Leaflet: information for the user

NUROFEN RAPID 400 mg soft capsules

Ibuprofen

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

Follow exactly the administration instructions for 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 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 you get worse 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.

1. What is Nurofen Rapid and what it is used for.

2. What you need to know before starting to take Nurofen Rapid.

3. How to take Nurofen Rapid.

4. Possible side effects.

5. Storage of Nurofen Rapid.

6. Contents of the pack and additional information.

The active ingredient ibuprofen in this medication acts by reducing pain and fever.

It is indicated in adults and adolescents over 12 years old for symptomatic relief of occasional mild or moderate pain, such as headache, toothache, menstrual pain, muscle pain (muscle cramps) or back pain (lumbago), as well as in febrile states.

Consult a doctor if it worsens or does not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Do not take Nurofen Rapid:

• If you are allergic to ibuprofen, other NSAIDs (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other components of this medication (listed in section 6). 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, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• 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 have severe heart failure.
• If you are in the third trimester of pregnancy.
• This medication contains soy oil. Do not use it if you are allergic to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nurofen Rapid:

• 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, in patients with a history of peptic ulcer disease, and in elderly patients.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart condition or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1-2 weeks), your doctor may need to perform regular checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.

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

• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or corticosteroids and selective serotonin reuptake inhibitors (SSRIs). If necessary, your doctor will perform blood clotting tests.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor needs to monitor kidney function.
• If you have 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 aseptic meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine or liver disease), as your doctor needs to assess the suitability of ibuprofen treatment.
• If you are receiving ibuprofen treatment, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• There is a possibility of allergic reactions with this medication.
• Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
• If you have an infection; see the "Infections" heading below.
• It is recommended not to take this medication if you have chickenpox.
• 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.

Allergic reactions to ibuprofen have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you notice any of these symptoms.

Cardiovascular precautions

NSAIDs 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 must inform your doctor or pharmacist before taking Nurofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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.

Additionally, this type of medication may 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 (GAP), have been reported in association with ibuprofen treatment. Stop using Nurofen and seek medical attention immediately if you notice any of these symptoms.

Infections

Nurofen Rapid may mask the signs of an infection, such as fever and pain. Consequently, Nurofen Rapid may delay or prolong 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.

Use of Nurofen Rapid with other medications

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

Nurofen may affect or be affected by other medications.

For example:

• Anticoagulant medications (e.g. for treating blood clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

• Antiplatelet agents (preventing blood clot formation in blood vessels) like ticlopidine or acetylsalicylic acid.
• Other NSAIDs like acetylsalicylic acid.
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (SSRIs) for depression.
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in heart conditions).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and co-trimoxazole (used to treat bacterial infections).
• Diuretics (medications to increase urine production).

• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Insulin and oral hypoglycemic agents (used to lower blood glucose).
• Ciclosporin and tacrolimus (used to prevent organ transplant rejection).
• Antihypertensives (to lower high blood pressure).
• Thrombolytics (medications that dissolve or break down blood clots).
• Zidovudine (medication for HIV/AIDS).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Baclofen (used to treat involuntary muscle contractions).
• Phenytoin (used to treat epilepsy).
• Ion exchange resins like cholestyramine (used to lower cholesterol levels).
• Tacrine (used to treat Alzheimer's disease).
• CYP2C9 inhibitors like voriconazole and fluconazole.

Other medications may also affect or be affected by concurrent Nurofen treatment. Therefore, always consult your doctor or pharmacist before using Nurofen with other medications.

Interaction 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 or have recently taken this medication, as it may alter the results.

Taking Nurofen Rapid with food, drink, and alcohol

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

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

Consuming ibuprofen by patients who regularly consume alcohol (3 or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed, and delay or prolong labor more than expected. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor advises it. In these cases, the dose and duration will be limited to the minimum necessary.

From week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or 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.

Breastfeeding

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

Fertility

For women of childbearing age, consider that ibuprofen has been associated with a decrease in fertility. Avoid taking this medication if you are trying to become pregnant.

Driving and operating machinery

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

This medication contains red iron oxide A (Ponceau 4R), (E-124), potassium, sorbitol (E-420), and soy oil

This medication may cause allergic reactions because it contains red iron oxide A (Ponceau 4R) (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Patients with kidney insufficiency or those on low-potassium diets should note that this medication contains 31.23 mg (0.8 mmol) of potassium per capsule.

This medication contains 69.13 mg of sorbitol (E-420) per capsule.

Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you (or they) have a fructose intolerance or hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

For information on soy oil, see the "Do not take Nurofen Rapid" heading.

