Descrizione Clinica
Anti-inflammatory Brufenlik 20bust 400mg 10ml Brufen
BRUFENLIK ORAL SUSPENSION IN THE POUCH
active ingredients
Each sachet (10 ml) contains 200 mg of ibuprofen. Each sachet (10 ml) contains 400 mg of ibuprofen. Excipient (i) with known effects Each sachet (10 ml) contains 2500 mg of maltitol (E 965), 20 mg of benzoate sodium (E 211), 14 mg of ethanol, 48 mg of glycol propylene and 17 mg sodium. Each sachet (10 ml) contains 5000 mg of maltitol (E 965), 10 mg of benzoate sodium (E 211), 0,0017 mg of benzilic alcohol and 58 mg of sodium. For the full list of excipients, see paragraph 6.1.Excellent
Glycerol, Liquid Maltitol E965, Xanthanol Rubber, Citric Acid, Sodium Citrate, Benzoate Sodium E211, Sodium Sodium, Purified Water. Only 200 mg: Microcrystalline cellulose, Polysorbate 80, Orange aroma containing glycol propylene and ethanol. Only 400 mg: Sodium chloride, Ipromellosa, Strawberry aroma containing benzilic alcohol, Taumatina E957.Therapeutic indications
Brufenlik is indicated for the symptomatic treatment of short duration of mild-moderate pains and/or fever in adults and children aged 6 years (> 20 kg).Contraindications
- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - In patients who have manifested asthma, hives or allergic reactions after intake of acetylsalicylic acid or other NSAIDs; - Severe heart failure (IV class NYHA). - Severe liver failure - Severe kidney failure (glomerular filtration speed less than 30 ml/min). - Disorders leading to increased bleeding or active bleeding. - Anamnesi of gastrointestinal hemorrhage or drilling related to previous treatments with NSAIDs. - Gastric ulcer or active duodenal ulcer or history of recurrent gastrointestinal ulceration/blood (two or more obvious episodes of ulceration or demonstrable bleeding). During the last quarter of pregnancy.Population
Population The therapy must begin with the effective minimum dose, which can be subsequently adjusted, depending on the therapeutic response and any side effects (see paragraph 4.4). Adults and teenagers over the age of 12 (≥ 40 kg) The dose of ibuprofen depends on the age and body weight of the patient. The maximum single daily dose for adults and adolescents should not exceed 400 mg of ibuprofen. More than 400 mg at a time do not provide a better analgesic effect. A total dose should not exceed 1,200 mg of ibuprofen over 24 hours. Initial dose, 200 mg or 400 mg of ibuprofen. If necessary, additional doses of 1 or 2 sachets (from 200 mg to 400 mg of ibuprofen) may be taken up to 3-4 times a day at intervals of 4-6 hours. If this medicine is necessary for more than 3 days in children and adolescents, or if symptoms worsen you should consult a doctor.| Body weight | 200 mg oral suspension in sachet | 400 mg oral suspension in sachet | Frequency | Maximum daily dose |
| ≥ 40 kg (Adolescents, adults and elderly) | 1 or 2 sachets (200 mg or 400 mg) | 1 sachet (400 mg) | Up to 3 or 4 times a day depending on the single dose | 1200 mg of ibuprofen |
| Body age/weight | 200 mg oral suspension in bag Single dose | Frequency | Maximum daily dose |
| 6-7 years (20-30 kg) | 1 sachet (200 mg) | Up to 3 times a day | 30 mg per kg body weight |
| 8-12 years (> 30 kg) | 1 sachet (200 mg) | Up to 4 times a day | 30 mg per kg body weight |
Conservation
This medicine does not require any special condition of conservationWarnings
General Undesirable effects can be minimised using the minimum effective dose for the least time needed to obtain symptoms control (see paragraph 4.2, and gastrointestinal and cardiovascular effects listed below). During prolonged use of analgesics, cephalea can be found, which should not be treated with higher doses of the drug. Following concurrent consumption of alcohol, the side effects related to the active ingredient, especially those concerning the gastrointestinal tract or the central nervous system, can increase during use of NSAIDs. Seniors Senior patients are subject to an increase in the frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal. Blood, ulceration and gastrointestinal perforation NSAIDs should be administered with caution in patients with peptic ulceration anamnesis and other gastrointestinal diseases as such conditions may be exacerbated (see paragraph 4.3). During treatment with all NSAIDs, at any time during therapy, bleeding, ulceration or gastrointestinal perforation were reported. These events may be fatal and may occur with or without warning symptoms or anamnes of serious gastrointestinal events. In patients with ulcer anamnesis, especially if complicated by bleeding or perforation, and in the elderly the risk of bleeding, ulceration or gastrointestinal perforation is greater with the increase in doses