BRUFENLIK * 20BUST 400MG 10ML

BRUFENLIK * 20BUST 400MG 10ML

Therapeutic indications

Brufenlik is indicated for the short-term symptomatic treatment of mild to moderate pain and / or fever in adults and children over 6 years of age (> 20 kg).

Dosage and method of use

DosageTherapy should be started with the lowest effective dose, which can be subsequently adjusted, depending on the therapeutic response and any undesirable effects.Adults and adolescents over 12 years of age (≥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 does not provide a better analgesic effect. A total dose should not exceed 1,200 mg of ibuprofen over a 24 hour period. Starting dose, 200 mg or 400 mg of ibuprofen. If needed, additional doses of 1 or 2 sachets (200 mg to 400 mg ibuprofen) can be taken up to 3-4 times a day at 4-6 hour intervals. If this medicine is needed for more than 3 days in children and adolescents, or if symptoms worsen, a doctor should be consulted.

Pediatric populationChildren 6-12 years old (20kg-39kg)

The maximum total daily dose of ibuprofen is 30 mg per kg of body weight, divided into 3-4 single doses at 6-8 hour intervals. The maximum recommended daily dose should not be exceeded.

Brufenlik 200 mg is not indicated for children under 6 years of age. (Elderly No specific dosage adjustments are required unless renal or hepatic function is impaired, in which case the dosage must be assessed individually. Care should be taken. to the dosage in this group.Renal impairmentIn patients with mild to moderate renal impairment. no dose reduction is necessary (for patients with severe renal impairment, see section 4.3).Hepatic impairmentIn patients with mild to moderate hepatic impairment. no dose reduction is necessary (for patients with severe hepatic dysfunction, see section 4.3)Method of administrationFor oral use. Mix the contents of the sachet well before ingesting it by pressing the top and bottom of the sachet several times with your fingers. The contents of the sachet cannot be divided between doses and the entire contents of the sachet must be used. In order to achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with gastric sensitivity problems are recommended to take ibuprofen with food.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - In patients who have experienced asthma, hives or allergic reactions after taking acetylsalicylic acid or other NSAIDs; - Severe heart failure ((NYHA class IV) - Severe hepatic insufficiency - Severe renal insufficiency (glomerular filtration rate less than 30ml / min) - Disorders resulting in increased tendency to bleeding or active bleeding - History of haemorrhage gastrointestinal or perforation related to previous NSAID treatment - Presence or history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding) - During the last trimester of pregnancy.

Side effects

Adverse reactions possibly related to ibuprofen are listed below by frequency and MedDRA system organ class. The frequency groups are classified according to the following categories: very common (≥1 / 10), common (≥1 / 100,

Side effects seen with ibuprofen are generally common to other NSAIDs.Gastrointestinal disordersThe most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.3). Gastritis, duodenal ulcer and gastric ulcer and gastrointestinal perforation have been observed less frequently. A transient burning sensation in the mouth or throat can occur with ibuprofen suspension or ibuprofen granules.Disorders of the immune systemHypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) reactivity of the respiratory tract including asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) various skin disorders, including rash of various types, itching, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).Infections and infestationsExacerbation of skin infection-related inflammations (e.g. development of necrotizing fasciitis) has been described in conjunction with the use of NSAIDs. If signs of an infection appear or worsen while using ibuprofen, the patient should be advised to consult a physician immediately.Skin and subcutaneous tissue disordersIn exceptional cases, severe skin infections and soft tissue complications may occur in the course of chickenpox infection (see also “Infections and infestations” and section 4.4).Cardiac and vascular diseasesClinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events such as 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/hu/content/segnalazioni-reazioni-avverse By reporting side effects you can help provide more information on the safety of this medicine.

