BuscofenPocket 400mg 10 sachets oral powder

BuscofenPocket 400 mg is a painkiller and anti-inflammatory based on ibuprofen , indicated for the rapid and effective treatment of headaches, toothaches, menstrual pain and feverish states. Thanks to its formulation in sachets of orosoluble powder , it is taken without water, ensuring rapid action against pain and inflammation. NSAID drug , helps reduce discomfort and improve daily well-being.

ACTIVE INGREDIENTS

Active ingredients contained in Buscofenpocket 400mg 10 sachets oral powder - What is the active ingredient of Buscofenpocket 400mg 10 sachets oral powder?

Each single-dose sachet contains ibuprofen 400 mg. Excipient with known effect: isomaltitol (E953) For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Buscofenpocket 400mg 10 sachets oral powder - What does Buscofenpocket 400mg 10 sachets oral powder contain?

Isomaltitol (E953), Citric acid, Acesulfame potassium (E 950), Glycerol distearate (Type I), Lemon flavour 502336 TP0551 (contains corn maltodextrin, alpha tocopherol (E 307)).

DIRECTIONS

Therapeutic indications Buscofenpocket 400mg 10 sachets oral powder - Why is Buscofenpocket 400mg 10 sachets oral powder used? What is it used for?

BUSCOFENPOCKET is indicated for the short-term symptomatic treatment of mild-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 (aged 12 years or over).

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Buscofenpocket 400mg 10 sachets oral powder - When should Buscofenpocket 400mg 10 sachets oral powder not be used?

- 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 nonsteroidal anti-inflammatory drugs. - History of gastrointestinal bleeding or perforation related to previous NSAID therapy. - Presence or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). - Cerebrovascular haemorrhage or other active haemorrhage. - Patients with severe hepatic insufficiency, severe renal insufficiency (glomerular filtration rate less than 30 ml/min) or severe cardiac insufficiency (NYHA class IV) (see section 4.4). - Severe dehydration (due to vomiting, diarrhoea or insufficient fluid intake). - Haematopoietic disorders of unknown origin, e.g. thrombocytopenia. - During the last trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Buscofenpocket 400mg 10 sachets oral powder - How do you take Buscofenpocket 400mg 10 sachets oral powder?

Dosage For short-term use only. Undesirable effects may be limited by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults should consult a doctor if symptoms worsen or if the 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 a doctor if symptoms worsen in adolescents over 12 years of age or if the use of this medicine is required for more than 3 days. Adults and adolescents with a body weight of 40 kg or more (aged 12 years or over) The initial dose is 1 sachet of BUSCOFENPOCKET 400 mg. If necessary, an additional sachet of BUSCOFENPOCKET 400 mg may be taken. The interval between doses should be chosen in line with the symptoms observed and the maximum recommended daily dose. It should 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 greater caution is required (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). In patients with mild-moderate impairment of renal or hepatic function, a dose reduction is not necessary, however greater caution is required (see section 4.4). Method of administration Oral use. Place the oral powder on the tongue, let it dissolve and then swallow it; water is not necessary. It is recommended to take it during meals, especially for people with a delicate stomach.

CONSERVATION

Storage Buscofenpocket 400mg 10 sachets oral powder - How do you store Buscofenpocket 400mg 10 sachets oral powder?

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

WARNINGS

Warnings Buscofenpocket 400mg 10 sachets oral powder - About Buscofenpocket 400mg 10 sachets oral powder it is important to know that:

