Buscofen 12 Soft Capsules 200mg

Pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscle pain).

Therapeutic indications

Pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscle pain).

Dosage and method of use

Do not administer to children under 12 years of age. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration necessary to control symptoms (see section 4.4). Coated tablets Adults and adolescents over 12 years 1-2 tablets, two - three times a day, preferably with food. However, do not exceed the dose of 1200 mg (6 tablets) per day. Do not exceed the recommended dose. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of the symptoms, the doctor should be consulted. Elderly Elderly patients should comply with the minimum doses indicated. Patients with renal insufficiency In the presence of renal insufficiency, elimination may be reduced and the dosage adjusted accordingly. Soft capsules Adults and adolescents over 12 years 1–2 soft capsules, two – three times a day, preferably with food. However, do not exceed the dose of 1200 mg (6 soft capsules) per day. Do not exceed the recommended dose. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of the symptoms, the doctor should be consulted. Elderly Elderly patients should comply with the minimum doses indicated. Patients with renal insufficiency In the presence of renal insufficiency, elimination may be reduced and the dosage adjusted accordingly. Buscofen should not be used for more than 7 days. If higher doses are required or if longer treatment is required, then you should consult your doctor. The coated tablets and soft capsules should be swallowed without chewing, preferably with some water. It is recommended to take it during or after meals, especially for people with gastric disorders.

Contraindications

– Hypersensitivity to the active substance or to any of the excipients. – Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when the hypersensitivity is associated with nasal polyposis, angioedema and/or asthma. – Severe hepatic insufficiency. – Severe renal insufficiency (glomerural filtration less than 30 ml/min). – Severe heart failure (NYHA class IV). – Subjects with blood dyscrasias of unknown origin, porphyria, hypertension, severe uncontrolled coronary insufficiency. – Severe or active peptic ulcer. – History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). – Subjects with medical conditions that result in an increased bleeding tendency. – In conjunction with surgery (including dental operations). – Subjects who have experienced significant fluid loss (from vomiting, diarrhea, or poor fluid intake). – During the third trimester of pregnancy (see par. 4.6). - Children under 12 years old.

Side effects

The side effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. Gastrointestinal disorders : The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Gastrointestinal perforation with the use of ibuprofen has been observed rarely. After administration of Buscofen the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, epigastric pain, gastric heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Gastritis has been observed less frequently. Pancreatitis has also been observed very rarely. Immune system disorders : Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of a) non-specific allergic reaction and anaphylaxis, b) respiratory tract reactions including asthma, including severe asthma, bronchospasm or dyspnoea or c) skin disorders including various types of rash, itching, urticaria, purpura , angioedema and, more rarely, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular disorders : Edema and fatigue, 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/day), may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Other less frequently reported adverse events for which causality has not necessarily been established include: Blood and lymphatic system disorders : leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anaemia. Psychiatric disorders : insomnia, anxiety, depression, confusional state, hallucinations. Nervous system disorders : headache, paresthesia, dizziness, somnolence, optic neuritis. Infections and infestations : rhinitis and aseptic meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4). Respiratory, thoracic and mediastinal disorders : bronchospasm, dyspnoea, apnea. Eye disorders : rare cases of ocular alteration with consequent visual disturbances, toxic optic neuropathy. Pathologies of the ear and labyrinth : compromised hearing, tinnitus, vertigo. Hepatobiliary disorders : impaired liver function, liver failure, hepatitis and jaundice. Skin and subcutaneous tissue disorders : Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), and photosensitivity reactions. Renal and urinary disorders : impairment of renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. General disorders and administration site conditions : malaise, fatigue. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at "www.agenziafarmaco.gov.it/it/responsabili".

