Label:Information for the User

Ibuprofeno Winadol 600 mg Film-Coated Tablets

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

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhave the same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

6. Contents of the pack and additional information

Ibuprofeno belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the treatment of fever, the treatment of moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not takeIbuprofeno Winadol

• If you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or any of the other ingredients in this medicine (listed in section 6). Allergic reactions may include skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have an inflammatory bowel disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have had a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulant medications (used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have heart disease.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (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 have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking anticoagulant medications (such as warfarin, ticlopidine) or other medications that alter blood clotting, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you are in the first or second trimester of pregnancy.
• If you are breastfeeding.
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease).
• If you experience headaches after prolonged treatment (more than 3 months), do not take higher doses of the medication. If this occurs, stop treatment and consult your doctor.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is not recommended to take this medication if you have chickenpox.
• Patients taking ibuprofen for a prolonged period should be under regular medical supervision to monitor adverse reactions.
• If you have an infection; see the "Infections" section below.
• Signs of allergic reactions to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services if you observe any of these signs.

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, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking ibuprofen and seek medical attention 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.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Children and adolescents

In dehydrated children and adolescents, there is a risk of renal insufficiency.

Cardiovascular precautions

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

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

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, chronic bronchitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer them during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

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

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

Use of Ibuprofeno Winadol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Ibuprofen may affect or be affected by other medications. For example:

• Other NSAIDs, such as acetylsalicylic acid, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., for blood clotting problems or to prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
• Colestiramine (used to treat high cholesterol).
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Selective serotonin reuptake inhibitors (SSRIs) for depression.
• Lithium (used to treat depression). Your doctor may need to adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Ginkgo biloba extracts.
• CYP2C9 inhibitors (responsible for metabolizing many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Interference with laboratory tests

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum urea nitrogen concentrations and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase values.

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

Taking Ibuprofeno Winadol with food, drinks, and alcohol

You can take it alone or with food. In general, it is recommended to take it during or after meals or with milk to reduce the possibility of stomach discomfort. You should avoid consuming alcohol while taking ibuprofen.

Pregnancy, breastfeeding, and fertility

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

Do not take Ibuprofeno Winadol 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 bleeding and delay or prolong delivery more than expected. Do not take Ibuprofeno Winadol during the first 6 months of pregnancy unless it is strictly 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 result in low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

The use of this medication is not recommended for women trying to become pregnant.

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

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

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

Driving and operating machinery

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

Ibuprofen may slow your reaction time, which should be taken into account before engaging in activities that require increased vigilance, such as driving and operating machinery.

This is especially true in combination with alcohol.

Ibuprofeno Winadol contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

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

Administration Form

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs are recommended to take ibuprofen with food.

Take ibuprofen with sufficient amounts of water. Tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

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

Adults and Adolescents Over 14 Years

The recommended dose for adults and adolescents over 14 years is one tablet (600 mg) every 6 to 8 hours, depending on the severity of the condition and response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 14 to 18 years.

Use in Children and Adolescents Under 14 Years

This medication is not recommended for use in children and adolescents under 14 years, as the dose of ibuprofen contained is not suitable for the recommended dosage in this patient group.

Older Adults

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If this is the case, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with Kidney and/or Liver Diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If this is the case, take the exact dose prescribed by your doctor.

If You Take MoreIbuprofeno WinadolThan You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination problems. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In rare cases, cases of metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, low potassium levels in the blood, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

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 next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

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

Side effects of medications such as ibuprofen are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations:

Uncommon:rhinitis (nasal mucositis, sneezing, nasal congestion and/or itching).

Very rare:aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor, although cases have also been reported in patients without any chronic disease. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Exacerbation of infections-related inflammation (such as necrotizing fasciitis) has been described coinciding with the use of NSAIDs. If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to go to the doctor immediately.