of NSAIDs. These patients must begin treatment with the lowest dose available. It is appropriate to consider the administration in association with protective drugs (e.g. misoprostol or protonic pump inhibitors) both for these patients and for patients taking in conjunction with low doses of acetylsalicylic acid/aspirin or other drugs that may increase the risk of gastrointestinal events (see paragraph 4.5). Concurrent administration of ibuprofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors (Cox-2), must be avoided due to increased risk of ulceration or bleeding (see paragraph 4.5). Patients with gastrointestinal toxicity anamnesis, especially elderly patients, must report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment. Precaution is required in the treatment of patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating drugs such as acetilsalicylic acid/aspirin (see paragraph 4.5). If bleeding or gastrointestinal ulceration occurs in patients taking ibuprofen, treatment must be suspended. Respiratory diseases Precautionary should be given to patients with early or concurrent anamnesis of bronchial asthma, chronic rhinitis or allergic diseases since it has been reported that NSAIDs accelerate bronchospasm, urticaria or angioedema in these patients. Allergic reactions Very rarely there are severe acute reactions of hypersensitivity (e.g. anaphylactic shock). In the first signs of a reaction of hypersensitivity following the intake/administration of ibuprofen the therapy must be suspended. The medical measures required must be implemented by specialized personnel. Caution is required in patients who have had allergic reactions or hypersensitivity to other substances, since there may be a greater risk for such patients to experience hypersensitivity reactions as a result of hiring ibuprofen. There is a greater risk of allergic reactions in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders. Such reactions may occur as asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Compromise of kidney and liver functionPrecaution is required in patients with kidney, liver or cardiac impairment since the use of NSAIDs can cause a deterioration of kidney function. The usual concurrent intake of similar analgesics further increases this risk. For patients with kidney, liver or heart failure, use the minimum effective dose for the shortest possible treatment duration (see paragraph 4.3). 400 mg envelopes: see also the paragraph “Information concerning excipients (benzilic alcohol)”. Cardiovascular and cerebrovascular effects It requires caution (disputing with the doctor or pharmacist) before starting treatment in patients with anamnesi of hypertension and/or heart failure, because in association with NSAID therapy water retention and edema were reported. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤1200 mg/die) are associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Severe skin reactions Severe skin reactions, some of which fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, heosinophilia and systemic symptoms ( DRESS syndrome) have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk for these reactions, in fact the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute (AGEP) esantelosis was reported in relation to medicines containing ibuprofen. The administration of ibuprofen should be suspended at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosa lesions or any other sign of hypersensitivity. Exceptionally, chickenpox can be the origin of severe infectious complications of the skin and soft tissues. Currently, the active role of NSAs on the worsening of these infections cannot be excluded. Therefore, it is recommended to avoid the use of ibuprofen in case of chickenpox. Masking the symptoms of underlying infections Brufenlik may mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Brufenlik is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. . Renal effects When treatment with ibuprofen begins, care should be given to patients with considerable dehydration. There is a risk of alteration of kidney function especially in dehydrated children and adolescents and elderly people. As with other NSAIDs, prolonged administration of ibuprofen in animals resulted in kidney papillar necrosis and other pathological kidney modifications. Renal toxicity cases were also observed in patients where prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, administration of NSAIDs can cause a dose-dependent reduction in prostaglandin production and, secondly, kidney blood flow, which can cause kidney failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, elderly and all those patients taking diuretics and ACE inhibitors. The