Leaflet: information for the user

Ibufén Infantil Forte 40 mg/ml oral suspension

ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, 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 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 your symptoms worsen or do not improve after 3 days in case of fever or 5 days (3 days in children from 6 months) in case of pain. In the case of children from 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

1. What Ibufén Infantil Forte is and for what it is used

2. What you need to know before starting to take Ibufén Infantil Forte

3. How to take Ibufén Infantil Forte

4. Possible side effects

5. Storage of Ibufén Infantil Forte

6. Contents of the pack and additional informationl

Ibufén Infantil Forte contains ibuprofen as the active ingredient and belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication is used in children from 3 months old, adolescents, and adults for the symptomatic relief of occasional mild to moderate pain, as well as in febrile states.

Do not take Ibufén Infantil Forte

• if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include skin rash with itching, facial swelling, lip or tongue swelling, 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 bleeding, 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 or clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood).If it is necessary to use anticoagulants at the same time as ibuprofen, your doctor will perform blood clotting tests.
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• if you have edema (fluid retention).
• if you have or have had any heart problems or high blood pressure.
• if you have asthma or any other respiratory problems.
• if you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making its diagnosis more difficult.
• 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 tell you how often these checks should be done.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider adding a stomach-protecting medicine.

• if you take other medicines that affect blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
• if you are taking diuretics (medicines 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• if you have intermittent acute porphyria (a metabolic disease that affects your blood and may cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• if you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• it is possible that allergic reactions may occur with this medicine.
• your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.
• it is not recommended to take this medicine if you have chickenpox.
• if you have an infection: see the "Infections" heading later.
• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Ibufén Infantil immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

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

Skin reactions

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

Stop taking ibuprofen and see your doctor immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

CARDIOVASCULAR PRECAUTIONS

Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking ibuprofen if:

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

These types of medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-type medicines with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medicine during the first and second trimesters of pregnancy, unless strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, the administration of this medicine is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with a decrease in the ability to conceive.

Infections

Ibufén Infantil Forte may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibufén Infantil Forte may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Taking Ibufén Infantil Forte with other medicines

Inform your doctor or pharmacist if you are using or have recently used another medicine, even those purchased without a prescription.

Ibufén Infantil Forte may affect or be affected by other medicines. For example:

The following medicines may interfere and should not be taken together with ibuprofen without consulting your doctor:

• Other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.

• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants, e.g. for treating blood clotting problems (e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• 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.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by treatment with Ibufén Infantil Forte. Therefore, always consult your doctor or pharmacist before using Ibufén Infantil Forte with other medicines.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Glucose concentration in blood (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Concentrations of urea nitrogen in blood and serum concentrations of creatinine and potassium (may increase).
• With liver function tests: increase in transaminase values.

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibufén Infantil Forte with food, drinks, and alcohol

It is recommended to take Ibufén Infantil Forte with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Use of this medicine is not recommended in women trying to become pregnant. If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Do not take ibuprofen if you are in 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 your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do 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 week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Pregnancy

Due to the association of ibuprofen-type medicines with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medicine during the first and second trimesters of pregnancy, unless strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

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

Fertility

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with a decrease in the ability to conceive.

Breastfeeding

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

Therefore, if you become pregnant or are breastfeeding, consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibufén Infantil Forte contains maltitol liquid, sodium, sodium benzoate, benzyl alcohol, and ethanol

This medicine contains maltitol liquid. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine. It may have a mild laxative effect. Caloric value: 2.3 kcal/g of maltitol.

This medicine contains 5.79 mg of sodium (main component of table salt/for cooking) in each milliliter. This is equivalent to 0.29% of the maximum daily sodium intake recommended for an adult. This medicine contains 1 mg of sodium benzoate (E-211) in each milliliter. Sodium benzoate (E-211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medicine contains 0.00021 mg of benzyl alcohol in each milliliter. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless your doctor recommends it.

