Buscofen 200mg Ibuprofene Analgesico 12 Capsule Molli

NAME
BUSCOFEN

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory and antirheumatic product.

ACTIVE PRINCIPLES
Ibuprofen.

EXCIPIENTS
Coated tablets - blister packs of 20 tablets: corn starch, sodium carboxymethyl starch, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol 6000, talc, titanium dioxide, antifoam emulsion. Soft capsules - blister packs of 12 or 24 capsules: macrogol 600, potassium hydroxide, purified water, gelatin, partially dehydrated liquid sorbitol.

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

CONTRAINDICATIONS / SECONDARY EFFECT
- Hypersensitivity to the active substance or to any of the excipients. - Subjects with hypersensitivity to acetylsalicylic acid or to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), particularly when 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 suffering from blood dyscrasias of unknown origin, from porphyria, from hypertension, from severe uncontrolled coronary insufficiency. - Severe or active peptic ulcer. - History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of proven ulceration or bleeding). - Subjects with clinical conditions that cause an increased tendency to bleed. - In conjunction with surgical interventions (including dental operations). - Subjects who have suffered significant fluid losses (due to vomiting, diarrhea or poor ingestion of fluids). - During the third trimester of pregnancy. - Children under 12 years old.

DOSAGE
Do not administer to children under the age of 12 years. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. >> Coated tablets. Adults and adolescents over 12 years: 1-2 tablets, two - three times a day, preferably on a full stomach. 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 symptoms, the doctor should be consulted. Elderly: Elderly patients should adhere to the minimum doses indicated. Patients with renal insufficiency: in the presence of renal insufficiency the elimination can be reduced and the dosage should be adjusted accordingly. >> Soft capsules. Adults and adolescents over 12 years: 1-2 soft capsules, two - three times a day, preferably full astomach. 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 drug is necessary for more 'than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Elderly: Elderly patients should adhere to the minimum doses indicated. Patients with renal insufficiency: in the presence of renal insufficiency the elimination can be reduced and the dosage should be adjusted accordingly. The drug should not be used for more than 7 days. If higher doses are needed or if more prolonged treatment is required, then it is necessary to contact 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, particularly for people with gastric disorders.

STORAGE
Coated tablets - blister packs of 20 tablets: store at room temperature. Soft capsules - blister packs of 12 or 24 capsules: no storage conditions.

WARNINGS
Avoid using the drug concomitantly with other NSAIDs, due to an increased risk of ulceration or bleeding. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms. Ibuprofen can mask signs of infection. There is a risk of impaired renal function in dehydrated adolescents. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation which can be fatal have been reported. These patients should start treatment with the lowest dose available. For these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events, consider concomitant use of protective agents. Caution should be exercised by patients taking concomitant medications that could increase the risk of ulceration or bleeding. When gastrointestinal bleeding or ulceration occurs in patients taking the drug discontinue treatment. Administer NSAIDs with caution to patients with a history of gastrointestinal disease as these conditions may be exacerbated. Use with caution in patients with coagulation defects. Adequate monitoring and appropriate instructions are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. The use of ibuprofen, particularly at high doses (2400 mg per day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events. In general, epidemiological studies do not suggest that low doses of ibuprofen are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular events. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs. 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; stop treatment. Caution should be exercised in patients with considerable dehydration when starting treatment with ibuprofen. Long-term use of ibuprofen has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics can lead to permanent renal lesions with the risk of onset of renal failure. Renal toxicity has been reported in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. Administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, in renal blood flow. This can quickly lead to kidney failure. Patients most at risk of these reactions are those with impaired renal 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 of the pretreatment state. In case of prolonged use, monitor renal function particularly in case of diffuse lupus erythematosus. Prescribe the drug with caution in patients with bronchial asthma or current or previous allergic diseases because bronchospasm may arise. The same applies to those subjects who have experienced bronchospasm after the use of aspirin or other NSAIDs. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious, 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 these 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. Use caution when treating patients with severely impaired cardiac, hepatic or renal function; resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. Ibuprofen may lead to an increase in serum concentrations of aminotransferases, and other markers of liver function, in patients with no previous evidence of liver function disturbance. These usually include relatively modest and transient increases from the normal range. If these abnormalities are clinically significant or if they are persistent then discontinue treatment and monitor response following treatment discontinuation. Ibuprofen may cause sodium, potassium and water retention in patients who have not previously shown signs of renal disorders due to the effect on renal perfusion. Discontinuation of treatment is usually followed by a rapid return to pre-treatment renal function status. Ibuprofen can also interfere with the natriuretic effects of diuretics. Ibuprofen can mask symptoms of an infection. Ibuprofen can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. On rare occasions, aseptic meningitis has been observed in patients receiving ibuprofen. Although it is more likely to occur in patients with systemic lupusithematosus and related connective tissue disorders, it has also been observed in patients who did not have concomitant chronic diseases. It is recommended, in case of prolonged treatments, to carry out periodic ophthalmological checks. The use of the drug is not recommended in women who intend to become pregnant. Discontinue in women who have fertility problems 'or who are undergoing investigation of fertility'.

