Descrizione Clinica
Anti-inflammatory Buscofenpocket os 10bust 400mg Buscofen
BUSCOFENPOCKET 400 MG ORAL POWDER IN THE POUCH
active ingredients
Each single-dose bag contains ibuprofen 400 mg. Excipient with known effects: isomaltitol (E953) For the complete list of excipients, see paragraph 6.1.Excellent
Isomaltitol (E953), Citric Acid, Potassium Acesulphame (E 950), Distearate Glycerol (Tipo I), Lemon Aroma 502336 TP0551 (contains corn maltodextrin, alpha tocopherol (E 307).Therapeutic indications
BUSCOFENPOCKET is indicated for the symptomatic treatment of short duration of mild-moderate intensity pains such as headache, toothache and dysmenorrhea. BUSCOFENPOCKET is also indicated for the short-term symptomatic treatment of fever. BUSCOFENPOCKET 400 mg is recommended for adults and adolescents with a body weight of 40 kg (aged or older than 12 years).Contraindications
- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Patients with an amnesi of bronchospasm, asthma, rhinitis, urticaria or angioedema associated with the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. - Anamnesis of bleeding or gastrointestinal perforation related to previous NSAID therapy. - Presence or anamnesi of peptic ulcer/recurring bleeding (two or more distinct episodes of ulceration or bleeding demonstrated). - Cerebrovascular bleeding or other bleeding in place. - Patients with severe liver failure, severe kidney failure (glomeral filtration rate below 30 ml/min) or severe heart failure (NYHA class IV) (see paragraph 4.4). - Severe dehydration (due to vomiting, diarrhea or insufficient intake of liquids). - Disorders of unknown origin, e.g. thrombocytopenia. - During the last trimester of pregnancy (see paragraph 4.6).Population
Population Only for short-term use. Undesirable effects can be limited using the effective minimum dose for the minimum duration needed to control symptoms (see paragraph 4.4). Adults should contact the doctor if symptoms worsen or if use of the medicine is required for more than 3 days in case of fever or more than 4 days in case of pain. Consult your doctor if symptoms worsen in adolescents over the age of 12 or if the use of this medicine is necessary for more than 3 days. Adults and adolescents with a body weight of 40 kg (aged or older than 12 years) The initial dose is 1 packet of BUSCOFENPOCKET 400 mg. If necessary, you can take another bag of BUSCOFENPOCKET 400 mg. The interval between doses must be chosen in line with the observed symptoms and the recommended maximum daily dose. It must not be less than six hours. Do not exceed 1200 mg (3 packets of BUSCOFENPOCKET 400 mg) in 24 hours. Children under 12 years of age and adolescents with body weight BUSCOFENPOCKET 400 mg is not suitable for children under 12 years of age and adolescents with Elderly Body Weight In older patients, the dosage is the same as for adults, but more caution is required (see paragraph 4.4). Compromise of liver or kidney functionBUSCOFENPOCKET 400 mg is contraindicated in patients with severe hepatic insufficiency or severe renal insufficiency (see section 4.3).In patients with mild-moderate renal or hepatic impairment, a dose reduction is not necessary, however, greater caution is necessary (see section 4.4). Method of administration Oral use.Place the oral powder on the tongue, let it dissolve and then swallow it;no water is necessary.It is recommended to take it during meals, especially for people with sensitive stomachs.Conservation
Store in the original packaging to protect the medicine from light.Warnings
Caution is required in patients: - with an amnesia of hypertension and/or heart failure, since in association with NSAID therapy, water retention and edema were reported (see paragraphs 4.3 and 4.8); - with renal impairment, as further deterioration of renal function may occur (see paragraphs 4.3 and 4.8); - with liver dysfunction (see paragraphs 4.3 and 4.8); - that they have just been subjected to important surgery; - congenital alteration of porphyrin metabolism (e.g. acute intermittent porphyria). Undesirable effects can be limited by using the minimal effective dose for the minimum duration necessary to control symptoms (see paragraph 4.2 and subsequent sections relating to gastrointestinal and cardiovascular risks). Respiratory disorders Bronchospasm may occur in patients with bronchial asthma or allergic disease or with a history of these disorders. Seniors The elderly have an increased frequency of adverse reactions to the NSAIDs, in particular bleeding and gastrointestinal perforations, which can be fatal (see paragraph 4.8). Gastrointestinal safety Blood, ulceration and potentially fatal gastrointestinal perforations have been reported with all NSAIDs at any time during treatment, with or without premonitory symptoms or an earlier history of serious gastrointestinal events. The risk of bleeding, ulceration or gastrointestinal perforation is greater when the doses of the NSAIDs increase, in patients with an amnesia of ulcer, in particular if complicated