BUSCOFENACT * 12CPS 400MG

BUSCOFENACT * 12CPS 400MG

Therapeutic indications

Short-term symptomatic treatment 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 weighing more than 40 kg (aged 12 years and over).

Dosage and method of use

Dosage Adults and adolescents with body weight> 40 kg (12 years of age and older): starting dose of 400 mg of ibuprofen. If necessary, an additional 400 mg dose of ibuprofen can be taken. The interval between doses should be established 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. For short-term treatments only. 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). If BuscofenAct soft capsules are to be taken in adults for more than 3 days in case of fever or for more than 4 days for pain treatment or if symptoms worsen, the patient is advised to consult their doctor. It is recommended to take on a full stomach for people with gastric disorders. When taken shortly after eating, the onset of BuscofenAct's effect may be delayed. If this happens, do not take BuscofenAct more than recommended in section 4.2 (posology) or until the correct interval between doses has elapsed.Particular patient populations Elderly peopleNo special dosage changes are required. Due to possible undesirable effects (see section 4.4), elderly subjects should be carefully monitored.Kidney failureNo special dose adjustments are required in patients with mild or moderate renal impairment (for patients with severe renal impairment, see section 4.3).Hepatic insufficiency (see section 5.2)No special dose adjustments are required in patients with mild or moderate hepatic impairment (for patients with severe hepatic dysfunction, see section 4.3).Pediatric populationBuscofenAct is contraindicated in adolescents with body weight below 40 kg and in children under 12 years of age due to the high active substance content (see section 4.3). If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Method of administration For oral use. The soft capsules should not be chewed.

Contraindications

BuscofenAct soft capsules are contraindicated in case of: - hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1; - history of hypersensitivity (e.g. 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 recurrent or ongoing peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); - history of gastrointestinal bleeding or perforation related to previous NSAID therapy; - cerebrovascular haemorrhage 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).

Side effects

The list of undesirable effects below refers to all undesirable effects that have occurred during treatment with ibuprofen, including those observed during long-term and high-dose treatment in patients with rheumatic diseases. The reported frequencies, which occur with incidence higher than 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 suppositories. . It should be taken into account that the following undesirable effects are fundamentally dose-dependent and vary from individual to individual. The most commonly observed undesirable events are gastrointestinal in nature. Peptic ulcer, gastrointestinal perforation or haemorrhage may occur, including with fatal outcome, especially in the elderly (see section 4.4). Following administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, aggravation of colitis and Crohn's disease have been reported (see section 4.4). Gastritis was 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 increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Patients should be advised to stop taking BuscofenAct immediately and to consult their physician if a serious adverse reaction occurs. Adverse reactions are listed below by system organ class, and by frequency, according to the following categories: Very common (≥1 / 10) Common (≥1 / 100,

