Nurofen Rapid 400 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NUROFEN RAPID 400 mg soft capsules

Ibuprofen

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

Follow exactly the instructions for taking this medicine as described 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 adverse effects not listed in this leaflet (see section 4).
• You should consult a doctor if you worsen or do not get better, if fever persists for more than 3 days in adolescents or more than 5 days in adults, or if pain persists for more than 3 days in adolescents or 5 days in adults.

Contents of the leaflet:

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

1. What Nurofen Rapid 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 (strains), or back pain (lumbago), as well as for feverish conditions.

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

2. What you need to know before taking Nurofen Rapid.

Do not take Nurofen Rapid:

• 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 a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you suffer from severe liver or kidney disease.
• If you have bleeding disorders or blood coagulation problems, or if you are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants at the same time, your doctor will carry out blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.

Warnings and precautions

Consult your doctor or pharmacist before taking Nurofen Rapid:

• If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses are used, with prolonged treatment, 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 any heart condition 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 case could lead to kidney 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 mention 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 suffer from Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as ibuprofen-containing medicines may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor should monitor kidney function.
• If you suffer from systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various 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, making diagnosis more difficult.
• 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 carry out stricter monitoring if you receive ibuprofen after 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 dose that relieves/controls the pain and not to take this medicine longer than necessary to control your symptoms.

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and contact your doctor or emergency medical services immediately 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 Nurofen if:

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

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

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

Skin reactions

Serious skin reactions have been reported with ibuprofen, such as 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). Stop treatment with Nurofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Nurofen Rapid may mask signs of infection, such as fever and pain. Therefore, Nurofen Rapid may delay appropriate treatment of the 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 without delay.

Use of Nurofen Rapid with other medicines

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

Nurofen may affect 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 (prevent blood clots or thrombi 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 need to adjust the dose of this medicine.
• Mifepristone (used for medical 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 medicine).
• 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 Nurofen treatment. Therefore, always consult your doctor or pharmacist before using Nurofen with other medicines.

Interaction with diagnostic tests:

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

Taking Nurofen Rapid 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.

Do not take ibuprofen with alcohol to avoid stomach damage.

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take ibuprofen during the last 3 months of pregnancy, as it may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed, and may delay or prolong labour beyond expected. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor advises otherwise. In such 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 levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

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 Nurofen Rapid 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 cochineal red A (Ponceau 4R) (E-124), potassium, sorbitol (E-420) and soya oil

This medicine may cause allergic reactions as it contains cochineal red A (Ponceau 4R) (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Patients with kidney impairment or on low-potassium diets should be aware that this medicine contains 31.23 mg (0.8 mmol) of potassium per capsule.

This medicine contains 69.13 mg of sorbitol (E-420) in each capsule.

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

For information about soya oil, see the section “Do not take Nurofen Rapid”.

3. How to take Nurofen Rapid

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. In case of 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) in 24 hours.

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

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if 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 must not take this medicine 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, treatment 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 pain for more than 5 days, consult a doctor.

If you take more Nurofen Rapid than you should

If you or someone else takes more medicine than recommended, or if a child has accidentally ingested the medicine, contact a doctor immediately or call the Toxicology Information Service at 915620420, stating the medicine and the amount taken, or go to the nearest hospital to assess the risk and obtain advice on necessary measures. It is recommended to bring the medicine packaging and patient information leaflet to the healthcare professional.

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

In cases of ingestion of large quantities, 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 may cause adverse effects, although not everyone experiences 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 very rare but serious allergic reaction, such as worsening asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or decreased blood pressure leading to shock. These may occur even with the first use of this medicine
• Non-elevated red, target-shaped or circular skin rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions 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 red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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, nausea, indigestion, diarrhoea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestine, which may exceptionally lead to anaemia.

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 bowel disease (ulcerative colitis or Crohn's disease), gastritis
• disorders of the central nervous system such as headache, dizziness, insomnia, agitation, irritability and fatigue
• visual disturbances
• various skin rashes
• hypersensitivity reactions with urticaria 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)
• decrease in haemoglobin levels.

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

• oesophagitis, pancreatitis and development of diaphragm-type intestinal strictures
• heart failure, heart attack and swelling of the face and hands (oedema)
• reduced urine output, swelling (oedema) 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 feel depressed, stop taking Nurofen Rapid and consult your doctor immediately, as these may be early signs of kidney damage or failure
• psychotic-type reactions, depression
• high blood pressure, vasculitis
• palpitations
• hepatic 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 tiredness, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. 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 with the use of some painkillers (NSAIDs). If signs of infection appear or worsen, seek medical advice immediately. Antibiotic therapy should be evaluated
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or confusion have been observed during treatment with ibuprofen. 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 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 dyspnoea.
• 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 Nurofen Rapid if you experience these symptoms and seek immediate medical attention. See also section 2.
• 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 stroke). Prolongation of bleeding time, oedema (fluid retention), high blood pressure and heart failure have also been observed in association with treatments using medicines such as Nurofen Rapid.

Based on experience with NSAIDs, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (a 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 adverse effect, consult your doctor, pharmacist or nurse, even if it is an effect 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 Nurofen Rapid

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

Store in the original packaging to protect it from moisture.

Store below 30 ºC.

Do not use this medicine after the expiry date stated on the packaging, following 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 or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nurofen Rapid

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

The other components are:

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

Capsule shell: gelatin, liquid sorbitol (E-420), cochineal red A (Ponceau 4R) (E-124), lecithin (E-322) (from soya), 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.

Appearance of the product and contents of the pack:

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

They are available in packs containing 10 or 20 soft capsules in PVC/PE/PVdC/Al or PVC/PVdC/Al blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Reckitt Benckiser Healthcare, S.A.
Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer:

RB NL Brands B.V.
Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the most recent revision of this 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 Health Products (AEMPS) http://www.aemps.gob.es/