IBUPROFEN CINFA 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

ibuprofeno cinfa 20 mg/ml oral suspension EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is ibuprofeno cinfa and what is it used for
2. What you need to know before you take ibuprofeno cinfa
3. How to take ibuprofeno cinfa
4. Possible side effects
5. Storing ibuprofeno cinfa
6. Contents of the pack and other information

1. What is ibuprofeno cinfa and what is it used for

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

This medicine is used in infants over 3 months and children up to 12 years for the treatment of:

• Symptomatic relief of mild or moderate occasional pain.
• Febrile conditions.

2. What you need to know before you take ibuprofeno cinfa

Do not takeibuprofeno cinfa

• If you are allergic 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. Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have had 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 clotting problems 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 clotting 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 (see "Pregnancy, breastfeeding, and fertility" section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

• If you have fluid retention (edema).
• 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. It may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning signs. This risk is higher when using high doses and prolonged treatments, 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 are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you are being treated with diuretics (medicines used 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 acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" section below.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofeno cinfa immediately and contact your doctor or the emergency medical 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue ibuprofeno cinfa treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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

Cardiovascular precautions

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

You should discuss your treatment with your doctor or pharmacist before taking 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").
• If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

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

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

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 strictly 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 monitoring.

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other medicines and ibuprofeno cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as the risk of stomach ulcers and gastrointestinal bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulant medications, e.g., to treat coagulation problems/prevent coagulation, (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (a medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for the treatment of cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (inducer of abortions).
• Digoxin and cardiac glycosides (for the treatment of heart disorders).
• Hydantoins, such as phenytoin (for the treatment of epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (for the treatment of certain bacterial infections).
• Corticosteroids, such as cortisone and prednisone.
• Diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Sulfonylureas, such as tolbutamide (for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used to prevent organ rejection in transplants).
• Zidovudine (a 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 (medicines that eliminate blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Ginkgo biloba tree extracts.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking ibuprofen may affect 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.

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

Taking ibuprofeno cinfa with food, drinks, and alcohol

It is recommended to take this medication with milk or with food, or immediately after eating, to reduce the possibility of stomach upset. Do not drink alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of this medication is not recommended in women who are trying to become pregnant.

Do not take ibuprofen during pregnancy, especially during the third trimester (see "Precautions during pregnancy and in women of childbearing age" section).

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

Driving and using machines

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

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

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

ibuprofeno cinfa contains maltitol liquid (E-965)

This medicine contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

Caloric value: 2.3 kcal/g maltitol/isomalt.

ibuprofeno cinfa contains sodium benzoate (E-211)

This medicine contains 2 mg of sodium benzoate (E-211) in each milliliter.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

ibuprofeno cinfa contains sodium

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

ibuprofeno cinfa contains ethanol (alcohol)

This medicine contains 1.43 mg of alcohol (ethanol) in each milliliter, which is equivalent to 0.14% (v/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.

ibuprofeno cinfa contains propylene glycol (E-1520)

This medicine contains 4.77 mg of propylene glycol in each milliliter.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

3. How to take ibuprofen cinfa

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

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 without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

The recommended dose of ibuprofen depends on the child's age and weight. 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 the symptoms, divided into three doses (see table).

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

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 at each dose, every 6 hours, will be recalculated/reduced proportionally.

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

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 cardiac, renal, or hepatic failure.

If this medication is required 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.

Form of administration

ibuprofen cinfa is an oral suspension.

For exact dosing, the containers contain a 5 ml oral syringe, and the steps to follow are as follows:

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

Patients with stomach upset 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 are recommended to ensure that the bottle has been shaken well before use.

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

If you take moreibuprofeno cinfathan you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital immediately 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 difficulties 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 been reported. Also, cases of cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate) have been produced.

If severe poisoning occurs, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma 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 forgot to takeibuprofeno cinfa

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the missed 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 or pharmacist.

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 1,200 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 stools, vomiting with blood, headache, dizziness or feeling of 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, etc., 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 (inflammation of the liver), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea.

• Rare adverse effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (beats 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, the signs can be facial swelling, tongue and larynx, 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 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 pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure 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 shedding of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe liver deterioration), 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.

• Frequency not known(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, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking ibuprofen 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 consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blisters.
• 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-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth sores, throat, nose, genitals, and eyes. These severe skin rashes may 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of ibuprofen cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications that are no longer needed at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Package contents and additional information

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.

Product appearance and packaging contents

Suspension of white or almost white color and homogeneous after shaking.

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

Marketing authorization holder and manufacturer

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus 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

QR code to: https://cima.aemps.es/cima/dochtml/p/66020/P_66020.html