Caution is advised in patients: - with a history of hypertension and/or heart failure, since fluid retention and oedema have been reported in association with NSAID therapy (see sections 4.3 and 4.8); - with renal impairment, since further deterioration of renal function may occur (see sections 4.3 and 4.8); - with liver dysfunction (see sections 4.3 and 4.8); - who have just undergone major surgery; - with congenital impairment of porphyrin metabolism (e.g. acute intermittent porphyria). Undesirable effects may be limited by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and subsequent sections on gastrointestinal and cardiovascular risks). Respiratory disorders Bronchospasm may occur in patients with bronchial asthma or allergic disease or with a history of these conditions. Elderly Elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may 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 higher 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 on the lowest dose available. For these patients, as well as for patients requiring concomitant use of low dose aspirin or other drugs likely to increase gastrointestinal risk (see below and section 4.5), combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. Patients with a history of gastrointestinal toxicity, particularly when 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 which 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 aspirin (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn (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 conditions may be exacerbated (see section 4.8). Severe skin reactions Very rarely, serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of developing these reactions early in therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in connection with medicinal products containing ibuprofen. Therapy with BUSCOFENPOCKET should be discontinued if skin rash, mucosal lesions, or any other sign of hypersensitivity appears. Exceptionally, chickenpox may be the cause of serious infectious complications affecting the skin and soft tissues. It is recommended to avoid the use of ibuprofen during chickenpox. Masking of symptoms of underlying infections BUSCOFENPOCKET may mask the symptoms of infection, which may delay initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When BUSCOFENPOCKET is administered for the relief of infection-related fever or pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. 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 of aseptic meningitis (see section 4.8). Cardiovascular and cerebrovascular effects Caution is advised (also discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or mild-moderate congestive heart failure, since fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be made before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg/day) are required. Allergic reactions Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction following the intake/administration of BUSCOFENPOCKET, therapy should be discontinued. The required medical measures should be implemented by specialized personnel, depending on the symptoms. Caution is advised in patients who have had allergic or hypersensitivity reactions, as these patients may be at increased risk of experiencing hypersensitivity reactions following intake of Ibuprofen. There is an increased risk of allergic reactions in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory disease. These reactions may present as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria. Renal effects In general, habitual use of analgesics, particularly combinations of several analgesic active ingredients, may lead to permanent kidney damage with risk of renal failure (analgesic nephropathy). This risk may be increased by physical exertion associated with salt loss and dehydration and should therefore be avoided. Caution is advised in patients with hypertension and/or heart failure, as further deterioration of renal function may occur (see sections 4.3 and 4.8). Other notes Ibuprofen, the active substance of BUSCOFENPOCKET, may 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 counts are necessary. The use of the medicinal product together with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided, due to potential additive effects (see section 4.5). These effects may worsen with prolonged use of any type of headache painkiller. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Alcohol consumption should be avoided as it may increase the side effects of NSAIDs, particularly those affecting the gastrointestinal tract and the central nervous system. Paediatric population There is a risk of renal impairment in dehydrated adolescents. Information on some of the excipients This medicinal product contains isomaltitol (E953): Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains potassium, less than 1 mmol (39 mg) per sachet, i.e. essentially “potassium-free”.

INTERACTIONS

Interactions Buscofenpocket 400mg 10 sachets oral powder - Which medicines or foods can modify the effect of Buscofenpocket 400mg 10 sachets oral powder?

For patients taking ibuprofen concomitantly with the medicinal products listed below, monitoring of clinical and biological parameters should be considered. The use of ibuprofen in combination with the following medicinal products is not recommended : • Other NSAIDs, including cyclooxygenase-2 selective inhibitors : use in combination with other NSAIDs, including COX-2 inhibitors, should be avoided due to the potential for additive effects (see section 4.4). The concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to the synergistic effect. • Acetylsalicylic acid. 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 effects are considered likely with occasional use of ibuprofen (see section 5.1). Ibuprofen should be used with caution in combination with the following medicinal products : Diuretics, ACE inhibitors, beta-blocking drugs and angiotensin-II antagonists . NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of an ACE inhibitor, a beta-blocking medicinal product or an angiotensin-II antagonist and agents that inhibit cyclooxygenase may result in 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter. Concomitant administration of BUSCOFENPOCKET and potassium-sparing diuretics may cause hyperkalemia. Cardiac glycosides NSAIDs may exacerbate heart failure, reduce glomerular filtration and increase plasma levels of cardiac glycosides (e.g. digoxin). Lithium Concomitant administration of ibuprofen and lithium-containing medicinal products may cause an increase in serum lithium levels. Phenytoin NSAIDs may reduce the elimination of phenytoin. Methotrexate There is evidence of a possible increase in plasma levels of methotrexate. NSAIDs inhibit the tubular secretion of methotrexate and may reduce its clearance. In case of treatment with high-dose methotrexate, the administration of ibuprofen (NSAIDs) should be avoided. The risk of interaction between NSAIDs and methotrexate must be taken into account even in case of treatment with low-dose methotrexate, 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 medicinal products are administered concomitantly. Ciclosporin Increased risk of nephrotoxicity when NSAIDs are administered concomitantly. Mifepristone Due to the antiprostaglandin properties of NSAIDs, a decrease in the efficacy of the medicinal product may theoretically occur. Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of the medicinal product on pregnancy termination. 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 enhance the effect of sulfonylureas. Rare cases of hypoglycaemia have been reported in patients receiving sulfonylureas who were taking ibuprofen. During concomitant administration, monitoring of blood glucose levels 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 haematoma in HIV-positive haemophiliacs when treated concomitantly with zidovudine and ibuprofen. Probenecid and sulfinpyrazone Medicines containing 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 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. CYP2C9 inhibitors Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an approximately 80-100% increased exposure to S-(+)-ibuprofen was observed. Consideration should be given to reducing the ibuprofen dose when strong CYP2C9 inhibitors are co-administered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. Cholestyramine Concomitant administration of ibuprofen and cholestyramine delays and reduces the absorption of ibuprofen (25%). The medicines should be administered a few hours apart. Alcohol, bisphosphonates, pentoxifylline (oxypentifylline) Alcohol, bisphosphonates and pentoxifylline may 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