Special warnings

GeneralUndesirable effects can be minimized by using the lowest effective dose for the shortest time necessary to achieve symptom control (see section 4.2, and the gastrointestinal and cardiovascular effects listed below). Like other NSAIDs, ibuprofen can mask the signs of infection. Headache may occur during prolonged use of analgesics and should not be treated with higher doses of the medicinal product. Following concomitant alcohol consumption, undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase during the use of NSAIDs.Elderly peopleElderly patients are prone to an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.Gastrointestinal bleeding, ulceration and perforationNSAIDs should be administered with caution to patients with a history of peptic ulceration and other gastrointestinal diseases as these conditions may be exacerbated (see section 4.3). Gastrointestinal bleeding, ulceration or perforation has been reported during treatment with all NSAIDs at any time during therapy. These events can be fatal and can occur with or without warning symptoms or a history of serious gastrointestinal events. In patients with a history of ulcer, particularly if complicated with bleeding or perforation, 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. Combination administration with protective drugs (e.g. misoprostol or proton pump inhibitors) should be considered for both these patients and patients taking concomitantly low doses of acetylsalicylic acid / aspirin or other drugs that may increase the risk of events. gastrointestinal (see section 4.5). Concomitant administration of ibuprofen and other NSAIDs, including selective cyclooxygenase-2 (Cox-2) inhibitors, should be avoided due to the increased risk of ulceration or bleeding (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early 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 drugs such as acetylsalicylic acid / aspirin (see section 4.5 ). If gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be discontinued.Respiratory pathologiesCaution should be exercised if ibuprofen is administered to patients with a previous or concomitant history of bronchial asthma, chronic rhinitis or allergic disease as NSAIDs have been reported to accelerate bronchospasm, urticaria or angioedema in these patients.Allergic reactionsVery rarely severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed. At the first signs of a hypersensitivity reaction following the intake / administration of ibuprofen, therapy should be discontinued. The required medical measures must be implemented by specialized personnel. Caution is warranted in patients who have experienced allergic or hypersensitivity reactions to other substances, as such patients may have an increased risk of hypersensitivity reactions following taking ibuprofen. There is an increased risk of allergic reactions occurring in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disease. These reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria.Impaired renal and hepatic functionCaution is required in patients with renal, hepatic or cardiac impairment as the use of NSAIDs may result in deterioration of renal function. Usual concomitant intake of similar analgesics further increases this risk. For patients with renal, hepatic or cardiac insufficiency, use the lowest effective dose for the shortest possible duration of treatment (see section 4.3). 400 mg sachets: see also section “Information on excipients (benzyl alcohol)”.Cardiovascular and cerebrovascular effectsCaution is required (discuss with doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention and edema have been reported in association with NSAID therapy. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased 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 / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. ). Careful consideration should also be exercised before initiating long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg / die) of ibuprofen.Severe skin reactionsSerious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, eosinophilia and systemic symptoms (DRESS syndrome) 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 for these reactions, in fact the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in connection with medicinal products containing ibuprofen. Ibuprofen administration should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally, chickenpox can be the cause of serious infectious complications of the skin and soft tissues. Currently, the active role of NSAIDs in worsening these infections cannot be ruled out. Therefore, it is advisable to avoid the use of ibuprofen in case of chickenpox.Kidney effectsWhen initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. There is a risk of impaired renal function especially in dehydrated children and adolescents and the elderly. As with other NSAIDs, prolonged administration of ibuprofen in animals resulted in renal papillary necrosis and other pathological renal changes. Cases of renal toxicity have also been observed in patients in whom prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, NSAID administration may cause a dose-dependent reduction in prostaglandin production and, secondarily, in renal blood flow, which may lead to renal failure. The patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, the elderly and all those patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery from the pretreatment state.Hematological effectsIbuprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time in normal people.Aseptic meningitisOn rare occasions, aseptic meningitis has been observed in patients receiving ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been seen in patients who did not have concomitant chronic diseases.FertilityThere is evidence 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 on discontinuation of treatment (see section 4.6).Information relating to excipients 200 mgIbuprofen 200 mg contains: • maltitol (E 965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. • 20 mg of sodium benzoate (E211) in each sachet equivalent to 2 mg / ml. • 17 mg of sodium per 10 ml sachet, equivalent to 1% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. • orange flavor containing 14 mg of alcohol (ethanol), in each 10 ml sachet. The amount in each sachet of this medicine is equivalent to less than 1ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. • 48 mg of propylene glycol in each sachet, equivalent to 4.8 mg / ml.400 mgIbuprofen 400 mg contains: • maltitol (E 965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. • 10 mg of sodium benzoate (E 211) in each sachet equivalent to 1 mg / ml. • 58 mg of sodium per sachet, equivalent to 3% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. • Strawberry flavor containing 0.0017 mg of benzyl alcohol in each 10 ml sachet. Benzyl alcohol can cause allergic reactions. Large volumes should be used with caution and only if necessary, especially in pregnant women and patients with hepatic or renal insufficiency due to the risk of accumulation and toxicity (metabolic acidosis). (See “Heart failure, renal and hepatic impairment” above and section 4.6).

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can have adverse effects on pregnancy and / or embryo-fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, heart 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.400 mg sachets:Brufenlik 400 mg oral suspension in sachet also contains benzyl alcohol and due to the risk of accumulation and toxicity (metabolic acidosis) associated with high volumes of benzyl alcohol, caution should be exercised in pregnant women. See also section 4.4 “Information on excipients (benzyl alcohol)”. In 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 oligohydramnios; - At the end of pregnancy, prostaglandin synthesis inhibitors can expose the mother and the newborn, at the end of pregnancy, to: - a possible prolongation of bleeding time - an inhibition of uterine contractions, with consequent delay or prolongation of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.Feeding time 200 mg sachets: Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment the risk of influenza in the newborn seems unlikely. If, however, long-term treatment is prescribed, early weaning should be considered.400 mg sachets:Ibuprofen is excreted in breast milk, but with therapeutic doses during short-term treatment the risk of influenza on the baby seems unlikely. However, Brufenlik 400 mg oral suspension in sachet contains benzyl alcohol and, due to the risk of accumulation and toxicity (metabolic acidosis) associated with high volumes of benzyl alcohol, caution should be exercised in breastfeeding women (see also section 4.4 "Information related to excipients (benzyl alcohol). ”If, however, long-term treatment is prescribed, early weaning should be considered.FertilityThe use of Ibuprofen may impair female fertility and is not recommended in women awaiting conception. In women who have difficulty conceiving or who are being investigated for infertility, discontinuation of ibuprofen treatment should be considered (see section 4.4).

