Buscofenact

Symptomatic treatment of short duration of: - mild to moderate pain such as headache, toothache and menstrual pain; - fever and pain associated with the common cold. BuscofenAct is indicated in adults and adolescents with a body weight greater than 40 kg (aged 12 years or older).

BuscofenAct soft capsules is contraindicated in case of: - hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1; - history of hypersensitivity (eg bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); - haematological disorders of unknown origin; - history of peptic ulcer / recurrent or ongoing haemorrhage (two or more distinct episodes of proven ulceration or bleeding); - history of gastrointestinal bleeding or perforation, related to previous NSAID therapy; - cerebrovascular hemorrhage or other bleeding episodes; - severe heart failure (NYHA class IV) (see also section 4.4); - severe hepatic insufficiency or severe renal insufficiency (see also section 4.4); - patients in the third trimester of pregnancy (see section 4.6); - adolescents with a body weight below 40 kg and children under 12 years of age; - patients with severe dehydration (due to vomiting, diarrhea or insufficient fluid intake).

Posology Adults and adolescents with body weight> 40 kg (aged 12 years or over): starting dose of 400 mg ibuprofen. If necessary, an additional 400 mg dose of ibuprofen can be taken. The interval between one dose and another should be determined based on the symptoms observed and the maximum recommended daily dose, and should not be less than 6 hours. Do not take more than 1200 mg of ibuprofen in 24 hours. Only for short-term treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment necessary to control symptoms (see section 4.4). If BuscofenAct soft capsules should be taken in adults for more than 3 days in case of fever or for more than 4 days for the treatment of pain or if the symptoms get worse, the patient is advised to consult the doctor. It is recommended that people with gastric disorders eat on a full stomach. If taken shortly after eating, the onset of the BuscofenAct effect may be delayed. If this happens do not take BuscofenAct more than recommended in section 4.2 (posology) or until the correct interval has passed between one dose and another. Particular patient populations Elderly No special dose adjustments are required. Due to possible side effects (see section 4.4), elderly subjects should be carefully monitored. Renal impairment No special dose adjustments are required in patients with mild or moderate renal impairment (for patients with severe renal impairment, see section 4.3). Hepatic impairment (see section 5.2) No specific dose modifications are required in patients with mild or moderate hepatic impairment (for patients with severe hepatic dysfunction, see section 4.3). Pediatric population BuscofenAct is contraindicated in adolescents with a body weight below 40 kg and in children below 12 years of age due to the high content of the active substance (see section 4.3). If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of a worsening of symptoms, the doctor must be consulted. Method of administration For oral use. Soft capsules should not be chewed.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to achieve symptom control (see the paragraphs below dedicated to gastrointestinal and cardiovascular risks). Caution is required in patients with certain clinical conditions, which could worsen: - patients with systemic lupus erythematosus and various connective tissue disorders have an increased risk of developing aseptic meningitis (see section 4.8); - congenital pathology of porphyrin metabolism (eg acute intermittent porphyria); - gastrointestinal diseases and chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease) (see section 4.8); - hypertension and / or cardiac impairment as renal function may deteriorate (see sections 4.3 and 4.8); - renal damage (see sections 4.3 and 4.8); - hepatic dysfunction (see sections 4.3 and 4.8); - immediately after major surgical interventions; - in patients who have allergic reactions to other substances, since for such patients there is a greater risk of hypersensitivity reactions occurring even after the use of BuscofenAct; - in patients suffering from hay fever, nasal polyps or chronic obstructive airway diseases as there is a greater risk of allergic reactions for these patients. Such reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Gastrointestinal effects The use of BuscofenAct soft capsules in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse reactions and should be avoided. Elderly Elderly subjects have a higher frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation, which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration or perforation Gastrointestinal hemorrhage, ulceration or perforation, sometimes fatal, have been reported, at any stage of treatment, with the use of all NSAIDs, with or without prodromal symptoms or a past history of gastrointestinal events. If gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be discontinued. The risk of gastrointestinal bleeding, ulceration or perforation increases with higher doses of NSAIDs, in patients with a history of ulcer, particularly if complicated by bleeding or perforation (see section 4.3), and in elderly patients. These patients should start treatment with the lowest available dose. Concomitant therapy with protective agents (eg misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking 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 the elderly, must report any unusual abdominal symptoms (especially gastrointestinal haemorrhage), especially in the early stages of treatment. Caution should be exercised in patients receiving concomitant medication 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). NSAIDs should be administered with caution to patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease) as their condition may worsen (see section 4.8). Skin reactions Severe skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with the use of NSAIDs (see section 4.8). Patients appear to be at greater risk for these reactions in the early stages of therapy; in fact, in most cases, the reaction occurs in the first month of treatment. Administration of BuscofenAct soft capsules should be discontinued on the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity. Exceptionally, chickenpox may be the cause of severe skin infections and soft tissue complications. So far, it could not be excluded that NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use BuscofenAct soft capsules during chickenpox. Cardiovascular and cerebrovascular effects Caution is required (discuss this with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure, since fluid retention, hypertension and edema have been reported in association with NSAID therapy . Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (eg myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (eg ≤ 1200 mg per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III NYHA class), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg daily ). Careful consideration should also be given to patients with risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit) before starting long-term treatment, especially if high doses are required (2400 mg per day). day) of ibuprofen. Other warnings and precautions Severe acute hypersensitivity reactions (eg anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction following the administration / administration of BuscofenAct soft capsules, therapy should be discontinued. The required medical measures must be carried out by expert personnel. Ibuprofen, the active ingredient of BuscofenAct soft capsules, can temporarily inhibit platelet function (platelet aggregation). Therefore, patients with platelet disorders should be carefully monitored. In the case of prolonged treatment with ibuprofen, hepatic and renal parameters as well as the blood picture should be checked regularly. Prolonged use of any analgesic for headache can make it worse. If this situation occurs or is suspected, consult your doctor and stop treatment. The diagnosis of over-medication headache (MOH) should be suspected in patients with frequent or daily headaches, despite (or because of) the regular use of headache medications. In general, the usual use of analgesics, in particular the association of different analgesic active ingredients, can lead to permanent renal lesions with the risk of renal insufficiency (analgesic nephropathy). This risk can be increased under physical effort associated with loss of salts and dehydration. Therefore this must be avoided. In the case of concomitant consumption of alcohol during the use of NSAIDs, adverse events related to the active ingredient, especially those affecting the gastrointestinal tract or central nervous system, may increase. NSAIDs can mask the symptoms of infection and fever. Pedriatric population There is a risk of impaired renal function in dehydrated adolescents. BuscofenAct contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The list of side effects below refers to all the side effects that were seen during treatment with ibuprofen, including those observed during long-term treatment and at high doses in patients with rheumatic diseases. The declared frequencies, which occur with a higher incidence than the very rare cases, refer to the short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for the oral dosage form and a maximum of 1800 mg for the suppositories . It must be taken into account that the following side effects are basically dose-dependent and vary from individual to individual. The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcer, perforation or gastrointestinal bleeding, even with fatal outcome, may occur, especially in the elderly (see section 4.4). Following administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported (see section 4.4). Gastritis has been observed less frequently. The risk of gastrointestinal bleeding depends on the dose and duration of treatment. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (eg myocardial infarction or stroke) (see section 4.4). Patients should be advised to stop taking BuscofenAct immediately and to consult a doctor if a serious adverse reaction occurs. Adverse reactions are listed below by system and organ classification, and by frequency, according to the following categories: Very common (≥1 / 10) Common (≥1 / 100, <1/10) Uncommon (≥1 / 1000 , <1/100) Rare (≥ 1 / 10,000, <1/1000) Very rare (<1 / 10,000)