INTERACTIONS
Ibuprofen (like other NSAIDs) should be used with caution in combination with: - corticosteroids: increased risk of gastrointestinal ulceration or bleeding; - Anticoagulants: NSAIDs can increase the effects of anticoagulants such as warfarin. It is advisable to monitor patients being treated with coumarins; - acetylsalicylic acid and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract. 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 the 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 relevant clinical effects are considered likely following occasional use of ibuprofen. However, it is advisable not to combine ibuprofen with aspirin or other NSAIDs; - antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding; - diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may 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 the cyclo-oxygenase system may lead to further deterioration of renal function, which includes possible acute renal failure, usually reversible. These interactions should be considered in patients taking the medicinal product 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 combination is necessary, monitor lithemia in order to adapt the lithium dosage during concomitant treatment with ibuprofen. - methotrexate: NSAIDs can inhibit the tubular secretion of dimethotrexate 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 rate of glomerular filtration and increase plasma levels of cardiac glycosides; - phenytoin: NSAIDs may 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; - ciclosporins: increase risk of nephrotoxicity with NSAIDs. - COX-2 inhibitors and other NSAIDs: concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effect; - plant extracts: Ginkgo Biloba can increase the risk of bleeding in association with NSAIDs; - mifepristone: due to the antiprostaglandin properties of NSAIDs, it can theoretically lead to a decrease in the efficacy of the drug. 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; - 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; - sulfonylureas: NSAIDs can increase the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas 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 concomitantly treated with zidovudine and other NSAIDs. - ritonavir: an increase in the concentration of NSAIDs is possible; - probenecid: slows down the excretion of NSAIDs with possible increase in their plasma concentrations; - sulfinpyrazone: can 'delay the excretion of ibuprofen; - CYP2C9 inhibitors: 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 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 and fluconazole.

SIDE EFFECTS
The side effects seen 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. Gastrointestinal perforation with the use of ibuprofen has been rarely observed. Following administration have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's hemorbo. Gastritis was 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, even severe, bronchospasm or dyspnoea or c) skin disorders, including various types of rash, itchy urticaria, purpura , angioedema and, more rarely, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and evascular 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 modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Other adverse events reported less frequently and for which a causality has not necessarily been established. Disorders of the blood and lymphatic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders: insomnia, anxiety, depression, confusion, hallucinations. Nervous system disorders: headache, paraesthesia, dizziness, somnolence, optic neuritis. Infections and infestations: rhinitis and meningitiseptic (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck rigidity, headache, nausea, vomiting, fever or disorientation. Respiratory, thoracic and mediastinal disorders: bronchospasm, dyspnoea, apnea. Eye disorders: rare cases of ocular alteration with consequent visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders: impaired hearing, tinnitus, dizziness. 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. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. When used by women in the process of conception or during the first and second trimester of pregnancy, the dose and duration of treatment should be respectively the lowest and the shortest possible. During 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 oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. In the few studies available to date, NSAIDs can be found in breast milk in very low concentrations. If possible, NSAIDs should be avoided during breastfeeding. The use of ibuprofen can compromise female fertility and is not recommended in women waiting for conception. In women who have difficulty conceiving or who are being investigated on fertility, discontinuation of treatment with ibuprofen should be considered.