Buscofen 12 Soft Capsules 200mg

Buscofen 12 Soft Capsules is a drug based on ibuprofen (200 mg per capsule), an active ingredient belonging to the category of nonsteroidal anti-inflammatory drugs (NSAIDs), indicated for the treatment of pain of various origins . It is particularly effective for relieving pain related to conditions such as menstrual pain , headache , toothache , neuralgia , and osteoarticular and muscular pain . Thanks to its formulation in soft capsules , it is rapidly absorbed by the body, offering faster relief than other solid formulations.

Buscofen 12 Soft Capsules is indicated for the symptomatic treatment of mild to moderate pain, including:

• Menstrual cramps (dysmenorrhea);

• Heachache ;

• Toothache ;

• Neuralgia ;

• Muscle and joint pain (such as lumbago, back pain and arthralgia);

• Rheumatic and inflammatory pain of musculoskeletal origin.

ACTIVE INGREDIENTS

Active ingredients contained in Buscofen 12 Soft Capsules 200mg - What is the active ingredient of Buscofen 12 Soft Capsules 200mg?

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

EXCIPIENTS

Composition of Buscofen 12 Soft Capsules 200mg - What does Buscofen 12 Soft Capsules 200mg contain?

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

DIRECTIONS

Therapeutic indications Buscofen 12 Soft Capsules 200mg - Why is Buscofen 12 Soft Capsules 200mg used? What is it used for?

Pain of various origins and natures (menstrual pain, headache, toothache, neuralgia, osteoarticular and muscular pain).

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Buscofen 12 Soft Capsules 200mg - When should Buscofen 12 Soft Capsules 200mg not be used?

Hypersensitivity to the active substance or to any of the excipients. Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis, angioedema and/or asthma. Severe hepatic insufficiency. Severe renal insufficiency (glomerular filtration rate less than 30 ml/min). Severe cardiac insufficiency (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 clinical conditions that determine an increased tendency to bleeding. In conjunction with surgical procedures (including dental operations). Subjects who have undergone significant fluid loss (through vomiting, diarrhoea or insufficient fluid intake). During the third trimester of pregnancy (see section 4.6). Children under 12 years of age.

DOSAGE

Quantity and method of taking Buscofen 12 Soft Capsules 200mg - How to take Buscofen 12 Soft Capsules 200mg?

Do not administer to children under 12 years of age. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration of treatment 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 on a full stomach. However, do not exceed the dose of 1200 mg (6 tablets) per day. Do not exceed the recommended doses. If the use of the medicine is necessary for more than 3 days in adolescents, or in the event of worsening of symptoms, a doctor should be consulted. Elderly: elderly patients should stick to the minimum doses indicated. Patients with renal insufficiency: in the presence of renal insufficiency, elimination may 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 on a full stomach. Do not exceed the dose of 1200 mg (6 soft capsules) per day. Do not exceed the recommended doses. If the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of the symptoms, a doctor must be consulted. Elderly: elderly patients must stick to the minimum doses indicated. Patients with renal insufficiency: in the presence of renal insufficiency, elimination may be reduced and the dosage must be adjusted accordingly. Buscofen must not be used for more than 7 days. If higher doses are necessary or if a more prolonged treatment is required, then it is necessary to contact your doctor. The coated tablets and soft capsules must be swallowed without chewing, preferably with a little water. It is recommended to take them during or after meals, especially for people with gastric disorders.

CONSERVATION

Storage Buscofen 12 Soft Capsules 200mg - How to store Buscofen 12 Soft Capsules 200mg?

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

WARNINGS

Warnings Buscofen 12 Soft Capsules 200mg - About Buscofen 12 Soft Capsules 200mg it is important to know that:

The use of Buscofen with concomitant NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors, should be avoided due to an increased risk of ulceration or bleeding (see section 4.5). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks). Paediatric population: There is a risk of impaired renal function in dehydrated adolescents. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest dose available. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients who are taking low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be advised 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 anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving Buscofen, the treatment should be withdrawn. NSAIDs should be given 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 advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trials suggest that 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). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic 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, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required. Severe 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 highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in connection with medicinal products containing ibuprofen. Treatment with Buscofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Buscofen may mask the symptoms of infection, which may delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of varicella. When Buscofen is administered for the relief of infection-related fever or pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Renal effects: Caution should be exercised in patients with considerable dehydration when initiating treatment with ibuprofen.

INTERACTIONS

Interactions Buscofen 12 Soft Capsules 200mg - Which medicines or foods can modify the effect of Buscofen 12 Soft Capsules 200mg?'

Ibuprofen (like other NSAIDs) should be used with caution in association with: corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4); anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin (see section 4.4). It is advisable to monitor patients treated with coumarins; acetylsalicylic acid and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). The concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased undesirable effects. Experimental data suggest that ibuprofen may competitively inhibit low dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. 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 clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). It is however advisable not to combine 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 may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter; lithium: concomitant administration of lithium and NSAIDs causes an increase in lithium levels in the blood due to reduced elimination, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithium levels in order to adapt the lithium dosage during concomitant treatment with ibuprofen; methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce its clearance, resulting in an increased risk of toxicity; aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides; cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce the glomerular filtration rate and increase plasma levels of cardiac glycosides; phenytoin: NSAIDs may lead to an increase in plasma concentrations of phenytoin; cholestyramine: concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown; ciclosporin: increased 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); herbal extracts: Ginkgo Biloba may increase the risk of bleeding in association with NSAIDs; mifepristone: due to the antiprostaglandin properties of NSAIDs, a decrease in the efficacy of the medicinal product may theoretically occur. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of the medicinal product on pregnancy termination; quinolone antibiotics: animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions; sulfonylureas: NSAIDs may increase sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas who were taking ibuprofen; tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus; zidovudine: increased risk of haematotoxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-infected haemophiliac patients receiving concomitant treatment with zidovudine and other NSAIDs; ritonavir: possible increase in the concentration of NSAIDs; probenecid: slows the excretion of NSAIDs with possible increase in their plasma concentrations; sulfinpyrazone: may 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 by approximately 80% to 100% was observed. A reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are co-administered, particularly when high doses of ibuprofen are administered with voriconazole and fluconazole.

SIDE EFFECTS

Like all medicines, Buscofen 12 Soft Capsules 200 mg can cause side effects - What are the side effects of Buscofen 12 Soft Capsules 200mg?

The undesirable 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, perforation or gastrointestinal 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, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. 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 rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular disorders: Oedema and fatigue, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Other adverse events reported less frequently and for which causality has not necessarily been established include: Blood and lymphatic system disorders: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Psychiatric disorders: insomnia, anxiety, depression, confusional state, hallucinations. Nervous system disorders: headache, paraesthesia, dizziness, somnolence, optic neuritis. Infections and infestations: aseptic rhinitis and 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, apnoea. Eye disorders: rare cases of ocular alteration resulting in visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders: impaired 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), photosensitivity reactions and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) (frequency not known), acute generalized exanthematous pustulosis (AGEP) (frequency not known). Renal and urinary disorders: impaired 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 of suspected adverse reactions that occur after authorisation 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Buscofen 12 Soft Capsules 200mg.

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the 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 increases from less than 1%, up 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 result in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If 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 may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time and antiaggregant effect which may 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. Breastfeeding: in the few studies available to date, NSAIDs may be found in breast milk in very low concentrations. NSAIDs should, if possible, 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 have difficulties conceiving or who are undergoing investigation of fertility, discontinuation of ibuprofen should be considered.