suspension of treatment with NSAIDs is usually followed by the recovery of pretreatment. Ematologic effects Hybuprofen, like other NSAIDs, can inhibit piastrinic aggregation and prolong bleeding time in normal subjects. Synthetic Meningitis On rare occasions in patients with ibuprofen has been observed aseptic meningitis. Although it is more likely that this occurs in patients with systemic erythematous lupus and related connective tissue pathologies, it has also been observed in patients who did not manifest concomitant chronic pathologies. Fertility There are evidence that drugs that inhibit cycloxygenase/synthesis of prostaglandins can cause impairment of female fertility as a result of an effect on ovulation. This event is however reversible with the suspension of treatment (see paragraph 4.6). Information about excipients 200 mg Ibuprofen 200 mg contains: • maltitol (E 965). Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. • 20 mg of benzoate sodium (E211) in each bag equivalent to 2 mg/ml. • 17 mg sodium per sachet of 10 ml, equivalent to 1% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. • orange aroma containing 14 mg of alcohol (ethanol), in each bag of 10 ml. The quantity in each bag of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. • 48 mg of glycol propylene in each bag, equivalent to 4.8 mg/ml. 400 mg Ibuprofen 400 mg contains: • maltitol (E 965). Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. • 10 mg benzoate sodium (E 211) in each bag equivalent to 1 mg/ml. • 58 mg sodium per sachet, equivalent to 3% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. • Strawberry aroma containing 0,0017 mg of benzilic alcohol in each bag of 10 ml. Benzyl alcohol can cause allergic reactions. Large volumes should be used with caution and only if necessary, especially in pregnant women and patients with liver or kidney failure due to the risk of accumulation and toxicity ( metabolic acidosis). (See “Heart failure, renal and hepatic impairment” above and paragraph 4.6).Interactions
You should pay attention in patients treated with one of the following medications since in some interactions have been reported. Other NSAIDs including selective cyclooxygenase-2 inhibitors Concurrent use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided by potential additive effect (see paragraph 4.4). Heart glycosides NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Courtesy Increased risk of gastrointestinal ulceration or hemorrhage with NSAIDs. Anticoagulants NSAIDs can enhance the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) (e.g. clopidogrel and ticlopidine) Increased risk of gastrointestinal bleeding with NSAIDs. Acetylsalicylic acid As with other products containing NSAIDs, concurrent administration of ibuprofen and acetylsalicylic/aspirin acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic/aspirin acid at low doses on piastrinic aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data from the clinical situation, it cannot be ruled out the possibility that regular use, long term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Lithium FANS can reduce lithium elimination. Antihypertensives, beta-blockers and diuretics NSAIDs can reduce the effect of these drugs. Diuretics can increase the risk of nephrotoxicity associated with NSAIDs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), the concomitant administration of an ACE inhibitor or antagonists of angiotensin II and drugs that inhibit cyclooxygenase can cause further deterioration of kidney function, including a possible acute kidney failure, generally reversible. Therefore co-administration must be carried out with caution, especially in the elderly. Patients should be properly hydrated and renal function monitoring should be taken into consideration after the start of treatment and subsequently on a periodic basis. Methodology The NSAIDs can inhibit the tubular secretion of the metotrexate and reduce its clearance. Ciclosporine Increased risk of nephrotoxicity with NSAIDs. Tacrolimus Possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudina Increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increase in the risk of hematoma and hematoma in hemophilic patients with HIV in contemporary treatment with zidovudine and ibuprofen. Chinolonic Antibiotics Animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have a greater risk of developing seizures. CYP2C9 inhibitors Concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to the S (+)-ibuprofen from approximately 80% to 100%. You should consider reducing the dose of ibuprofen when administering strong inhibitors of CYP2C9, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Sulfaniluree NSAIDs can increase the