Ibuprofen Rapid Stadapharm 400 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen rapid Stadapharm 400 mg Soft Capsules

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

Always follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet (see section 4).
• You must consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days in adolescents or more than 5 days in adults, or if pain lasts longer than 3 days in adolescents or 5 days in adults.

Leaflet Contents

1. What Ibuprofen rapid Stadapharm is and what it is used for.
2. What you need to know before taking Ibuprofen rapid Stadapharm.
3. How to take Ibuprofen rapid Stadapharm.
4. Possible side effects.
5. How to store Ibuprofen rapid Stadapharm.
6. Contents of the pack and other information.

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

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

It is indicated in adults and adolescents over 12 years of age for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for febrile conditions.

You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain lasts more than 3 days in adolescents or 5 days in adults.

2. What you need to know before taking Ibuprofeno rapid Stadapharm.

Do not take Ibuprofeno rapid Stadapharm:

• If you are allergic to ibuprofen, to other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced gastrointestinal perforation.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have severe 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 have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofeno rapid Stadapharm:

• 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 or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients.
• If you have oedema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you have or have had heart problems or high blood pressure.
• 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 carry out regular monitoring.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to renal failure due to dehydration.

In dehydrated adolescents, there is a risk of impaired kidney function.

• If you are taking concomitant medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have 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 ibuprofen-containing medicines may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urination), because your doctor must monitor kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, thereby complicating diagnosis.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform closer monitoring if you receive ibuprofen following major surgery.
• If you have an infection; see the "Infections" section below.
• It is advisable not to take this medicine if you have chickenpox.
• It is important to use the lowest effective dose to relieve/control pain and not to take this medicine longer than necessary to control your symptoms.
• Serious allergic reactions have been reported with ibuprofen, such as breathing difficulties, swelling of the face and neck region (angioedema), and chest pain. Stop using this medicine immediately and contact your doctor or emergency medical services without delay if you notice any of these signs.

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.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno rapid Stadapharm 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 smoke.

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 ibuprofen, including 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). Discontinue treatment with Ibuprofeno rapid Stadapharm and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, Ibuprofeno rapid Stadapharm may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Use of Ibuprofeno rapid Stadapharm with other medicines

Tell your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Ibuprofeno rapid Stadapharm may interact with or be affected by other medicines.

For example:

• Anticoagulant medicines (e.g. to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Antiplatelet agents (to prevent blood clots in blood vessels), such as ticlopidine or aspirin (acetylsalicylic acid).
• Other NSAIDs such as aspirin.
• Corticosteroids such as cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (medicines for depression).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (used to induce abortion).
• Digoxin and other cardiac glycosides (used for heart disorders).
• Hydantoins such as phenytoin (used in epilepsy treatment).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medicines used to increase urine output).
• Pentoxifylline (used for circulatory disorders).
• Probenecid (used in gout patients or together with penicillin for infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout treatment).
• Insulin and oral hypoglycaemics (used to lower blood glucose).
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection).
• Antihypertensives (to lower high blood pressure).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (an anti-HIV drug).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Phenytoin (used in epilepsy treatment).
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Tacrine (used in the treatment of Alzheimer's disease).
• CYP2C9 inhibitors such as voriconazole and fluconazole.

Other medicines may also interact with or be affected by Ibuprofeno rapid Stadapharm. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno rapid Stadapharm with other medicines.

Interaction with laboratory 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 or have recently taken this medicine, as it may alter test results.

Taking Ibuprofeno rapid Stadapharm with food, drink and alcohol

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

You should not take ibuprofen with alcohol to avoid stomach damage.

Taking ibuprofen in patients who habitually consume alcohol (3 or more alcoholic drinks—beer, wine, spirits—per day) may cause stomach bleeding.

Pregnancy, breastfeeding and fertility

Pregnancy

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

Because the use of ibuprofen-containing medicines has been associated with an increased risk of congenital abnormalities/miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

During the third trimester, the use of this medicine is contraindicated.

Breastfeeding

This medicine passes into breast milk, but may be taken during breastfeeding if used at the recommended dose for the shortest possible duration.

Fertility

For women of childbearing age, it should be noted that medicines such as Ibuprofeno rapid Stadapharm have been associated with reduced fertility. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, do not drive or operate dangerous machinery.

This medicine contains Allura Red (E-129) and sorbitol (E-420)

This medicine may cause allergic reactions because it contains Allura Red (E-129). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 58.25 mg of sorbitol (E-420) per capsule.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Ibuprofeno rapid Stadapharm

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents over 12 years of age: 1 capsule of 400 mg every 6-8 hours, if necessary.

Do not take more than 3 capsules (1200 mg) within 24 hours.

• Patients with kidney, liver, or heart disease should consult their doctor, as it may be necessary to reduce the dose.
• Patients over 65 years of age: the dose should be determined by the doctor, as a reduction from the usual dose may be required.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children and adolescents under 12 years of age

This medicine must not be taken by children under 12 years of age due to the 400 mg dose of ibuprofen. Other formulations more suitable for this population are available.

