BUSCOFOKUS * 20CPR RIV 200MG

BUSCOFOKUS * 20CPR RIV 200MG

Therapeutic indications

Buscofokus is indicated in adults for the short-term symptomatic treatment of acute mild to moderate pain and inflammation such as - musculoskeletal pain such as, back pain, - dental pain, pain after tooth extraction, - menstrual pain, - pain headache - pain associated with colds and flu.

Dosage and method of use

DosageDosage should be adjusted according to the severity of the disorder and the patient's problems. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). The maximum recommended daily dose is 600 mg of dexibuprofen, divided up to three single doses of 200 mg. The interval between one dose and another should not be less than 6 hours. The maximum daily dose for dispensing without a prescription is 600 mg of dexibuprofen (3 Buscofokus tablets) in 24 hours. The tablets can be divided into equal doses. The tablet should be placed on a hard surface and pressed with two fingers, index or thumb, to be divided.Pediatric populationNo studies have been conducted on the use of dexibuprofen in children and adolescents. (Elderly No special dosage adjustments are required in the elderly. However, individual dose reduction and assessment should be considered due to increased susceptibility in the elderly. gastrointestinal (GI) adverse reactions (see section 4.4).Hepatic dysfunctionPatients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored.Renal dysfunctionIn patients with mildly to moderately impaired renal function the starting dose should be reduced.Method of administrationThe film-coated tablets can be taken with or without food (see section 5.2). In general, NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with a meal to reduce gastrointestinal irritation, particularly in the case of chronic use. However, in some patients, a delay in onset of action is to be expected when the tablets are taken with or immediately after meals.Duration of treatmentIf the condition does not improve within 4 days (3 days if fever is present), the patient is advised to consult the doctor.

Contraindications

Dexibuprofen must not be administered to patients: - With hypersensitivity to the active substance, to any other NSAID or to any of the excipients listed in section 6.1; - In which, substances with a similar action (eg acetylsalicylic acid or other NSAIDs) trigger attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic edema; - Who have a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy; - With ongoing or history of recurrent peptic ulcer / bleeding (two or more distinct episodes of proven ulceration or bleeding); - With unexplained hematopoietic disorders; - With cerebrovascular or other ongoing bleeding; - With active Crohn's disease or active ulcerative colitis; - With severe heart failure (New York Heart Association, NYHA Class IV) (see section 4.4); - With severe renal dysfunction (GFR

Side effects

to. Summary of the safety profile Clinical experience has shown that the risk of dexibuprofen-induced undesirable effects is broadly comparable to that of racemic ibuprofen, see also section 5.1. The most common adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Adverse events are predominantly dose-dependent and vary individually, in particular the risk of onset of gastrointestinal side effects depends on the dose interval and duration of treatment. Some of the undesirable effects listed below are less frequent when the maximum daily dose is 600 mg of dexibupropfen when comparing high dose versus long term therapy, e.g. in rheumatic patients.

