Leaflet: information for the user

APIROFENO 40 mg/ml oral suspension

Ibuprofen

Read this leaflet carefully before you start taking this medicine, as 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 should not be given 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.

1. What is Apirofeno and for what it is used

2. What you need to know before starting totake Apirofeno

3. How to take Apirofeno

4. Possible side effects

5. Storage of Apirofeno

6. Contents of the pack and additional information

Apirofeno belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication is indicated for the symptomatic treatment of fever and mild to moderate pain.

Do not take Apirofeno

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, naproxen, etc., or any other component of Apirofeno.Symptoms of an allergic reaction may include skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have a severe liver or kidney disease.
• If you have bleeding or clotting disorders or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.

Warnings and precautions

Special caution is recommended with Apirofeno.

Inform your doctor:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain or persistent pain and/or black stools, even without previous warning symptoms.
• This risk is higher when taking high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider adding a stomach protector medication.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart condition or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will inform you of the frequency of these checks.
• If you experience dehydration symptoms, such as severe diarrhea or vomiting, drink plenty of fluids and immediately contact your doctor, as ibuprofen may cause kidney failure due to dehydration.
• If you are taking anticoagulants or other medications that affect blood clotting, such as aspirin, antiplatelet agents, corticosteroids, or selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as Apirofeno may worsen these conditions.
• If you are taking diuretics (water pills), as your doctor will need to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic autoimmune disease that can affect various vital organs, the nervous system, blood vessels, skin, and joints), as Apirofeno may cause meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), as your doctor will need to evaluate the need for ibuprofen treatment.
• If you have an infection; see the "Infections" section below.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• Use the smallest dose necessary to alleviate or control pain and do not take this medication for longer than necessary to control your symptoms.

Allergic reactions

Ibuprofen has been associated with signs of allergic reactions to this medication, such as respiratory problems, facial swelling, and neck region swelling (angioedema), and chest pain. Stop using Apirofeno immediately and contact your doctor or emergency medical services if you observe any of these signs.

CARDIOVASCULAR PRECAUTIONS

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

Inform your doctor or pharmacist before taking Apirofeno if:

- You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

- You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

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

Infections

Apirofeno may mask the signs of an infection, such as fever and pain. Consequently, Apirofeno 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 medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Dermatological 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 (GAPP), have been reported in association with ibuprofen treatment. Stop Apirofeno treatment and seek medical attention immediately if you notice any of these severe skin reaction symptoms.

Pregnancy and lactation

Due to the association of ibuprofen with an increased risk of congenital anomalies/abortions, it is not recommended to administer Apirofeno during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

Apirofeno is contraindicated in the third trimester of pregnancy.

For women of childbearing age, consider that ibuprofen has been associated with a decrease in fertility.

Use of Apirofeno with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Apirofeno may affect or be affected by other medications. For example:

• Anticoagulants (e.g., aspirin and warfarin).
• Antiplatelet agents (e.g., ticlopidine).
• Corticosteroids (e.g., cortisone and prednisolone).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Other NSAIDs (e.g., aspirin).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and other cardiac glycosides (used to treat heart conditions).
• Hydantoins (e.g., phenytoin) used to treat epilepsy.
• Sulfonamides (e.g., sulfamethoxazole and trimethoprim) used to treat bacterial infections.
• Diuretics (used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics (e.g., norfloxacin).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas (e.g., tolbutamide) used to treat diabetes.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolytics (medications that dissolve blood clots).
• Zidovudine (used to treat HIV/AIDS).
• Aminoglycoside antibiotics (e.g., neomycin).
• Herbal extracts (from the Ginkgo biloba tree).

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

Interference with laboratory tests

Ibuprofen may alter the following laboratory tests:

• Prothrombin time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Concentrations of urea nitrogen, creatinine, and potassium in the blood (may increase)
• Function tests: increased values of transaminases

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

Apirofeno with food and beverages

It is recommended to take Apirofeno with milk or food, or immediately after eating, to reduce the possibility of stomach discomfort.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Do not take Apirofeno during pregnancy, especially during the third trimester (see the "Pregnancy and lactation" section below).

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for extended periods during lactation.No interruption of breastfeeding is necessary for a short treatment with the recommended dose for pain and fever.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and operating machinery

If you only take one dose of Apirofeno or take it for a short period, no special precautions are necessary.

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

Apirofeno contains azorubine (E-122), maltitol liquid (E-965), sodium benzoate (E-211), and sodium

This medication:

Contains azorubine (E-122), which may cause allergic reactions. It may cause asthma, especially in patients allergic to aspirin.

Contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 2.5 g of maltitol liquid (E-965) per 5 ml dose. Caloric value: 2.3 kcal/g of maltitol.

Contains 1 mg of sodium benzoate (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

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

Apirofeno is an oral suspension for administration. It can be administered directly or diluted in water.

To ensure an exact dosage, the containers contain an oral syringe graduated. The syringe is inserted into the perforated cap, the bottle is turned upside down, the plunger is pulled until the liquid reaches the ml mark, or the equivalent in kg of the child's weight, the bottle is returned to its initial position, and the syringe is removed.

The syringe must be cleaned and dried after each use.

