Buscofen Pocket 400mg 10 Orosoluble Sachets

Buscofen Pocket 400mg - Medical Device

Each single-dose sachet contains 400 mg ibuprofen. For the full list of excipients, see section 6.1.

Excipients

Hydrated dextrates Citric acid anhydrous Acesulfame potassium (E 950) Glycerol distearate (Type I) Lemon flavor 502336 TP0551 (contains maize maltodextrin, alpha tocopherol (E 307))

Therapeutic indications

BUSCOFENPOCKET is indicated for the short-term symptomatic treatment of mild to moderate pain 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 or more (12 years of age and older).

Contraindications / Undesirable Effects

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients with a history of bronchospasm, asthma, rhinitis, urticaria or angioedema associated with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. - History of gastrointestinal bleeding or perforation related to previous NSAID therapy. - Presence or history of recurrent peptic ulcer / bleeding (two or more distinct episodes of proven ulceration or bleeding). - Cerebrovascular haemorrhage or other ongoing haemorrhage. - Patients with severe hepatic insufficiency, severe renal insufficiency (glomerular filtration rate less than 30 ml / min) or severe heart failure (NYHA class IV) (see section 4.4). - Severe dehydration (due to vomiting, diarrhea or insufficient fluid intake). - Disorders of hematopoiesis of unknown origin, eg. thrombocytopenia. - During the last trimester of pregnancy (see section 4.6).

Dosage

Posology For short term use only. Undesirable effects can be limited by using the lowest effective dose for the minimum duration necessary to control symptoms (see section 4.4). Adults should seek medical attention 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 12 years of age or if the use of this medicine is necessary for more than 3 days. Adults and adolescents with a body weight of 40 kg or more (aged 12 years and over) The starting dose is 1 sachet of BUSCOFENPOCKET 400 mg. If necessary, an additional 400 mg BUSCOFENPOCKET sachet can be taken. The interval between doses should be chosen in line with the symptoms observed and the maximum recommended daily dose. It must not be less than six hours. Do not exceed the dose of 1200 mg (3 sachets of BUSCOFENPOCKET 400 mg) in 24 hours. Children under 12 years of age and adolescents with body weight <40 kg BUSCOFENPOCKET 400 mg is not suitable for children under 12 years of age and adolescents with body weight <40 kg. Elderly In elderly patients, the dosage is the same as for adults, but more caution should be exercised (see section 4.4). Impaired hepatic or renal function BUSCOFENPOCKET 400 mg is contraindicated in patients with severe hepatic insufficiency or severe renal insufficiency (see section 4.3). No dose reduction is required in patients with mild to moderate impairment of renal or hepatic function, however more caution should be exercised (see section 4.4). Method of administration Oral use. Put the oral powder on the tongue, let it dissolve and then swallow it; no water is needed. It is recommended to be taken with meals, particularly for people with a sensitive stomach.

storage

Do not store above 25 ° C. Store in the original package to protect the medicine from light.

