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BUSCOFENACT * 12CPS 400MG

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041631021
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SANOFI Srl
041631021

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 Senior citizens No special dosage changes are required. Due to possible undesirable effects (see section 4.4), elderly subjects should be carefully monitored. Kidney failure 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 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 population BuscofenAct 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,

Infections and infestations Very rare Worsening of infectious inflammations (e.g. development of necrotizing fasciitis) has been observed in conjunction with the use of non-steroidal anti-inflammatory drugs. This is likely associated with the mechanism of action of non-steroidal anti-inflammatory drugs. Symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or clouding of consciousness have been observed during treatment with ibuprofen. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be predisposed.
Disorders of the blood and lymphatic system Very rare Haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, superficial sores in the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In long-term therapy, blood counts should be checked regularly.
Disorders of the immune system Uncommon Hypersensitivity reactions with skin rashes, and itching, asthma attacks (with possible drop in blood pressure).
Very rare Severe generalized hypersensitivity reactions, the signs of which may be facial edema, swelling of the tongue, swelling of the larynx with constriction of the respiratory tract, respiratory distress, tachycardia, drop in blood pressure, up to life-threatening shock. If any of these symptoms occur, and this can happen even on first use, immediate medical attention is required.
Psychiatric disorders Very rare Psychotic reactions, depression.
Nervous system disorders Uncommon Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.
Eye disorders Uncommon Visual disturbances.
Ear and labyrinth disorders Rare Tinnitus.
Cardiac pathologies Very rare Palpitations, heart failure, myocardial infarction.
Vascular pathologies Very rare Arterial hypertension, vasculitis.
Gastrointestinal disorders Common Gastro-intestinal disorders, such as heartburn, abdominal pain, nausea, dyspepsia, vomiting, flatulence, diarrhea, constipation, slight gastrointestinal blood loss which in exceptional cases lead to anemia.
Uncommon Gastrointestinal ulcer with potential for bleeding and perforation. Ulcerative stomatitis, worsening of colitis and Crohn's disease (see section 4.4), gastritis.
Very rare Esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures. If you feel severe pain in the upper abdomen or if melaena or haematemesis occurs, you are advised to inform your doctor immediately and stop taking the medicine.
Hepatobiliary disorders Very rare Hepatic dysfunction, liver damage, especially in case of prolonged therapy, liver failure, acute hepatitis.
Skin and subcutaneous tissue disorders Uncommon Several skin rashes.
Very rare Bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia. In exceptional cases, severe skin and soft tissue infections can occur in chickenpox infection (see also "Infections and Infestations").
Not knownDrug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Reactions of photosensitivity.
Renal and urinary disorders Rare Renal tissue damage (papillary necrosis) and elevated uric acid concentrations in the blood may also be observed rarely.
Very rare Formation of edema, especially in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. Kidney function should be checked regularly.

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 reactions Reporting 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-re action-adverse.

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 even after using 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 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. Senior citizens Elderly 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 perforation Gastrointestinal 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). Skin reactions Serious 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. 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. So far, it has not been possible to exclude that NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use BuscofenAct soft capsules in the course of chickenpox. Cardiovascular and cerebrovascular effects Caution 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 precautions Severe 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. 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.

Pregnancy and breastfeeding

Pregnancy Inhibition 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 by less than 1%, down to about 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 administered 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 time Ibuprofen 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. Fertility There 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.

Expiry and retention

This medicinal product does not require any special storage temperatures.

Interactions with other drugs

Concomitant use of ibuprofen with: Possible effects:
Other NSAIDs, including salicylates Concomitant administration of several NSAIDs may increase the risk of gastrointestinal bleeding and ulcers due to a synergistic effect. Therefore, concomitant use of ibuprofen with other NSAIDs should be avoided (see section 4.4).
Digoxin Concomitant use of BuscofenAct soft capsules with digoxin-containing drugs may increase serum digoxin levels. Usually, if digoxin is used correctly (for up to 4 days) it is not necessary to check its serum levels.
Corticosteroids Corticosteroids may increase the risk of adverse reactions, particularly of the gastrointestinal tract (gastrointestinal bleeding or ulceration) (see section 4.4).
Antiplatelet agents Increased risk of gastrointestinal bleeding (see section 4.4).
Acetylsalicylic acid Concomitant 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 extrapolation of these data to 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).
Anticoagulants NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).
Phenytoin Concomitant use of BuscofenAct and phenytoin preparations may increase serum phenytoin levels. Usually, if used correctly (for up to 4 days) it is not necessary to check serum phenytoin levels.
Selective Serotonin Reuptake Inhibitors (SSRIs) Increased risk of gastrointestinal bleeding (see section 4.4).
Lithium Concomitant use of BuscofenAct with lithium preparations may increase serum lithium levels. Usually, if used correctly (for up to 4 days) it is not necessary to check serum lithium levels.
Probenecid and sulfinpyrazone Drugs containing probenecid and sulfinpyrazone can delay the elimination of ibuprofen.
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 (especially dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor, a beta-blocker or angiotensin II antagonists and agents that inhibit cyclo-oxygenase may result in further worsening of renal function, including possible acute renal failure, usually reversible. Therefore, these combinations should be administered with caution especially in elderly patients. Patients should be adequately hydrated and renal function monitoring should be considered at the initiation of concomitant therapy and on a periodic basis thereafter.
Potassium-sparing diuretics Concomitant intake of BuscofenAct and potassium-sparing diuretics can lead to hyperkalaemia.
Methotrexate BuscofenAct administered within 24 hours before or after taking methotrexate can increase its concentrations and therefore its toxicity.
Ciclosporine The risk of cyclosporine-induced kidney damage may be increased by the concomitant use of some NSAIDs. This effect cannot be excluded if cyclosporine and ibuprofen are taken at the same time.
Tacrolimus The risk of nephrotoxicity increases with concomitant administration of ibuprofen and tacrolimus.
Zidovudine In case of concomitant administration of ibuprofen and zidovudine, there is evidence of an increased risk of haemarthroses and hematomas in HIV positive haemophiliacs.
Sulfonylureas Clinical research has shown that there are interactions between non-steroidal anti-inflammatory drugs and antidiabetic drugs (sulphonylureas). Although interactions between ibuprofen and sulphonylureas have not been described so far, it is advisable to monitor blood glucose when these two drugs are used concomitantly.
Quinolone antibiotics CYP2C9 inhibitors Mifepristone Animal studies indicate that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S (+) - ibuprofen was observed from approximately 80% at 100%. Dose reduction of ibuprofen should be considered when strong inhibitors of CYP2C9 are administered concomitantly, particularly when high doses of ibuprofen are administered with voriconazole and fluconazole. NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs may reduce the effect of mifepristone.

Overdose

Symptoms in case of overdose Symptoms 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 overdose There 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. 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

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