BUSCOFEN 24CPS MOLLI 200MG

BUSCOFEN 200 MG

active ingredients

Covered tablets: 1 tablet contains: ibuprofen 200 mg Soft jelly capsules: 1 soft capsule contains: ibuprofene 200 mg For the full list of excipients, see the paragraph 6.1.

Excellent

Covered tablets - blister from 20 tablets Corn starch, sodium starch glycolate, 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.

Therapeutic indications

Pain from various origins and nature (menstrual pains, headaches, toothaches, nerves, osteoarticocular and muscle pains).

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients. - Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal polyposes, angioedema and/or asthma. - Severe liver failure. - Severe renal insufficiency (glomeral filtration less than 30 ml/min). - severe heart failure (IV class NYHA). - Subjects with ethical disorders of unknown origin, porphyria, hypertension, severe uncontrolled coronary insufficiency. - Severe or active peptic ulcer. - History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). - Subjects with clinical conditions that determine an increase in the tendency to bleeding. - In conjunction with surgery (including dental operations). - Subjects that have suffered significant liquid losses (for vomiting, diarrhea or poor ingestion of liquids). - During the third quarter of pregnancy (see par. 4.6). - Children under 12.

Population

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 necessary to control symptoms (see section 4.4). Covered tablets Adults and teenagers over 12 years 1-2 tablets, two - three times a day, preferably on a full stomach.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 case of worsening of the symptoms, a doctor should be consulted. Seniors Senior patients must comply with 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. Soft capsules Adults and teenagers 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 should be consulted. Seniors Senior patients must comply with the minimum doses indicated. Patients with renal insufficiency In the presence of kidney failure, elimination can be reduced and posology is therefore appropriate. Buscofen should not be used for more than 7 days. If you need higher doses or if a longer treatment is required, then you should contact your doctor. The coated tablets and soft capsules must be swallowed without chewing, preferably with some water. Intake is recommended during or after meals, especially for people with gastric disorders.

Conservation

Covered tablets - blister from 20 tablets Store at room temperature. Soft capsules - blister pack of 12 or 24 capsules No storage conditions.

Warnings

The use of Buscofen in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors (COX-2), must be avoided due to an increase in the risk of ulceration or bleeding (see par. 4.5). Undesirable effects can be minimized with the use of the lowest effective dose for the shortest duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Pediatric population In dehydrated adolescents there is a risk of alteration of kidney function. Seniors Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Gastrointestinal bleeding, ulceration and drilling During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation have been reported that may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin 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 should be taken into account the concomitant use of protective agents (misoprostol or protonic pump inhibitors) (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly people, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage), especially in the early stages of treatment. Caute should be lent by patients taking medications at the same time that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective inhibitors of reuptake of serotonin (SSRI) or pyastrinic anti-aggregating agents such as acetylsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking Buscofen the treatment must be suspended. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Carefully use in patients with clotting defects. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for 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 modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).Overall, 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 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 in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses (2400 mg/day) of ibuprofen are required. Strict 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 generalized exanthematous pustulosis (AGEP) has been reported in association 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 the symptoms of underlying infections Buscofen can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Buscofen is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if the symptoms persist or worsen. Renal effects When treatment with ibuprofen begins, care should be given to patients with considerable dehydration. Long-term use of ibuprofen, as with other NSAIDs, has led to kidney papillar necrosis and other kidney pathological alterations. In general, the habitual use of analgesics, especially of the associations of different active analgesics, can lead to permanent kidney injuries with risk of kidney failure (nephropathy from analgesics). Renal toxicity has been found in patients where kidney prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, kidney blood flow. This can lead quickly to kidney failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, elderly and all those patients taking diuretics and ACE inhibitors. The suspension of treatment with NSAIDs is usually followed by the recovery of pretreatment. In case of prolonged use, watch the kidney function particularly in case of widespread erythematosum lupus. Respiratory disorders Buscofen should be prescribed with caution in patients with bronchial asthma or allergic diseases in progress or in the past because bronchospasm may occur.The same applies to those subjects who have manifested bronchospasm after the use of aspirin or other NSAIDs. Reactions of hypersensitivity Analgesic, antipyretic, non-steroidal anti-inflammatory reactions can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in individuals not previously exposed to this type of medication. The risk of hypersensitivity reactions after taking ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposi or previous angioedema episodes (see par. 4.2 and 4.8). Reduced heart, kidney and liver function Particular caution should be taken in the treatment of patients with severely reduced heart, liver or kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. Ibuprofen can increase the serious concentrations of aminotransferases, and other markers of liver function, in patients without prior evidence of liver function disorders. These usually include relatively modest and transient increases compared to normal range. If these abnormalities are significant from the clinical point of view or if they are persistent then treatment with ibuprofen should be stopped and the response as a result of the termination of treatment should be monitored. Ibuprofen can cause sodium, potassium and water retention in patients who previously did not show signs of kidney disorders, due to the effect on kidney perfusion. This can cause edema or cause acute breakdown of heart function or hypertension in predisposed subjects. Patients with greater risk of manifest renal breakdown are elderly people, dehydrated or hypovolemic patients, patients with congestive heart failure, cirrhosis, nephrotic syndrome, kidney failure, those in treatment with diuretics and patients who have recently undergone surgery. Treatment interruption is usually followed by a rapid return to the pre-treatment renal function. Ibuprofen can also interfere with the natriuretic effects of diuretics. Ematologic effects Ibuprofen, like other NSAIDs, can inhibit piastrinic aggregation and has given evidence to prolong bleeding time in healthy subjects. Aseptic meningitis On rare occasions, aseptic meningitis has been observed in patients treated with ibuprofen.Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients without concomitant chronic diseases (see section 4.8).Since ocular alterations have been observed in animal studies with non-steroidal anti-inflammatory drugs, periodic ophthalmological checks are recommended in case of prolonged treatment.The use of Buscofen, as with any other drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant (see also section 4.6).The administration of Buscofen should be suspended in women who have fertility problems or who are undergoing investigations of fertility.

