IBLASIN 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Iblasin 20 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 administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or if the fever or pain does not improve after 3 days (5 days in adults, in case of pain).

Contents of the Package Leaflet

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

1. What is Iblasin and what is it used for

The active substance of this medicine, ibuprofen, acts by reducing pain and fever.

Iblasin is used in children from 6 months of age and adults for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, menstrual, muscular (cramps) or back (lumbago) pain, as well as in febrile conditions.

You should consult a doctor if it worsens or if it 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 non-steroidal anti-inflammatory medicines (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications 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

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

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with Iblasin, as it may mask fever, which is an important sign of infection, making its diagnosis more difficult.
• If you have an infection; see the "Infections" section 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration.
• 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 high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If your doctor has prescribed an antiplatelet medication(to prevent blood clots) that contains acetylsalicylic acid, and you also take Iblasin, you should separate the intake of both medications. To do this, you can follow either of the following guidelines:

• Take the dose of acetylsalicylic acid and wait at leasthalf an hourbefore administering the dose of Iblasin.
• Take the dose of Iblasin at least 8 hours beforeadministering acetylsalicylic acid.

• If you take 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 may 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 bloody diarrhea) or ulcerative colitis, as medications like Iblasin may worsen these conditions.
• If you are undergoing treatment with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• It is essential to use the smallest dose that relieves-controls the pain and not to take this medication for longer than necessary to control your symptoms.

Iblasin may mask the signs of an infection, such as fever and pain. Consequently, Iblasin 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 take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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 treatment with Iblasin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop using Iblasin immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Skin reactions

Severe skin reactions have been reported with Iblasin treatment. Stop taking Iblasin and consult a doctor immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of 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 Iblasin 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, stroke, or if you are a smoker.

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

Precautions during pregnancy and in women of childbearing age

Since the administration of medications like 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.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that medications like ibuprofen have been associated with a decrease in fertility.

Interference with laboratory tests

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

Other medications and Iblasin

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or discontinue treatment. Iblasin may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory medications, such as aspirin.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Corticosteroids, such as cortisone and prednisolone.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (inducer of abortions).
• Digoxin and other 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).
• Diuretics (medications used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group, such as norfloxacin.
• Ion exchange resins, such as cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Oral hypoglycemic agents (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 (medication against the AIDS virus).
• Medications that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin-II receptor antagonists, such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

If your doctor has prescribed an antiplatelet medication(to prevent blood clots) that contains acetylsalicylic acid, and you also take Iblasin, you should separate the intake of both medications (see section Warnings and precautions).

Other medications may also affect or be affected by treatment with Iblasin. Therefore, you should always consult your doctor or pharmacist before using Iblasin with other medications.

Taking Iblasin with food, drinks, and alcohol

You can 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 upset.

You should not take ibuprofen with alcohol to avoid damaging the stomach.

The use of ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages: beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

Do not take this medication if you are in the last 3 months of pregnancy, as it could 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 delivery more than expected. You should not take this medication during the first 6 months of pregnancy unless it is absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the lowest dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, potentially causing 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 monitoring.

Breastfeeding women should consult their doctor or pharmacist before taking this medication. Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

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

IMPORTANT FOR WOMEN:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

Although it is not expected to have effects in this sense, if you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Iblasin contains sodium benzoate, sorbitol, and sodium

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

This medication 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 indicated that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

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

3. How to take Iblasin

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

The effective lowest dose should be used for the shortest time 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 age and weight of the child. For children from 6 months to 12 years, the recommended daily dose is 20 to 30 mg/kg of weight, divided into three or four doses (see table). The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

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

Orientatively, the doses in the following table can be repeated every 6-8 hours, without exceeding the maximum daily amount indicated in the third column for the corresponding weight range.

Adultsand adolescents from 12 years (and weight over40 kg):the doses will be 10 ml of suspension (200 mg) every 4-6 hours, if necessary. If the pain or fever does not respond to this dose, 400 mg can be administered every 4-6 hours (20 ml of suspension). Do not administer more than 60 ml (1200 mg) of ibuprofen, equivalent to 6 doses of 200 mg (1200 mg), per day.

Due to the dose, it is recommended to use other more suitable presentations for the treatment with ibuprofen in adults and adolescents.

Elderly patients:in elderly patients, the dosage should be established by the doctor, as these patients are more prone to adverse effects and sometimes a reduction of the usual dose is necessary.

Patients with reduced kidney, liver, or heart function:consult your doctor because they may need a dose reduction.

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

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

If you need to use this medication in children from 6 months and adolescents for more than 3 days or if symptoms worsen, you should consult your doctor.

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

Method of administration

This medication is a suspension for oral administration. It can be administered directly or diluted in water.

For exact dosing, the containers contain a syringe. First, shake the solution, then insert the syringe into the perforated cap, turn the bottle upside down, pull the plunger until the liquid reaches the amount prescribed by the doctor, return the bottle to its initial position, and remove the syringe.

The syringe must be disassembled, washed, and dried, and can be sterilized by boiling in water or immersing it in the sterilizing solution used for baby bottles.

The syringe should be cleaned and dried after each use.

Take the medication with meals or with milk, especially if you notice digestive discomfort.

If you take more Iblasin than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the container and the prospectus of the medication to the healthcare professional.

Mild symptoms that may occur after an overdose are: abdominal pain, nausea, vomiting, indifference, sleep, headache, rapid involuntary eye movements, ringing in the ears, and lack of muscle coordination.

It is rare for more serious symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, dyspnea/acute adult respiratory distress syndrome, low potassium levels in the blood, and transient respiratory arrest in children (after ingesting large amounts).

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

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

If you forgot to take Iblasin

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the missed dose and take the next dose at its usual time.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them. The adverse effects of medications like Iblasin are more common in people over 65 years of age.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

• Reddish, non-raised, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

• Generalized skin rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequent (may affect up to 1 in 10 people): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (skin rashes, itching), and ringing in the ears.

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

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

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

Frequency not known (the frequency cannot be estimated from the 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 start of treatment (acute generalized exanthematous pustulosis). Chest pain, which can 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 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 Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Iblasin

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

This medication must be used within 9 months after opening.

Do not use this medication after the expiration date that appears on the container after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Container contents and additional information

Composition of Iblasin

The active ingredient is ibuprofen. Each ml of suspension contains 20 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 flavor (contains triacetin and alpha-tocopherol), and purified water.

Appearance of Iblasin and container contents

Fluid white suspension, viscous, with cherry odor and flavor, packaged in 100 ml topaz-colored PET bottles with a polyethylene cap and child-resistant closure, and a graduated polystyrene and polyethylene syringe.

Marketing authorization holder and manufacturer

ITALFARMACO S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Date of the last revision of this prospectus:September 2024

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