Warnings

Caution is required in patients: - with a history of hypertension and / or heart failure, as fluid retention and edema have been reported in association with NSAID therapy (see sections 4.3 and 4.8). - with renal impairment, as further deterioration of renal function may occur (see sections 4.3 and 4.8). - with hepatic dysfunction (see sections 4.3 and 4.8). - who have just undergone major surgery. - with congenital alteration of porphyrin metabolism (e.g. acute intermittent porphyria). Undesirable effects can be limited by using the lowest effective dose for the minimum duration necessary to control symptoms (see section 4.2 and subsequent sections on gastrointestinal and cardiovascular risks). Respiratory Disorders Bronchospasm may develop in patients with bronchial asthma or allergic disease or with a history of these disorders. Elderly The elderly have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal (see section 4.8). Gastrointestinal safety Life-threatening gastrointestinal bleeding, ulceration and perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should start treatment with the lowest available dose. For these patients, as well as for patients requiring concomitant use of low doses of acetylsalicylic acid or other drugs that may increase gastrointestinal risk (see below and section 4.5), combination therapy with protective agents should be considered ( e.g. misoprostol or proton pump inhibitors). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. Caution is advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, treatment should be stopped (see section 4.3). NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these disorders may be exacerbated (see section 4.8). 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 increased risk of developing these reactions at the start of therapy: in most cases, the reactions occur within the first month of treatment. BUSCOFENPOCKET therapy should be discontinued as soon as skin rashes, mucosal lesions or any other signs of hypersensitivity appear. Exceptionally, chickenpox can be the cause of serious infectious complications affecting the skin and soft tissues. To date, it cannot be excluded that NSAIDs contribute to the worsening of these infections. It is therefore recommended to avoid the use of ibuprofen during chickenpox. Systemic lupus erythematosus and mixed connective tissue disease. Caution is advised in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, as they may be at increased risk for aseptic meningitis (see section 4.8). Cardiovascular and cerebrovascular effects. Caution is needed (also discuss with doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or mild to moderate congestive heart failure, as fluid retention, hypertension have been reported in association with NSAID therapy. and edema. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg / day), may be associated with a modest increased 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 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 avoiding high doses (2400 mg / day). Careful evaluation should also be made before initiating long-term treatments of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high dosages of ibuprofen (2400 mg / day). Allergic reactions Severe acute hypersensitivity reactions (eg anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction following the intake / administration of BUSCOFENPOCKET the therapy should be discontinued. The medical measures required must be implemented by specialized personnel, according to the symptoms. Caution is needed in patients who have experienced allergic or hypersensitivity reactions, as there may be an increased risk of hypersensitivity reactions for such patients following taking Ibuprofen. There is an increased risk of allergic reactions occurring in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disease. These reactions can present as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Kidney effects. In general, the habitual use of analgesics, in particular combinations of different analgesic active ingredients, can lead to permanent renal lesions with the risk of renal failure (analgesic nephropathy). This risk can increase under physical exertion associated with salt loss and dehydration and should therefore be avoided. Caution is required in patients with hypertension and / or heart failure, as further deterioration of renal function may occur (see sections 4.3 and 4.8). Other annotations. Ibuprofen, the active substance in BUSCOFENPOCKET, can temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be carefully monitored. In case of prolonged administration of BUSCOFENPOCKET, periodic checks of liver values, renal function and blood count are necessary. The use of the medicinal product together with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects (see section 4.5). These effects may worsen with prolonged use of any type of pain reliever for headache. If this occurs or is suspected, a physician should be consulted and treatment discontinued. The diagnosis of headache caused by drug overuse (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications. Alcohol consumption should be avoided, as it can increase undesirable effects of NSAIDs, particularly those affecting the gastrointestinal tract and central nervous system. NSAIDs can mask the symptoms of infection and fever. Pediatric population There is a risk of renal impairment in dehydrated adolescents.

Interactions

Monitoring of clinical and biological parameters should be considered for patients taking ibuprofen concomitantly with the medicinal products listed below. The use of ibuprofen in combination with the following medicinal products is not recommended: • Other NSAIDs, including selective cyclooxygenase-2 inhibitors : use in combination with other NSAIDs, including COX-2 inhibitors, should be avoided due to potential additive effects (see section 4.4). Concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to the synergistic effect. • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended, due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. Clinically relevant effects are not considered to be likely with occasional use of ibuprofen (see section 5.1). L 'Ibuprofen should be used with caution in combination with the following drugs: diuretics, ACE inhibitors, beta blockers and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated or elderly patients with impaired renal function), co-administration of an ACE inhibitor, a beta-blocker drug or an angiotensin-II antagonist and agents that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, this combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter. Concomitant administration of BUSCOFENPOCKET and potassium-sparing diuretics may result in hyperkalaemia. Cardiac glycosides NSAIDs can exacerbate heart failure, reduce glomerular filtration and increase plasma levels of cardiac glycosides (eg digoxin). Lithium Co- administration of ibuprofen and lithium-containing medicinal products may cause an increase in serum lithium levels. Phenytoin NSAIDs can reduce the elimination of phenytoin. Methotrexate There is evidence of a possible increase in plasma methotrexate levels. NSAIDs inhibit the tubular secretion of methotrexate and may reduce its clearance. In case of treatment with methotrexate in high doses, the administration of ibuprofen (NSAID) should be avoided. The risk of interaction between NSAIDs and methotrexate should be considered even in the case of low dose methotrexate treatment, especially in patients with renal impairment. If methotrexate and NSAIDs are combined, renal function should be monitored. Caution is advised if NSAIDs and methotrexate are administered within 24 hours, as plasma levels of methotrexate may increase, resulting in increased toxicity. Tacrolimus Increased risk of nephrotoxicity when the two medicines are given simultaneously. Ciclosporin Increased risk of nephrotoxicity in case of concomitant use of NSAIDs. Mifepristone Due to the antiprostaglandin properties of NSAIDs, it can theoretically lead to a decrease in the efficacy of the drug. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the drug's clinical efficacy on termination of pregnancy. Corticosteroids Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) Increased risk of gastrointestinal bleeding (see section 4.4). Sulfonylureas NSAIDs may potentiate the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients treated with sulfonylureas taking ibuprofen. During concomitant intake, a check of blood glucose values ​​is recommended as a precaution. Zidovudine Increased risk of haematological toxicity when NSAIDs are administered concomitantly with zidovudine. There is evidence of an increased risk of haemarthrosis and hematoma in HIV positive haemophiliacs when treated concomitantly with zidovudine and ibuprofen. Probenecid and sulfinpyrazone Medicines that contain probenecid or sulfinpyrazone may delay the excretion of ibuprofen. The uricosuric action of these substances is decreased. Aminoglycosides NSAIDs may decrease the excretion of aminoglycosides. Quinolone antibiotics Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at an increased risk of developing seizures. CYP2C9 inhibitors Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S - (+) - ibuprofen exposure of approximately 80-100% was observed. Dose reduction of ibuprofen should be considered when co-administering strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are co-administered with voriconazole or fluconazole. Cholestyramine Concomitant administration of ibuprofen and cholestyramine delays and reduces the absorption of ibuprofen (25%). Medicines should be administered within a few hours of each other. Alcohol, bisphosphonates, pentoxifylline (oxypentifylline) Alcohol, bisphosphonates and pentoxifylline can increase gastrointestinal side effects and the risk of bleeding and ulceration. Plant extracts Ginkgo biloba may increase the risk of bleeding in association with NSAIDs.

