IBUFEN INFANTIL FORTE 40 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibufén Infantil Forte 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 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 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 case of children from 3 to 5 months, you should consult a doctor if symptoms worsen or if after 24 hours they persist.

Contents of the Package Leaflet

1. What is Ibufén Infantil Forte and what is it used for
2. What you need to know before taking 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 further information

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

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

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

2. What you need to know before taking Ibufén Infantil Forte

Do not take Ibufén Infantil Forte

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. Reactions that indicate allergy could 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 dehydration (caused by vomiting, diarrhea, or insufficient 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 disorder or have high blood pressure.
• if you have asthma or any other respiratory disorder.
• if you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis 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 indicate the frequency of these checks.
• 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 greater 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 you take simultaneously medications that alter blood coagulation such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that could increase the risk of such bleeding 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 produces, usually, bloody diarrhea) or ulcerative colitis, as medications of the Ibufén Infantil Forte type may worsen these conditions.
• if you are being treated with diuretics (medicines used to increase urine production) because 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 produce aseptic meningitis (inflammation of the meninges, which are the membranes 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 suffer from headaches after prolonged treatment, you should not take higher doses of the medication.
• it is possible that allergic reactions may occur with this medication.
• your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• it is advisable not to take this medication if you have chickenpox.
• if you have an infection: see the "Infections" section later.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibufén Infantil immediately and contact your doctor or medical emergency service immediately if you observe any of these signs.

It is important that you use the smallest dose that relieves/controls the pain and do not take this medication 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 syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue 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 go to the doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

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

Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and Adolescents

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

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of medications of the Ibufén Infantil Forte type 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 considered strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

For patients of childbearing age, it should be taken into account that medications of the Ibufén Infantil Forte type have been associated with a decrease in fertility.

Infections

Ibufén Infantil Forte may mask the signs of an infection, such as fever and pain. Consequently, Ibufén Infantil Forte 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 your doctor without delay.

Taking Ibufén Infantil Forte with Other Medications

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

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

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

• Other non-steroidal anti-inflammatory drugs like aspirin, as they may increase the risk of ulcer and gastrointestinal bleeding.

• Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine.
• Anticoagulant medications, e.g., to treat coagulation problems/prevent coagulation (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• 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 (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluticonazole (used to treat fungal infections).

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

Taking ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are going 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

The use of this medication is not recommended in women who are trying to become pregnant. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Pregnancy

Because the administration of ibuprofen-type medications 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 considered 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.

Fertility

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

Breastfeeding

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 become pregnant or are breastfeeding, consult your doctor or pharmacist before using any medication.

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, 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, you do not need to take special precautions.

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

This applies to a greater extent to the combination with alcohol.

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

This medication contains maltitol liquid. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may have a slight laxative effect. Caloric value: 2.3 kcal/g of maltitol.

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

This medication contains 0.00021 mg of benzyl alcohol per milliliter. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This product should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

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

This medication contains less than 0.00007 mg of alcohol (ethanol) per milliliter. The amount of alcohol in this medication is much less than 1 ml of beer. The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to Take Ibufen Infantil Forte

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

Only for occasional use and during limited periods.

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

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

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

The recommended dose is 5-10 ml (200-400 mg of ibuprofen) at intervals of no 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 intake should not exceed 400 mg of ibuprofen. More than 400 mg in a single intake does not provide a better analgesic effect.

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

In adults and adolescents, a doctor should be consulted if this medication is required for more than 3 days in case of fever or 5 days in case of pain, or if symptoms worsen.

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the child's age and weight. As a general rule, for children from 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 done under medical prescription.

As a guide, 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 in 24 hours. The dose to be administered in each dose every 6 hours will be recalculated/reduced proportionally.

The use of this medication is not recommended in children under 3 months or with a weight below 5 kg.

• Over 65 years: the dosage should be established by the doctor, as there may be a need to reduce the usual dose.
• Patient with kidney, liver, or heart disease: should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe heart, kidney, and liver failure.

Adult and adolescent 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.

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

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

Method of administration

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

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

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

Patient with stomach upset should take the medication with milk and/or during meals.

If you take more Ibufen Infantil Forte than you should

If you have taken more ibuprofen than you should, or if a child has ingested the medication accidentally, consult a doctor immediately or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out 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.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. In rare cases, cases of increased blood acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system have occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

If a severe poisoning has occurred, kidney failure 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 Ibufen Infantil Forte

Do not take a double dose to make up for forgotten 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 forgotten dose and take the next dose at the usual time.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

The incidence of adverse effects is lower in short 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 1200 mg of oral ibuprofen:

• Frequent adverse effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting blood, headache, dizziness or instability, fatigue.

• Uncommon adverse effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or prickling, more frequent in hands, feet, arms, or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (liver inflammation), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder) and nephrotic syndrome (disorder characterized by proteins in the urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, 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 larynx, shortness of breath, 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 suffered from 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 adverse effects are decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and skin pallor), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• Very rare adverse effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe liver damage), heart failure, myocardial infarction, hypertension. Exacerbation of inflammation-related infections has been observed with the use of NSAIDs. If signs of infection or worsening occur during the use of ibuprofen, it is recommended to consult 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 usually produces bloody diarrhea). A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome 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 blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibufen Infantil Forte if you experience these symptoms and seek medical attention immediately. See also section 2.

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

If any of the following adverse effects occur, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Reddish, non-elevated, target-shaped, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, 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. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of Adverse Effects

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

5. Conservation of Ibufen Infantil Forte

Keep this medication out of 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 shown on the container after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibufen Infantil Forte

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• 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), thaumatin, and purified water.

Product Appearance and Package Contents

Ibufen Infantil Forte is a viscous oral suspension, white or almost white in color, and with a strawberry flavor.

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

It is available in 30, 100, 150, and 200 ml containers. Some package sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes (Madrid)

Spain

“or”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191 Spain

“or”

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

“or”

FARMALIDER, S.A.

C/ Aragoneses, 2

28108- Alcobendas-Madrid

Spain

“or”

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this prospectus: November 2024

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