If necessary, patients should be adequately advised to discontinue BuscofenAct treatment and consult a physician immediately if any of the following occur: - severe gastro-intestinal disturbances, heartburn or abdominal pain; - haematemesis; - melaena or blood in the urine; - skin reactions, such as itchy rashes; - respiratory distress and / or edema of the face or larynx; - fatigue associated with loss of appetite; - sore throat, associated with aphthous ulcers, fatigue and fever; - severe nosebleeds and skin bleeding; - abnormal fatigue associated with reduced urinary excretion; - edema in the feet or legs; - chest pain; - visual disturbances.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 possible duration of treatment needed to achieve symptom control (see gastrointestinal and cardiovascular risks below). Caution is warranted in patients with certain clinical conditions, which may 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 disorders and chronic inflammatory bowel 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, as there is a greater risk of hypersensitivity reactions occurring for these patients also following the use of BuscofenAct; - in patients suffering from hay fever, nasal polyps or chronic obstructive diseases of the airways as there is an increased risk of allergic reactions for these patients. These reactions may present as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria.Gastrointestinal effectsThe 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 peopleElderly subjects have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Gastrointestinal bleeding, ulceration or perforationGastrointestinal bleeding, 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 previous 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 with haemorrhage 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 (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also 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 the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment. Caution should be exercised in patients being treated concomitantly with drugs 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 disease (ulcerative colitis, Crohn's disease) as their condition may worsen (see section 4.8).Severe skin reactionsSerious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at increased risk for these reactions early in therapy; in fact, in most cases, the reaction occurs in the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. Administration of BuscofenAct soft capsules should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally, chickenpox can be the cause of serious skin infections and soft tissue complications. It is recommended not to use BuscofenAct soft capsules in the course of chickenpox.Masking of symptoms of underlying infectionsBuscofenAct soft capsules can mask the symptoms of infection, which could delay the start 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 BuscofenAct soft capsules are 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.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, 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 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 per 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 per 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 per day) are required. day) of ibuprofen.Other warnings and precautionsSevere acute hypersensitivity reactions (eg anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction following the intake / administration of BuscofenAct soft capsules, therapy should be discontinued. The required medical measures must be carried out by experienced personnel. Ibuprofen, the active substance in BuscofenAct soft capsules, can temporarily inhibit platelet function (platelet aggregation). Therefore, patients with platelet disorders should be carefully monitored. In case of prolonged treatment with ibuprofen, the liver and kidney parameters as well as the blood picture should be checked regularly. Prolonged use of any pain reliever for headache can make it worse. If this occurs or is suspected, you should consult your doctor and discontinue treatment. The diagnosis of drug overuse 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 habitual use of analgesics, in particular the combination of different analgesic active ingredients, can lead to permanent renal lesions with the risk of renal failure (analgesic nephropathy). This risk can be increased under physical exertion associated with salt loss and dehydration. Therefore this must be avoided. In case of concomitant alcohol consumption during NSAID use, adverse events related to the active substance, especially those affecting the gastrointestinal tract or central nervous system, may increase.Pediatric populationThere is a risk of impaired renal function in dehydrated adolescents. Sorbitol BuscofenAct contains 95.94 mg of sorbitol in each capsule. Patients with hereditary fructose intolerance, a rare genetic disorder, should not take this medicine.

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed 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 malformations, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis. During the first and second trimester of pregnancy, ibuprofen should only be given if absolutely necessary. If ibuprofen is used in women intending 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 can expose the fetus to the risk of: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can worsen up to renal failure with oligo-hydroamniosis. At the end of pregnancy, the mother and the newborn to: - possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions which can result in a delay or prolongation of labor at the time of delivery. Consequently, ibuprofen administration is contraindicated during the third trimester of pregnancy.Feeding timeIbuprofen and its metabolites can pass in low concentrations into breast milk. To date, no deleterious effects on infants are known. Therefore, for short-term treatment of pain and fever at the recommended dose, it should generally not be necessary to stop breastfeeding.FertilityThere is some evidence that drugs that inhibit cyclo-oxygenase / prostaglandin synthesis may impair female fertility by affecting ovulation. Once treatment with ibuprofen has ended, the effect is reversible.

Expiration and retention

This medicinal product does not require any special storage temperatures.

Interactions with other drugs

Overdose

Symptoms in case of overdoseSymptoms of overdose may manifest themselves with central nervous system symptoms such as headache, dizziness, light-headedness and loss of consciousness (myoclonic seizures even in children), abdominal pain, nausea, vomiting, gastrointestinal bleeding and liver and kidney dysfunction, hypotension , respiratory depression and cyanosis. In cases of severe poisoning, metabolic acidosis may occur.Therapeutic measures in case of overdoseThere is no specific antidote. If after one hour of ingestion, the patient has potentially toxic levels of the drug, resort to oral administration of activated charcoal.

Active principles

One soft capsule contains 400 mg of ibuprofen.Excipients with known effect: Sorbitol 95.94 mg / capsule (see section 4.4). For the full list of excipients, see section 6.1.

Excipients

Capsule content: Macrogol 600 Potassium hydroxide Purified water Capsule shell :Gelatin Liquid sorbitol Purified water Printing ink Ingredients of Opacode WB black NS-78-17821: Black iron oxide (E172) Propylene glycol (E1520) Hypromellose 6cP