Nurofen 400 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NUROFEN 400 mg coated tablets

Ibuprofen

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

Follow exactly the instructions for use contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further 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 get worse or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Leaflet contents:

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

1. What Nurofen 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 feverish conditions.

You should consult a doctor if symptoms worsen or do 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 Nurofen.

Do not take Nurofen

• 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, facial swelling, swelling of the lips or tongue, runny nose, breathing difficulties, or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a 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 clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant treatment must be used at the same time, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before taking Nurofen:

• 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 have 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 such cases could lead to kidney failure as a consequence of dehydration.

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

• If you are taking other medicines that affect blood clotting, 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that 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 urine production), because your doctor needs to monitor kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may 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 that your doctor can assess whether ibuprofen treatment is appropriate.
• If you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, thereby delaying diagnosis.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions to this medicine may occur.
• Your doctor will monitor you more closely if you are receiving 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 that relieves or controls your pain, and not to take this medicine longer than necessary to control your symptoms.

Allergic reactions to ibuprofen, such as breathing difficulties, facial or neck swelling (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and contact your doctor or emergency medical services right away if you experience any of these symptoms.

Cardiovascular precautions

Anti-inflammatory/pain-relieving 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 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, these types of medicines 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 Nurofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Nurofen may mask signs of infection, such as fever and pain. Therefore, Nurofen 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 the symptoms persist or worsen, consult a doctor immediately.

Use of Nurofen 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 interact with or be affected by other medicines. For example:

• Anticoagulant medicines (e.g. to treat or prevent blood clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine).

• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin-II receptor antagonists such as losartan).

• Antiplatelet agents (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 in 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 in circulatory disorders).

• Probenecid (used in gout patients or together with penicillin for infections).

• Quinolone antibiotics such as norfloxacin.

• Sulfinpyrazone (for the treatment of gout).

• Insulin and oral hypoglycaemics (used to lower blood glucose).

• Cyclosporine and tacrolimus (used to prevent organ transplant rejection).

• Thrombolytics (medicines that dissolve or break down blood clots).

• Zidovudine (an anti-HIV medication).

• 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 to have 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 Nurofen with food, drink and alcohol

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

Do not take ibuprofen with alcohol, as this may damage the stomach.

Taking ibuprofen in patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, spirits—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 medicine.

Pregnancy

Do not take ibuprofen during the last 3 months of pregnancy, as it may cause kidney and heart problems in the unborn baby. It may also affect your and your baby's tendency to bleed, and may delay or prolong labour. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor advises otherwise. In such cases, the dose and duration will be kept to a minimum.

From week 20 of pregnancy, ibuprofen may cause kidney problems in the unborn baby if taken for more than a few days, leading 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 used during breastfeeding if taken at the recommended dose for the shortest possible duration.

Fertility

For women of childbearing age, it should be noted that medicines such as Nurofen 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 machinery.

This medicine contains sucrose and sodium

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 27.42 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 1.37% of the maximum daily sodium intake recommended for an adult.

3. How to take Nurofen

Follow exactly the instructions for use 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 tablet of 400 mg every 6–8 hours, if necessary.

Do not exceed 3 tablets (1200 mg) in 24 hours.

• Patients with kidney, liver, or heart disease: consult your doctor, as it may be necessary to reduce the dose.

• Patients over 65 years of age: the dose must 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 used in 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 tablet 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 than you should

If you have taken more medicine than you should, 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’s packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, rapid involuntary eye movements, tinnitus, and confusion. At high doses, gastrointestinal bleeding, hypotension, metabolic acidosis, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), coma, weakness, dizziness, blood in the urine, 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, Nurofen can have 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 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, drop in blood pressure leading to shock. These may occur even with the first use of this medicine
• non-elevated red skin spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, 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)
• widespread skin rash, high body temperature and enlarged 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:

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

• stomach problems such as heartburn, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence (gas), constipation, and minor blood loss 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, 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)
• decrease in haemoglobin levels.

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

• oesophagitis, pancreatitis and formation 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 sadness, stop taking Nurofen 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 the production of blood cells. 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 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 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 serious 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 located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Nurofen 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.

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 ruled out.

Reporting of adverse effects

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

5. Storage of Nurofen

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Nurofen

Each coated tablet contains 400 mg of ibuprofen as the active substance.

The other components are:

Core: croscarmellose sodium, sodium lauryl sulfate, sodium citrate (E-331), stearic acid, colloidal anhydrous silica.

Coating: carmellose sodium, talc, dehydrated acacia, sucrose, titanium dioxide (E-171), macrogol 6000, industrial methylated spirit, purified water.

Printing ink containing red iron oxide (E-172), Shellac glaze in SD-45, n-butyl alcohol, isopropyl alcohol, propylene glycol (E-1520), ammonium hydroxide and simethicone.

Appearance of the product and contents of the pack

Nurofen are biconvex coated tablets, white or almost white in colour.

It is supplied in a pack containing 12 coated tablets, presented in PVC/PVdC/Al or PVC/Al blisters.

Marketing Authorisation Holder and Manufacturer

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