Side effects

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcer, gastrointestinal perforation or bleeding may occur, sometimes with a fatal outcome, especially in the elderly. Following administration of ibuprofen, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have been reported (see section 4.4). Gastritis has been observed less frequently. Immune system disorders: Hypersensitivity reactions have been reported following treatment with ibuprofen, which may consist of: (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, including asthma, including severe, bronchospasm or dyspnoea, or (c) various skin disorders, including rash of various types, pruritus, urticaria, purpura, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis). Infections and infestations: Worsening of inflammation associated with varicella-zoster virus infection (e.g. development of necrotizing fasciitis) has been reported in conjunction with the use of ibuprofen. This is probably associated with the mechanism of action of NSAIDs. Therefore, if the patient notices the appearance or worsening of signs of infection while taking ibuprofen, it is recommended to seek immediate medical attention. It should be investigated whether there is an indication for anti-infectious / antibiotic therapy. Skin and subcutaneous tissue disorders: In exceptional cases, severe skin infections and soft tissue complications in varicella infection may occur (see section 4.4). Cardiac and vascular disorders: Edema, hypertension and heart failure have been reported in association with NSAID therapy. Clinical studies suggest that the use of ibuprofen, especially in high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4). Adverse reactions possibly related to ibuprofen are listed below by frequency and MedDRA system organ class. The frequency groups are classified according to the following categories: very common (≥ 1/10); common (≥ 1/100 - <1/10); uncommon (≥ 1 / 1,000 - <1/100); rare (≥ 1 / 10,000 - <1 / 1,000); very rare (<1 / 10,000) and not known (cannot be estimated from the available data):

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdose

Toxicity In children or adults, no signs and symptoms of toxicity were generally observed at doses below 100 mg / kg. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or more. In adults, the dose-response effect is less clear. The half-life in case of overdose is 1.5-3 hours. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headaches, tinnitus, dizziness, convulsions and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, CNS and respiratory depression have also been reported rarely. Cardiovascular toxicity including hypotension, bradycardia and tachycardia has been reported. In cases of severe poisoning, metabolic acidosis may occur. Renal failure and liver damage may occur in cases of significant overdose. Treatment There is no specific antidote for ibuprofen overdose. If the amount ingested in the preceding hour exceeds 400 mg / kg, oral administration of activated charcoal or gastric lavage followed by supportive measures is recommended. For more up-to-date information contact your local poison control center.

Pregnancy and breastfeeding

Pregnancy. Inhibition of prostaglandin synthesis can have adverse effects on 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 in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. Ibuprofen should not be given during the first and second trimester of pregnancy unless absolutely necessary. If ibuprofen is used by women who are trying to conceive or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should 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 the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - a possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; - an inhibition of uterine contractions, with consequent delay or prolongation of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.3). Feeding time. Only small amounts of ibuprofen and its metabolites are excreted in breast milk. Since there are no known harmful effects on infants, it is not usually necessary to stop breastfeeding during short-term use of ibuprofen at recommended doses. Fertility. There is some evidence that substances that inhibit cyclooxygenase / prostaglandin synthesis may impair female fertility through an effect on ovulation. This effect is reversible after discontinuation of treatment.

Format

Box of 10 buccal sachets.