Leaflet: information for the user

ibuprofen cinfa 20 mg/ml oral suspension EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicineis used in infants over 3 months and children up to 12 yearsfor the treatment of:

• Relief of occasional mild or moderate pain.
• Fever states.

Do not takeibuprofen cinfa

• If you are allergic to ibuprofen or any of the other ingredients in 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, 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 bleeding, or have suffered a perforation of the digestive system.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood clotting problems or are taking anticoagulants (medicines used to "thin" the blood). If you need to take 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 (see "Pregnancy, breastfeeding, and fertility" section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

• 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. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in older patients. In these cases, your doctor may consider prescribing a stomach protector.
• If you are taking anticoagulants (medicines used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medicines that may increase the risk of 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 intestines, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
• If you are taking diuretics (medicines used to increase urine production), as your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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 disorder that affects your blood and can cause symptoms such as reddish urine, bloody urine, or liver disease), as your doctor will assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible to experience allergic reactions with this medicine.
• Your doctor will perform closer monitoring if you take 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" section below.
• Signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported. Stop using ibuprofen cinfa immediately and contact your doctor or emergency medical services 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 Ibuprofen cinfa 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 experience any skin rash, 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 increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

• If you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• If you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

This type of medicine may 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.

Pregnancy and breastfeeding

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 tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy, unless your doctor considers it strictly necessary and tells you to. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. 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 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 monitoring.

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria 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.

Other medicines and ibuprofen cinfa

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

Ibuprofen may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) like ticlopidine.
• Anticoagulants (medicines used to "thin" the blood) such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) (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 like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat some bacterial infections).
• Corticosteroids like cortisone and prednisone.
• Diuretics (medicines 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 like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used to prevent organ transplant rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medicines that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Thrombolytics (medicines that eliminate blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (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 ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medicines.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (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: increased values of transaminases.

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

Taking ibuprofen cinfa with food, drinks, and alcohol

It is recommended to take this medicine with milk or with food, or immediately after eating, to reduce the likelihood of stomach discomfort.Do not take alcohol, as it may increase gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended for women trying to become pregnant.

Do not take ibuprofen during pregnancy, especially during the third trimester (see "Pregnancy, breastfeeding, and fertility" section).

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

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.

ibuprofen cinfa contains maltitol liquid (E-965)

This medicine contains maltitol liquid (E-965).Consult your doctor or pharmacist if you have been told you are intolerant to certain sugars before taking this medicine.

It may cause a mild laxative effect because it contains 212.5 mg of maltitol per milliliter.

Caloric value: 2.3 kcal/g maltitol/isomalt.

ibuprofen cinfa contains sodium benzoate (E-211)

This medicine contains 2 mg ofsodium benzoate(E-211) per ml.

Sodium benzoatemay increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

ibuprofen cinfa contains sodium

This medicine contains 34.2 mg of sodium (main component of table salt/for cooking) in 20 ml. This is equivalent to 1.71% of the recommended daily maximum sodium intake for an adult.

ibuprofen cinfa contains ethanol (alcohol)

This medicine contains 1.43 mg of alcohol (ethanol) per ml, which is equivalent to 0.14% (P/V). The amount in 20 ml of this medicine is equivalent to less than 1 ml of beer or wine.The small amount of alcohol in this medicine does not produce any noticeable effect.

ibuprofen cinfa contains propylene glycol (E-1520)

This medicine contains 4.77 mg of propylene glycol per ml.

Consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol, if the baby is less than 4 weeks old.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

The recommended dose of ibuprofen depends on the age and weight of the child. For children from 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, divided into three doses (see table).

This medication should only be used in children under 2 years by prescription.

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

It is not recommended to use ibuprofen in children under three months or with a weight of less than 5 kg.

Patients with kidney, liver, or heart diseases

They should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe heart, kidney, or liver failure.

If this medication needs to be used for more than 3 days or if symptoms worsen in children from 6 months to 12 years, consult a doctor.

In children aged 3 to 5 months, consult a doctor if symptoms worsen or persist after 24 hours.

Administration form

ibuprofen cinfa is an oral suspension for oral administration.

To ensure an exact dose, the containers contain a 5 ml oral syringe, and the following steps should be followed:

• Shake the bottle before using it.
• Insert the syringe into the bottle
• Invert the bottle and remove the prescribed dose.
• Administer directly from the syringe or pour the contents into a spoon.
• The syringe should be cleaned and dried after each use.

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

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension, so patients should ensure that the bottle has been well shaken before using it.

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

If you take moreibuprofen cinfathan 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 go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), 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, prolonged prothrombin time/INR has been reported, 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 and respiratory nervous system depression have been reported.Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

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

Asthma exacerbation is possible in asthmatics.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeibuprofen cinfa

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 doubts about the use of this medication, ask your doctor or pharmacist.

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

The incidence of side effects is lower in short-term treatments and when 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 older patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness, or feeling unsteady, fatigue.

• Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching, or tingling, urticaria, purpura (purple spots on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, 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, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare side effects(may affect up to 1 in 1,000 people):Disorientation or confusion, depression, vertigo, tinnitus (ringing or buzzing in the ears), 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, symptoms may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, tachycardia, and hypotension), 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 arethrombocytopenia, 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 (decrease in neutrophils), 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, unexplained bleeding, and hematomas.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) 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 (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Frequency unknown(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. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). A generalized red, scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). The skin becomes sensitive to light.Stop taking ibuprofen 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 medical attention immediately:

• 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.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, red, and 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 leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://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.

This medicationdoes not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines that you do not need in the SIGRE collection pointof the pharmacy. In case of doubt,ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition ofibuprofen cinfa

• The active ingredient is ibuprofen.Each milliliter of oral suspension contains 20 mg of ibuprofen.
• The other components(excipients) are: glycerol (E-422), liquid maltitol (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate,sodium benzoate (E-211), polysorbate 80, sodium saccharin, orange flavor (contains ethanol and propylene glycol (E-1520) ) and purified water.

Appearance of the product and contents of the packaging

White or almost white suspension that becomes homogeneous after agitation.

Each package contains a 200 ml amber-colored polyethylene terephthalate (PET) bottle with a high-density polyethylene (HDPE) white cap and a translucent stopper, with a 5 ml syringe for oral dosing.

Holder of the marketing authorization and responsible for manufacturing

Laboratories Cinfa, S.A.

Carretera Olaz-Chipi, 10 Industrial Park Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66020/P_66020.html

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