Package Leaflet: Information for the User

Ibuprofen Stadapharm 400 mg Oral Suspension

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

Follow exactly the administration instructions 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 any 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 adolescents).

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

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

3. How to take Ibuprofen Stadapharm

4. Possible side effects

5. Storage of Ibuprofen Stadapharm

6. Contents of the pack and additional information

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

This medication is used in adults and adolescents 12 years of age and older and weighing more than 40 kg for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle spasms, or back pain (lumbago), as well as in febrile states.

Do not take Ibuprofeno Stadapharm:

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

Warnings and precautions

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

Inform your doctor:

• 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 this medication, 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 medication 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 experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case may cause kidney failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood) or other medications that affect blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, or medications that increase the risk of bleeding, 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 meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), as your doctor should assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform more frequent checks if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" heading 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 this medication immediately and contact your doctor or emergency medical services if you observe any of these signs.

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.

Infections

Ibuprofeno Stadapharm may mask the signs of an infection, such as fever and pain. Consequently, it 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.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration. Inform your doctor or pharmacist before taking this medication if:

- You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

- You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

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

Skin Reactions

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 (GAPP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Stadapharm treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

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

Taking Ibuprofeno Stadapharm with Other Medications

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

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

• Do not take this medication if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots in blood vessels) like ticlopidine.
• Anticoagulants (medications used to "thin" the blood), such as aspirin, warfarin.
• Medications that lower high blood pressure, such as ACE inhibitors (e.g., captopril), beta-blockers (e.g., atenolol), and angiotensin II receptor antagonists (e.g., losartan).
• Baclofen (used to treat involuntary muscle contractions).
• Lithium (used to treat depression). Your doctor may adjust your lithium dose.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust your methotrexate dose.
• Mifepristone (abortion inducer).
• Digoxin (cardiotonic glycosides) (used to treat heart conditions).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat bacterial infections).
• Diuretics (medications to increase urine production).
• Corticosteroids like cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Ion exchange resins like cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• CYP2C9 inhibitors (responsible for metabolizing many medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba tree.

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

Interference with Diagnostic Tests

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

Taking Ibuprofeno Stadapharm with Food, Drinks, and Alcohol

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

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

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

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 predisposition to bleeding and delay or prolong delivery. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 time possible. After 20 weeks of pregnancy, ibuprofen 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 a 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 monitoring.

Fertility

For fertile women, it is essential to consider that medications like ibuprofen have been associated with a decrease in the ability to conceive.

Breastfeeding

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

Driving and Operating Machinery

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

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

Patients on a low-sodium diet should note that this medication contains 57.94 mg (2.5 mmol) of sodium per packet.

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

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

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

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

Dosage

Adults and adolescents (over 40 kg in weight) from 12 years old:

The recommended dose is one packet (400 mg of ibuprofen) every 4-8 hours, depending on the intensity of symptoms and response to treatment. Do not take more than 3 packets (1,200 mg) within 24 hours.

Older patients:

The dosage should be established by the doctor, as there may be a need to reduce the usual dose. Older people are more prone to adverse effects.

Patients with kidney, liver, or heart diseases:

Reduce the dose and consult the doctor. 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 adolescents), you must consult the doctor.

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

Use in children and adolescents:

This medication is not recommended for use in children or adolescents weighing less than 40 kg.

Administration form

This medication is a suspension, administered orally.

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

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

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

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

In case of digestive discomfort, it is recommended to take the medication with meals.

If you take more Ibuprofeno Stadapharm than you should

If you have taken more oral suspension than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you have taken more Ibuprofeno Stadapharm than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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

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

If you forget to take Ibuprofeno Stadapharm

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at your usual time.

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

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

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

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

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

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

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

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

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe skin reactions including 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), erythema multiforme (skin lesion). In case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue swelling, and laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other very rare side effects are thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decrease in red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

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

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

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

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

The skin becomes sensitive to light.

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

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

• Allergic reactions such as skin rashes, facial swelling, shortness of breath, or difficulty breathing.
• Vomiting blood or blood-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red spots, often with blisters in the center, on the trunk, which may be accompanied by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of side effects

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

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

Store below 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Stadapharm

• The active ingredient is ibuprofen. Each 10 ml suspension sachet contains 400 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), 99.5% glycerol (E-422), liquid maltitol (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, hypromellose 15 cps, strawberry flavor, and purified water.

Appearance of the product and contents of the packaging

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

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

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

“ó”

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

“ó”

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

“ó”

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

Last review date of this leaflet:October 2024

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