Ibuprofen Aldo-Unión 20 mg/ml oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Aldo-Unión 20 mg/ml oral suspension EFG

Ibuprofen

Read the entire package 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 must not be given to other people, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Ibuprofen Aldo-Unión is and what it is used for
2. What you need to know before taking Ibuprofen Aldo-Unión
3. How to take Ibuprofen Aldo-Unión
4. Possible adverse effects
5. Storage of Ibuprofen Aldo-Unión
6. Contents of the pack and other information

1. What Ibuprofeno Aldo-Unión is and what it is used for

Ibuprofeno Aldo-Unión 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 to moderate pain.
• Fever.
• Juvenile rheumatoid arthritis.

2. What you need to know before starting to take Ibuprofeno Aldo-Unión

Allergic reactions to this medicine, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno Aldo-Unión immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

It is important that you use the smallest dose that relieves/controls the pain and that you do not take this medicine longer than necessary to control your symptoms.

Do not take Ibuprofeno Aldo-Unión:

• If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• If you have had allergic-type reactions such as asthma, rhinitis, or urticaria when taking aspirin or other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have had stomach or duodenal bleeding or gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than once: a stomach or duodenal ulcer or bleeding.
• If you are vomiting blood.
• If you have black stools or diarrhea with blood.
• 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 concomitant use of anticoagulant medicines is necessary, 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:

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

Take special care:

• If you have edema (fluid retention).
• If you have liver or kidney disease.
• If you have or have had heart disorders or high blood pressure.
• If you have bronchial asthma or any allergic disease.
• If you are being treated with Ibuprofeno Aldo-Unión, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular checks. Your doctor will advise you on how often these checks should occur.
• If you have symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case could lead to renal failure as a consequence of dehydration.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), as your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial cause) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the section «Infections» below.
• Serious 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. Stop treatment with Ibuprofeno Aldo-Unión and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Ibuprofeno Aldo-Unión may mask signs of infection such as fever and pain. Therefore, Ibuprofeno Aldo-Unión may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with 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

Non-steroidal anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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), have had a heart attack, coronary bypass surgery, peripheral arterial 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 if you are a smoker.

In addition, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with Ibuprofeno Aldo-Unión. Stop taking Ibuprofeno Aldo-Unión and see a doctor immediately if you develop any skin rash, lesions of the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless considered strictly necessary. In such cases, the dose and duration of treatment should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Use of Ibuprofeno Aldo-Unión with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs such as aspirin.
• Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat coagulation disorders/prevent coagulation, 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 (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (an abortion-inducing agent).
• 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 to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine elimination).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplantation to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

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 up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for a clinical test 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 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 drinks—beer, wine, spirits—per day) may cause stomach bleeding.

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 medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age).

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

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

Driving and use of machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are necessary.

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 medicine, containing glycerol as an excipient, may be harmful at high doses. It may cause headache, stomach discomfort, and diarrhea.

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

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

This medicine contains maltitol (E-965); therefore, if you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Ibuprofen Aldo-Unión

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest 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 medicine.

Your doctor will tell you how long to take Ibuprofen Aldo-Unión. Do not stop treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

Ibuprofen Aldo-Unión is an oral suspension.

Instructions for use:

For accurate dosing, the package contains a 5 ml graduated oral syringe. First, shake the suspension, then insert the dosing syringe 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 upright position, and remove the dosing syringe.

The syringe should be cleaned and dried after each use.

If you have a sensitive stomach, take the medicine with food.

Use in children and adolescents

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

Age	Body weight	Dosage
Infants 6 to 12 months	Approx. 7.7 – 9 kg	2.5 ml 3 to 4 times daily (corresponds to 150–200 mg of ibuprofen/day)
Infants 1 to 2 years Children 2 to 3 years	Approx. 10 to 15 kg	5 ml 3 times daily (corresponds to 300 mg of ibuprofen/day)
Children 4 to 6 years	Approx. 16 to 20 kg	7.5 ml 3 times daily (equivalent to 450 mg of ibuprofen/day)
Children 7 to 9 years	Approx. 21 to 29 kg	10 ml 3 times daily (equivalent to 600 mg of ibuprofen/day)
Children 10 to 12 years	Approx. 30 to 40 kg	15 ml 3 times daily (equivalent to 900 mg of ibuprofen/day)

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

Ibuprofen use is not recommended in infants under six months of age.

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

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

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

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Aldo-Unión than you should:

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the necessary measures. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see section 4 below), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in patients with asthma. In addition, low blood pressure and reduced breathing may occur.

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

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

If you forget to take Ibuprofeno Aldo-Unión:

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects associated with medicines like ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in diarrhea with blood) have also been observed.

Less frequently, gastritis has been observed.

Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis presenting with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment with ibuprofen-type medications such as Aldo-Unión.

Dermatological:

Frequent: skin rash.

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

Very rare: hair loss, erythema multiforme (skin lesions), photosensitivity reactions, inflammation of blood vessels in the skin.

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

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

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

Immune system:

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi restricting airflow to the lungs).

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

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

Central nervous system:

Frequent: fatigue or drowsiness, headache, dizziness or feeling of instability.

Rare: paresthesia (numbness, tingling, "pins and needles" sensations, more frequent in hands, feet, arms, or legs).

Very rare: aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included 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: tinnitus (ringing or buzzing in the ears).

Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood:

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells).

Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medicines like Ibuprofeno Aldo-Unión may rarely be associated with liver injury. Other rare adverse effects include hepatitis (liver inflammation), abnormalities in liver function, and jaundice (yellowing of the skin and eyes).

Frequency unknown: liver failure (severe deterioration of liver function).

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive 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 adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Aldo-Unión

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP:. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Ibuprofen Aldo-Unión

• The active substance 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 flavour, and purified water.

Appearance of the product and contents of the container

After shaking, the medicine forms a white suspension with an orange odour. It is supplied in a 200 ml bottle and includes a 5 ml dosing syringe.

Marketing Authorization Holder and Manufacturer:

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

SPAIN

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/