Patient Information

Neobrufen 400 mg Film-Coated Tablets

ibuprofen

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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

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

Do not take Neobrufen:

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate 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 problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are already taking Neobrufen, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.

This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.

• If you are taking anticoagulants (blood thinners) or other medications that affect blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, or corticosteroids and selective serotonin reuptake inhibitors (SSRIs). If necessary, your doctor will perform blood clotting tests.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as Neobrufen may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor will need to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" section below.

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

Signs of allergic reaction to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Neobrufen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Severe skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GPP), have been reported in association with ibuprofen treatment. Discontinue Neobrufen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

NSAIDs, such as 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 inform your doctor or pharmacist before taking Neobrufen if:

- You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

- You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or allergic diseases, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible. The risk is believed to increase with dose and treatment duration.

During the third trimester, administration of Neobrufen is contraindicated.

For fertile women, it is essential to consider that ibuprofen has been associated with a decrease in fertility.

Infections

Neobrufen may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Neobrufen

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

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

• Other NSAIDs, such as aspirin, which may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents, such as ticlopidine.
• Anticoagulants, such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (used to induce abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hidantoins, such as phenytoin (used to treat epilepsy).
• Sulfamides, such as sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (used to increase urine production), which may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonilureas, such as tolbutamide (used to treat diabetes), which may cause hypoglycemia.
• Tacrolimus or ciclosporin (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).
• Trombolotics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts, such as Ginkgo biloba.
• CYP2C9 inhibitors, such as voriconazole and fluconazole (used to treat fungal infections).

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

Neobrufen 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).
• Urea nitrogen concentration, serum creatinine, and potassium concentration (may increase).
• Liver function tests: increased transaminase values.

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

Taking Neobrufen with food and drinks

It is recommended to take Neobrufen with milk or food, or immediately after eating, to reduce the risk of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

This medication is not recommended for women trying to become pregnant.

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women), 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 predisposition to bleeding and delay or prolong delivery.

Do not take Neobrufen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest time necessary. From week 20 of pregnancy onwards, Neobrufen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in your 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 operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Neobrufen 400 mg tablets contain lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with Neobrufen. Do not discontinue treatment beforehand, as the expected results will not be obtained. Similarly, do not use Neobrufen for a longer period than indicated by your doctor.

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

Adults and adolescents over 12 years (≥ 40 kg):

The recommended dose in adults and adolescents over 12 years is one tablet (400 mg) every 6 to 8 hours, depending on the severity 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 12 to 18 years old.

Use in children:

This medication is not recommended for use in children under 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these children.

Older 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 confirmed that you tolerate the medication well.

Patients with kidney and/or liver diseases::

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

Administration form:

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs are recommended to take ibuprofen with food.

Take ibuprofen with sufficient water. Tablets should be swallowed whole, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination loss. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency 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 forgot to take Neobrufen:

Do not take a double dose to compensate for the missed doses.

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

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

Side effects of medicines like Neobrufen are more common in people over 65 years old.

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

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

• Infrequent side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety,auditory disturbances, visual disturbances,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 (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

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

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction,vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia,hepatic lesions, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction may appear facial swelling, tongue, and larynx, dyspnea (shortness of breath), 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 had 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 side effects are platelet decrease,decrease in white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decrease in red blood cells (may manifest as difficulty breathing and pale skin),neutropenia (decrease in neutrophils) and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency 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 unknown bruises.

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

Exacerbation of inflammation related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or they worsen during the use of ibuprofen, it is recommended to see a doctor as soon as possible.

• Unknown frequency(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 produces diarrhea with blood).

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

If any of the following side effects appear, interrupt treatment and seek medical attention immediately:

• Flat, circular, or daisy-like red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

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

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

Do not use this medication after the expiration date that appears on the packaging after “CAD or EXP”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Composition of Neobrufen 400 mg coated tablets :

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are:
• • Tablet core: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.
  • Coating: hypromellose, titanium dioxide (E-171), and talc.

Appearance of the product and content of the packaging

Oval, biconvex, white coated tablets. They are presented in packs of 30 tablets, conditioned in aluminum-PVC/PVDC or aluminum-PVC blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Responsible for manufacturing:

Famar A.V.E. Anthoussa Plant

Anthoussa Avenue, 7

15349 Anthoussa Attiki

Greece

Mylan Hungary Kft.

Mylan utca 1

Komárom 2900

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was revised in January 2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https:// www.aemps.gob.es /