Ibuprofen Winadol 100 mg oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofeno Winadol 100 mg oral suspension

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if fever or pain worsens or does not improve after 3 days.

Contents of the leaflet

1. What Ibuprofeno Winadol is and what it is used for
2. What you need to know before taking Ibuprofeno Winadol
3. How to take Ibuprofeno Winadol
4. Possible adverse effects
5. Storage of Ibuprofeno Winadol
6. Contents of the pack and other information

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

Ibuprofen, the active ingredient in this medicine, works by reducing pain and fever.

This medicine is used in children weighing more than 20 kg (from 7 years of age) for the symptomatic relief of mild to moderate occasional pain, as well as febrile conditions.

2. What you need to know before taking Ibuprofeno Winadol

Do not take Ibuprofeno Winadol:

• if you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6) or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• if you have previously had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract
• if you are vomiting blood
• if you have black stools or bloody diarrhoea
• if you have severe heart failure
• if you suffer from a serious liver or kidney disease
• if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

Warnings and precautions

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

Inform your doctor:

• if you have oedema (fluid retention)
• if you suffer from or have previously had heart disorders or high blood pressure
• if you suffer from asthma or any other respiratory disorder
• if you are being treated with this medicine, as it may mask fever, an important sign of infection, thereby complicating diagnosis
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on the frequency of these checks
• if you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of dehydration
• if you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine
• if you are taking concomitantly medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs)
• if you suffer from Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions
• if you are taking diuretics (medicines to increase urination), because your doctor must monitor your kidney function
• if you suffer from systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur
• if you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate
• if you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine
• allergic reactions may occur with this medicine
• your doctor will perform stricter monitoring if you receive ibuprofen after major surgery
• it is advisable not to take this medicine if you have chickenpox
• if you have an infection; see the section "Infections" below

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

Infections

Ibuprofeno Winadol may mask signs of infection such as fever and pain. Therefore, Ibuprofeno Winadol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. Discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA")
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with treatment using Ibuprofeno Winadol. Stop taking Ibuprofeno Winadol and seek medical advice immediately if you develop any skin rash, lesions of mucous membranes, blisters or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Children

There is a risk of kidney damage in dehydrated children.

Taking Ibuprofeno Winadol with other medicines

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

The following medicines may interact and therefore should not be taken together with ibuprofen without first 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 gastrointestinal ulcer and bleeding.
• Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)
• Baclofen (used to treat involuntary and persistent muscle contractions)
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine
• Mifepristone (abortion-inducing agent)
• Digoxin (cardiac glycosides) (used in the treatment of heart disorders)
• Hydantoins such as phenytoin (used in the treatment of epilepsy)
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections)
• Diuretics (medicines used to increase urine elimination)
• Corticosteroids such as cortisone and prednisolone, used in inflammatory conditions
• Selective serotonin reuptake inhibitors (SSRIs), used for depression
• Pentoxifylline (to treat intermittent claudication)
• Probenecid (used in patients with gout or together with penicillin in infections)
• Quinolone antibiotics such as norfloxacin
• Ion-exchange resins such as cholestyramine (used to reduce blood cholesterol levels)
• Sulfinpyrazone (for gout)
• Sulfonylureas such as tolbutamide (for diabetes)
• Tacrine (used in the treatment of Alzheimer's disease)
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
• Zidovudine (an anti-HIV medicine)
• Thrombolytics (medicines that dissolve blood clots)
• Aminoglycoside antibiotics such as neomycin
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole or fluconazole, used to treat fungal infections
• Herbal extracts: Ginkgo biloba

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

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Ibuprofeno Winadol with food, drinks and alcohol

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

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond expected duration. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Precautions during pregnancy and in women of childbearing age

Pregnancy

Because administration of this type of medicine has been associated with an increased risk of congenital malformations or miscarriage, it is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine is contraindicated during the third trimester.

Fertility

For women of childbearing age, it should be noted that medicines such as ibuprofen have been associated with a reduced ability to conceive.

Breastfeeding

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

Driving and using machines

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

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

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

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

3. How to take Ibuprofen Winadol

Follow exactly the dosing instructions for the medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

It is important to always take the lowest dose that relieves pain, and you should not take the medicine for longer than necessary to control your symptoms.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Dosage

The recommended dose of ibuprofen depends on the child's body weight. Generally, a single dose of 5 to 10 mg/kg of body weight should be administered, depending on the severity of symptoms, up to a maximum total daily dose of 20–30 mg/kg of body weight.

Do not administer this medicine to children under 7 years of age or weighing less than 20 kg.

In general, dosing is recommended according to the following table:

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

Use only for short-term treatment.

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

Special patient groups

Renal impairment:

Dose reduction is not necessary in patients with mild or moderate renal impairment (for patients with severe renal impairment, see section 4.3).

Hepatic impairment:

Dose reduction is not necessary in patients with mild or moderate hepatic impairment (for patients with severe hepatic impairment, see section 4.3).

Method of administration

This medicine is a suspension and is administered orally.

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

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

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

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

If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

If you take more Ibuprofeno Winadol than you should

If you have taken more oral suspension than you should, or have accidentally ingested the contents of the container, consult your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the container and the package leaflet to the healthcare professional.

If you have taken more Ibuprofeno Winadol than you should, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

More severe symptoms such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient cessation of breathing in children (after ingestion of large quantities) are rare.

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 scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, dizziness or feeling unsteady, 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 skin spots), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paraesthesia (numbness, tingling, pins and needles, etc., more frequent in hands, feet, arms or legs), headache and drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), 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, dizziness, tinnitus (ringing or noises in the ears), reversible toxic amblyopia, liver injury, oedema (swelling due to 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 two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesions). In case of severe generalized hypersensitivity reaction, symptoms may include swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other very rare adverse effects include thrombocytopenia (decreased platelets), leukopenia (decreased white blood cells, which may present as frequent infections with fever, chills or sore throat), decreased red blood cells (which may present as difficulty breathing and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use), associated with increased urea levels.

Exacerbation of inflammation associated with infections has been observed during use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, medical advice should be sought promptly.

• 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 results in diarrhoea with blood).

Generalized red scaly rash, with lumps 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). Stop taking Ibuprofen Winadol if you experience these symptoms and seek medical attention immediately. See also section 2.

Skin becomes sensitive to light.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).

If any of the following adverse effects occur, stop taking the medicine and contact your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhoea with blood.
• Severe stomach pain.
• Blisters or significant peeling of the skin.
• 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 arms or legs.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es.

5. Storage of Ibuprofeno Winadol

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not refrigerate.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ibuprofeno Winadol

• The active substance is ibuprofen. Each sachet containing 5 ml of suspension contains 100 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), glycerol 99.5% (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 contents of the container

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

It is available in packs of 12 or 20 units.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La Granja 1, 3ºB

28108 Alcobendas (Madrid), Spain.

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 most recent revision of this leaflet: November 2024

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”