Special warnings

The concomitant use of Buscofen with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided due to an increased risk of ulceration or bleeding (see section 4.5). Undesirable effects may be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see sections on gastrointestinal and cardiovascular risks below). Like other NSAIDs, ibuprofen can mask signs of infection. Pediatric population There is a risk of impairment of renal function in dehydrated adolescents. Elderly Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). Gastrointestinal haemorrhage, ulceration and perforation Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported at any time with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased NSAID doses. These patients should start treatment on the lowest available dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs which 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 gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be exercised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as acetylsalicylic acid (see section 4.5 ). When gastrointestinal bleeding or ulceration occurs in patients taking Buscofen, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Use with caution in patients with coagulation defects. Cardiovascular and cerebrovascular effects Appropriate monitoring and appropriate instructions are required in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and edema have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is 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 of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, cigarette smoking), especially if high doses are required (2400 mg/ day) of ibuprofen. Dermatological effects 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). In the early stages of therapy, patients appear to be at higher risk; the onset of the reaction occurs in most cases within the first month of treatment. Treatment with Buscofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Renal effects When initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy). Renal toxicity has been reported in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may lead to a dose-dependent reduction in prostaglandin formation and, as a secondary effect, in renal blood flow. This can quickly lead to renal failure. Patients most at risk of these reactions are those with impaired renal function, heart failure, liver dysfunction, the elderly and all patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery of the pretreatment state. In case of prolonged use monitor renal function especially in case of widespread lupus erythematosus. Respiratory disorders Buscofen should be prescribed with caution in patients with bronchial asthma or current or previous allergic diseases because bronchospasm could arise. The same applies to those subjects who have experienced bronchospasm after the use of aspirin or other NSAIDs. Hypersensitivity reactions Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have presented such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema ( see par. 4.2 and 4.8). Reduced cardiac, renal and hepatic function Particular caution should be taken when treating patients with severely reduced cardiac, hepatic or renal function. In such patients it is appropriate to resort to periodic monitoring of clinical and laboratory parameters, especially in the case of prolonged treatment. Ibuprofen can give an increase in serum concentrations of aminotransferases, and other markers of liver function, in patients with no previous evidence of liver function disorders. These usually include relatively small and transient increases from the normal range. If these abnormalities are clinically significant or if they are persistent then ibuprofen treatment should be discontinued and response following treatment discontinuation monitored. Ibuprofen can cause retention of sodium, potassium and water in patients who have previously shown no signs of renal disorders, due to the effect on renal perfusion. This may cause edema or cause acute decompensation of cardiac function or hypertension in susceptible individuals. Patients at greatest risk of manifest renal decompensation are elderly people, dehydrated or hypovolaemic patients, patients with congestive heart failure, cirrhosis, nephrotic syndrome, renal insufficiency, those on diuretics and patients who have recently undergone surgery. Treatment discontinuation is usually followed by a rapid return to pre-treatment renal function. Ibuprofen can also interfere with the natriuretic effects of diuretics. Ibuprofen may mask symptoms (fever, pain, swelling) of an infection. Haematological effects Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Aseptic meningitis Aseptic meningitis has been observed on rare occasions in patients receiving ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients who did not have any underlying chronic disease (see section 4.8). Since ocular alterations have been detected during animal studies with non-steroidal anti-inflammatory drugs, it is recommended, in the case of prolonged treatments, to carry out periodic ophthalmological checks. The use of Buscofen, like any other prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women who intend to start a pregnancy (see also section 4.6). Buscofen administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first period of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. When used by women attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: – possible prolongation of bleeding time and antiplatelet effect which can occur even at very low doses; – inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Breastfeeding In the few studies available to date, NSAIDs can be found in breast milk in very low concentrations. NSAIDs, if possible, should be avoided during breastfeeding. Fertility The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who are having difficulty conceiving or who are under investigation of fertility, discontinuation of ibuprofen treatment should be considered.

Expiration and conservation

Coated tablets - blister of 20 tablets Store at room temperature. Soft capsules - blisters of 12 or 24 capsules No storage conditions.

