Leaflet: information for the patient user

Ibudol rapid 400 mg granulated for oral solution

Ibuprofen (arginine)

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

Follow exactly the administration instructions for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if the symptoms worsen, or the fever persists for more than 3 days or the pain for more than 5 days

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

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

3. How to take Ibudol rapid

4. Possible side effects

5. Storage of Ibudol rapid

6. Contents of the pack and additional information

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents 12 years of age or older (weight equal to or greater than 40kg), for symptomatic relief of occasional mild or moderate pains, such as headaches, toothaches, menstrual cramps, muscle pains (contractures) or back pain (lumbago) as well as feverish states.

Do not take Ibudol rapid

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have an allergy to other medications such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. Such reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have a serious liver or kidney disease.

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

Inform your doctor

• If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or corticosteroids and selective serotonin reuptake inhibitors (SSRIs) antidepressants.

• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-containing medications may worsen these conditions.

• If you have kidney or liver disease.

• If you have heart disease or high blood pressure.

• If you have phenylketonuria (a genetic disorder affecting metabolism).

• If you have edema (fluid retention).

• If you have asthma or any other respiratory disorder.

• If you are over 65 years old or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.

• If you have an infection; see the "Infections" heading later.

• If you experience redness, inflammation, or skin lesions; see the "Skin Reactions" heading later.

Skin Reactions

Be especially cautious with Ibudol rapid:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GAP), have been reported in association with ibuprofen treatment. Discontinue Ibudol rapid treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

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

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

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

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or if you are a smoker.

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

Interference with laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen concentrations, serum creatinine, and potassium concentrations (may increase).
• With liver function tests: increased values of transaminases.

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

Children and adolescents

This medication is not recommended for children and adolescents weighing less than 40 kg or under 12 years old.

Use of Ibudol rapid with other medications

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

This medication may affect or be affected by other medications. For example:

• Oral anticoagulants (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

The following medications may interfere and should not be taken together with this medication without consulting your doctor:

• Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs: increase the risk of gastrointestinal ulcers and bleeding.Anti-hypertensive medications (beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other anti-hypertensive substances. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) like ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of blood clots) like warfarin.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).

• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins like phenytoin (used in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used in the treatment of certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Fluconazole (used in the treatment of fungal infections).
• Pentoxifylline (used in the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used in gout).
• Sulfonylureas like tolbutamide (used in diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).

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

Taking Ibudol rapid with food, drinks, and alcohol

You can take this medication with or without food. It is generally recommended to take it with meals or immediately after eating to reduce the possibility of gastrointestinal discomfort.

Do not take this medication with alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Due to the association of ibuprofen-containing medications with an increased risk of congenital anomalies/abortions, administration during the first and second trimesters is not recommended unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

This medication is contraindicated in the third trimester of pregnancy. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong labor more than expected. Do not take ibuprofen during the first six months of pregnancy unless clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for extended periods during breastfeeding.

Fertility

Ibuprofen use may alter female fertility and is not recommended for women trying to conceive.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose or take it for a short period, no special precautions are necessary.

Ibudol rapid contains aspartame (E-951), saccharose, and sodium

This medication contains 20 mg of aspartame (E-951) in each sachet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per mg; it is essentially "sodium-free."

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

This medication is only for occasional use and for limited periods. The effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 12 years (weight equal to or greater than 40kg)

1 tablet (400 mg of ibuprofen) every 6 or 8 hours as needed. Do not take more than 3 tablets (1,200 mg of ibuprofen) in 24 hours.

Senior patients

The dose should be established by your doctor, as it may be necessary to reduce the usual dose.

Patients with kidney, liver or heart diseases:

Your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

Always use the lowest effective dose

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

You should consult a doctor if symptoms 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.

Use in children

This medication is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Administration form:

This medication is administered orally.

Dissolve completely the contents of a packet in a glass of water and ingest it immediately. Take this medication with meals or with milk, especially if digestive discomfort is noted.

If you take more Ibudol rapid than you should

If you have taken more of the medication than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Low potassium levels in the blood, chills, and breathing difficulties have also been reported.

If a severe overdose has occurred, your doctor will take the necessary measures.

If a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

If you forgot to take Ibudol rapid granulated for oral solution

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Frequencies are established according to the following classification: side effectsvery frequent(may affect more than 1 in 10 patients); side effectscommon(may affect up to 1 in 10 patients); side effectsinfrequent(may affect up to 1 in 100 patients); side effectsrare(may affect up to 1 in 1,000 patients); side effectsvery rare(may affect up to 1 in 10,000 patients); side effects ofunknown frequency(cannot be estimated from the available data).

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with ibuprofen-containing medicines are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients.

Very frequent:indigestion, diarrhea

Common:nausea, vomiting, abdominal pain

Infrequent:gastritis, bleeding and gastrointestinal ulcers, ulcerative stomatitis.

Rare:gastrointestinal perforation, flatulence, constipation, esophagitis, esophageal stenosis, exacerbation of diverticular disease, non-specific hemorrhagic colitis, ulcerative colitis or Crohn's disease.

Skin and subcutaneous tissue disorders

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

• Flat, red, non-elevated spots, in the form of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Common:skin eruption.

Infrequent:skin redness, itching or swelling, swelling of the lips, face, or tongue, increased nasal secretion, and breathing difficulty

Rare:severe allergic reaction (anaphylactic shock).

Very rare:intense skin itching or sudden blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions influenced by light.

Ibuprofen-containing medicines may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Unknown frequency:A severe skin reaction known as DRESS syndrome may occur.

The symptoms of DRESS syndrome include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema).Stop taking this medicine if you experience these symptoms and seek immediate medical attention.

Nervous system disorders

Common:fatigue or drowsiness, headache, dizziness, or feeling unstable.

Infrequent:insomnia, anxiety, restlessness, visual disturbances, ringing or buzzing in the ears.

Rare:disorientation or confusion, nervousness, depression, abnormal or blurred vision, and hearing difficulty.

Very rare:aseptic meningitis.

Blood disorders

Very rare:prolonged bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, symptoms similar to the flu, excessive fatigue, nasal and skin bleeding)

Cardiovascular and vascular disorders

Ibuprofen-containing medicines may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

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

Very rare:hypertension, edema (fluid retention)

Renal and urinary disorders

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration)

Ibuprofen-containing medicines may be associated, in rare cases, with liver damage.

General disorders

Very rare:exacerbation of inflammatory processes during infectious processes

Reporting of side effects

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

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

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Ibudol rapid

• The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen in the form of ibuprofen (arginine).
• The other components are: Arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, a mint compound aroma consisting of aromatic components (natural flavor preparations, natural flavor substances, and identical natural flavor substances), non-aromatic components (which contain modified cornstarch (E-1450), maltodextrin, triacetin (E-1518)), active substances (menthol), and purified water.

Appearance of Ibudol rapid and content of the container

Sachets with oral solution granules.

White granules with a characteristic mint odor packaged in paper/aluminum/polyethylene sachets.

Presented in containers with 20 sachets.

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

or

Lamp S. Prospero S.P.A

Via Della Pace, 25/A´

41030 San Prospero (MO)

Italy

Last review date of this leaflet: August 2024

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