PAIDOFEBRIL 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Paidofebril 20 mg/ml Oral Suspension

Ibuprofen

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Paidofebril and what is it used for

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.
• Juvenile rheumatoid arthritis.

2. What you need to know before you take Paidofebril

It is important that you use the smallest dose that relieves your pain and do not take this medicine 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 ingredients of this medicine (listed in section 6).
• If you have had allergic reactions of the asthma type, rhinitis, or urticaria when taking aspirin or other non-steroidal anti-inflammatory drugs.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than one occasion: an ulcer or stomach or duodenal bleeding.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an exacerbation of ulcerative colitis or Crohn's disease.
• If you have severe liver or kidney disease.
• If you have a blood coagulation disorder or are taking anticoagulants (medicines to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and Precautions:

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

Be especially careful:

• If you have edema (fluid retention).
• If you have any liver or kidney disease.
• If you have or have had any heart disorder or have high blood pressure.
• If you have bronchial asthma or any allergic disease.
• If you are receiving treatment with Ibuprofeno Aldo-Unión, as it may mask fever, which is an important sign of infection, making its 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 experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this case could 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 produces bloody diarrhea) or ulcerative colitis, as medications like ibuprofen can worsen these conditions.
• If you are being treated with diuretics (medicines 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 produce aseptic meningitis (inflammation of the meninges 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 suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the "Infections" section later.

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of suffering a 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 Ibuprofeno Aldo-Unión 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").
• 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 medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin Reactions

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

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless 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 patients of childbearing age, it should be taken into account that ibuprofen-type medications have been associated with a decrease in fertility.

Use of Ibuprofeno Aldo-Unión with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Other non-steroidal anti-inflammatory drugs like aspirin.

• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat blood clotting problems/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medicine against the AIDS virus).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

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

Taking 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)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• Liver function tests: increased transaminase values

Tell your doctor if you are going 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 upset.

Do not take it with alcohol.

Taking ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor - per day) may cause stomach bleeding.

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.

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

Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding. It is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

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

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or use machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary 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 Ingredients of Ibuprofeno Aldo-Unión 20 mg/ml Oral Suspension

This medicine, as it contains glycerol as an excipient, may be harmful in high doses. It can cause headaches, stomach upset, and diarrhea.

This medicine contains 10 mg of benzoic acid salt (as sodium benzoate) in each unit of volume (5ml).

The benzoic acid salt may increase the risk of jaundice (yellowish skin and eye color) in newborns (up to 4 weeks of age).

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This medicine 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 medicine.

3. How to take Paidofebril

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.

The effective lowest 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).

Remember to take your medication.

Your doctor will indicate the duration of treatment with Paidofebril. Do not suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use Paidofebril for longer than indicated by your doctor.

Paidofebril is an oral suspension.

Instructions for use:

For exact dosing, the package contains a 5 ml oral syringe. First, shake the suspension, then insert the doser into the perforated cap, invert the bottle, pull the plunger until the liquid reaches the amount prescribed by the doctor, return the bottle to its initial position, and remove the doser.

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 administered dose of ibuprofen depends on the child's age and weight. 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.

The use of ibuprofen is not recommended in infants under six months.

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

Elderly patients: In general, no special dose modifications are required.

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

If you think the effect 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 find out 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 take the package and the prospectus of the medication to the healthcare professional.

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 appear. Occasionally, patients develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (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. Acute renal failure and liver damage may occur. An exacerbation of asthma in asthmatics is possible. Additionally, there may be low blood pressure and reduced breathing.

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

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

If you forget to take Paidofebril:

Do not take a double dose to make up for forgotten 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 forgotten dose and take the next dose at the usual time.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse 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, heartburn, abdominal pain, blood in stools, oral 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.

Rare: esophagitis, esophageal stricture, exacerbation of diverticular disease, non-specific hemorrhagic colitis (gastroenteritis that occurs with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Chest pain, which can be a sign of a potentially serious 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 ("stroke").

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with medication of the Paidofebril type.

Skin:

Frequent: skin rash.

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

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the skin blood vessels.

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

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

• Reddish, non-raised, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing to 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 appear.

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

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or instability.

Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges 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 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:

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

Ocular:

Uncommon: vision changes. 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 can predispose to infections), pancytopenia (deficiency of red, white, and platelet blood cells), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure 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, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Kidney:

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

Hepatic:

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

Unknown frequency: liver failure (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, intense and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects appear, stop treatment and go immediately to your doctor:

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• 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.

Reporting of adverse effects

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

5. Conservation of Paidofebril

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be thrown away through drains or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofen Aldo-Unión

• The active principle 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 package contents

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

Marketing authorization holder and manufacturer:

Aldo-Unión Laboratory, S.L.

Baronesa de Maldá Street, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of the last revision of this prospectus: November 2024

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