IBUPROFENO WINADOL 100 MG ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Winadol 100 mg Oral Suspension

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if the fever or pain worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What is Ibuprofen Winadol and what is it used for
2. What you need to know before taking Ibuprofen Winadol
3. How to take Ibuprofen Winadol
4. Possible side effects
5. Storage of Ibuprofen Winadol
6. Package Contents and Additional Information

1. What is Ibuprofen Winadol and what is it used for

Ibuprofen, the active ingredient of this medicine, acts by reducing pain and fever.

This medicine is used in children with a weight over 20 kg (from 7 years old) for the symptomatic relief of occasional mild or moderate pain, as well as febrile conditions.

2. What you need to know before taking Ibuprofen Winadol

Do not take Ibuprofeno Winadol:

• if you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory medicines (NSAIDs) or to aspirin. Allergic reactions may include: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• if you have previously had a stomach or duodenal ulcer 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 have severe liver or kidney disease.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine.

Tell your doctor:

• if you have edema (fluid retention)
• If you have or have had any heart disorder or have high blood pressure.
• if you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure in this specific case due to dehydration.
• if you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medicine.
• if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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 ibuprofen-type medications may 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 cause aseptic meningitis.
• if you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the 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 below.

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

Infections

Ibuprofen Winadol may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Winadol may delay adequate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this 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 this medicine 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 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 Ibuprofen Winadol treatment. Stop taking Ibuprofen Winadol and consult a 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 serious skin reaction. See section 4.

Children

There is a risk of kidney damage in dehydrated children.

Taking Ibuprofen Winadol with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those obtained without a prescription.

The following medicines may interfere and should not be taken with ibuprofen without first consulting your doctor:

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory medicines (NSAIDs) such as aspirin, as this may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (which prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• 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 (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).
• Diuretics (medicines used to increase urine production).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used for depression.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medicine against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba tree.

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

Interference with Analytical Tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), tell your doctor that you are taking this medicine, as it may alter the results.

Taking Ibuprofen Winadol with Food, Drinks, and Alcohol

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach upset.

If you drink alcohol while taking this medicine, you may be more prone to side effects.

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.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Winadol may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Precautions during Pregnancy and in Women of Childbearing Age

Pregnancy

Since the administration of this type of medicine 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 this medicine is contraindicated.

Fertility

For patients of childbearing age, it should be taken into account that medicines like ibuprofen have been associated with a decrease in fertility.

Breastfeeding

Although the levels of the medicine in breast milk are negligible, it is recommended to consult a doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and Using Machines

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

Ibuprofen Winadol contains Sodium and Liquid Maltitol (E-965)

Patients on low-sodium diets should note that this medicine contains 17.92 mg (0.8 mmol) of sodium per sachet.

This medicine contains liquid maltitol (E-965). 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 Ibuprofeno Winadol

Follow exactly the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

It is essential to always take the smallest dose that relieves the pain and not take the medication for longer than necessary to control your symptoms.

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).

Dosage

The recommended dose of ibuprofen depends on the child's body weight. As a general rule, 5 to 10 mg/kg of body weight are administered as a single dose, depending on the intensity of the symptoms, up to a maximum of 20-30 mg/kg of body weight as the total daily dose.

Do not administer this medication to children under 7 years of age or with a weight below 20 kg.

Generally, it is recommended to dose according to the following table:

The interval between doses should be chosen according to the symptoms and the maximum daily dose and should be 6 or 8 hours (or with a minimum of 6 hours between each dose). Do not exceed the recommended maximum daily dose.

Use only for short treatments.

If symptoms worsen or persist for more than 3 days, consult a doctor.

Special patient groups

Renal insufficiency:

No dose reduction is necessary in patients with mild or moderate renal insufficiency (for patients with severe renal insufficiency, see section 4.3)

Hepatic insufficiency:

No dose reduction is necessary in patients with mild or moderate hepatic insufficiency (for patients with severe hepatic insufficiency, see section 4.3)

Method of administration

This medication is a suspension, administered orally.

It is necessary to homogenize the suspension before taking it, as indicated in the following figure:

1 – Press with your fingers the top and bottom of the sachet several times

2 – Press from the top and bottom and vice versa for a minimum of 30 seconds

It can be taken directly from the sachet or diluted in water.

In case of digestive discomfort, it is recommended to take the medication with meals.

If you take more Ibuprofeno Winadol than you should

If you have taken more oral suspension than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the prospectus of the medication to the healthcare professional.

If you have taken more Ibuprofeno Winadol than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported

It is rare for more severe symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts).

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

If you forgot to take Ibuprofeno Winadol

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 of the next dose is very close, skip the forgotten dose and take the next dose at its usual time

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Frequent adverse effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting with blood, dizziness or feeling of instability, fatigue.

• Uncommon adverse effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs), headache and drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm (difficulty breathing).

• Rare adverse effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis.

• Very rare adverse effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion). In case of severe generalized hypersensitivity reaction, the signs may be facial swelling, tongue and larynx swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other very rare adverse effects are decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (significant decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogrippal symptoms, extreme fatigue, bleeding, and bruises of unknown cause. Severe liver failure, heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Exacerbation of inflammation-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Unknown frequency(cannot be estimated from the available data):

Colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Winadol if you present these symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

If any of the following adverse effects occur, discontinue treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Bloody vomiting or coffee-ground-like vomiting.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin blistering or peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (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 or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use, www.notificaRAM.es.

5. Conservation of Ibuprofeno Winadol

Keep this medication out of sight and reach of children.

Store below 30°C

Do not refrigerate.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. 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 Ibuprofeno Winadol

• The active ingredient is ibuprofen. Each sachet with 5 ml of suspension contains 100 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), 99.5% glycerol (E-422), maltitol liquid (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, 15 cps hypromellose, strawberry flavor, and purified water.

Appearance of the product and package contents

Ibuprofeno Winadol is a white oral suspension with a strawberry flavor contained in single-dose sachets formed by a complex of polyester, aluminum, polyester, and polyethylene.

It is presented in packages of 12 units or 20 units.

Only some package sizes may be commercialized.

Marketing authorization holder and manufacturer

Marketing authorization holder

NUTRA ESSENTIAL OTC, S.L.

C/ La Granja 1, 3ºB

28108 Alcobendas (Madrid)

Manufacturer

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

“or”

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

“or”

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

“or”

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

Date of the last revision of this prospectus: November 2024

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