment or high doses are needed during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are usually necessary.

Ibudol contains maltitol liquid and sodium

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

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

3. How to take Ibudol

Follow exactly the instructions for administering the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Recommended dose:

Adults and adolescents (weighing over 40 kg) aged 12 years and older:

Take one 400 mg sachet every 6–8 hours, if needed. Do not take more than 3 sachets (1200 mg) within 24 hours.

Children and adolescents:

This medicine is not recommended for use in children or adolescents weighing less than 40 kg, as the ibuprofen dose contained is not suitable for the recommended dosing regimen in these patients.

Elderly patients (> 65 years):

Dosage should be determined by a physician, as a reduction from the usual dose may be necessary. Elderly individuals are more likely to experience adverse effects, so dose reduction may sometimes be required. Consult your doctor.

Patients with kidney, liver, or heart disease:

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

Method of administration

This medicine is for oral use.

Ibudol is a suspension. It must be homogenized before taking by pressing several times with your fingers on the upper and lower parts of the sachet. It can be taken directly from the sachet or diluted in water. If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

Always use the lowest dose that is effective. Treatment should be administered only when pain or fever is present. As these symptoms subside, the medication should be discontinued.

If symptoms worsen, if fever persists for more than 3 days, or if pain lasts longer than 5 days (3 days in adolescents), consult your doctor.

If you take more Ibudol than you should

If you have taken more Ibudol than recommended, or if a child has accidentally ingested the contents of the package, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91 562 04 20, or go to the nearest hospital to assess the risk and receive advice on necessary measures, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination. More severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingestion of large amounts). At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

In cases of severe poisoning, the doctor will take the necessary measures.

If you forget to take Ibudol

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

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

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

4. Possible adverse effects

Like all medicines, Ibudol may cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as Ibudol 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.

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

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines containing ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects include:

Uncommon: inflammation of the oral mucosa with ulcer formation.

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

Very rare: pancreatitis.

Cardiovascular:

Medicines containing ibuprofen may be associated with a moderate increase in the 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), hypertension, and heart failure have also been observed in association with treatment with ibuprofen-type medicines.

Dermatological:

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

Red, non-elevated 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).
Generalized red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Medicines containing ibuprofen may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of 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: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Other adverse effects are:

Common: skin rash.

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

Very rare: hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of blood vessels in the skin.

Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Generalized 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 Ibudol if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi preventing air passage to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of 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).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling of instability.

Rare: paresthesia (numbness, tingling, "pins and needles," more commonly in hands, feet, arms, or legs).

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

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

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

Auditory:

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

Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood-related:

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

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 urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Medicines containing ibuprofen may, in rare cases, be associated with liver injury.

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

Frequency not known: liver failure (severe liver impairment).

General:

Worsening of inflammation during infectious processes.

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

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

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or significant skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibudol

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

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibudol

The active substance 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.

Appearance of Ibudol and contents of the pack

Viscous white oral suspension with a characteristic strawberry odor.

It is presented in thermo-sealed sachets made of an aluminum complex (polyester, aluminum, polyethylene, polyester, and polyethylene).

Each pack contains 20 sachets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: July 2024.

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