b. Table of adverse reactions

^1-6

See subsection c. (Description of selected adverse reactions) for more information. c. Description of the selected adverse reactions ¹Description of infections and infestations:This is probably associated with the mechanism of action of NSAIDs. Therefore, if any signs of infection occur or these worsen while using Buscofokus, it is recommended that you consult your doctor immediately. The possibility of an indication for anti-infectious / antibiotic therapy should be considered.In exceptional cases, severe skin infections and soft tissue complications can occur during chickenpox infection. ²Description of pathologies of the blood and lymphatic system:The first signs of haematopoietic disorders are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nasal and skin bleeding. In these cases, the patient should be advised to stop the drug immediately, to avoid any self-medication with analgesics or antipyretics and to consult a doctor.. ³Description of immune system disorders:If hypersensitivity reactions occur with skin rashes and itching sensation, as well as asthma attacks, the patient should be instructed to inform a doctor immediately and not to take Buscofokus again..If you develop severe symptoms of general hypersensitivity reactions, which may occur even after the first dose, you should seek immediate medical attention..⁴Description of Aseptic Meningitis: The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on NSAID-related aseptic meningitis indicate a hypersensitivity reaction (due to a temporal relationship with drug intake and disappearance of symptoms after drug discontinuation). Note that single cases of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, various tissue diseases connective).⁵ Description of cardiac pathologies:Clinical studies suggest that the use of ibuprofen, particularly at a high dose (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high-dose dexibuprofen (1200 mg / day) is similar to that associated with high-dose ibuprofen (2400 mg / day)..⁶ Description of gastrointestinal pathologies:The patient should be instructed to stop taking the medicinal product and consult a physician immediately if relatively severe pain in the upper abdomen, melaena or haematemesis occurs.. d. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and GI and cardiovascular risks below). Caution is advised in patients: - With systemic lupus erythematosus and various connective tissue diseases as there is an increased risk of developing aseptic meningitis (see section 4.8); - With congenital pathology of porphyrin metabolism (for example, acute intermittent porphyria); - With a history of gastrointestinal or chronic inflammatory bowel disease (ulcerative colitis and Crohn's disease) (see section 4.8); - With hypertension and (or) mild to moderate heart failure as fluid retention and edema have been reported in association with NSAID therapy; - With renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8); - With hepatic dysfunction (see sections 4.3 and 4.8); - Immediately after major surgery; - With allergic rhinitis, nasal polyps or chronic obstructive pulmonary diseases, as there is an increased risk of allergic reactions. These can present as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria.Other NSAIDsThe concomitant use of dexibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.Elderly peopleThe elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal.Gastrointestinal RisksGastrointestinal bleeding, ulceration and perforation, sometimes fatal, have been reported at any stage of treatment with the use of all NSAIDs, with or without prodromal symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal ulceration or perforation or haemorrhage increases with higher doses of NSAIDs, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), alcoholism and in elderly patients. These patients should start treatment with the lowest available dose. Concomitant therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any abdominal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution is advised in patients on concomitant treatment with drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral or parenteral anticoagulants (e.g. heparin or its derivatives, vitamin K antagonists, such as acenocoumarol or warfarin and anticoagulants non-vitamin K antagonists, such as rivaroxaban, apixaban or dabigatran), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Buscofokus, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of inflammatory gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may worsen (see section 4.8).HypersensitivityAs with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may occur, even in the absence of previous drug exposure. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) occur very rarely. At the first signs of a hypersensitivity reaction following ibuprofen intake, therapy should be discontinued. The medical measures required on the basis of symptoms must be carried out by experienced personnel.Respiratory effectsBronchospasm may occur in patients with or with a previous history of bronchial asthma or allergic disease.Cardiovascular and cerebrovascular effectsPatients with a history of mild to moderate hypertension and / or congestive heart failure require adequate monitoring and advice, as fluid retention and edema have been reported in association with NSAID therapy. at high doses (2400 mg / day), it 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 per day) are associated with an increased risk of arterial thrombotic events. Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high-dose dexibuprofen (1200 mg / day) is similar to that associated with high-dose ibuprofen (2400 mg / day). 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 dexibuprofen after careful consideration and high doses (1200 mg / day) should be avoided. . Care should also be taken before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, cigarette smoking), particularly if high doses of dexibuprofen (1200 mg) are required. / day).Renal and hepatic effectsCare should be taken in patients with liver and kidney disease; the risk of fluid retention, edema and deterioration of renal function should be taken into account. When treating these patients with dexibuprofen, the lowest possible dose should be used and renal function should be regularly monitored. As with other NSAIDs, dexibuprofen may be associated with adverse effects on the renal system, which can lead to glomerulonephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure (see sections 4.2, 4.3 and 4.5). As with all NSAIDs, dexibuprofen can increase BUN and creatinine values. As with other NSAIDs, dexibuprofen can cause transient mild increases in some liver parameters and also significant increases in SGOT and SGPT levels. In the event of a significant increase in these parameters, therapy should be discontinued (see sections 4.2 and 4.3). In general, the habitual use of analgesics, particularly the combination of several analgesic drugs, can lead to lasting kidney damage with the risk of renal failure (analgesic nephropathy). Therefore, associations with ibuprofen or other NSAIDs (including self-medication products and selective COX-2 inhibitors) should be avoided.Severe skin reactionsSerious skin reactions, some of them fatal, including exfoliative dermatitis, Steven-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 these reactions at the start of therapy, as the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. Administration of dexibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Masking the symptoms of underlying infections Buscofokus can mask the symptoms of infection, which could delay the 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 Buscofokus is given for the relief of infection-related fever or pain, monitoring of infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. It is advisable to avoid the use of dexibuprofen in case of chickenpox.CoagulationLike other NSAIDs, dexibuprofen can reversibly inhibit platelet aggregation and function and prolong bleeding time. Caution should be exercised in patients with haemorrhagic diathesis and other coagulation disorders and when dexibuprofen is administered concomitantly with oral anticoagulants (see section 4.5). Data from preclinical studies suggest that the inhibition of platelet aggregation caused by low doses of acetylsalicylic acid may be altered if NSAIDs such as dexibuprofen are administered concomitantly. This interaction could reduce the cardiovascular protective effect. Therefore in the case of concomitant administration of low dose acetylsalicylic acid, particular care should be taken if the duration of treatment exceeds the short term (see sections 4.5 and 5.1).Medication overuse headacheProlonged use of any type of pain reliever for headache can make it worse. If this situation is present or suspected, the doctor should be consulted and treatment discontinued. Diagnosis of headache caused by overuse of medication (Medication Overuse Headache, MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications.Additional warnings and precautions for usePatients on long-term treatment with dexibuprofen should be monitored as a precautionary measure (renal, hepatic and haematological function / blood count).

