Ibudol Rapid 400 mg granules for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibudol rapid 400 mg oral solution granules

Ibuprofen (arginine)

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Leaflet Contents

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

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

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

This medicine is used in adults and adolescents aged 12 years and older (weighing 40 kg or more) for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (strains), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Ibudol rapid

Do not take Ibudol rapid

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Such reactions may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you suffer from severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have severe liver or kidney disease.

Signs of allergic reaction to this medicine, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported with ibuprofen. Stop using Ibudol rapid immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Inform your doctor

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms. This risk is higher when high doses are used, with prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medication.

• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such 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 results in bloody diarrhea) or ulcerative colitis, as medicines 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 (hypertension).

• If you have phenylketonuria (an inherited metabolic disorder).

• If you have edema (fluid retention).

• If you have asthma or any other respiratory disorder.

• If you are over 65 years of age or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should occur.

• If you have an infection; see the section titled «Infections» below.

• If you develop skin redness, inflammation, or skin lesions; see the section titled «Skin reactions» below.

Skin reactions

Take special care with Ibudol rapid:

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 rapid and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

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

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

Do not exceed the recommended dose or duration of treatment.

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

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a “mini-stroke” or transient 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 types of medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Interference with 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 alter test results.

Children and adolescents

This medicine is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years of age.

Use of Ibudol rapid with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Anticoagulant medicines (e.g., used 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).

The following medicines may interact and therefore should not be taken together with this medicine without first consulting your doctor:

• 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 effectiveness of diuretics and other antihypertensive agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia and increase the risk of renal toxicity.

• Antiplatelet agents (prevent blood clots in blood vessels), such as ticlopidine.

• Anticoagulants (medicines used to “thin” the blood and prevent clots), such as warfarin.

• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.

• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (which slows the growth of certain body cells).

• Mifepristone (abortion-inducing agent).

• Digoxin and cardiac glycosides (used in the treatment of heart disorders).

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

• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).

• Corticosteroids such as cortisone and prednisolone.

• Diuretics (medicines used to increase urine output).

• Fluconazole (used to treat fungal infections).

• Pentoxifylline (used for intermittent claudication).

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

• Quinolone antibiotics such as norfloxacin.

• Sulfinpyrazone (for gout).

• Sulfonylureas such as tolbutamide (for diabetes).

• Tacrolimus (used in organ transplants to prevent rejection).

• Zidovudine (an anti-HIV medicine).

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

Taking Ibudol rapid with food, drinks and alcohol

You may take this medicine with or without food. It is generally recommended to take it during or immediately after meals to reduce the possibility of stomach discomfort.

Do not take this medicine 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Because administration of medicines containing ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, use during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

This medicine is contraindicated during 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 may delay or prolong labor beyond expected duration. 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 fetus if taken for more than a few days, which may 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Fertility

The use of ibuprofen may impair female fertility and is not recommended for women attempting to conceive.

Driving and using machines

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

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

This medicine contains 20 mg of aspartame (E-951) per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body’s inability to properly eliminate it.

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

This medicine contains less than 23 mg of sodium (1 mmol) per mg; hence, it is essentially “sodium-free”.

3. How to take Ibudol rapid

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

For occasional use only and for limited periods. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 12 years of age (weighing 40 kg or more)

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

Elderly patients

The dose should be determined by your doctor, as a reduction from the usual dose may be necessary.

Patients with kidney, liver, or heart disease:

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

Always use the lowest effective dose

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

Consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days in adolescents or 5 days in adults, or if pain persists beyond these periods.

Use in children

The use of this medicine is not recommended in children and adolescents weighing less than 40 kg or under 12 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing regimen in this patient group.

Method of administration:

This medicine is for oral use.

Dissolve the entire contents of one sachet completely in a glass of water and take immediately. Take this medicine with food or milk, especially if you experience gastrointestinal discomfort.

If you take more Ibudol rapid than you should

If you have taken more of the medicine than you should or have accidentally ingested the contents of the package, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. 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.

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

If a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

If you forget to take Ibudol rapid granules for oral solution

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

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

4. Possible adverse effects

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

Frequencies are defined according to the following classification: very common adverse effects (may affect more than 1 in 10 people); common adverse effects (may affect up to 1 in 10 people); uncommon adverse effects (may affect up to 1 in 100 people); rare adverse effects (may affect up to 1 in 1,000 people); very rare adverse effects (may affect up to 1 in 10,000 people); adverse effects with unknown frequency (cannot be estimated from the available data).

The following adverse effects have been observed:

Gastrointestinal disorders

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

Very common: dyspepsia (indigestion), diarrhoea

Common: nausea, vomiting, abdominal pain

Uncommon: gastritis, gastrointestinal haemorrhage and ulcers, ulcerative stomatitis

Rare: gastrointestinal perforation, flatulence, constipation, oesophagitis, oesophageal stenosis, exacerbation of diverticular disease, haemorrhagic colitis, ulcerative colitis or Crohn's disease

Skin and subcutaneous tissue disorders

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

• Non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Common: skin rash

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

Rare: severe allergic reaction (anaphylactic shock)

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

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

Frequency not known: A serious 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).

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

Nervous system disorders

Common: fatigue or drowsiness, headache, dizziness or feeling unsteady

Uncommon: insomnia, anxiety, restlessness, visual disturbances, tinnitus (ringing or buzzing in the ears)

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

Very rare: aseptic meningitis

Blood disorders

Very rare: prolonged bleeding time, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds and skin bleeding)

Cardiac and vascular disorders

Ibuprofen-containing medicines 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.

Very rare: hypertension (high blood pressure), oedema (fluid retention)

Renal and urinary disorders

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

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

General disorders

Very rare: worsening of inflammation during infectious processes

Reporting of adverse effects

If you experience any adverse effect, talk to 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 rapid

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibudol rapid

• The active substance 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, mint flavour composed of flavouring components (natural flavouring preparations, natural flavouring substances and natural-identical flavouring substances), non-flavouring components (containing modified maize starch (E-1450), maltodextrin, triacetin (E-1518)) and active substances (pulegone) and purified water.

Appearance of Ibudol rapid and contents of the pack

Granules for oral solution in sachets.

White-coloured granules with a characteristic mint odour, packed in paper/aluminium/polyethylene sachets.

Packaged in containers of 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 most recent review of this leaflet: August 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/.