If necessary, patients should be adequately informed to stop treatment with BuscofenAct and consult a doctor immediately if one of the following conditions occurs: - severe gastro-intestinal disorders, heartburn or abdominal pain, - hematemesis; - melena or blood in the urine; - skin reactions, such as rashes with itching; - respiratory distress and / or edema of the face or larynx; - fatigue associated with loss of appetite; - sore throat, associated with canker sores, fatigue and fever; - severe epistaxis and skin bleeding; - abnormal tiredness associated with reduced urinary excretion; - edema of the feet or legs; - chest pain; - visual disturbances. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis, following the use of an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular malformations has increased from less than 1% to about 1.5%. The risk is thought to increase with increasing dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor resulted in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of malformations, including cardiovascular ones, has been reported in animals treated with an inhibitor of prostaglandin synthesis during the organogenesis period. During the first and second trimester of pregnancy, ibuprofen should only be administered if absolutely necessary. If ibuprofen is used in women who intend to conceive or during the first and second trimester of pregnancy the dose should be kept as low as possible and the duration of treatment should be as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to the risk of: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can worsen to renal failure with oligo-hydroamniosis. At the end of pregnancy, the mother and the newborn to: - possible prolongation of the bleeding time, an anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions which can cause a delay or prolongation of labor at the time of delivery. As a result, ibuprofen administration is contraindicated during the third trimester of pregnancy. Lactation Ibuprofen and its metabolites may pass into low concentrations in breast milk. Until now, there are no known deleterious effects on infants. Therefore, for short-term treatment of pain and fever at the recommended dose, it should generally not be necessary to stop breast-feeding. Fertility There is some evidence that drugs that inhibit cyclo-oxygenase / prostaglandin synthesis can compromise female fertility by acting on ovulation. Once the treatment with ibuprofen is completed, the effect is reversible.

Format: 20 Capsules 400mg