Buscofen 200 mg - pain reliever 12 soft capsuless

Product Description

Non-steroidal analgesic, anti-inflammatory, antirheumatic drug based on ibuprofen, useful for calming pain of various kinds.

Indications

What is Buscofen used for? This drug is used to reduce pain that can have various origins. In particular, Buscofen soft capsules act on:

• menstrual pain;
• headache;
• toothache;
• neuralgia;
• muscle pain;
• osteoarticular pain.

Once ingested, how long does it take for Buscofen capsules to take effect? ​​The active ingredient in Buscofen is ibuprofen which, in this drug, is contained in a liquid solution: in this way it is more easily absorbed. Easily absorbed by the body and acts quickly on pain.

Dosage and Directions for Use

Buscofen soft capsules can be taken according to the following dosage:
Adults and adolescents over 12 years of age can take 1 - 2 capsules 2 - 3 times a day. Buscofen capsules should be swallowed with water and should not be chewed. It is not recommended to take Buscofen on an empty stomach. Do not exceed a dose of 6 capsules per day. The medicine should not be used for more than 7 days in adults and for more than 3 days in adolescents.
If the medicine is intended for use in the elderly, they must adhere to the minimum doses indicated.

Composition

Each Buscofen softgel tablet contains:

Active ingredient

Ibuprofen 200 mg

Excipients

Macrogol 600, potassium hydroxide, purified water, gelatin, partially dehydrated liquid sorbitol.

Contraindications

Below we list the conditions in which Buscofen should not be used:

• Hypersensitivity to the active ingredient or to any of the excipients.
• Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal 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 medical conditions that increase the bleeding tendency.
• In conjunction with surgery (including dental procedures).
• Subjects who have suffered significant fluid losses (through vomiting, diarrhea, or insufficient fluid intake).
• During the third trimester of pregnancy.
• Children under 12 years of age.

Storage

Buscofen soft capsules do not require any special storage conditions.

Warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms.
Avoid using the drug in conjunction with other NSAIDs, due to an increased risk of ulceration or bleeding. Ibuprofen may mask signs of infection.
In dehydrated adolescents, there is a risk of altered renal function. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. These patients should start treatment on the lowest dose available. For these patients, and also for patients taking low-dose aspirin or other drugs that may increase the risk of gastrointestinal events, consider the concomitant use of protective agents. Caution should be exercised in patients receiving concomitant medications that could increase the risk of ulceration or bleeding. If gastrointestinal bleeding or ulceration occurs in patients receiving the drug, discontinue the drug. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease, as these conditions may be exacerbated.
Use with caution in patients with coagulation defects.
Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure, as these conditions may be exacerbated. Fluid retention and edema have been reported in association with NSAID treatment.
Use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events.
Overall, epidemiological studies do not suggest that low-dose ibuprofen is 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 consideration should be given before initiating long-term treatment in patients with risk factors for cardiovascular events.
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. Patients appear to be at highest risk early in the course of therapy; the onset of the reaction occurs in most cases within the first month of treatment; discontinue treatment.
When initiating treatment with ibuprofen, caution should be exercised in patients with significant dehydration.
Long-term use of ibuprofen has led to renal papillary necrosis and other pathological renal changes. In general, the habitual use of analgesics can lead to permanent renal damage with the risk of renal failure. Renal toxicity has been observed in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. The administration of NSAIDs in these patients may be detrimental. NSAIDs may cause a dose-dependent reduction in prostaglandin formation and, as a secondary effect, renal blood flow. This can quickly lead to renal failure. Patients most at risk of these reactions are those with reduced renal function, heart failure, liver dysfunction, the elderly, and all those taking diuretics and ACE inhibitors.
Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. In case of prolonged use, monitor renal function, particularly in cases of diffuse lupus erythematosus.
Prescribe the drug with caution in patients with bronchial asthma or current or previous allergic diseases because bronchospasm may occur.
The same applies to those who have experienced bronchospasm after using aspirin or other NSAIDs.
Analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious, even in subjects not previously exposed to these types of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after using other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs, and in subjects with bronchial hyperreactivity (asthma), nasal polyps, or previous episodes of angioedema. Use caution when treating patients with severely reduced cardiac, hepatic, or renal function; periodic monitoring of clinical and laboratory parameters is recommended, especially during prolonged treatment.
Ibuprofen may cause an increase in serum concentrations of aminotransferases and other markers of liver function in patients without previous evidence of impaired liver function. These usually include relatively modest and transient increases compared to the normal range. If these abnormalities are clinically significant or persistent, discontinue treatment and monitor the response following discontinuation. Ibuprofen may cause sodium, potassium, and water retention in patients who have previously shown no signs of renal dysfunction due to its effect on renal perfusion. Discontinuation of treatment is usually followed by a rapid return to pre-treatment renal function. Ibuprofen may also interfere with the natriuretic effects of diuretics. Ibuprofen may mask symptoms of infection. Ibuprofen can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Aseptic meningitis has been observed rarely in patients receiving ibuprofen. Although it is more common in patients with renal impairment, it is more likely that aseptic meningitis may occur. It is likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, but has also been observed in patients without concomitant chronic diseases. Periodic ophthalmological checks are recommended in case of prolonged treatment.

