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Treatment of pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscle pain).
1. Therapeutic indications
Buscofen is used in the treatment of pain of various origins and nature (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscle pain).
2. Dosage and method of use
Buscofen Soft Capsules:
Adults and children over 12 years: 1-2 soft capsules, two-three times a day, preferably on a full stomach.
However, do not exceed the dose of 4 soft capsules per day. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above.
Ibuprofen is contraindicated in cases of hypersensitivity to the components of the product, in patients with hypersensitivity to salicylates or to other anti-inflammatory or antirheumatic agents.
History of gastrointestinal bleeding or perforation related to previous active treatments. History of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure.
Ibuprofen should not be used in patients suffering from blood dyscrasias of unknown origin, from porphyria, from hypertension, from severe uncontrolled coronary insufficiency, with severe alterations in liver or kidney function and in concomitance with surgical interventions (including dental operations), in patients who have suffered significant fluid loss (due to vomiting, diarrhea or low fluid ingestion).
It is contraindicated in children under the age of 12, pregnant and breastfeeding.
Ibuprofen should not be given to patients who have had symptoms of asthma, nasal polyps, angioedema, or urticaria following administration of salicylates or other NSAIDs.
4. Pregnancy and breastfeeding
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was 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. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. 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.
The medicine is contraindicated in breastfeeding.
5. Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
The use of Buscofen should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks).
Elderly: 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: Gastrointestinal bleeding, ulceration and perforation which can be fatal have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events.
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 by patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. 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.
Patients with systemic lupus erythematosus or with various connective tissue disorders have an increased risk of developing aseptic meningitis or hepatitis. Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. Ibuprofen can 'cause 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 modest and transient increases from the normal range. If these abnormalities are clinically significant or persistent then treatment with ibuprofen should be discontinued and the response following treatment discontinuation monitored. Ibuprofen can cause sodium, potassium and water retention in patients who have not previously shown signs of renal disorders, due to the effect on renal perfusion. This can cause edema or cause acute decompensation of cardiac function or hypertension in predisposed individuals.
Patients at increased risk for overt renal failure are elderly people, dehydrated or hypovolaemic patients, patients with congestive heart failure, cirrhosis, nephrotic syndrome, renal failure, those being treated with diuretics, and patients who have recently undergone surgery. 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 (fever, pain, swelling) of an infection. The use of Buscofen, like any other drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women who intend to become pregnant.
The administration of Buscofen should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'. 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 a higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Buscofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity '.
Cardiovascular and cerebrovascular effects: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg / day) and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events ( eg myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen
Active ingredient: ibuprofen 200 mg
Excipients: Macrogol 600, potassium hydroxide, purified water, gelatin, partially dehydrated liquid sorbitol.
Buscofen 24 soft capsules 200mg
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