Interactions with other drugs

Ibuprofen (like other NSAIDs) should be used with caution in combination with: – corticosteroids : increased risk of gastrointestinal ulceration or bleeding (see section 4.4); – anticoagulants : NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4). It is advisable to monitor patients being treated with coumarins; - acetylsalicylic acid and other NSAIDs : these substances can increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effects are considered likely for occasional ibuprofen use (see section 5.1). However, it is advisable not to associate ibuprofen with aspirin or other NSAIDs; – antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) : increased risk of gastrointestinal bleeding (see section 4.4); – diuretics, ACE inhibitors and angiotensin II antagonists : NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated or elderly patients) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclo-oxygenase system may lead to further deterioration of renal function. renal, which includes possible acute renal failure, usually reversible. These interactions should be considered in patients taking Buscofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, this combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter; – lithium : the simultaneous administration of lithium and NSAIDs causes an increase in the levels of lithium in the blood due to reduced elimination, with the possibility of reaching the toxic threshold. If this association is necessary, monitor lithium levels in order to adjust the dosage of lithium during simultaneous treatment with ibuprofen. – methotrexate : NSAIDs can inhibit the tubular secretion of methotrexate and reduce its clearance with a consequent increase in the risk of toxicity; – aminoglycosides : NSAIDs can decrease the excretion of aminoglycosides; – cardiac glycosides : NSAIDs can exacerbate heart failure, reduce the glomerular filtration rate and increase plasma levels of cardiac glycosides; – phenytoin : NSAIDs can lead to an increase in plasma concentrations of phenytoin; – cholestyramine : the concomitant administration of ibuprofen and cholestyramine can reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is not known; – cyclosporine : increase the risk of nephrotoxicity with NSAIDs. – COX-2 inhibitors and other NSAIDs : concomitant use with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential additive effect (see section 4.4); – plant extracts : Ginkgo Biloba can increase the risk of bleeding in combination with NSAIDs; – mifepristone : due to the antiprostaglandin properties of NSAIDs, a decrease in the efficacy of the medicine can theoretically occur. Limited evidence suggests that co-administration of NSAIDs on prostaglandin dosing day does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the medicinal product's clinical efficacy on pregnancy termination; Quinolone antibiotics : Animal 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; – sulphonylureas : NSAIDs can increase the effect of sulphonylureas. Rare cases of hypoglycemia have been reported in patients treated with sulphonylureas taking ibuprofen; – tacrolimus : possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus; - zidovudine : increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-infected haemophiliac patients receiving concomitant treatment with zidovudine and other NSAIDs. – ritonavir : an increase in the concentration of NSAIDs is possible; – probenecid : slows down the excretion of NSAIDs with a possible increase in their plasma concentrations; – sulfinpyrazone : can delay the excretion of ibuprofen; – CYP2C9 inhibitors : Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase the exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased S(+)-ibuprofen exposure by approximately 80% to 100% was observed. Consideration should be given to reducing the dose of ibuprofen when co-administering strong CYP2C9 inhibitors, especially when high doses of ibuprofen are co-administered with voriconazole and fluconazole.

Overdose

Toxicity Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. 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 greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported overdose symptoms include nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and unconsciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, excitation, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Treatment There is no specific antidote for ibuprofen overdose. Symptomatic and supportive treatment is therefore indicated in the event of an overdose. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Within 1 hour of ingestion of a potentially toxic amount, administration of activated charcoal should be considered. Alternatively, gastric lavage should be considered within 1 hour of ingestion of a potentially life-threatening overdose in adults. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient should be observed for at least four hours following the ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. For more information, contact your local poison control center.

Active principles

Coated tablets : 1 tablet contains: 200 mg ibuprofen Soft gelatin capsules : 1 soft capsule contains: 200 mg ibuprofen For the full list of excipients, see section 6.1.

Excipients

Coated tablets - blister of 20 tablets Corn starch, sodium carboxymethyl starch, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, talc, titanium dioxide, antifoam emulsion. Soft capsules - blister of 12 or 24 capsules Macrogol 600, potassium hydroxide, purified water, gelatin, partially dehydrated liquid sorbitol.