Expiration and retention

This medicine does not require any special storage conditions

Interactions with other drugs

Caution should be exercised in patients treated with any of the following drugs as interactions have been reported in some.Other NSAIDs including selective cyclooxygenase-2 inhibitorsConcomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effect (see section 4.4).Cardiac glycosidesNSAIDs can exacerbate heart failure, reduce the rate of glomerular filtration and increase plasma levels of cardiac glycosides.CorticosteroidsIncreased risk of gastrointestinal ulceration or bleeding with NSAIDs.AnticoagulantsNSAIDs can potentiate the effects of blood thinners, such as warfarin.Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) (e.g. clopidogrel and ticlopidine)Increased risk of gastrointestinal bleeding with NSAIDs.Acetylsalicylic acidAs with other NSAID-containing products, concomitant administration of ibuprofen and acetylsalicylic acid / aspirin 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 / aspirin 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).LithiumNSAIDs can reduce the elimination of lithium.Antihypertensives, beta-blockers and diureticsNSAIDs can reduce the effect of these drugs. Diuretics may increase the risk of NSAID-associated nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), concomitant administration of an ACE inhibitor or angiotensin II antagonists and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function. , including possible acute renal failure, usually reversible. Therefore, co-administration should be done with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of treatment and on a periodic basis thereafter.MethotrexateNSAIDs can inhibit the tubular secretion of methotrexate and reduce its clearance.CiclosporineIncreased risk of nephrotoxicity with NSAIDs.TacrolimusPossible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus.ZidovudineIncreased risk of blood toxicity when co-administered with NSAIDs. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-infected haemophilia patients concomitantly treated with zidovudine and ibuprofen.Quinolone antibioticsAnimal 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.CYP2C9 inhibitorsConcomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S (+) - ibuprofen from approximately 80% to 100% was observed. Dose reduction of ibuprofen should be considered when co-administered strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.SulfonylureasNSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen.CholestyramineConcomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown.AminoglycosidesNSAIDs can reduce the excretion of aminoglycosides.Plant extractsGinkgo Biloba may increase the risk of bleeding in combination with NSAIDs.MifepristoneDue to the anti-prostaglandin properties of NSAIDs, including acetylsalicylic acid, a decrease in the efficacy of the drug can theoretically occur. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the drug's clinical efficacy on termination of pregnancy.

Overdose

ToxicityIn children or adults, no signs and symptoms of toxicity were generally observed at doses below 100 mg / kg. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or more. In cases of severe poisoning, metabolic acidosis may occur.SymptomsMost patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headaches, tinnitus, dizziness, convulsions and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, CNS and respiratory depression have also been reported rarely. Cardiovascular toxicity including hypotension, bradycardia and tachycardia has been reported. Renal failure and liver damage may occur in cases of significant overdose. Major overdoses are generally well tolerated as long as no other medicinal products are involved.TreatmentThere is no specific antidote for ibuprofen overdose. If the amount ingested in the preceding hour exceeds 400 mg / kg, gastric emptying followed by supportive measures is recommended. For the most up-to-date information, contact your local poison control center.

Active principles

Each sachet (10 ml) contains 200 mg of ibuprofen. Each sachet (10 ml) contains 400 mg of ibuprofen.Excipient (s) with known effectEach sachet (10 ml) contains 2500 mg of maltitol (E 965), 20 mg of sodium benzoate (E 211), 14 mg of ethanol, 48 mg of propylene glycol and 17 mg of sodium. Each sachet (10 ml) contains 5000 mg of maltitol (E 965), 10 mg of sodium benzoate (E 211), 0.0017 mg of benzyl alcohol and 58 mg of sodium. For the full list of excipients, see section 6.1.

Excipients

Glycerol Liquid maltitol E965 Xanthan gum Citric acid Sodium citrate Sodium benzoate E211 Sodium saccharin Purified waterOnly 200 mg: Microcrystalline cellulose Polysorbate 80 Orange flavor containing propylene glycol and ethanolOnly 400 mg:Sodium chloride Hypromellose Strawberry flavor containing benzyl alcohol Taumatin E957