IBUPROFEN WINADOL 200 mg ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Winadol 200 mg Oral Suspension

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this 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 leaflet. See section 4.
• You should consult a doctor if the fever worsens or does not improve after 3 days or the pain after 5 days (3 days in children and adolescents).

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. Contents of the pack and further 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 adults and children 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 Ibuprofen Winadol:

if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may be: 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 diarrhea with blood.
  • 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 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 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 severe abdominal pain or persistent 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 diarrhea with blood) 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 can 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.
• It is important to use the smallest dose that relieves/controls the pain and you should not take this medicine for longer than necessary to control your symptoms.
• if you have an infection; see the "Infections" section below.

Infections

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of 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 if you are a smoker.

Similarly, this type of medication 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, lesions on the mucous membranes, 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 Ibuprofen Winadol with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

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

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory drugs (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 medications (e.g. to treat blood coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin).
• Medications 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 medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• 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 medication 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 and fluconazole (used for fungal infections).
• Herbal extracts: Ginkgo biloba tree.

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

If you are going to have any diagnostic tests (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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 labor 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 can 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

Because the administration of this type of medication has been associated with an increased risk of congenital anomalies/abortions, it is not recommended 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, administration is contraindicated

Fertility

For patients of childbearing age, it should be noted that medications like ibuprofen have been associated with a decrease in fertility.

Breastfeeding

Although the levels of the medication 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 use 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 Maltitol Liquid (E-965)

Patients on low-sodium diets 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 some sugars, consult with them before taking this medicine.

3. How to take Ibuprofeno Winadol

Follow 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

Pediatric population

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

In general, the following dosage guideline is recommended:

• Children weighing 25 to 40 kg (approximately 7-12 years old): The recommended daily dose is 600-800 mg of ibuprofen, divided into 3 or 4 doses (1 dose every 3 or 4 times a day), with a maximum recommended daily dose of 800 mg.
• Children weighing more than 40 kg and adolescents (over 12 years old): The recommended daily dose is 800-1200 mg of ibuprofen, divided into 3 or 4 doses (1-2 doses 3 or 4 times a day), with a maximum recommended daily dose of 1200 mg.

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

The use of this medication is not recommended in children with a weight of 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 sachets (200-400 mg of ibuprofen) every 4-8 hours, depending on the intensity of symptoms and response to treatment. Do not take more than 6 sachets (1200 mg) 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 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 disappear, the medication should be suspended.

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 the top and bottom of the sachet with your fingers several times

2 – Press from top to bottom and vice versa for at least 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 ibuprofen 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 quantities).

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

If you forget 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 suffer from them.

The incidence of adverse 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 1200 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 stools, 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, urticaria, 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 purplish lesions, preferably on the trunk) 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, signs may include swelling of the face, tongue, and larynx, 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 paleness of the skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow 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. Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by proteins in the urine and swelling of the body), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea.

• Frequency not known(cannot be estimated from 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 can 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.
• Vomiting blood or coffee-ground-like material.
• Blood in stools 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 Pharmacovigilance System for Human Use Medicines, www.notificaRAM.es.

5. Conservation of Ibuprofeno Winadol

Keep this medication out of sight and reach of children.

Store below 30°C.

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 down the drain or into 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 contains 200 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 10 ml monodose sachets formed by a polyester, aluminum, polyester, and polyethylene complex.

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

Only some package sizes may be marketed.

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