NeoBrufen Retard 800 mg prolonged-release tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Neobrufen retard 800 mg prolonged-release tablets

ibuprofen

Read the entire leaflet carefully before you start taking 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Neobrufen retard is and what it is used for
What you need to know before taking Neobrufen retard
How to take Neobrufen retard
Possible side effects
How to store Neobrufen retard

Pack contents and other information

1. What Neobrufen retard is and what it is used for

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

Neobrufen retard is used to treat the symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), osteoarthritis (a chronic condition causing damage to the cartilage), and other acute or chronic rheumatic conditions, as well as for the treatment of moderate pain and non-rheumatic inflammation.

2. What you need to know before taking Neobrufen retard

Do not take Neobrufen retard:

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
If you are vomiting blood.
If you have black stools or bloody diarrhoea.
If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used at the same time, your doctor will perform blood clotting tests.
If you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).
If you have severe heart failure.
If you are in the third trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Neobrufen:

If you have oedema (fluid retention).
If you have or have had heart problems or high blood pressure.
If you have asthma or any other respiratory disorder.
Inform your doctor if you are already taking Neobrufen retard, 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 medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be done.
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually leads to bloody diarrhoea) or ulcerative colitis, as medicines like Neobrufen retard may worsen these conditions.
If you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions to this medicine may occur.
Your doctor will carry out stricter monitoring if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
If you have an infection: see the section “Infections” below.

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking Neobrufen retard immediately and contact your doctor or medical emergency services right away if you notice 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 have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Stop treatment with Neobrufen retard and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

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

Discuss your treatment with your doctor or pharmacist before taking Neobrufen retard if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in 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 potential

Because administration of medicines like Neobrufen retard has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be kept to a minimum. The risk is believed to increase with higher doses and longer treatment duration.

Administration of Neobrufen retard is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines like Neobrufen retard have been associated with reduced fertility.

Infections

Neobrufen may mask signs of infection such as fever and pain. Therefore, Neobrufen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and symptoms persist or worsen, consult your doctor immediately.

Other medicines and Neobrufen retard

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

Neobrufen retard may interact with or be affected by other medicines. For example:

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcers and bleeding.
Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used in depression).
Lithium (used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (used to induce abortion).
Digoxin and cardiac glycosides (used to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV drug).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as 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 medicines may also interact with or be affected by Neobrufen retard. Therefore, always consult your doctor or pharmacist before using Neobrufen retard with other medicines.

Taking ibuprofen may alter the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Haematocrit or haemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
Liver function tests: increased transaminase levels

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.

Taking Neobrufen retard with food and drinks

It is recommended to take Neobrufen retard with milk or food, or immediately after eating, to reduce the possibility of stomach discomfort. Avoid alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

The use of this medicine is not recommended in women trying to become pregnant.

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

You should not take Neobrufen retard during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, use the lowest effective dose for the shortest possible time. From week 20 of pregnancy onwards, Neobrufen retard may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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 medicine, do not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not required.

Ibuprofen may delay your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is particularly relevant when combined with alcohol.

3. How to take Neobrufen retard

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment prematurely, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

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

Adults and adolescents:

The recommended dose is two tablets daily, each containing 800 mg, taken as a single dose, preferably at night before going to bed, corresponding to a total daily dose of 1,600 mg.

Elderly patients:

No special dosage adjustments are required unless kidney or liver function is impaired, in which case the dosage should be individually assessed and use of other formulations of the medicine that are not prolonged-release may be indicated. Caution should be exercised in this patient group.

Use in children:

Use of this medicine is not recommended in children under 12 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing in these children.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose, and use of other formulations of the medicine that are not prolonged-release may be indicated. If so, take exactly the dose prescribed by your doctor.

Method of administration

This medicine is administered orally.

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

Take the ibuprofen tablets with a sufficient amount of water. The 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 think that the effect of this medicine 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 medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken.

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

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

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

If you forget to take Neobrufen retard:

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

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

4. Possible adverse effects

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

Adverse effects of medicines such as Neobrufen retard are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling of unsteadiness, fatigue have also been observed.
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 exposure, hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs) and somnolence, insomnia, anxiety, auditory disorders, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.
Rare adverse effects (may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, oedema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting 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 represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as difficulty breathing and paleness of the skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce different types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising.

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

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice 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, which usually produces diarrhoea with blood).

A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, lymph node swelling 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 beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Neobrufen retard if you experience these symptoms and seek immediate medical attention. See also section 2.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

A characteristic drug-related skin allergic reaction known as drug-induced fixed eruption, which usually reappears in the same area upon re-exposure to the medicine and typically presents as round or oval-shaped spots of redness and swelling of the skin, blisters (urticaria) and itching.

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

Flat, non-elevated reddish spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Generalized skin rash, high 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 beginning of treatment (acute generalized exanthematous pustulosis).
Allergic reactions such as skin rashes, swelling of the face, wheezing or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or diarrhoea with blood.
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 arms or legs.

Reporting of adverse effects

If you experience any adverse effect, 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Neobrufen retard

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

Do not store above 25°C.

Do not use Neobrufen retard after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Neobrufen retard

The active substance 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 pack

White, oval-shaped tablets. Packaged in packs of 40 tablets in 4 blisters.

Marketing Authorization Holder and Manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Manufacturer:

Famar A.V.E. Anthoussa Plant

Anthoussa Avenue 7

15349 Anthoussa Attiki

Greece

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet has been reviewed in January 2026

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