Package Insert: Information for the User

Ibuprofen Winadol 200 mg Oral Suspension

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if the fever worsens or does not improve after 3 days or the pain does not improve after 5 days (3 days in children and adolescents).

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

2. What you need to know before starting to take Ibuprofen Winadol

3. How to take Ibuprofen Winadol

4. Possible adverse effects

5. Storage of Ibuprofen Winadol

6. Contents of the package and additional information

The active ingredient, Ibuprofeno, acts by reducing pain and fever.

This medication is used in adults and children 7 years and older for the symptomatic relief of occasional mild to moderate pain, as well as feverish states.

Do not take Ibuprofeno Winadol:

if you are allergic to ibuprofen or any of the other ingredients in this medicine (listed in section 6) or to other nonsteroidal anti-inflammatory drugs (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 had a stomach or duodenal ulcer or bleeding in the past.

- if you vomit blood.

- if you have black stools or bloody diarrhea.

• if you have severe heart failure
• if you have a severe liver or kidney disease.
• if you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If you need to take anticoagulants and ibuprofen at the same time, your doctor will perform blood clotting tests.
• if you are in the third trimester of pregnancy
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake)

Warnings and precautions

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

Inform your doctor:

• if you have swelling (fluid retention).
• if you have or have had any heart problems or high blood pressure.
• if you have asthma or any other breathing problems.
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a long time (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• if you present symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case could cause kidney failure due to dehydration.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when taking high doses and long-term treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector.
• if you take anticoagulants (blood thinners) or other medications that affect blood clotting, such as warfarin, aspirin, or ticlopidine.
• if you take diuretics (medicines that increase urine production), as your doctor will need to 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 meningitis.
• if you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the suitability of ibuprofen treatment.
• if you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible to have allergic reactions with this medicine.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medicine if you have chickenpox.
• It is recommended to use the smallest dose that relieves or controls pain and not to take this medicine for longer than necessary to control your symptoms.
• if you have an infection; see the heading "Infections" below.

Infections

Ibuprofeno Winadol may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno Winadol 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 medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

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

These types of medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Skin Reactions

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

Children and Adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Taking Ibuprofeno Winadol with other medicines

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

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

• Do not take this medicine if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine. Anticoagulants (e.g., to treat blood clotting problems, 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 muscle contractions).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (induces abortion).
• Digoxin (cardiotonic glycosides) (used in the treatment of heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Diuretics (medicines that increase urine production). Corticosteroids such as cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Fibrinolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).
• Herbal extracts: from the Ginkgo biloba tree.

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

Interference with diagnostic tests

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

Taking Ibuprofeno Winadol with food, drinks, and alcohol

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

If you take alcohol while taking this medicine, you may be more prone to adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do 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 week 20 of pregnancy, Ibuprofeno Winadol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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 fertile women

Pregnancy

Due to the association of administering this type of medicine with an increased risk of congenital anomalies/abortions, it is not recommended to administer it 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.

During the third trimester, administration is contraindicated.

Fertility

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

Breastfeeding

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

Driving and operating machinery

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

Ibuprofeno Winadol contains sodium and maltitol liquid (E-965)

Patients on a low-sodium diet should note that this medicine contains 35.84 mg (1.6 mmol) of sodium per sachet.

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

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

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

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

Dosage

Children

The dose of ibuprofen to be administered depends on the age and weight of the child. Generally, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses.

Generally, the following dosage regimen is recommended:

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

This medication is not recommended for use in children weighing less than 25 kg (approximately 7 years old) since the dose (200 mg of ibuprofen) does not adapt to the recommended dosage in these patients.

Adults:

The recommended dose is 1 to 2 tablets (200-400 mg of ibuprofen) every 4-8 hours, depending on the intensity of symptoms and the response to treatment. No more than 6 tablets (1,200 mg) should be taken within 24 hours.

Patients with kidney, liver, or heart disease:

In patients with mild or moderate disease, the initial dose should be reduced. Ibuprofen should not be used in patients with severe renal, hepatic, or cardiac insufficiency.

If symptoms worsen, if fever persists for more than 3 days, or pain lasts for more than 5 days (3 days in children and adolescents), consult a doctor.

The administration of this medication is subject to the appearance of pain or fever. As these symptoms disappear, the medication should be discontinued.

Administration Form

This medication is a suspension, administered orally.

The suspension must be homogenized before taking it, as indicated in the following figure:

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

2 – Press from the top and bottom and vice versa for at least 30 seconds

It can be taken directly from the package 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 ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet 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 inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Rarely, more severe symptoms such as intestinal hemorrhage, hypotension, hypothermia, metabolic acidosis, seizures, renal function impairment, coma, respiratory distress in adults, and transient cessation of breathing in children (after ingesting large quantities) may appear.

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

If you forget to take Ibuprofeno Winadol

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.

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

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

. The incidence of side effects is lower in short-term 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:

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

• Uncommon side effects(may affect up to 1in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, aching, etc. more frequent in hands, feet, arms, or legs), headache and drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm (difficulty breathing).

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

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

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread skin and mucous membrane erosions and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (skin erosions and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesions), In case of severe generalized hypersensitivity reactions, signs may include facial swelling, tongue swelling, laryngeal swelling, dyspnea (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 had 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 side effects are thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decrease in red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency 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, pseudogripal symptoms, extreme fatigue, unexplained bleeding and bruising. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Exacerbation of inflammatory reactions related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Frequency unknown(cannot be estimated from available data):

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

Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (pustular psoriasis). Stop taking Ibuprofeno Winadol if you experience these symptoms and seek medical attention immediately. See section 2.

The skin becomes sensitive to light.

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

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood, or blood that looks like coffee grounds.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling on the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use,www.notificaRAM.es.

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

Store below 30°C.

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

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

Composition of Ibuprofeno Winadol

• The active ingredient is ibuprofen. Each sachet contains 200 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), 99.5% glycerol (E-422), liquid maltitol (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, hypromellose 15 cps, strawberry flavor, and purified water.

Appearance of the product and content of the container

Ibuprofeno Winadol is a white oral suspension with a strawberry flavor contained in single-dose sachets of 10 ml formed by a complex of polyester, aluminum, polyester, and polyethylene.

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

NUTRA ESSENTIAL OTC, S.L.

C/ La Granja 1, 3ºB

28108 Alcobendas (Madrid)

Responsible for manufacturing

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

“ó”

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

“ó”

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

“ó”

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

Last review date of this leaflet: November 2024

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