by hemorrhage or perforation (see paragraph 4.3), and in the elderly. These patients must begin treatment with the minimum dose available. For these patients, as well as for patients requiring the concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the gastrointestinal risk (see below and paragraph 4.5), the combined therapy with protective agents (e.g. misoprostol or protonic pump inhibitors). Patients with a gastrointestinal toxicity analogy, especially elderly people, must report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment. Precaution is recommended in patients who receive 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 acetyllic acid (see paragraph 4.5). If there is bleeding or gastrointestinal ulceration in patients taking ibuprofen, the treatment must be stopped (see paragraph 4.3). NSAIDs should be administered with caution in patients with a gastrointestinal disease anamnesi ( ulcerative colitis, Crohn's disease), because these disorders may be exacerbated (see paragraph 4.8). Strict skin reactions Very rarely, in association with the use of NSAIDs serious skin reactions were reported, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis (see paragraph 4.8). Patients seem to be at greater risk of developing these reactions at the beginning of therapy: in most cases reactions arise within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. The therapy with BUSCOFENPOCKET must be interrupted as soon as skin rashes appear, mucosa lesions or any other sign of hypersensitivity. Exceptionally, the chickenpox can be the origin of serious infectious complications to the skin and soft tissues. It is recommended to avoid the use of ibuprofen in progress of chickenpox. Masking the symptoms of underlying infections BUSCOFENPOCKET can mask the symptoms of infection, which may delay the start of proper treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When BUSCOFENPOCKET 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 symptoms persist or worsen. Systemic erythematous lupus and mixed connective tissue disease Precaution is recommended in patients with systemic erythematous lupus (LES) and mixed connective tissue disease, as they may be at greater risk of aseptic meningitis (see paragraph 4.8). Cardiovascular and cerebrovascular effects Precaution is necessary (discuss also with the doctor or pharmacist) before starting treatment in patients with an anamnesi of hypertension and/or mild-moderate congestive heart failure, since in association with NSAID therapy water retention, hypertension and edema were reported. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/day) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), proven ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular disease should be treated with ibuprofen only after careful evaluation and avoiding high doses (2400 mg/day). A careful assessment must also be made before starting long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen are needed (2400 mg/day). Allergic reactions Very rarely there are severe acute reactions of hypersensitivity (e.g. anaphylactic shock). To the first signs of a reaction of hypersensitivity following the intake/administration of BUSCOFENPOCKET the therapy must be suspended. The medical measures required must be implemented by specialized personnel, depending on the symptoms. Precaution is required in patients who have had allergic reactions or hypersensitivity, since there may be a greater risk for those patients to experience hypersensitivity reactions as a result of taking Ibuprofen. There is a greater risk of allergic reactions in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disorders. Such reactions may occur as asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Renal effects In general, the habitual use of analgesics, in particular associations of different analgesic active ingredients, can lead to permanent kidney injuries with risk of kidney failure (nephropathy from analgesics). This risk can increase under physical effort associated with loss of salts and dehydration and therefore must be avoided. Caution is required in patients with hypertension and/or heart failure, as further deterioration of kidney function may occur (see paragraphs 4.3 and 4.8). Other notes Ibuprofene, the active ingredient of BUSCOFENPOCKET, can temporarily inhibit the pyasternic function (platelet aggregation). Therefore, patients with clotting disorders must be carefully monitored. In case of prolonged administration of BUSCOFENPOCKET, periodic checks of liver values, kidney function and blood count are required. The use of the drug along with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided, due to potential additive effects (see paragraph 4.5). Such effects can worsen with prolonged use of any kind of painkiller for headache. If you present or suspect this situation, you should consult a doctor and the treatment must be stopped. Diagnosis of headache caused by excessive drug use (MOH) should be suspected in patients presenting frequent or daily headaches despite (or due to) regular use of headache medications. Alcohol consumption must be avoided, as it can increase the undesirable effects of NSAIDs, particularly those with the gastrointestinal tract and central nervous system. Pediatric population There is a risk of kidney impairment in dehydrated adolescents. Information about some excipients This medicine contains isomaltitol (E953): Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains potassium, less than 1 mmol (39 mg) per sachet, i.e. essentially “without potassium”.Interactions
