Iblasin 40 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Iblasin 40 mg/ml 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 provided in this leaflet or as directed 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if fever or pain does not improve after 3 days (5 days in adults, in the case of pain).

Contents of the leaflet

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

1. What Iblasin is and what it is used for

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

Iblasin is used in children from 6 months of age and adults 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 in febrile conditions.

You should consult a doctor if your condition worsens or does not improve after 3 days (5 days in adults, in case of pain).

2. What you need to know before taking Iblasin

Do not take Iblasin

• 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 ingredients of this medicine (listed in section 6). Signs of allergy may include skin rash with itching, 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 gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines at the same time, 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

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

• If you have oedema (fluid retention).

• If you have or have previously had heart problems or high blood pressure.

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

• If you are being treated with Iblasin, as it may mask fever, an important sign of infection, making diagnosis more difficult.

• 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 for a prolonged period (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, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal 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 or long-term treatment are used, 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 your doctor has prescribed a platelet anti-aggregation medicine (to prevent blood clot formation) containing acetylsalicylic acid, and you are also taking Iblasin, you must separate the administration of both medicines. You may follow either of the following regimens:

  • Take the dose of acetylsalicylic acid and wait at least half an hour before taking Iblasin.
  • Take the dose of Iblasin at least 8 hours before taking acetylsalicylic acid.

• If you are taking other medicines that affect blood coagulation, such as oral anticoagulants or platelet anti-aggregation agents like acetylsalicylic acid. You should also inform your doctor about 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 results in bloody diarrhoea) or ulcerative colitis, as medicines like Iblasin may worsen these conditions.

• If you are taking diuretics (medicines to increase urine production), as your doctor needs to monitor your kidney function.

• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) 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 perform closer monitoring if you receive ibuprofen after major surgery.

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

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

Iblasin may mask signs of infection, such as fever and pain. Therefore, Iblasin may delay appropriate treatment of 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 immediately.

Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Iblasin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Iblasin immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions

Serious skin reactions have been reported with Iblasin treatment. Stop taking Iblasin and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See 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.

Discuss your treatment with your doctor or pharmacist before taking Iblasin 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 ischaemic 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).

Precautions during pregnancy and in women of childbearing age

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

Administration of ibuprofen is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with reduced fertility.

Interference with diagnostic tests

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

Other medicines and Iblasin

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

In particular, if you are using any of the following medicines, it may be necessary to adjust the dose or discontinue treatment. Iblasin may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs such as aspirin.
• Anticoagulant medicines, e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Corticosteroids such as cortisone and prednisolone.
• Lithium (used to treat depression). Your doctor may need to adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to 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).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• 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).
• Oral hypoglycaemic agents (sulphonylureas) such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplantation to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

If your doctor has prescribed a platelet anti-aggregation medicine containing acetylsalicylic acid, and you are also taking Iblasin, you must separate the administration of both medicines (see section Warnings and precautions).

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

Taking Iblasin with food, drinks, and alcohol

You may take it alone or with food. In general, it is recommended to take it during meals or with milk to reduce the possibility of stomach discomfort.

Do not take ibuprofen with alcohol, as this may damage the stomach.

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

Do not take this medicine during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond expected duration. Do not take this medicine during the first 6 months of pregnancy unless absolutely necessary and specifically advised by your doctor. If treatment is needed during this period or while trying to become pregnant, take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus 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 more than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding women should consult their doctor or pharmacist before taking this medicine. Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

IMPORTANT FOR WOMEN:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

Although effects in this regard are not expected, if you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are necessary.

Iblasin contains sodium benzoate, sorbitol (E420), and sodium

This medicine contains 100 mg of sodium benzoate (E211) per 100 ml of suspension, equivalent to 1 mg/ml of sodium benzoate in the suspension.

This medicine contains 11.62 g of sorbitol (E420) per 100 ml of suspension, equivalent to 116.2 mg of sorbitol/ml of suspension. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, you (or your child) should consult your doctor before taking this medicine.

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

3. How to take Iblasin

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

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

The recommended dose of ibuprofen depends on the child's age and weight. For children from 6 months to 12 years of age, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four doses (see table). The interval between doses will depend on the progression of symptoms, but must never be less than 4 hours.

Before administering the medicine to children under 2 years of age, consult a doctor.