Like all medicines, Buscofenpocket 400mg 10 sachets oral powder can cause side effects - What are the side effects of Buscofenpocket 400mg 10 sachets oral powder?

Gastrointestinal disorders : The most commonly observed adverse events are gastrointestinal in nature. Peptic ulceration, perforation or gastrointestinal bleeding, sometimes with fatal outcome, especially in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have been reported following the administration of ibuprofen (see section 4.4). Less frequently, gastritis has been observed. 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 asthma, bronchospasm or dyspnoea, or (c) various skin disorders, including rashes 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 the inflammation associated with varicella-zoster virus infection (e.g. development of necrotising fasciitis) has been described in association 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 medical advice immediately. Whether there is an indication for anti-infective/antibiotic therapy should be investigated. Skin and subcutaneous tissue disorders : In exceptional cases, serious skin infections and soft tissue complications may occur in the course of varicella infection (see section 4.4). Cardiac and vascular disorders : Oedema, hypertension and cardiac failure 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, 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. 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 suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Buscofenpocket 400mg 10 sachets oral powder - What are the risks of Buscofenpocket 400mg 10 sachets oral powder in case of overdose?

Toxicity In children or adults, signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg. However, in some cases supportive treatment may be necessary. Children have been observed to show signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or higher. In adults, the dose-response effect is less clear. The half-life in 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. Central nervous system (CNS) effects include headache, 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. In cases of significant overdose, renal failure and liver damage may occur. Treatment There is no specific antidote for ibuprofen overdose. If the amount ingested in the previous hour exceeds 400 mg/kg, oral administration of activated charcoal or gastric lavage followed by supportive measures is recommended. Contact your local poison control center for the most up-to-date information.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Buscofenpocket 400mg 10 sachets oral powder.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal 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 result in increased pre- and post-implantation loss and embryo-foetal 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 clearly necessary. If ibuprofen is used by women attempting to conceive or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus 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: - a possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; - an inhibition of uterine contractions, resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.3). Breast-feeding Only small amounts of ibuprofen and its metabolites are excreted in breast milk. Since no harmful effects on the newborn are known, it is not usually necessary to stop breast-feeding during short-term use of ibuprofen at recommended doses. Fertility There is some evidence that substances which inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by an effect on ovulation. This effect is reversible after cessation of treatment.

DRIVING AND USE OF MACHINERY

Taking Buscofenpocket 400mg 10 sachets oral powder before driving or using machinery - Does Buscofenpocket 400mg 10 sachets oral powder affect driving or using machinery?

When taken at the recommended doses, ibuprofen has a generally negligible influence on the ability to drive and use machines. Since side effects such as tiredness, dizziness and visual disturbances may occur with the use of ibuprofen, the ability to react and to actively participate in road traffic and to operate machinery may be impaired in isolated cases. This applies in particular in combination with alcohol.