For patients taking ibuprofen in conjunction with the medicines listed below, the monitoring of clinical and biological parameters should be considered. We do not recommend the use of ibuprofen in association with the following medicines: • Other NSAIDs, including selective cyclooxygenase-2 inhibitors: use in association with other NSAIDs, including COX-2 inhibitors, must be avoided, due to potential additive effects (see paragraph 4.4). Concurrent use of several NSAIDs can increase the risk of gastrointestinal ulcers and bleeding due to synergistic effect. • Acetylsalicylic acid. 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 these data to the clinical situation, the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid to low dosages can be excluded. Clinically relevant effects are not considered likely in case of occasional use of ibuprofen (see paragraph 5.1). Hybuprofen should be used carefully in conjunction with the following medicines: Diuretics, ACE inhibitors, betabloccant drugs 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 with impaired kidney function), co-administration of an inhibitor ACE, betabloccant medicine or angiotensin angiotensin antagonist- II and agents inhibiting cyclooxygenase can lead to further deterioration of kidney function, which includes a possible acute renal failure, generally reversible. Therefore, this association must be administered with caution, especially in the elderly. Patients should be properly hydrated and monitoring kidney function must be taken into consideration after the start of the concomitant therapy and periodically afterwards. Concurrent administration of BUSCOFENPOCKET and potassium-saving diuretics can cause hyperkaliemia. Heart glycosides NSAIDs can exacerbate heart failure, reduce glomerular filtration and increase plasma levels of cardiac glycosides (e.g. digoxin). Litio The simultaneous administration of ibuprofen and lithium-containing medicines can cause an increase in serum lithium levels. Fenitoin NSAIDs can reduce the elimination of phenytoin. Methodology There are evidence of a possible increase in plasma levels of metotrexate. The NSAIDs inhibit the tubular secretion of metotrexate and can reduce its clearance. In case of treatment with metotrexate at high doses, the administration of ibuprofen should be avoided. The risk of interaction between NSAIDs and metotrexates should also be taken into consideration in case of treatment with metotrexate at low doses, especially in patients with kidney impairment. If you associate metotrexato and FANS, you must monitor the kidney function. It is recommended caution if FANS and metotrexate are administered within 24 hours, since plasma levels of metotrexate can increase, resulting in increased toxicity. Tacrolimus Increased risk of nephrotoxicity when the two medicines are administered simultaneously. Ciclosporin Increased risk of nephrotoxicity in case of concomitant intake of 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. Courtesy Increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Antiagulants NSAIDs can increase the effects of anticoagulants such as warfarin (see paragraph 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRI) Increased risk of gastrointestinal bleeding (see paragraph 4.4). Sulfaniluree NSAIDs can enhance the effect of sulfaniluree. Rare cases of hypoglycemia have been reported in patients treated with sulfaniluree taking ibuprofen. During concurrent intake, it is recommended to precaution a control of blood glucose values. Zidovudina Increased risk of hematological toxicity when NSAIDs are administered simultaneously to zidovudine. There are evidence of a greater risk of hematoma and hematoma in positive HIV hemophiliacs when treated simultaneously with zidovudine and ibuprofen. Probenecid and the Finpirazone Medicinal products containing probenecid or sulfinpirazone may delay the excretion of ibuprofene. The uricreal action of these substances is diminished. Aminoglycosides NSAIDs can decrease aminoglycoside excretion. Chinolonic Antibiotics Animal studies indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones can present a greater risk of developing seizures. CYP2C9 inhibitors Concurrent administration of ibuprofen with CYP2C9 inhibitors can increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an exposure to S-(+)-ibuprofene increased by about 80-100% was observed. You should consider reducing the dose of ibuprofen when administering strong CYP2C9 inhibitors simultaneously, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Colestiramine Concurrent administration of ibuprofen and cholesteramine delays and reduces the absorption of ibuprofen (25%). Drugs must be administered a few hours away from each other. Alcohol, biphosphonate, pentoxyphylline (oxideethylene) Alcohol, biphosphonate and pentoxyphylline can increase the unwanted gastrointestinal effects and the risk of bleeding and ulceration. Plant extracts Ginkgo biloba can increase the risk of bleeding in association with NSAIDs.Effects