As a general guide, the doses in the following table may be repeated every 6–8 hours, without exceeding the maximum daily amount indicated in the third column for the corresponding weight range.

Adults and adolescents from 12 years of age (and weighing over 40 kg): the dose is 5 ml of suspension (200 mg) every 4–6 hours, if necessary. If pain or fever does not respond to this dose, 400 mg every 4–6 hours (10 ml of suspension) may be administered. Do not exceed 30 ml (1200 mg) of ibuprofen, equivalent to 3 doses of 400 mg (1200 mg), per day.

Due to the dosage, other more suitable formulations are recommended for ibuprofen treatment in adults and adolescents.

Elderly patients: dosage in elderly patients should be determined by the physician, as these patients are more susceptible to adverse effects and dose reduction may sometimes be necessary.

Patients with reduced kidney, liver, or heart function: Consult your doctor, as dose reduction may be required.

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

Administration of the medicine depends on the occurrence of pain or fever. As these symptoms subside, treatment should be discontinued.

If this medicine needs to be used in children from 6 months of age and adolescents for more than 3 days, or if symptoms worsen, consult your doctor.

Adult patients should consult a doctor if symptoms worsen or do not improve after 3 days in case of fever, or 5 days in case of pain.

Method of administration

This medicine is a suspension for oral administration. It may be taken directly or diluted in water.

For accurate dosing, the packaging contains a syringe. First, shake the solution, then insert the syringe into the perforated cap, invert the bottle, pull the plunger until the liquid reaches the amount prescribed by the doctor, return the bottle to its upright position, and remove the syringe.

The syringe should be disassembled, washed, and dried. It may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

The syringe should be cleaned and dried after each use.

Take the medicine with food or milk, especially if gastrointestinal discomfort occurs.

If you take more Iblasin than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Mild symptoms that may occur after an overdose include: abdominal pain, nausea, vomiting, apathy, drowsiness, headache, rapid involuntary eye movements, tinnitus, and lack of muscle coordination.

More severe symptoms such as intestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, dyspnea/acute respiratory distress syndrome in adults, low blood potassium levels, and transient respiratory arrest in children (after ingestion of large amounts) are rare.

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

In case of ingestion of large quantities, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Iblasin

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 it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.

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. Adverse effects of medicines such as Iblasin are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

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

• Non-elevated reddish 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].

• Widespread rash, high body temperature, and swollen 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).

Common (may affect up to 1 in 10 people): fatigue, headache, stomach and intestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rashes, itching), and tinnitus.

Uncommon (may affect up to 1 in 100 people): allergic reactions, asthma, rhinitis and urticaria, gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity or changes in color perception, and auditory disturbances.

Rare (may affect up to 1 in 1,000 people): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestinal perforation, liver disorders (including jaundice), kidney disorders such as: acute interstitial nephritis with hematuria (blood in urine), proteinuria (excretion of protein in urine), and occasionally nephrotic syndrome; depression, vision disorders (darkening of vision), neck stiffness, bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing), and angioedema (swelling of the deep layers of the skin, with swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing).

Very rare (may affect up to 1 in 10,000 people): aseptic meningitis (inflammation of the meninges not caused by bacteria), blood disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin disorders (cutaneous erythema), and eye and mucous membrane disorders such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions causing skin detachment), and erythema multiforme.

Frequency not known (frequency cannot be estimated from available data): 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). Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. Stop taking Iblasin if you experience these symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

Reporting of adverse effects

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

5. Storage of Iblasin

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

This medicine should be used within 9 months after opening.

Do not use this medicine after the expiry date stated on the packaging 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. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iblasin

The active substance is ibuprofen. Each ml of suspension contains 40 mg of ibuprofen.

The other components (excipients) are: xanthan gum, polysorbate 80, anhydrous citric acid, sodium benzoate (E211), sodium saccharin, glycerol (E422), sorbitol (E420), sodium hydroxide, cherry flavour (containing triacetin and alpha-tocopherol), and purified water.

Appearance of Iblasin and contents of the pack

White, viscous, free-flowing suspension with cherry odour and taste, packed in amber-coloured PET bottles with a closure and polyethylene child-resistant cap containing 100 ml of suspension. Supplied with a graduated polystyrene and polyethylene syringe.

Marketing Authorisation Holder and Manufacturer

ITALFARMACO S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Date of the latest revision of this leaflet: September 2024

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