IBUPROFEN WINADOL 600 mg FILM-COATED TABLETS

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

Do not takeIbuprofen Winadol

• If you are allergic to ibuprofen, to other medicines of the non-steroidal anti-inflammatory drug (NSAID) group, to acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have an inflammatory disease of the intestine.
• If you have 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 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 have severe dehydration (caused by vomiting, diarrhea, or insufficient 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 disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with ibuprofen as it may mask fever, which is an important sign of infection, making its diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), it is possible that your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• 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 medication.
• 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-like medications can worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production) because 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 (inflammation of the meninges 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 a disease called porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease).
• If you experience headaches after prolonged treatment (more than 3 months), you should not take higher doses of the medication. If this occurs, you should stop treatment and consult your doctor.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• Patients treated with 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 reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofeno. Stop using Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services if you observe any of these signs.

Infections

Ibuprofen Winadol may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofen Winadol may delay the appropriate 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very 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 syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

It is important that you use the smallest dose that relieves/control the pain and do not 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 (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Children and adolescents

In dehydrated children and adolescents, there is a risk of kidney failure.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of having 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 ibuprofen 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 medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

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

Using Ibuprofen Winadol with other medications

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

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

• Other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems or prevent coagulation, such as acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medication used to treat high cholesterol).
• Methotrexate (for the treatment of cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Selective serotonin reuptake inhibitors (for the treatment of depression).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins, such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (for the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group, such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas, such as tolbutamide (for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication for the treatment of HIV).
• 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 herb extracts.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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

Taking Ibuprofen 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 upset. You should avoid consuming alcohol when being treated with ibuprofen.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ibuprofen 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 and your baby's ability to clot and prolong or prolong delivery more than expected. You should not take Ibuprofen Winadol 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 the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

The use of this medication is not recommended in women who are trying to become pregnant.

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

Although only small amounts of the 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 using machines

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

Ibuprofen may delay your reaction time; this should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

This applies to a greater extent in combination with alcohol.

Ibuprofen Winadolcontains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Ibuprofeno Winadol

Follow the administration instructions for this medication exactly 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 stop treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

The lowest effective 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).

Method of administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

Take ibuprofen with a sufficient amount of water. The tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid discomfort in the mouth and throat irritation.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Adults and adolescents over 14 years old

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

In some processes, 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 from 14 to 18 years old.

Use in children and adolescents under 14 years old

The use of this medication is not recommended in children and adolescents under 14 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly patients

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

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, 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 take the package and the medication prospectus to the healthcare professional.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, low potassium levels in the blood, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (decreased blood pressure, decreased and increased heart rate).

If a severe poisoning has occurred, kidney failure 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. Stomach emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes after ingestion.

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 the 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 experience them.

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

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

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (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 adverse effects have been observed:

Infections and infestations:

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

Very rare:aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient 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 inflammation-related infections (e.g., development of 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:decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and blood platelets), agranulocytosis (very large decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare:prolonged 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, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear.

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

Psychiatric disorders:

Uncommon:insomnia, anxiety, restlessness.

Rare:disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Nervous system disorders:

Frequent:headache and dizziness or feeling of instability.

Uncommon:paresthesia (sensation of numbness, tingling, prickling, 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:ringing or buzzing in the ears, vertigo, hearing difficulty.

Respiratory, thoracic, and mediastinal disorders:

Uncommon:asthma, bronchospasm, difficulty breathing.

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. Edema (fluid retention), high blood pressure, and heart failure have also been observed.

Very rare:heart failure, myocardial infarction.

Vascular disorders:

Very rare:high blood pressure.

Gastrointestinal disorders:

Frequent:digestive disorders such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, bloody stools (melena), vomiting blood (hematemesis), gastrointestinal bleeding.

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

Very rare:pancreatitis.

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

Hepatobiliary disorders:

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

Frequency not known:liver failure (severe liver impairment).

Skin and subcutaneous tissue disorders:

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

Very rare:severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and purplish-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the blood vessels of the skin. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

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).

Frequency not known: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), the skin becomes sensitive to light. Stop taking ibuprofen if you present these symptoms and seek medical attention immediately. See also section 2.

Renal and urinary disorders:

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

General disorders and administration site conditions:

Frequent:fatigue.

Very rare:worsening of inflammation during infectious processes.

To date, 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 rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

Investigations:

Rare:increased blood urea nitrogen, serum transaminases, and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibited platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid.

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

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• 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.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Red, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Winadol

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 package after CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Ibuprofeno Winadol

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components (excipients) are:

Core:sodium croscarmellose, 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 package contents

Oval, biconvex, and white coated tablets. They are packaged in blisters in packages containing 40 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

1. Alcobendas. Madrid

Spain

Manufacturer

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

Date of the last revision of this prospectus: November 2024

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