Buscofen and Fertility

The use of the drug is not recommended in women intending to become pregnant: ibuprofen, in fact, may compromise female fertility. Discontinue use in women who have difficulty conceiving or who are undergoing fertility investigations.

Buscofen in Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after 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 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. Additionally, 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 trimesters of pregnancy, ibuprofen should not be administered unless clearly necessary. If used by women attempting to conceive or during the first and second trimesters 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 can be found in breast milk in very low concentrations. NSAIDs, if possible, should be avoided during breastfeeding.

Interactions

Ibuprofen (like other NSAIDs) should be used with caution in combination with:

• corticosteroids: increased risk of gastrointestinal ulceration or bleeding;
• anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin. Patients receiving coumarins should be monitored;
• acetylsalicylic acid and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract.

The concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse 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 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.

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 nephrotoxicity associated with NSAIDs. In some patients with compromised renal function (e.g. dehydrated or elderly patients), the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may increase the risk of nephrotoxicity. lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking the drug 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: the concomitant administration of lithium and NSAIDs causes increased blood lithium levels due to reduced elimination, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor blood 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 heart 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 increase the risk of toxicity. reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown;
• cyclosporines: increase the 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 the potential additive effect;
• plant 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 drug may theoretically occur. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely affect the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of the drug 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 be at increased risk of developing convulsions;
• Sulfonylureas: NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycemia 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 increase the risk of haemarthrosis and haematoma in HIV-infected haemophiliac patients receiving concomitant treatment with zidovudine and other NSAIDs.
• delay the excretion of ibuprofen;
• CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen of approximately 80% to 100% was observed. Consideration should be given to reducing the ibuprofen dose when strong CYP2C9 inhibitors are administered concomitantly, particularly when high doses of ibuprofen are administered with voriconazole and fluconazole.

Undesirable effects

The undesirable effects observed with ibuprofen are generally common to other analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs.

• Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Gastrointestinal perforation has been observed rarely with the use of ibuprofen. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. 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, pruritus, urticaria, purpura, angioedema and, more rarely,
  d) skin disorders, including various types of rash, pruritus, urticaria, purpura, angioedema and, more rarely,
  e) skin reactions, including various types of rash, pruritus, urticaria, purpura, angioedema and, more rarely,
  f) skin reactions, including various types of rash, pruritus, urticaria, purpura, angioedema and, more rarely,
  g ... Rarely, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).
• Cardiac and vascular disorders: Edema 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 small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Other adverse events reported less frequently and for which causality has not necessarily been established. Blood and lymphatic system disorders: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia.
• 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.
• 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: altered 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: 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 suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Format

12 soft capsules of 200 mg.