Leaflet: information for the user

Paidofebril 20 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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Paidofebril and what it is used for

2. What you need to know before you start taking Paidofebril

3. How to take Paidofebril

4. Possible side effects

5. Storage of Paidofebril

6. Contents of the pack and additional information

Paidofebril contains ibuprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of:

• Mild or moderate pain.
• Fever.

It is essential to use the smallest effective dose to alleviate/control pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Ibuprofeno Aldo-Unión:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have had allergic reactions such as asthma, rhinitis, or urticaria when taking aspirin or other nonsteroidal anti-inflammatory drugs.
• If you have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you currently have or have had more than one occasion: stomach or duodenal ulcers.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have a worsening of ulcerative colitis or Crohn's disease.
• If you have a severe liver or kidney disease.
• If you have a bleeding disorder, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Ibuprofeno Aldo-Unión.

Be especially careful:

• If you have edema (fluid retention)
• If you have liver or kidney disease.
• If you have any heart disease or high blood pressure.
• If you have asthma or any allergic disease.
• If you are receiving treatment with Ibuprofeno Aldo-Unión as it may mask fever, 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 medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to increase urine production) as your doctor must 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 intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" heading later.

Ibuprofeno Aldo-Unión may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno Aldo-Unión may delay the appropriate treatment of the infection, which may increase 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 symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

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

You must discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Aldo-Unión if:

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

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

Skin Reactions

Severe skin reactions associated with treatment with Ibuprofeno Aldo-Unión have been reported. Stop taking Ibuprofeno Aldo-Unión and see your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Precautions during pregnancy and in fertile women

Due to the administration of ibuprofen-type medications being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication 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.

In the third trimester, the administration of ibuprofen is contraindicated.

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Use of Ibuprofeno Aldo-Unión with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Ibuprofeno Aldo-Unión may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs such as aspirin.

• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants (e.g., to treat bleeding problems or prevent coagulation, e.g., aspirin, warfarin, ticlopidine).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medication used to treat depression). Your doctor may need to adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (an abortifacient).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against HIV).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

Other medications may also affect or be affected by treatment with Ibuprofeno Aldo-Unión. Therefore, you must always consult your doctor or pharmacist before using Ibuprofeno Aldo-Unión with other medications.

The use of ibuprofen may alter the following laboratory tests:

- Bleeding time (may be prolonged for 1 day after stopping treatment)

- Blood glucose concentration (may decrease)

- Creatinine clearance (may decrease)

- Hematocrit or hemoglobin (may decrease)

- Serum concentrations of urea nitrogen and creatinine and potassium (may increase)

- With liver function tests: increase in transaminase values

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

Taking Ibuprofeno Aldo-Unión with food, drinks, and alcohol.

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

Do not take it with alcohol.

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor - per day) may cause stomach hemorrhage.

Pregnancy, breastfeeding, and fertility

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

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

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for extended periods during breastfeeding. You do not need to stop breastfeeding during a short treatment with the recommended dose for pain and fever.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

Ibuprofeno Aldo-Unión contains sodium benzoate (E-211), glycerol (E-422), and maltitol (E-965).

Important information about some of the components of Ibuprofeno Aldo-Unión 20 mg/ml oral suspension

This medication, containing glycerol as an excipient, may be harmful in high doses. It may cause headaches, stomach discomfort, and diarrhea.

This medication contains 10 mg of sodium benzoate (as sodium benzoate) in each unit of volume (5ml).

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

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This medication contains maltitol (E-965), so if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

The most effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

Remember to take your medication.

Your doctor will indicate the duration of treatment with Paidofebril.Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use Paidofebril for a longer period than indicated by your doctor.

Paidofebril is an oral suspension for administration.

Instructions for use:

To achieve an exact dosage, the container contains a 5 ml oral syringe. First, the suspension must be shaken, then the dosing syringe is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the prescribed amount by the doctor, the bottle is returned to its initial position, and the dosing syringe is removed.

The syringe should be cleaned and dried after each use.

If you have a sensitive stomach, take the medication with meals.

Use in children and adolescents

The dose of ibuprofen administered depends on the age and weight of the child. For children from 6 months to 12 years, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four doses (see table). The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

For the treatment of juvenile rheumatoid arthritis, higher doses may be necessary, although it is recommended not to exceed 40 mg/kg/day of ibuprofen.

It is not recommended to use ibuprofen in infants under six months.

Adults and adolescents 12 years and older: The recommended dose is 20 ml 3 to 4 times a day (equivalent to 1200-1600 mg of ibuprofen/day), as long as symptoms persist.

Older patients: In general, no special dose adjustments are required.

Patients with renal or hepatic insufficiency:Your doctor will adjust the dose.

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

If you take more Paidofebril than you should:

If you have taken more Paidofebril 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. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the container and the medication package to the healthcare professional.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see section 4 below), 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 drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, bloody urine, low potassium levels in the blood, chills, and breathing difficulties may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. It is possible that asthma will worsen in asthmatics. Additionally, low blood pressure and reduced breathing may 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 Paidofebril:

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 medications, this medication may cause side effects, although not everyone will experience them.

Side effects of medications such as ibuprofen 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.

The following side effects have been observed:

Gastrointestinal:

The most frequent side effects that occur with medications like Paidofebril are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, 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 bloody diarrhea) have also been observed.

Less frequently, gastritis has been observed.

Rarely: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis that presents with bloody diarrhea).

Very rarely: pancreatitis.

Cardiovascular:

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

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medications like Paidofebril.

Dermatological:

Frequent: skin rash.

Infrequent: skin redness, itching or swelling of the skin, purpura (purple spots on the skin).

Very rarely: hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels.

Exceptionally, severe skin infections and soft tissue complications during chickenpox may occur.

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Flat, red, circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema polymorphum, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash with skin protuberances and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Immunological:

Infrequent: transient edema in skin areas, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rarely: joint pain and fever (lupus erythematosus).

Central nervous system:

Frequent: fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Rare: paresthesia (numbness, tingling, burning, etc. more common in hands, feet, arms, or legs). Very rarely: 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:

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

Auditory:

Frequent: vertigo. Infrequent: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Infrequent: vision disturbances. Rare: abnormal or blurred vision.

Blood:

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 difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (bone marrow insufficiency to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells).

Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nasal bleeding, and skin bleeding. Very rarely: prolonged bleeding time.

Renal:

Based on 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:

Medications like Paidofebril may be associated, in rare cases, with liver damage. Other rare side effects are: hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Unknown frequency: liver insufficiency (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects occur, stop treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like appearance.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Significant skin blistering or peeling.
• 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 fluid accumulation in the arms or legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect 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 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.

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 the packaging and unused medications at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Aldo-Unión

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

Appearance of the product and contents of the packaging

The medicine, after being shaken, will result in a white suspension with an orange odor. It is presented in a 200 ml bottle and includes a 5 ml dosing syringe.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of the last review of this leaflet: November 2024

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