Brufen analgesic 400mg 12 tablets minsan 042386348

BRUFEN ANALGES * 12CPR RIV 400MG

Therapeutic indications

For the symptomatic treatment of mild to moderate pain, such as headache, dental pain, menstrual pain and fever and pain in the common cold.

Dosage and method of use

Adults and adolescents ≥ 40 kg body weight (12 years of age and older): (Only 200 mg)Starting dose: 200 mg or 400 mg. An additional dose of 1 or 2 tablets (200 mg to 400 mg) can be taken if necessary. The corresponding dose interval should be chosen based on symptoms and the maximum recommended daily dose. It should not be less than 6 hours for a 400 mg dose and not less than 4 hours for a 200 mg dose. Do not exceed the dose of 1200 mg in any 24 hour period.(400 mg only)Initial dose: 400 mg. If necessary, an additional dose of 400 mg can be taken. The corresponding dose interval should be chosen based on symptoms and the maximum recommended daily dose. It should not be less than 6 hours for a 400 mg dose. Do not exceed the dose of 1200 mg in any 24 hour period.Pediatric population (Only 200 mg) Children over 6 years (20 kg - 40 kg body weight):Ibuprofen should only be used in children with a body weight of at least 20 kg. The maximum daily dose of ibuprofen is 20 - 30 mg of ibuprofen per kg of body weight, divided into 3 or 4 individual doses with an interval between doses of 6 to 8 hours. The maximum recommended daily dose should not be exceeded. A maximum dosage of 30 mg / kg of ibuprofen in any 24 hour period should not be exceeded. The following dosage information applies:

If this medicine is required for more than 3 days in children over 6 years of age and adolescents or if symptoms worsen you should seek medical attention.Children under 6 years oldBRUFEN ANALGESICO is contraindicated in children under 6 years of age.(400 mg only)BRUFEN ANALGESICO is contraindicated in adolescents below 40 kg body weight or in children under 12 years of age. If this medicine is required for more than 3 days in children over 12 years of age and adolescents or if symptoms worsen you should seek medical attention. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). For short term use only. If the medicine is required for more than 3 days in case of fever or for more than 4 days for pain treatment or if symptoms worsen, the patient should be advised to consult a physician.Elderly patientsNo dose adjustment is necessary. Elderly patients should be monitored particularly carefully due to the possible undesirable effect profile (see section 4.4).Patients with gastric sensitivityPatients with sensitive stomachs should take ANALGESIC BRUFEN with a meal. Taking ibuprofen after a meal can delay the onset of its action. If this happens, additional ibuprofen should not be taken beyond what is specified in section 4.2 (Posology) or until the corresponding dose interval has elapsed.Patients with renal impairmentNo dose reduction is required in patients with mild to moderate renal impairment. For patients with severe renal dysfunction, see section 4.3.Patients with hepatic impairmentNo dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severe hepatic dysfunction, see section 4.3.Method of administrationFor oral administration and short-term use only. Ibuprofen tablets should be swallowed whole with plenty of water. Do not chew the tablets.

Contraindications

Ibuprofen is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - with previous hypersensitivity reactions (e.g. bronchospasm, angioedema, rhinitis, urticaria or asthma) in response to acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs), - with presence or history of peptic ulcer / recurrent haemorrhage (two or more distinct episodes of proven ulceration or bleeding), - with history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs, - with severe hepatic insufficiency, severe renal insufficiency or severe heart failure (NYHA Class IV) (see section 4.4), -(Only 200 mg)children under 20 kg in weight (approximately 6 years of age) -(400 mg only)adolescents under 40 kg or children under 12 years of age - with cerebrovascular or other types of active bleeding, - with unexplained blood formation disorders, - with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake), - during the last trimester of pregnancy (see section 4.6).