effect of sulfaniluree. Rare cases of hypoglycemia have been reported in patients treated with sulfaniluree taking ibuprofen. Colestiramine The concurrent administration of ibuprofen and choleramine can reduce the absorption of ibuprofen at the gastrointestinal tract level. However, the clinical relevance of such interaction is not known. Aminoglycosides NSAIDs can reduce aminoglycoside excretion. Plant extracts Ginkgo Biloba can increase the risk of bleeding in association with NSAIDs. Mifepristone Due to the anti-prostaglandiniche properties of the NSAIDs, including acetylsalicylic acid, it can theoretically determine a decrease in the effectiveness of the drug. The limited evidence suggests that co-administration of NSAIDs on the day of administration of prostaglandins does not negatively affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the drug on the interruption of pregnancy.Effects
Adverse reactions possibly related to ibuprofen are listed below by frequency and classification for systems and organs according to MedDRA. Frequency groups are classified according to the following categories: very common (≥1/10), common (≥1/100,Overdosing
Toxicity In children or adults, signs and symptoms of toxicity were not generally observed at doses of less than 100 mg/kg. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses equal to or greater than 400 mg/kg. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include cephales, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, SNC depression and respiratory system were reported. It has been reported cardiovascular toxicity including hypotension, bradycardia and tachycardia. In cases of significant overdose, kidney failure and liver damage may occur. Relevant overdosages are generally well tolerated as long as other medicinal products are not involved. Treatment There is no specific antidote for overdosing ibuprofen. Patients must be treated symptomaticly as needed. Within an hour of ingestion of a potentially toxic quantity, it is necessary to consider activated charcoal. If necessary, the sieric electrolytic balance must be corrected. For more up-to-date information, contact the local anti-veleni center.Pregnancy
Inhibition of prostaglandin synthesis can have negative effects on pregnancy and/or embryo-fetal development. Data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has led to an increase in pre- and post-system loss and embryo-fetal mortality. In addition, in animals that had been given inhibitors of the synthesis of prostaglandin during the period of organgenesis, an increase in the incidence of various malformations, including cardiovascular disease was reported. During the first and second quarter of pregnancy, ibuprofen should not be administered, if not in strictly necessary cases. If ibuprofen is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. 400 mg bags: Brufenlik 400 mg oral suspension in sachet also contains benzilic alcohol and, due to the risk of accumulation and toxicity ( metabolic acidosis) associated with high volumes of benzilic alcohol, it is necessary to lend caution in pregnant women. See also paragraph 4.4 “Information concerning excipients (benzyl alcohol)”. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension) - kidney dysfunction, which can progress in kidney failure with oligoidramnios; - At the end of pregnancy, the inhibitors of prostaglandin synthesis can expose the mother and the newborn, at the end of pregnancy, to: - a possible extension of bleeding time - an inhibition of uterine contractions, resulting in delay or extension of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.Food
Bags of 200 mg: Hybuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment the risk of influence on the newborn seems unlikely. If, however, long-term treatment is prescribed, it should be considered early weaning. 400 mg bags: Hybuprofen is excreted in breast milk, but with therapeutic doses during short-term treatment the risk of influence on the child seems unlikely. However, Brufenlik 400 mg oral suspension in envelope contains benzilic alcohol and, due to the risk of accumulation and toxicity ( metabolic acidosis) associated with high benzilic alcohol volumes, it is necessary to pay caution in nursing women (see also paragraph 4.4 “Absent Alcohol Abzyl Information”. If, however, long-term treatment is prescribed, it should be considered early weaning.Fertility
The use of Ibuprofen can compromise female fertility and is not recommended in women waiting for conception. In women who have difficulty in conceiving or who are being investigated on infertility, it is necessary to consider the interruption of treatment with ibuprofen (see paragraph 4.4).Source: Farmadati
