Leaflet: information for the user

Neobrufen retard 800 mg prolonged-release 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as 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

This medication belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

Neobrufen retard is used in the treatment of the symptoms of rheumatoid arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), osteoarthritis (a chronic disorder causing cartilage damage) and other acute or chronic rheumatic processes and for the treatment of moderate pain and non-rheumatic inflammation.

Do not take Neobrufen retard:

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of 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 (medications used to "thin" the blood). 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 retard as it may mask fever, an important sign of infection, making its 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 to 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 when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.

• If you are taking anticoagulants (medications used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may 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 often results in bloody diarrhea) or ulcerative colitis, as Neobrufen retard may worsen these conditions.
• If you are taking diuretics (medications used to increase urine production), as your doctor should 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 intermittent acute 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 advisability or not of treatment with ibuprofen.
• 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 strict check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" heading later.

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 have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Neobrufen retard 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 (PEGA), have been reported in association with ibuprofen treatment. Discontinue Neobrufen retard 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 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 inform your doctor or pharmacist before taking Neobrufen retard if:

-You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery 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 ischemic attack "TIA").

-You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

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 has been reported to 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. It is believed that the risk increases with the dose and duration of treatment.

During the third trimester, the administration of Neobrufen retard is contraindicated.

For fertile women, it should be noted that ibuprofen has been associated with a decrease in the ability to conceive.

Infections

Neobrufen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Neobrufen may delay or prolong the 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 retard

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

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

• Other NSAIDs like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) like ticlopidine.
• Anticoagulants (prevent blood clotting) like aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat 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 (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hidantoins like phenytoin (used to treat epilepsy).
• Sulfamides like sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifilina (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpirazona (used to treat gout).
• Sulfonilureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or ciclosporina (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolíticos (medicines that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Clearance of creatinine (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Concentrations of urea nitrogen in the blood, serum creatinine, and potassium (may increase)
• With liver function tests: increased values of transaminases

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

Neobrufen retard with food and drinks

It is recommended to take Neobrufen retard with milk or with food, or immediately after eating, to reduce the possibility 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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

Do not take Neobrufen retard 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, you should use the lowest dose for the shortest time necessary. From week 20 of pregnancy onwards, Neobrufen retard 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 performing activities that require greater vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

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

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

The effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents:

The recommended dose is two tablets daily, 800 mg each, in a single dose, preferably at bedtime, totaling 1,600 mg per day.

Older patients:

No special dosage adjustments are required unless kidney or liver function is altered, in which case individual dosing should be studied and the use of other presentations of the medication that are not prolonged-release may be indicated. Caution should be exercised in this patient group.

Use in children:

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

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, and the use of other presentations of the medication that are not prolonged-release may be indicated. 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 tablets with sufficient water. Ibuprofen tablets should be swallowed whole, with a glass of water, 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 retard 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 ibuprofen intake.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-stained 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 forget to take Neobrufen retard:

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 next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

The side effects of medicines such as Neobrufen retard are more common in people over 65 years old.

The incidence of side effects is lower in short 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 stools, 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), skin reactions caused by light, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more common 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 renal insufficiency (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 disturbance, 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 bruises of unknown cause.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, prolongation of bleeding time, systemic lupus erythematosus (joint pain and fever),very severe bullous 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 epidermal detachment), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during varicella. 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 these 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 red scaly 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 retard if you experience these symptoms and seek medical attention immediately. See section 2.

Stop treatment and seek medical attention immediately if any of the following side effects appear:

• Flat, circular, or target-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 rash, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (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 leaflet. 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 store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Neobrufen retard

• The active ingredient is ibuprofen. Each tablet contains 800 mg of ibuprofen.
• The other components are: xanthan gum, povidone, stearic acid, anhydrous colloidal silica, hypromellose, titanium dioxide (E-171), and talc.

Appearance of the product and contents of the packaging

Oval-shaped white tablets. It is presented in packs of 40 tablets in 4 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

You can request more information about this medication 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 has been reviewed in January 2024

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