Interactions

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 can increase the effects of anticoagulants such as warfarin (see paragraph 4.4). It is appropriate to monitor patients in treatment with cumarinics; - acetylsalicylic acid and other NSAIDs: these substances may increase the risk of adverse reactions to the gastrointestinal tract (see paragraph 4.4). Concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of this data to the clinical situation, the possibility that regular use, long-term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). It is however appropriate not to associate ibuprofen with aspirin or other NSAIDs; - serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see par. 4.4); - diuretics, ACE inhibitors and antagonists of angiotensin II: nSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with impaired kidney function (e.g. dehydrated or elderly patients) co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxidase system may lead to further deterioration of the kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Buscofen in conjunction with ACE inhibitors or angiotensin II antagonists. Therefore, this combination should be administered with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function must be taken into consideration after the start of concomitant therapy and, periodically, from then on; - lithium: simultaneous administration of lithium and NSAID causes increased lithium levels in the blood for reduced elimination, with the possibility of reaching the toxic threshold. If this association is necessary, monitor lithemia in order to adapt lithium posology during the contemporary treatment with ibuprofen; - metotrexato: nSAIDs can inhibit the tubular secretion of metotrexate and reduce its clearance resulting in increased risk of toxicity; - aminoglycosides: nSAIDs may decrease the excretion of aminoglycosides; - heart glycosides: nSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides; - phenytoin: nSAIDs can lead to an increase in plasma concentrations of phenytoin; - colestiramina: the concomitant administration of ibuprofen and chotheramine can reduce the absorption of ibuprofen at the gastrointestinal tract level. However the clinical relevance of such interaction is not known; - cyclosporine: increase risk of nephrotoxicity with NSAIDs. - cOX-2 inhibitors and other FANS: concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided by potential additive effect (see par. 4.4); - plant extracts: Ginkgo Biloba can increase the risk of bleeding in association with NSAIDs; - mifepristone: due to the antiprostaglandiniche properties of the NSAIDs, it can theoretically determine a decrease in the effectiveness of the medicinal product. The limited evidence suggests that co-administration of NSAIDs on the day of administration of prostaglandins does not negatively affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the drug on the interruption of pregnancy; - chinolonic antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Knolones may have an increased risk of developing seizures; - solfaniluree: nSAIDs can increase the effect of sulphur dioxide. Rare cases of hypoglycemia were reported in patients treated with sulphanluree taking ibuprofen; - tacrolimus: possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus; - zidovudina: increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increase in the risk of hematoma and hematoma in hemophiliac patients with HIV in contemporary treatment with zidovudine and other NSAIDs; - ritonavir: an increase in the concentration of NSAIDs; - probenecid: slows down the excretion of NSAs with possible increase in their plasma concentrations; - on the ground : can delay the excretion of ibuprofen; - cYP2C9 inhibitors: concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. You should consider reducing the dose of ibuprofen when concurrently administering strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole and fluconazole.

Effects

The side effects observed with ibuprofen are generally common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. Gastrointestinal diseases: the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see par. 4.4). Gastrointestinal drilling with the use of ibuprofen has rarely been observed. After administration of Buscofen were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, gastric pyrosis, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see par. 4.4). Less frequently gastritis were observed. Pancreatitis were rarely observed. Immune system disorders: after treatment with NSAIDs, hypersensitivity reactions were reported. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) reactions to the respiratory tract including asthma, even severe, bronchospasm or dispnea or c) skin disorders, including rash of various types, itching, hives, porporous, angioedema and, more rarely, exfoliative and bollose dermatitis (including Stevens - Johnson syndrome, epidermal toxic necrolysis and multiform erythema). Heart and vascular disease: In combination with NSAID treatment, edema and fatigue, hypertension and heart failure were reported. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see par. 4.4). Other adverse events reported with less frequency and for which a causality has not necessarily been established include: Emolinfopoietic system pathologies: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders: insomnia, anxiety, depression, confusion, hallucinations. Diseases of the nervous system: headache, paresthesia, dizziness, drowsiness, optic neuritis. Infections and infestations: aseptic rhinitis and meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic erythematous lupus and mixed connectivity) with symptoms of nucan stiffness, headache, nausea, vomiting, fever or disorientation (see par. 4.4). Respiratory, chest and mediastinic pathologies: bronchospasmo, dispnea, apnea. Pathologies of the eye: rare cases of ocular alteration with consequent visual disorders, toxic optic neuropathy.Ear and labyrinth pathologies: hearing compromise, tinnitus, dizziness. Hepatobiliary diseases: altered liver function, liver failure, hepatitis and jaundice. Pathologies of skin and subcutaneous tissue: Bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis (very rare), photosensitivity reactions and drug reaction with heosinophilia and systemic symptoms (DrESS syndrome) (unknown frequency), generalized acute exantematic pustolosis (PEAG) (unknown frequency). Kidney and urinary pathologies: harm of the kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure. Systemic pathologies and conditions for administration: malaise, fatigue. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures, and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within 1 hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within 1 hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis during the first period of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. During the first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If used by women in conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be the lowest and the shortest possible respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Food

In the few studies available today, NSAIDs can be found in breast milk in very low concentrations. NSAIDs, if possible, should be avoided during breastfeeding.

Fertility

The use of ibuprofen can compromise female fertility and is not recommended in women waiting for conception. In women who have difficulty in conceiving or who are being investigated on fertility, it should be considered the interruption of treatment with ibuprofen.

Source: Farmadati