Side effects

Possible side effects are those seen with acidic ibuprofen. Side effects are mostly dose-dependent and vary individually. In particular, the risk of gastrointestinal bleeding is dose-dependent and duration of treatment. For other risk factors, see section 4.4. The following side effects are related to the short-term use of low-dose ibuprofen (up to 1200 mg per day for mild to moderate pain and fever). Other undesirable effects may occur with treatments for other indications or prolonged use. Undesirable effects associated with ibuprofen are listed in the table below by system organ class and frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 and

¹ Examples include anemia, leukopenia, thrombocytopenia, pancytopenia and agranulacytosis. First signs: fever, sore throat, mouth ulcers, flu-like symptoms, symptoms of severe fatigue, nasal and skin bleeding. ² Hypersensitivity reactions: may include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactions including asthma, exacerbation of asthma, bronchospasm and dyspnoea, or (c) various skin reactions, including urticaria, rash and purpura , sometimes associated with itching. Angioedema and, in rare cases, exfoliative and bullous dermatitis, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported. Some reactions including meningeal irritation and lethargy are considered to be associated with hypersensitivity reactions. Systemic lupus erythematosus and other collagen disorders are risk factors for severe cases of generalized hypersensitivity reactions. General hypersensitivity reactions are not common. Symptoms may include fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver damage and even meningeal symptoms. In rare cases, ibuprofen can lead to bronchospasm in predisposed individuals. ³ The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on NSAID-related aseptic meningitis suggest a hypersensitivity reaction (due to the temporal correlation between drug administration and disappearance of symptoms after discontinuation of treatment). Isolated cases of aseptic meningitis symptoms such as neck stiffness, headache, vomiting, fever and disorientation have been observed during treatment with ibuprofen in patients with pre-existing autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disorders).⁴Reversible effects have been observed.⁵The most common side effects are gastrointestinal side effects.⁶Uncommonly fatal, especially in elderly patients. See Special warnings and precautions for use.⁷see section 4.4⁸Hepatotoxic reactions can occur as part of generalized hypersensitivity reactions.⁹Reversible alopecia has been reported in black women.¹⁰Especially for prolonged use, associated with elevated serum urea concentrations, decreased urine excretion and edema. Includes papillary necrosis.¹¹Ibuprofen can prolong bleeding time at doses above 1000 mg per day. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day) and for prolonged periods, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest time necessary to achieve symptom control (see Effects on the Gastrointestinal and Cardiovascular Systems). Caution should be exercised when administering ibuprofen to patients suffering from the following conditions, which may worsen: - congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria), - coagulation disorders (ibuprofen may prolong the duration of coagulation), - directly after major surgery, - systemic lupus erythematosus and mixed connective tissue disease (e.g. increased risk of aseptic meningitis) (see section 4.8), - hypertension and / or heart failure, as renal function may deteriorate (see sections 4.3 and 4.8), - in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions for them. These may present with an asthma attack (so-called analgesic asthma), Quincke's edema or urticaria, - in patients who react with allergy to other substances, as there is also an increased risk of hypersensitivity reactions occurring during the use of ibuprofen.Elderly peopleThe elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Respiratory reactionsA bronchospasm can be precipitated in patients suffering from bronchial asthma or allergic diseases or with a history of such diseases.Other NSAIDsThe use of ibuprofen with other NSAIDs, including selective cyclo-oxygenase-2 inhibitors, increases the risk of adverse reactions and should be avoided (see section 4.5).Kidney effectsRenal impairment, as renal function may further deteriorate (see sections 4.3 and 4.8). In general terms, the habitual intake of analgesics, in particular the combination of different analgesic substances, can