NUROFEN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

NUROFEN 400 mg Coated Tablets

Ibuprofen

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

Follow exactly the administration instructions of the medicine 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 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 it worsens or does 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 Nurofen and what is it used for
2. What you need to know before taking Nurofen
3. How to take Nurofen
4. Possible side effects
5. Storage of Nurofen
6. Contents of the pack and further information

1. What is Nurofen and what is it used for

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

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

You should consult a doctor if it worsens or does 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 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 components of this medicine (listed in section 6). Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• If you have had a stomach or duodenal ulcer 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 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 blood coagulation 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 starting to take Nurofen:

• 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 had any heart disorder or have 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 have 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 type acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, because 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 produce 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 suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring 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.

Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a 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 Nurofen 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 if you 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 syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Nurofen treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

Nurofen may mask the signs of an infection, such as fever and pain. Consequently, Nurofen 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 Nurofen with other medicines

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

Nurofen may affect or be affected by other medicines. For example:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Antiplatelet agents (prevent the formation of 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 adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in heart disorders).
• Hydantoins such as phenytoin (in the treatment of epilepsy).
• Sulfonamides such as 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).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Insulin and oral hypoglycemic agents (used to decrease blood glucose levels).
• Cyclosporin and tacrolimus (used to prevent organ rejection in transplants).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (medicine against the AIDS virus).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Phenytoin (in the treatment of epilepsy).
• Ion exchange resins such as cholestyramine (used to decrease cholesterol levels in blood).
• Tacrine (used in the treatment of Alzheimer's disease).
• CYP2C9 inhibitors such as voriconazole and fluconazole.

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

Interaction with analytical tests:

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

Taking Nurofen with food, drink, and alcohol

You can 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 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

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 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 tendency and that of your baby to bleed and delay or prolong labor more than expected. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor indicates it. In these cases, the dose and duration will be limited to the minimum possible.

From the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which can 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 you need treatment for more than a few days, your doctor may recommend additional checks.

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 female patients of childbearing age, it should be noted that medications of the Nurofen 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 notice dizziness, vertigo, vision changes, or other symptoms while taking this medicine, do not drive or use hazardous machinery.

This medicine contains sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Nurofen

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

The recommended dose is:

• Adults and adolescents over 12 years: 1 tablet 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: consult your doctor, as it may be necessary to reduce the dose.

• Patient over 65 years: 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

Children under 12 years should not take this medicine due to the 400 mg dose of ibuprofen. Other presentations are 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 notice digestive discomfort.

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

In adolescents from 12 to 18 years, 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 Nurofen than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, 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 nausea, stomach pain, vomiting (which may contain blood), headache, rapid involuntary eye movements, ringing in the ears, and confusion. At high doses, intestinal bleeding, hypotension, metabolic acidosis, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), coma, weakness, and 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 after ingestion.

4. Possible Adverse Effects

Like all medications, Nurofen 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 medication 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 of 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 medication
• Reddish, non-raised spots, target-like or circular 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 skin 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).
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Inform 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 have a feeling of sadness, stop taking Nurofen 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 bruising of unknown origin. In these cases, you should stop treatment immediately and consult your doctor. Do 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 pain relievers (NSAIDs). If signs of infection appear or worsen, 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)
• widespread red scaly rash, with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Nurofen if you experience these symptoms and seek medical attention immediately. See also section 2
• the skin becomes sensitive to light.

Medications 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 medications like 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 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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nurofen

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Nurofen Composition

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

The other components are:

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

Coating: sodium carmellose, talc, dried acacia, sucrose, titanium dioxide (E-171), macrogol 6000, industrial methylated alcohol, and 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.

Product Appearance and Package Contents

Nurofen is a biconvex, white or off-white coated tablet.

It is presented in a package containing 12 coated tablets packaged in PVC/PVdC/Al or PVC/Al blisters.

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of this Leaflet:October 2024

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