IBUDOL RAPID 400 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ibudol Rapid 400 mg Granules for Oral Solution

Ibuprofen (arginine)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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

Contents of the Package Leaflet

1. What is Ibudol Rapid and what is it used for
2. What you need to know before taking 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

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

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

This medication is used in adults and adolescents from 12 years old (weight equal to or greater than 40 kg) for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), as well as febrile states.

2. What you need to know before taking Ibudol Rapid

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 non-steroidal anti-inflammatory drugs. Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you have severe heart failure
• If you are in the third trimester of pregnancy
• If you have a severe liver or kidney disease.

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

Tell your doctor

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

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

• If you have or have had kidney or liver disease

• If you have or have had heart disease or high blood pressure (high blood pressure).

• If you have phenylketonuria (a hereditary disorder that affects 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 a prolonged period (more than 1 to 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 notice redness and inflammation or skin injury; see the "Skin Reactions" heading later.

Skin Reactions

Be especially careful 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibudol Rapid treatment and seek immediate medical attention if you notice any 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, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

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

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

Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Interference with Laboratory Tests:

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

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

Children and Adolescents

The use of this medication is not recommended in children and adolescents weighing less than 40 kg or under 12 years old.

Use of Ibudol Rapid with Other Medications

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

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

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, 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).

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

• Acetylsalicylic acid or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding. Antihypertensives (beta-blockers, ACE inhibitors, and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. 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 or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as 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 medication (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 such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination).
• Fluconazole (for the treatment of fungal infections).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).

Other medications may also affect or be affected by ibuprofen treatment. Therefore, you should 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 alone or with food. In general, it is recommended to take it during meals or immediately after eating to reduce the possibility of stomach discomfort.

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

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Because the administration of medications containing ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is 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 and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Breastfeeding

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

Fertility

The use of ibuprofen may affect female fertility and is not recommended in women trying to conceive.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take one dose or take it for a short period, you do not need to take special precautions.

Ibudol Rapid Contains Aspartame (E-951), Sucrose, 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 case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains sucrose. 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; that is, it is essentially "sodium-free".

3. How to Take Ibudol Rapid

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

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

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

1 sachet (400 mg of ibuprofen) every 6 or 8 hours, as needed. Do not take more than 3 sachets (1200 mg of ibuprofen) in 24 hours.

Elderly patients

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

Patients with kidney, liver, or heart disease:

It is possible that your doctor will prescribe a lower dose than usual. If so, take the exact dose that your doctor has prescribed.

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

The use of this medication is not recommended in children and adolescents weighing less than 40 kg or under 12 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Method of Administration:

This medication is administered orally.

Dissolve the contents of one sachet completely in a glass of water and drink it immediately. Take this medication with food or milk, especially if you notice stomach discomfort.

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 contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If a severe poisoning has occurred, the 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 find out about the risk and ask for advice on the measures to be taken.

If You Forget to Take Ibudol Rapid Oral Granules

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequencies are established according to the following classification: very frequent adverse effects (may affect more than 1 in 10 patients); frequent adverse effects (may affect up to 1 in 10 patients); infrequent adverse effects (may affect up to 1 in 100 patients); rare adverse effects (may affect up to 1 in 1,000 patients); very rare adverse effects (may affect up to 1 in 10,000 patients); adverse effects of unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal Disorders

The most frequent adverse effects that occur with ibuprofen medications are gastrointestinal: peptic ulcers, digestive hemorrhages, perforations (in some cases fatal), especially in elderly patients.

Very frequent:dyspepsia (indigestion), diarrhea

Frequent:nausea, vomiting, abdominal pain

Infrequent: gastritis, gastrointestinal hemorrhages and 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.

Disorders of the Skin and Subcutaneous Tissue

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

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

Frequent:skin rash.

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

Rare: severe allergic reaction (anaphylactic shock).

Very rare: intense itching of the skin with sudden onset or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions due to light influence.

Ibuprofen medications 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 rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Widespread, red, scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you experience these symptoms and seek immediate medical attention.

Nervous System Disorders

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

Infrequent:insomnia, anxiety, restlessness, vision changes, 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, flu-like symptoms, excessive fatigue, nasal and skin bleeding)

Cardiac and Vascular Disorders

Ibuprofen medications 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: arterial hypertension, edema (fluid retention)

Renal and Urinary Disorders

Rare:hepatitis (liver inflammation) and jaundice (yellowing of the skin)

Ibuprofen medications may be associated, in rare cases, with liver damage.

General Disorders

Very rare: worsening of inflammation during infectious processes

Reporting of Adverse Effects

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

5. Conservation of Ibudol rapid

Keep this medication out of 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.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibudol 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, mint flavor composed of flavoring components (natural flavoring preparations, natural flavoring substances, and natural-identical flavoring substances), non-flavoring components (which contain modified corn starch (E-1450), maltodextrin, triacetin (E-1518)), and active substances (pulegone) and purified water.

Appearance of Ibudol rapid and Package Contents

Sachets with granules for oral solution.

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

It is presented in packages with 20 sachets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Manufacturer

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

Date of the Last Revision of this Prospectus:August 2024

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