How to take:

This medicine is taken orally.

Swallow the medicine with a little water.

Take the medicine with food or milk, especially if gastrointestinal discomfort occurs.

This medicine should only be taken when pain or fever occurs. As symptoms subside, the medication should be discontinued.

In adolescents aged 12 to 18 years, if this medicine is required for more than 3 days or if symptoms worsen, consult a doctor.

In adults, if symptoms worsen, if fever persists for more than 3 days, or if pain persists for more than 5 days, consult a doctor.

If you take more Ibuprofeno rapid Stadapharm than you should

If you or someone else accidentally takes more than the recommended dose, or if a child has accidentally ingested the medicine, contact a doctor immediately or call the Toxicology Information Service at 915620420, indicating the medicine and the amount taken, or go to the nearest hospital for advice on the risks and measures to take. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose may include stomach pain, nausea, vomiting (which may contain blood-stained sputum), headache, involuntary eye movements, tinnitus, and dizziness. At high doses, gastrointestinal bleeding, hypotension, metabolic acidosis, coma, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, hematuria, low blood potassium levels, chills, and breathing difficulties have been reported.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes of ingestion.

4. Possible adverse effects

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

Adverse effects are more common in people over 65 years of age. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

STOP taking this medicine and seek immediate medical help if you experience:

• signs of gastrointestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee
• signs of a rare but severe allergic reaction, such as worsening asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure leading to shock. These may occur even with the first use of this medicine
• severe skin reactions, such as rashes affecting the entire body, peeling, blisters or skin shedding.
• flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, and mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• widespread rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Tell your doctor if you experience any of the following adverse effects:

Common: (may affect up to 1 in 10 people)

• stomach problems such as heartburn, stomach pain and nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestine, which may exceptionally lead to anemia.

Uncommon: (may affect up to 1 in 100 people)

• gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane in the mouth with ulceration, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), gastritis
• disorders of the central nervous system, such as headache, dizziness, insomnia, restlessness, irritability, and fatigue
• visual disturbances
• various skin rashes
• hypersensitivity reactions with hives and itching.

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

• tinnitus (ringing in the ears)
• increased blood urea concentration, pain in the sides and/or abdomen, blood in the urine and fever, which may be signs of kidney damage (papillary necrosis)
• decreased hemoglobin levels.

Very rare: (in fewer than 1 in 10,000 patients)

• esophagitis, pancreatitis, and development of diaphragm-type intestinal strictures
• heart failure, heart attack, and swelling of the face and hands (edema)
• reduced urine output, swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If you experience any of the symptoms listed above, or if you feel sadness, stop taking Ibuprofen rapid Stadapharm and consult your doctor immediately, as these may be early signs of kidney damage or failure
• psychotic-type reactions, depression
• elevated blood pressure, vasculitis
• palpitations
• liver dysfunction (early symptoms may include skin discoloration), liver damage especially with prolonged treatment, liver failure, acute inflammation of the liver (acute hepatitis)
• problems in blood cell production. Early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and you must consult your doctor. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammation associated with infection (e.g., necrotizing fasciitis) has been reported in association with the use of some painkillers (NSAIDs). If signs of infection appear or worsen, seek medical attention immediately. Antibiotic therapy should be evaluated
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or confusion have been observed during ibuprofen treatment. This is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
• severe forms of skin reactions such as rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell's syndrome), and hair loss (alopecia).

Frequency not known: (cannot be estimated from available data)

• respiratory tract reactivity including asthma, bronchospasm or dyspnea.
• a severe 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).
• widespread red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen rapid Stadapharm if you experience these symptoms and seek immediate medical attention. See also section 2.
• skin becomes sensitive to light.
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines of this type may be associated with a slight increase in the risk of heart attack or stroke (myocardial infarction or stroke). Prolongation of bleeding time, edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments using medicines such as Ibuprofen rapid Stadapharm.

Based on experience with NSAIDs, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno rapid Stadapharm

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

Store below 30 ºC.

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

Do not use this medicine if you notice any deterioration of the capsules.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno rapid Stadapharm

Each soft capsule contains 400 mg of ibuprofen as the active substance.

The other components are:

Core: macrogol, potassium hydroxide, Allura red (E-129), and purified water.

Capsule shell: gelatin, non-crystallizable liquid sorbitol (E-420), and purified water.

Appearance of the product and contents of the pack

Ibuprofeno rapid Stadapharm are light red, transparent, oval soft capsules measuring 16.5 x 9.7 mm.

The product is available in packs containing 10 or 20 soft capsules, presented in PVC/PVdC/Al blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

HC Clover Productos y Servicios S.L.

C/ Alicante, 8-10

28500 Arganda del Rey (Madrid)

Spain

Date of the most recent review of this package leaflet: October 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/