NEOBRUFEN 600 mg EFFERVSCENT GRANULES

Introduction

Package Leaflet: Information for the User

Neobrufen 600 mg Effervescent Granules

ibuprofen

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

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Neobrufen and what is it used for
2. What you need to know before you take Neobrufen
3. How to take Neobrufen
4. Possible side effects
5. Storage of Neobrufen

Contents of the pack and additional information

1. What is Neobrufen and what is it used for

Neobrufen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the treatment of fever, treatment of moderate pain including migraine, treatment of arthritis (inflammation of the joints, including usually those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes damage to the cartilage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before you take Neobrufen

Do not take Neobrufen:

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other ingredients 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 a severe liver or kidney disease.
• 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 bleeding or blood clotting 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 clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• 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 Neobrufen:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• Inform your doctor if you are already taking Neobrufen, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• 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. Your doctor will indicate the frequency of these checks.
• 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 greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake 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, as medications like Neobrufen may worsen these conditions.
• If you are being treated with diuretics (medicines used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic 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 may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medication.
• Allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" section below.

It is important that you use the smallest dose that relieves-controls the pain and do not take this medication for longer than necessary to control your symptoms.

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

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

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 Neobrufen treatment and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Neobrufen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker. Likewise, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Precautions during pregnancy and in women of childbearing age

Because the administration of medications like Neobrufen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of Neobrufen is contraindicated.

For women of childbearing age, it should be taken into account that medications like Neobrufen have been associated with a decrease in fertility.

Infections

Neobrufen may hide the signs of an infection, such as fever and pain. Consequently, Neobrufen may delay the 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 medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Other medications and Neobrufen

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Neobrufen may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as it may increase the risk of stomach ulcers and gastrointestinal bleeding.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulants (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins, such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group, such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas, such as tolbutamide (for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin-II receptor antagonists, such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment
• Blood glucose concentration (may decrease
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

Tell your doctor if you are going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Neobrufen with food and drinks

It is recommended to take Neobrufen dissolved in a glass of water. You can take it alone or with food. In general, it is recommended to take it during meals or immediately after eating, to reduce the possibility of stomach discomfort. Do not drink alcohol, as it may increase gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

The use of this medication is not recommended in women who are trying to become pregnant.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age), as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected.

Do not take Neobrufen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest time necessary. From the 20th week of pregnancy onwards, Neobrufen may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medication, do not drive or use hazardous machinery. If you only take one dose of Neobrufen or for a short period, it is not necessary to take special precautions.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

This applies to a greater extent to the combination with alcohol.

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

Patients with diabetes mellitus should note that this medication contains 3.3 g of sucrose per sachet.

This medication contains 197 mg of sodium (the main component of table salt/cooking salt) in each sachet. This is equivalent to 9.9% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 2 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Neobrufen

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with Neobrufen. Do not stop treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication for longer than indicated by your doctor.

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 symptoms (such as fever and pain) persist or worsen (see section 2).

Adverse effects can be minimized by taking the lowest effective dose for the shortest time necessary to control symptoms.

Adults and adolescents over 14 years:

The recommended dose in adults and adolescents from 14 years is one sachet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents from 14 to 18 years.

Use in children and adolescents under 14 years:

The use of this medication is not recommended in children or adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Elderly patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has checked that you tolerate the medication well.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

If you think the effect of Neobrufen is too strong or too weak, inform your doctor or pharmacist.

Method of administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

Make sure the ibuprofen granules are dissolved in sufficient water. You may feel a transient burning sensation in the mouth or throat when taking ibuprofen granules.

If you take more Neobrufen than you should:

If you have taken more Neobrufen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, 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 package leaflet of the medication to the healthcare professional.

Normally, the symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate).

If a severe overdose occurs, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered.

If you forget to take Neobrufen

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

Adverse effects of medications like Neobrufen are more common in people over 65 years old.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

• Common adverse effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon adverse effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and kidney failure (sudden loss of kidney function). Acute kidney failure and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects are decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and skin pallor), neutropenia (decreased neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding, and bruising of unknown cause.

• Very rare adverse effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe liver damage), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation-related infections has been observed with the use of NSAIDs. If signs of infection or worsening of infection occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Frequency not known(cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Neobrufen if you experience these symptoms and seek medical attention immediately. See also section 2.

If any of the following adverse effects occur, discontinue treatment and consult your doctor immediately:

• 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 rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis)
• Allergic reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome

Reporting adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Neobrufen

Keep this medication out of sight and reach of children.

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

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Neobrufen 600 mg effervescent granules

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• The other ingredients are croscarmellose sodium, microcrystalline cellulose, anhydrous sodium carbonate, malic acid, sodium saccharin, sucrose, povidone, sodium hydrogen carbonate, orange flavor, sodium lauryl sulfate.

Appearance of the product and package contents

White effervescent granules. Each package contains 40 or 20 sachets.

Marketing authorization holder and manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Manufacturer:AbbVie S.R.L., 04011 Campoverde di Aprilia, Latina. Italy.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was revised in January 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

https://www.aemps.gob.es/