IBUPROFEN RAPID STADAPHARM 400 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Ibuprofen rapid Stadapharm 400 mg soft capsules

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, 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 your symptoms worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

Contents of the Package Leaflet

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

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

Ibuprofen, the active substance of this medicine, acts by reducing pain and fever.

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

You should consult a doctor if your symptoms worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 3 days in adolescents or 5 days in adults.

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

Do not takeIbuprofeno rapid Stadapharmif:

• You are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other components of this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• You have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• You vomit blood.
• You have black stools or diarrhea with blood.
• You have severe liver or kidney disease.
• 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 coagulation tests.
• You have severe heart failure.
• You are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno rapid Stadapharm:

• If you have had or developed an ulcer, bleeding or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in elderly patients.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have heart disease 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 to 2 weeks), your doctor may need to perform regular 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 as a consequence of dehydration.

In dehydrated adolescents, there is a risk of renal function deterioration.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. 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 medications can worsen these diseases.
• If you are being treated with diuretics (medicines to urinate) because your doctor should monitor kidney function.
• If you have 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 the blood and can cause symptoms such as reddish urine color or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you are receiving treatment with ibuprofen, as it can mask fever, which is an important sign of infection, making diagnosis difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform stricter controls if you receive ibuprofen after undergoing 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 smallest dose that relieves/controls the pain and not to take this medicine for longer than necessary to control your symptoms.
• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medicine immediately and contact your doctor or the medical emergency service immediately if you notice any of these signs.

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 Ibuprofeno rapid Stadapharm if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

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

Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno rapid Stadapharm may delay appropriate treatment of the infection, which can 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.

Use of Ibuprofeno rapid Stadapharm with other medications

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

Ibuprofeno rapid Stadapharm may affect or be affected by other medications.

For example:

• Anticoagulant medications (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (e.g. ACE inhibitors like captopril, beta blockers like atenolol, and angiotensin-II receptor antagonists like losartan)

• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine or aspirin (acetylsalicylic acid).
• Other NSAIDs like aspirin.
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (medications for depression).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in heart disorders).
• Hydantoins like phenytoin (in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used for bacterial infections).
• Diuretics (medicines used to increase urine elimination).

• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Insulin and oral hypoglycemic agents (used to decrease blood glucose levels).
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection)
• Antihypertensive agents (to decrease high blood pressure).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (medication against the AIDS virus).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Phenytoin (in the treatment of epilepsy).
• Ion exchange resins like cholestyramine (used to decrease cholesterol levels in blood).
• Tacrine (used in the treatment of Alzheimer's disease).
• CYP2C9 inhibitors like voriconazole and fluconazole.

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

Interaction with analytical tests:

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking or have recently taken this medicine, as it may alter the results.

Taking Ibuprofeno rapid Stadapharm with food, drink, and alcohol

You can take it alone or with food. It is generally recommended to take it during meals or with milk to reduce the possibility of stomach upset.

Do not take ibuprofen with alcohol to avoid damaging the stomach.

Taking ibuprofen by patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor... 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 taking medications with ibuprofen has been associated with an increased risk of congenital anomalies/abortions, its administration 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, taking this medicine is contraindicated.

Breastfeeding

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

Fertility

For women of childbearing age, it should be noted that medications of the Ibuprofeno rapid Stadapharm type have been associated with a decrease in fertility. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, do not drive or use hazardous 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 can 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 that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, consult your doctor before taking this medicine.

3. How to take Ibuprofeno rapid Stadapharm

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask 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 tablets (1200 mg) in 24 hours.

• Patient with kidney, liver, or heart disease should consult their doctor, as they may need to reduce the dose.
• Patient over 65 years of age: the amount to take should be established by the doctor, as it may be necessary to reduce the usual dose.

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

Use in children and adolescents under 12 years of age

Children under 12 years of age should not take this medicine due to the 400mg dose of ibuprofen. There are other presentations more suitable for this population.

How to take:

This medicine is taken orally.

Swallow the medicine with a little water.

Take the medicine with meals or with milk, especially if you experience digestive discomfort.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, the medication should be discontinued.

In adolescents from 12 to 18 years of age, if the use of this medicine is required for more than 3 days or if the symptoms worsen, a doctor should be consulted.

In adults, if the symptoms worsen, if the fever persists for more than 3 days or the pain for more than 5 days, a doctor should be consulted.

If you take more Ibuprofeno rapid Stadapharm than you should

If you take or accidentally administer more medicine than you should, or if a child has ingested the medicine accidentally, consult a doctor immediately or call the toxicology information service, phone 915620420, indicating the medicine and the amount used, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

Symptoms of overdose may include stomach pain, nausea, vomiting (which may contain bloody sputum), headache, involuntary eye movements, ringing in the ears. At high doses, intestinal bleeding, hypotension, metabolic acidosis, coma, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in the blood, chills, and breathing problems have been reported.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Adverse effects are more common in people over 65 years of age. The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

• signs of intestinal bleeding,such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble ground coffee beans
• signs of a very 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, decreased blood pressure that causes shock. These can occur even with the first use of this medicine
• severe skin reactionssuch as rashes that cover the entire body, exfoliation, blisters or skin peeling.
• red patches, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• widespread rash, elevated body temperature and hypertrophied lymph nodes (DRESS syndrome).
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Tell your doctor if you experience the following adverse effects:

Frequent:(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 that can cause anemia in exceptional cases.

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

• gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis
• central nervous system disorders, such as headache, dizziness, insomnia, agitation, 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 concentration of urea in the blood, pain in the sides and/or abdomen, blood in the urine and fever, may be signs of kidney damage (papillary necrosis)
• decrease in hemoglobin levels.

Very Rare:(in less than 1 in 10,000 patients)

• esophagitis, pancreatitis and formation of intestinal stenosis of the diaphragm type
• heart failure, heart attack and swelling of the face and hands (edema)
• decreased urine output, swelling (edema) and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that can lead to acute kidney failure. If you experience any of the above symptoms or if you have a feeling of sadness, stop taking Ibuprofeno rapid Stadapharm and consult your doctor immediately as it may be the first signs of kidney damage or failure
• psychotic reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction (the first symptoms may be skin discoloration), liver damage especially in prolonged treatment, liver failure, acute liver inflammation (acute hepatitis)
• problems with blood cell production. The first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds and skin bleeding and bruises of unknown origin. In these cases, you should stop treatment immediately and consult your doctor. You should not self-medicate with pain relievers or antipyretic medications
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammation associated with an infection (e.g. necrotizing fasciitis) has been described with the use of some analgesics (NSAIDs). If signs of infection or worsening appear, you should see a doctor immediately. It should be evaluated if antibiotic therapy is necessary
• symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or disorientation during ibuprofen treatment have been observed. It is more likely to affect patients with autoimmune disorders (e.g. SLE, mixed connective tissue disease). If this happens, contact your doctor immediately
• severe skin reactions such as skin rashes with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell 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. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation and elevated eosinophils (a type of white blood cell).
• Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno rapid Stadapharm if you experience these symptoms and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light.
• Chest pain, which can be a sign of a potentially severe 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 with medicines like Ibuprofeno rapid Stadapharm.

Based on experience with NSAIDs, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the 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 it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ibuprofeno rapid Stadapharm

Keep this medicine out of sight and reach of children.

Store below 30 ºC.

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

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno rapid Stadapharm

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

The other components are:

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

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

Appearance of the Product and Package Contents

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

They come in packages containing 10 or 20 soft capsules, packaged 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 Last Revision of this Leaflet: October 2024

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