This product should not be used for more than a week in children under 3 years old unless your doctor or pharmacist advises it.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medicine contains less than 0.00007 mg of ethanol per milliliter. The amount of alcohol in this medicine is much less than 1 ml of beer. The small amount of alcohol in this medicine has no perceptible effect.

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

Only for occasional use and for limited periods.

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

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

Adults and adolescents over 12 years (≥40 kg):

The recommended dose is 5-10 ml (200-400 mg of ibuprofen) at intervals not less than 4 hours, if necessary and while symptoms persist, without exceeding 1200 mg of ibuprofen in a 24-hour period.

The maximum dose per dose should not exceed 400 mg of ibuprofen. More than 400 mg in a single dose does not provide better analgesic effect.

The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

In adults and adolescents, consult a doctor if this medication needs to be used for more than 3 days in case of fever or 5 days in case of pain or if symptoms worsen.

Children 3 months to 12 years:

The recommended dose of ibuprofen depends on the age and weight of the child. Generally, for children 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight depending on the intensity of symptoms and is divided into three doses.

The use of this medication in children under 2 years will always be by medical prescription.

As a guideline, the following doses can be followed:

The suspension can also be dosed following a regimen of 4 daily doses. In this case, the maximum daily doses (see last column of the previous table) should not be exceeded. The dose to be administered in each dose every 6 hours will be recalculated/reduced proportionally.

This medication should not be used in children under 3 months or weighing less than 5 kg.

• Over 65 years: the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.
• Patients with kidney, liver or heart disease: they should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe heart, renal and hepatic failure.

Adults and adolescents 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.

Children 6 months to 12 years should consult a doctor if symptoms worsen or do not improve after 3 days.

Children 3 to 5 months should consult a doctor if symptoms worsen or persist after 24 hours.

Administration form

Ibufen Infantil Forte is a suspension for oral administration.It can be administered directly or diluted in water.

• Shake the container before use.
• Insert the syringe into the perforated cap.
• Invert the bottle and remove the necessary dose.
• Administer the contents of the syringe directly into the mouth or in a spoon.
• The syringe should be washed after each dose and can be sterilized by boiling it in water or by immersing it in the sterilizing solution used for bottles.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; make sure to shake the bottle well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals.

If you take more Ibufén Infantil Forte than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination loss. It may also cause agitation or disorientation. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, high blood pressure, low potassium levels in the blood, chills, and breathing problems may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. In rare cases, cases of metabolic acidosis, hypothermia, kidney function alteration, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forget to take Ibufén Infantil Forte

Do not take a double dose to compensate for the missed doses. If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Rare side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), skin reactions caused by light exposure, hypersensitivity, paresthesia (numbness, tingling, burning, etc., more common in hands, feet, arms, or legs), drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Very rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue, and laryngeal swelling, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decrease in red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, bleeding, and unknown bruises.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe allergic reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and painful lesions with necrosis and epidermal detachment), and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension. Exaggeration of inflammatory reactions related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood). A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibufén Infantil Forte if you experience these symptoms and seek medical attention immediately. See section 2.

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

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the extremities or fluid accumulation in the arms or legs.
• Flat, red patches, often with blisters in the center, on the trunk, which may be accompanied by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated 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 (generalized acute pustular exanthema).

Reporting of side effects

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

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

No special storage conditions are required.

Once the container is opened, store below 30°C for a maximum of 6 months.

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 disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Ibufén Infantil Forte

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), strawberry flavor (contains benzyl alcohol and ethanol), taumatine, and purified water.

Appearance of the product and content of the container

Ibufén Infantil Forte is an oral, viscous suspension, white or almost white in color, and with a strawberry odor.

It contains a 5 ml graduated syringe with a polipropylene cylinder and a polyethylene piston.

It is presented in containers of 30, 100, 150, and 200 ml. Some container sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorios Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes (Madrid)

Spain

“o”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191 Spain

“o”

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

“o”

FARMALIDER, S.A.

C/ Aragoneses, 2

28108- Alcobendas-Madrid

Spain

“o”

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: November 2024

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