lead to permanent renal damage with the risk of renal failure (analgesic nephropathy). This risk can increase under physical exertion associated with salt loss and dehydration. Therefore it must be avoided. There is a risk of renal impairment in dehydrated children and adolescents.Hepatic effectsHepatic dysfunction (see sections 4.3 and 4.8). It is appropriate to discontinue ibuprofen therapy when deterioration of liver function occurs in conjunction with its administration. After discontinuation of treatment, the state of health usually returns to normal. Occasional blood glucose monitoring is also appropriate.Cardiovascular and cerebrovascular effectsParticular caution (discuss with doctor or pharmacist) is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with NSAID therapy. Patients suffering from uncontrolled hypertension (NYHA class II-III), congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and doses should be avoided. high (2400 mg / day). Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus or smoking), particularly if high doses of ibuprofen (2400 mg / die). Clinical studies suggest that the use of ibuprofen, especially at a high dose (2400 mg / day) and for long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤ 1200 mg / day) are associated with an increased risk of arterial thrombotic events.Alteration of female fertilityThere is some evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause alterations in female fertility, through an effect on ovulation. This is reversible after discontinuation of treatment (see section 4.6).Gastrointestinal safetyNSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section 4.8). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported during treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or a previous history of serious gastrointestinal events. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly, the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for both these patients and for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events ( see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution is needed when treating patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, the treatment should be discontinued.Severe skin reactionsSerious skin reactions, some of them fatal, such as exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk of these reactions: in fact, the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. The use of ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally chickenpox can cause severe skin reactions and infectious soft tissue complications. So far the contributing role of NSAIDs in the worsening of these infections cannot be excluded. Therefore, it is advisable to avoid the use of ibuprofen in case of chickenpox. Masking the symptoms of underlying infections BRUFEN ANALGESICO can mask the symptoms of infection, which could delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When BRUFEN ANALGESICO is administered for the relief of infection-related fever or pain, monitoring of infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen.Other remarksIn rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Therapy should be discontinued at the first signs of a hypersensitivity reaction after taking / administering ibuprofen. Medical procedures appropriate to the symptoms must be performed by specialized personnel. Ibuprofen can temporarily inhibit platelet function (clumping of thrombocytes). Therefore it is recommended that patients with coagulation disorders be carefully monitored. In prolonged administration of ibuprofen, regular monitoring of liver parameters, renal function and blood cell counts is recommended. Prolonged use of any type of pain reliever for headache can cause them to worsen. If such a situation occurs or is suspected, medical advice should be obtained and treatment discontinued. The diagnosis of drug overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications. Medication overuse headache should not be treated by increasing the dose of the medicine. During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever or disorientation, have been observed in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease ). Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those related to the gastrointestinal tract or central nervous system. Patients being treated with ibuprofen should report signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema to their physician. If vision problems, blurred vision, scotoma or malfunction of color perception appear, treatment discontinuation is required.

