Ibufen Infantil Forte 40 mg/ml oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibufén Infantil Forte 40 mg/ml oral suspension

ibuprofen

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

Always follow exactly the instructions for taking this medicine as described 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 effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not feel better after 3 days in case of fever or 5 days (3 days in children from 6 months of age) in case of pain. For children aged 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

Leaflet Contents

1. What Ibufén Infantil Forte is and what it is 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. How to store Ibufén Infantil Forte
6. Contents of the pack and other information

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

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

This medicine is used in children from 3 months of age, adolescents, and adults for the symptomatic relief of mild to moderate occasional pain, as well as for feverish 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 to any of the other ingredients of this medicine (listed in section 6), or to other medicines of the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to aspirin. Reactions indicating allergy could include: itchy skin rash, 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 digestive tract.
• if you are vomiting blood.
• if you have black stools or bloody diarrhoea.
• if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines simultaneously, your doctor will carry out blood coagulation tests.
• if you have severe dehydration (caused by vomiting, diarrhoea, 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 oedema (fluid retention).
• if you have or have had heart problems or high blood pressure.
• if you have asthma or any other respiratory disorder.
• if you are being treated with this medicine, as it may mask fever, an important sign of infection, making 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 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
• 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 you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• 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 Ibufén Infantil Forte may worsen these conditions.
• if you are being treated with diuretics (medicines to increase urination), as your doctor must 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 your 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 headaches after prolonged treatment, you should not take higher doses of the medicine.
• allergic reactions to this medicine may occur.
• your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.
• it is advisable not to take this medicine if you have chickenpox.
• if you have an infection: see the "Infections" section below.
• Allergic reactions to ibuprofen, such as breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately stop using Ibufén Infantil and contact your doctor or emergency medical services if you notice any of these signs.

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

Skin reactions

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 with ibuprofen treatment. Discontinue treatment with Ibufén Infantil and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Stop taking ibuprofen and see your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe 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.

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

• You have heart problems, including heart failure, angina (chest pain), a history of 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.

Also, these medicines may 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 administration of medicines like Ibufén Infantil Forte has been associated with an increased risk of congenital malformations or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

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

For women of childbearing age, it should be noted that medicines like Ibufén Infantil Forte have been associated with reduced fertility.

Infections

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

Taking Ibufén Infantil Forte with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine, including those obtained without a prescription.

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (which prevent blood clots in blood vessels), such as ticlopidine.
• Anticoagulant medicines, e.g. to treat or prevent blood clotting (e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine 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 (an abortion-inducing agent).
• Digoxin and 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).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as hypoglycaemia may occur.
• Tacrolimus or cyclosporine (used in organ transplants 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.
• 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.

Taking ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are due to have a clinical test 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, during meals, or immediately after eating, to reduce the possibility of stomach discomfort. Do not drink alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended in women 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 medicine.

Do not take ibuprofen 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 your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour. Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, 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 is needed for more than a few days, your doctor may recommend additional monitoring.

Pregnancy

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

In the third trimester, administration of ibuprofen is contraindicated.

Fertility

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

Breastfeeding

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 or pharmacist before using any medicine.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do 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 usually necessary.

Ibuprofen may delay your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is especially important when combined with alcohol.

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

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine. It may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.

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

This medicine contains 0.00021 mg of benzyl alcohol per millilitre. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor.

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

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 alcohol (ethanol) per millilitre. The amount of alcohol per dose of this medicine is much less than 1 ml of beer. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Ibufén Infantil Forte

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

For occasional use only and for limited periods.

The lowest 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).

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

Adults and adolescents over 12 years of age (≥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 within a 24-hour period.

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

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

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

Children from 3 months to 12 years of age:

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

Use of this medicine in children under 2 years of age must always be under medical prescription.

As a general guide, the following doses in the table below may be followed:

The suspension may also be dosed according to a regimen of 4 doses per day. In this case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours will be recalculated/reduced proportionally.

The use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg.

• Patients over 65 years: dosage must be determined by the physician, as a reduction of the usual dose may be necessary.
• Patients with kidney, liver, or heart disease: dose reduction is required; consult a physician. Ibuprofen must not be used in patients with severe heart, renal, or hepatic failure.

Adults and adolescents should consult a physician if symptoms worsen or do not improve after 3 days in case of fever or 5 days in case of pain.

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

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

Method of administration

Ibufen Infantil Forte is an oral suspension. It may be administered directly or diluted in water.

• Shake the container well before use.
• Insert the syringe into the pierced cap opening.
• Invert the bottle and withdraw the required dose.
• Administer the contents of the syringe directly into the mouth or onto a spoon.
• The syringe should be washed after each use and may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; ensure that the bottle has been shaken well before administering the medicine.

Patients experiencing stomach discomfort should take the medicine 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 medicine, contact a physician or the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and amount ingested, or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhea, headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may be reported. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the physician will take the necessary measures.

Worsening of asthma is possible in asthmatic patients.

If you forget to take Ibufén Infantil Forte

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

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

4. Possible adverse effects

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

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

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

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue have also been observed.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, vision disorders, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein 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 levels.

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, dizziness, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, oedema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (reduced neutrophils) and agranulocytosis (severe reduction in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, pseudoinfluenza-like symptoms, extreme fatigue, unexplained bleeding and bruising.

• Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, serious skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension. Exacerbation of infection-related inflammation has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Frequency not known (cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually leading to bloody diarrhoea). A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes 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 beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibufén Infantil Forte if you experience these symptoms and seek immediate medical attention. See also section 2.

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

If any of the adverse effects listed below occur, stop treatment immediately and consult your doctor:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• Severe stomach pain.
• Blisters or extensive peeling of the skin.
• 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 arms or legs.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• 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).

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibufén Infantil Forte

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

No special storage conditions are required.

After opening the container, store below 30°C and use within a maximum of 6 months.

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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and other information

Composition of Ibufén Infantil Forte

• The active substance 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 flavour (contains benzyl alcohol and ethanol), thaumatin, and purified water.

Appearance of the product and contents of the container

Ibufén Infantil Forte is a viscous oral suspension, white or almost white in colour, with a strawberry odour.

It includes a 5 ml graduated oral syringe with a polypropylene barrel and a polyethylene plunger.

It is available in 30 ml, 100 ml, 150 ml and 200 ml containers. Some container 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 most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/