The syringe can be 3 or 5 ml, depending on the presentation. Including the 3 ml syringe in presentations adapted for children under 4 years (approximately less than 16 kg of weight) and the 5 ml syringe for presentations adapted for children over 4 years (approximately over 16 kg of weight).

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

Children:

The dose to be administered of ibuprofen depends on the age and weight of the child. Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg/kg of weight, divided into three or four doses.

It is recommended not to exceed the maximum daily dose of 40 mg/kg of weight of ibuprofen.

The use of this medication is not recommended in children under 3 months.

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

However, as a guideline, the following dosing schedule is recommended:

Adults and adolescents over 12 years:

The recommended dose is 10 ml 3 times a day (equivalent to 1.200 mg of ibuprofen).

Patients with kidney and/or liver diseases:

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that your doctor has prescribed.

Seniors:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, you can only increase the dose once your doctor has confirmed that you tolerate the medication well.

The lowest effective dose should be used for the shortest duration 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).

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Apirofeno than you should

If you have taken more Apirofeno 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.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, symptoms of numbness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing problems may occur. Furthermore, the prothrombin time with INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. Low blood pressure and reduced breathing may also occur.

If a severe overdose has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Apirofeno

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 time for the next dose is near, skip the missed dose and take the next dose at its usual time.

Like all medicines, Apirofeno can cause side effects, although not everyone will experience them.

The side effects of medicines such as Apirofeno are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (in more than 1 in 10 patients); common (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with medicines like Apirofeno are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, vomiting blood, mouth ulcers, worsening of ulcerative colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Uncommon: mucosal inflammation with ulcer formation. Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis that occurs with diarrhea with blood). Very rare: pancreatitis.

Cardiovascular:

Medicines like Apirofeno may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines of the type Apirofeno.

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

Cutaneous:

Medicines like Apirofeno may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions that affect the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis). Other side effects are: Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), skin reactions influenced by light, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur. Frequency unknown: skin becomes sensitive to light, a severe skin reaction called DRESS syndrome may also 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 skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Apirofeno if you experience these symptoms and seek medical attention immediately. See section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), mucosal inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, and dizziness or feeling of instability. Rare:paresthesia (numbness, tingling, prickling, etc., more common in hands, feet, arms, or legs). Very rare: 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 or other collagen diseases), which was a risk factor.The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: visual disturbances. Rare: abnormal or blurred vision.

Haematological:

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as respiratory difficulty and pale skin),decreased granulocytes (a type of white blood cell that may predispose to infections), pancitopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, symptoms similar to the flu, extreme fatigue, nasal and cutaneous hemorrhage.Very rare: prolonged bleeding time.

Renal:

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatic:

Medicines like Apirofeno may be associated, in rare cases, with liver damage.Other rare side effectsare: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Frequency unknown: liver insufficiency (severe deterioration of the liver).

General:

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with Apirofeno, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, swelling of the face, tongue, and throat, respiratory difficulty, asthma, palpitations, hypotension(lower than usual blood pressure)or shock.

If any of the following side effects appear, stop treatment and seek medical attention immediately:

• Allergic reactions such as skin rash, swelling of the face, chest tightness, or respiratory difficulty.
• Manchas rojizas no elevadas, en forma de diana o circulares en el tronco, a menudo conampollas en el centro, descamación de la piel, úlceras de boca, garganta, nariz, genitalesy ojos. Estas erupciones cutáneas graves pueden ir precedidas de fiebre y síntomassimilares a los de la gripe [dermatitis exfoliativa, eritema poliforme, síndrome deStevens-Johnson, necrólisis epidérmica tóxica].
• Erupción cutánea generalizada, temperatura corporal elevada y ganglios linfáticoshipertrofiados (síndrome DRESS).
• Erupción generalizada, roja y escamosa, con protuberancias bajo la piel y ampollas, acompañada de fiebre. Los síntomas suelen aparecer al inicio del tratamiento (pustulosis exantemática generalizada aguda).
• Vómitos de sangre o de aspecto similar a los posos de café.
• Sangre en las heces o diarrea con sangre.
• Dolor intenso de estómago.
• Dolor de cabeza intenso o persistente.
• Coloración amarilla de la piel (ictericia).
• Signos de hipersensibilidad grave (ver más arriba en este mismo apartado).
• Hinchazón de las extremidades o acumulación de líquido en los brazos o piernas.

Reporting of adverse reactions

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

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Apirofeno 40 mg/ml oral suspension

- The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen as the active ingredient.

- The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate (E-331), sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), thiomersal (E-957), strawberry flavor, azorubine (E-122), glycerol (E-422), and purified water.

Appearance of the product and contents of the packaging

Apirofeno 40 mg/ml oral suspension is a pink oral suspension. It is presented in containers of 30, 50, 100, 150, and 200 ml.

The 30 and 50 ml containersare accompanied by a 3 ml graduated syringe with divisions of1 ml and subdivisions of 0.10 ml.

The 100, 150, and 200 ml containersare accompanied by a 5 ml graduated syringe with divisions of1 ml and subdivisions of 0.20 ml.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Laboratorios ERN, S.A. C/Perú, 228 - 08020 Barcelona. Spain.

Responsible for manufacturing

Laboratorios ERN, S.A. C/Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

Date of the last review of this leaflet: October 2024.

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