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Data from epidemiological studies show an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors resulted in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the period of organogenesis. During the first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. If ibuprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions with consequent delay or prolongation of labor. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy.Feeding timeOnly small amounts of ibuprofen and its metabolic products are excreted in breast milk. No harmful effects on the infant are known to date. Consequently, ibuprofen can be used during breastfeeding for the treatment of short-term pain and fever and at recommended doses. Safety for prolonged use has not been established.FertilityThere is evidence showing that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause impairment of female fertility as a result of an effect on ovulation. However, this event is reversible upon discontinuation of treatment.

Expiration and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

The use of ibuprofen should be avoided in combination with: Acetylsalicylic acidConcomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data from the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1).Other NSAIDs including salicylates and selective cyclooxygenase-2 inhibitors: Avoid concomitant use of two or more NSAIDs, as it may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect (see section 4.4).Anticoagulants.NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4).Diuretics, ACE inhibitors, beta blockers and angiotensin II antagonists:NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor, a beta blocker or an angiotensin II antagonist and agents that inhibit the cyclooxygenase, may result in further deterioration of renal function, including acute renal failure, which is generally reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and on a regular basis thereafter.Potassium-sparing diuretics: Concomitant administration of ibuprofen and potassium-sparing diuretics may lead to hyperkalaemia (monitoring of serum potassium is recommended).Corticosteroids:increased risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal ulceration or haemorrhage) (see section 4.4).Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):increased risk of gastrointestinal bleeding (see section 4.4)Digoxin: NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma digoxin levels. A control of serum digoxin is not required, as a rule, in correct use (maximum 4 days).Phenytoin: Concomitant use of ibuprofen with phenytoin preparations may increase serum phenytoin levels. A control of serum phenytoin is not required, as a rule, in correct use (maximum 4 days).Lithium: There is evidence of potential increases in plasma lithium levels. A check of serum lithium is not required, as a rule, in correct use (maximum 4 days).Methotrexate:administration of ibuprofen within 24 hours prior to methotrexate administration may lead to an increase in methotrexate concentration and an increase in toxic effects.Cyclosporine: The risk of a damaging effect on the kidneys due to cyclosporine is increased by the co-administration of some NSAIDs. This effect cannot be excluded also due to the association of cyclosporine with ibuprofen.Mifepristone.NSAIDs should not be used for 8-12 days after mifepristone administration, because NSAIDs may reduce the effect of mifepristone.Sulfinpyrazone: Medicines containing sulfinpyrazone may delay the excretion of ibuprofen.Probenecid:medicinal products containing probenecid may reduce the excretion of NSAIDs and may increase their serum concentrations.Tacrolimus:Possible increased risk of nephrotoxicity if NSAIDs are co-administered with tacrolimus.Zidovudine:increased risk of haematological toxicity when NSAIDs are co-administered with zidovudine. A blood cell count is recommended 1-2 weeks after initiation of co-administration. There are indications of an increased risk of haemarthrosis and hematoma in HIV positive patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen.Sulfonylureas: NSAIDs can both increase and decrease the hypoglycemic effect of sulfonylureas. Caution is advised in case of simultaneous treatment.Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.Alcohol, bisphosphonates, oxpentifylline (pentoxifylline) and sulfinpyrazone: can potentiate gastrointestinal effects and the risk of bleeding or ulceration.Baclofen: increased baclofen toxicity.

Overdose

In children ingestion of more than 400 mg / kg can cause symptoms. In adults, the dose-response effect is less obvious. The half-life in case of overdose is 1.5-3 hours.SymptomsMajor overdoses are generally well tolerated as long as no other medicinal products are involved. Most patients who have ingested significant amounts of NSAIDs will no longer experience nausea, vomiting, epigastric pain or, more rarely, diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more severe poisonings central nervous system toxicity is observed, manifested by dizziness, somnolence, occasionally arousal, disorientation, loss of consciousness (also myoclonic seizures in children) or coma. Occasionally patients experience seizures. Metabolic acidosis may occur in severe poisoning and prothrombin time / INR may be prolonged, possibly due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage can occur. An asthma exacerbation is possible in asthmatics. In addition, hypotension, respiratory depression and cyanosis are also possible.TreatmentThere is no specific antidote available. Treatment should be symptomatic and supportive and includes maintaining a patent airway and monitoring cardiac and vital signs until stabilization. If necessary, a correction of the serum electrolyte balance should be made. Forced diuresis and hemodialysis are not helpful, as ibuprofen is extensively metabolised and almost totally protein bound. Gastric emptying or oral administration of activated charcoal is indicated if the patient presents within one hour of ingesting a large amount. In the event of gastrointestinal bleeding, activated charcoal could obstruct endoscopy. If frequent and prolonged, seizures should be treated with IV diazepam or lorazepam. Bronchodilators should be administered for asthma.

Active principles

Each tablet contains 200 mg of ibuprofen (as lysine salt) Each tablet contains 400 mg of ibuprofen (as lysine salt) For the full list of excipients, see section 6.1.

Excipients

Core of the tabletCellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (E1202) Povidone (E1201) Magnesium stearate (E572) Talc (E553b).Tablet coatingPolyvinyl alcohol hydrolyzed (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b).Printing inkShellac (E904) Black iron oxide (E172) Ammonium hydroxide (E527).