Gastrointestinal diseases: The most commonly observed adverse events are gastrointestinal. Peptic ulcer, perforation or gastrointestinal bleeding may occur, sometimes with fatal outcome, especially in the elderly. Following the administration of ibuprofen, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis and exacerbation of Crohn's colitis and disease (see paragraph 4.4). Less frequently gastritis were observed. Immune system disorders: Following the treatment with ibuprofen, hypersensitivity reactions have been reported, which may consist of: (a) non-specific allergic reactions and anaphylaxis, (b) reactivity of the respiratory tract, including asthma, also severe, bronchospasm or dispnea, or (c) various skin disorders, including skin rashes of various types, itching, urticaria, porchose. Infections and infestations: In conjunction with the use of ibuprofen, a worsening of inflammations associated with chicken-zoster virus infection (e.g. necrotizing fascites). This is probably associated with the NSA action mechanism. Therefore, if during hiring ibuprofen the patient notices the appearance or worsening of signs of infection, it is recommended to contact the doctor immediately. It must be investigated if there is an indication for anti-infective/antibiotic therapy. Pathologies of skin and subcutaneous tissue: In exceptional cases, severe skin infections and soft tissue complications may occur during chickenpox infection (see paragraph 4.4). Heart and vascular disease: In association with NSAID therapy, edema, hypertension and heart failure were reported. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg/day), may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke (see paragraph 4.4). Adverse reactions possibly related to ibuprofen are listed below by frequency and classification for systems and organs according to MedDRA. Frequency groups are classified according to the following categories: very common (≥ 1/10); common (≥ 1/100 -Overdosing
Toxicity In children or adults, signs and symptoms of toxicity were not generally observed at doses of less than 100 mg/kg. 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 equal to or greater than 400 mg/kg. In adults, the dose-response effect is less clear. The half-life in case of overdose is 1.5-3 hours. 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 cephales, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, SNC depression and respiratory system were reported. It has been reported cardiovascular toxicity including hypotension, bradycardia and tachycardia. In cases of severe poisoning, it is possible that metabolic acidosis occurs. In cases of significant overdose, kidney failure and liver damage may occur. Treatment There is no specific antidote for overdosing ibuprofen. If the quantity ingested in the previous hour exceeds 400 mg/kg, oral administration of activated charcoal or gastric lavender followed by support measures is recommended. For more up-to-date information contact the local anti-veleni center.Pregnancy
Inhibition of prostaglandin synthesis can have negative effects on 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 the synthesis of prostaglandins in the early stages of pregnancy. 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 pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. Hybuprofen should not be administered during the first and second quarter of pregnancy unless it is absolutely necessary. If ibuprofen is used by women who are trying to conceive or during the first and second quarter of pregnancy, the dose must be kept as low as possible and the duration of treatment must be as short as possible. In 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: - a possible extension of the bleeding time, an anti-aggregating effect that can also occur at very low doses; - an inhibition of uterine contractions, resulting in delay or extension of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.3).Food
Only small amounts of ibuprofen and its metabolites are excreted in breast milk. Since no known harmful effects for infants, it is usually not necessary to stop breastfeeding during short-term use of ibuprofen at recommended doses.Fertility
There are some evidence that substances that inhibit cyclooxygenase/prostaglandin synthesis can affect female fertility through an effect on ovulation. This effect is reversible after the termination of treatment.Source: Farmadati