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

The recommended dose is:

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

Do not take more than 3 tablets (1200 mg) in 24 hours.

• Patients with kidney, liver, or heart diseasesconsult your doctorbecause you may need to reduce the dose.
• Patients over 65 years old: the dose to be taken should be established by your doctor, as there is a possibility that a reduction in the usual dose may be needed.

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

Use in children and adolescents under 12 years old

Children under 12 years old cannot take this medication due to the 400mg dose of ibuprofen. There are other presentations more suitable for this population.

How to take:

This medication is taken orally.

Swallow the medication with a little water.

Take the medication with meals or with milk, especially if digestive discomfort is noticed.

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

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

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

If you take more Nurofen Rapid than you should

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

The symptoms of overdose may include stomach pain, nausea, vomiting (which may contain blood-stained mucus), headache, involuntary eye movements, buzzing in the ears. At high doses, intestinal hemorrhage, hypotension, metabolic acidosis, coma, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low potassium levels in 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 significant amounts have been ingested and within 60 minutes of ingestion.

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

Side effects are more common in people over 65 years old. The incidence of side effects is lower in short-term 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 with blood or dark particles that resemble ground coffee
• signs of a rare but severe allergic reaction,such as worsening of asthma, wheezing or unknown respiratory distress, facial, tongue or throat swelling, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These can occur even with the first use of this medicine
• Flat, red, non-elevated spots, in the shape of a target or circles 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 (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Inform your doctor if you experience the following side effects:

Frequent:(can affect up to 1 in 10 people)

• Stomach problems, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, gas, constipation, and mild bleeding in the stomach and/or intestines that can cause anemia in exceptional cases.

Rare:(can 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 headaches, dizziness, insomnia, agitation, irritability, and fatigue
• Visual disturbances
• Diverse skin eruptions
• Hypersensitivity reactions with urticaria and itching.

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

• Tinnitus (ringing in the ears)
• Increased urea concentration in the blood, side pain and/or abdomen, blood in the urine, and fever, which can be signs of kidney damage (papillary necrosis)
• Decreased hemoglobin levels

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

• Esophagitis, pancreatitis, and formation of intestinal stenosis of the diaphragm type
• Heart failure, myocardial infarction, and facial and hand swelling (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 mentioned symptoms or feel sad, stop taking Nurofen Rapid and consult your doctor immediately, as it may be the first signs of damage or kidney failure.
• Psychotic reactions, depression
• High blood pressure, vasculitis
• Palpitations
• Liver dysfunction (the first symptoms may be skin discoloration), liver damage, especially with prolonged treatment, liver insufficiency, acute hepatitis
• Blood cell production problems. The first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding, and unknown hematomas. In these cases, stop treatment immediately and consult your doctor. Do not self-medicate with analgesics or antipyretics.
• Severe skin infections and soft tissue complications during varicella infection
• There have been reports of worsening of inflammation associated with an infection (e.g., necrotizing fasciitis) associated with the use of some analgesics (NSAIDs). If you experience signs of infection or worsening, seek medical attention immediately. Antibiotic therapy may be necessary.
• There have been reports of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, or disorientation during treatment with ibuprofen. It is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately.
• Severe skin reactions, such as skin eruptions with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell syndrome) and hair loss (alopecia).

Unknown frequency:(cannot be estimated from available data)

• Reactivity of the respiratory tract, including asthma, bronchospasm, or dyspnea.
• 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).
• Generalized, red, scaly rash, with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Nurofen Rapid if you experience these symptoms and seek medical attention immediately. See section 2.
• The skin becomes sensitive to light.

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

Based on experience with NSAIDs, it cannot be ruled out that cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and acute kidney failure may occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture.

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.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Nurofen Rapid Composition

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

The other components are:

Core:polietilenglicol (macrogol) 600, potassium hydroxide, purified water.

Capsule:gelatine, liquid sorbitol (E-420), red cochineal A (Ponceau 4R) (E-124), lecithin (E-322) (from soy), isopropanol, nitrogen, medium-chain triglycerides, and printing ink containing hypromellose (E-464), titanium dioxide (E-171), propylene glycol (E-1520), isopropyl alcohol, and purified water.

Product appearance and packaging contents:

Nurofen Rapid are oval, transparent, red soft capsules with a white identifying logo.

They are presented in packaging containing 10 or 20 soft capsules in a PVC/PE/PVdC/Al or PVC/PVdC/Al blister. Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder:

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28 - 08403 Granollers – Barcelona

Spain

Manufacturer:

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Last review date of this leaflet:October 2024

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/