Blood and lymphatic system disorders:

Rare:thrombocytopenia, leukopenia (may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as shortness of breath and pale skin), granulocytopenia (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow 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, pseudogripal symptoms, extreme fatigue, nasal and cutaneous hemorrhage.

Very rare:prolongation of bleeding time.

Immune system disorders:

Uncommon:transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), bronchospasm (spasm of the bronchi that prevents air from passing 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:arthralgia and fever (systemic lupus erythematosus).

Mental disorders:

Uncommon:insomnia, anxiety, restlessness.

Rare:disorientationor confusion, nervousness, irritability, depression, psychotic reaction.

Nervous system disorders:

Common:headache and dizziness or sensation of instability.

Uncommon:paresthesia (numbness, tingling, burning, etc., more frequent in hands, feet, arms, or legs), somnolence or drowsiness.

Rare:optic neuritis (inflammation of the optic nerve).

Eye disorders:

Uncommon:vision disturbances.

Rare:retinal degeneration.

Ear and labyrinth disorders:

Uncommon:tinnitus or buzzing in the ears, vertigo, hearing difficulty.

Respiratory, thoracic and mediastinal disorders:

Uncommon:asthma, bronchospasm, breathing difficulty.

Cardiac disorders:

Ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack (myocardial infarction) or stroke. The risk may be higher if high doses (2,400 mg/day) are used. Also, edema (fluid retention), hypertension, and heart failure have been observed.

Very rare:heart failure, myocardial infarction.

Vascular disorders:

Very rare:hypertension.

Gastrointestinal disorders:

Common:gastrointestinal discomfort such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, bloody stools (melena), vomiting with blood (hematemesis), gastrointestinal hemorrhage.

Uncommon:gastritis, duodenal ulcer, gastric ulcer, inflammation of the buccal mucosa with ulcer formation, gastrointestinal perforation.

Very rare:pancreatitis.

Frequency not known:colitis and Crohn's disease(a chronic disease in which the immune system attacks the intestine, causing inflammation that produces bloody diarrhea).

Hepatobiliary disorders:

Rare:hepatic lesions, hepatitis (inflammation of the liver), abnormalities in liver function, and jaundice (yellowing of the skin and eyes).

Frequency not known:hepatic insufficiency(severe deterioration of the liver).

Skin and subcutaneous tissue disorders:

Uncommon:eruption andredness of the skin, itching or swelling of the skin, purpura (purple spots on the skin), photosensitivity reactions.

Very rare:severe bullous reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), hair loss, erythema multiforme (skin lesion), light-induced skin reactions, inflammation of skin blood vessels. Exceptionally, severe cutaneous infections and complications in soft tissue may occur during varicella.

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

Frequency not known:generalized red scaly eruption, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), the skin becomes sensitive to light. Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2.

Renal and urinary disorders:

Uncommon:interstitial nephritis (kidney disorder), nephrotic syndrome (kidney disorder characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function).

General disorders and administration site conditions:

Common:fatigue.

Very rare:aggravation of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen 600 mg, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin eruption, severe abdominal pain, intense and persistent headache, nausea, vomiting, facial swelling, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension, or shock.

Complementary examinations::

Rare:increase in blood urea nitrogen, serum transaminases, and alkaline phosphatase, decrease in hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decrease in serum calcium, increase in serum uric acid.

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction 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:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, 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 tablet contains 600 mg of ibuprofen.
• The other components (excipients) are:

Nucleus: croscarmelosa sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, purified water.

Coating: hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and content of the packaging

Oval-shaped, biconvex, white-coated tablets. They are presented in blister packs in containers with 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

28108. Alcobendas. Madrid

Spain

Responsible for manufacturing

Farmalider, S.A.

C/ Aragoneses, nº 2

28100 – Alcobendas (Madrid)

Spain

O

FROSST IBÉRICA, S.A.

Vía Complutense, 140,

Alcalá de Henares,

28805 Madrid

Spain

Last review date of this leaflet: November 2024

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