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to increase pre- and post-implantation loss and embryo-fetal lethality. In addition, higher incidences of various malformations, including cardiovascular ones, have been reported in animals that received a prostaglandin synthesis inhibitor during the organogenetic period (see section 5.3). During the first and second trimester of pregnancy, NSAIDs should not be administered unless strictly necessary. If NSAIDs are used during the first and second trimester of pregnancy, the lowest dose should be used for the shortest possible duration of treatment. During 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-hydroamniosis and can expose the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, dexibuprofen is contraindicated during the third trimester of pregnancy.Feeding timeIbuprofen is slightly excreted in human milk. Breastfeeding is possible with dexibuprofen if the dosage is low and the treatment period is short.FertilityDrugs known to inhibit prostaglandin / cyclooxygenase synthesis can reversibly impair fertility and are not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, discontinuation of dexibuprofen should be considered.

Expiry and retention

Do not store above 25 ° C.

Interactions with other drugs

The information in this section is also based on previous experience with dexibuprofen and other NSAIDs. In general, NSAIDs should be used with caution with other drugs that may increase the risk of gastrointestinal ulceration or gastrointestinal bleeding or kidney damage.It is not recommended to use concurrently with: Other NSAIDs and salicylates (acetylsalicylic acid as a pain reliever) Avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as simultaneous administration of different NSAIDs may increase the risk of gastrointestinal ulceration and bleeding (see section 4.4). Acetylsalicylic acid (as an antiplatelet treatment) Concomitant administration of dexibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen could 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 long-term regular use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid. Clinically relevant effects are not considered to be likely for occasional use of ibuprofen (see section 5.1). Although there are no data available for dexibuprofen, it is reasonable to assume that there is a similar interaction between dexibuprofen (= S (+) - ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low dose acetylsalicylic acid.Precautions: Antihypertensives (ACE inhibitors, beta receptor blockers or angiotensin II) and diuretics NSAIDs can reduce the effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the coadministration of ACE inhibitors, beta receptor blockers or angiotensin-II antagonists and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the 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 at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. Aminoglycoside antibiotics, cyclosporine, tacrolimus and sirolimus Concomitant administration with NSAIDs may increase the risk of nephrotoxicity due to reduced synthesis of prostaglandins in the kidney. During combined treatment, renal function should be closely monitored,especially in the elderly. Corticosteroids Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants NSAIDs may enhance the effects of anticoagulants, such as heparin or its derivatives, vitamin K antagonists, such as acenocoumarol or warfarin, and non-vitamin K antagonist oral anticoagulants such as rivaroxaban, apixaban or dabigatran (see section 4.4) . Digoxin, phenytoin, lithium Concomitant use of dexibuprofen with digoxin, phenytoin or lithium preparations may increase the serum levels of these medicinal products. Monitoring of serum lithium levels, serum digoxin levels and serum phenytoin levels are generally not required with proper use (3 days maximum). Methotrexate There is evidence of a potential increase in plasma methotrexate levels. Administration of dexibuprofen within 24 hours before or after administration of methotrexate can lead to elevated concentrations of methotrexate and an increase in its toxic effect. Sulfonylureas Clinical investigations have shown interactions between NSAIDs and antidiabetics (sulfonylureas). Although no interactions have been described between ibuprofen or dexibuprofen and sulphonylureas, monitoring of blood glucose values is recommended, as well as a precaution during concomitant use. Quinolone antibiotics Animal data 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 dexibuprofen with CYP2C9 inhibitors may increase exposure to dexibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (inhibitors of CYP2C9) an increase in exposure to S (+) - ibuprofen of approximately 80-100% was shown. Dose reduction of dexibuprofen should be considered when co-administered potent CYP2C9 inhibitors, particularly when high-dose dexibuprofen is administered with voriconazole or fluconazole. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) Increased risk of gastrointestinal bleeding (see section 4.4). Potassium-sparing diuretics Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalaemia (monitoring of serum potassium is recommended). Zidovudine (azidothymidine) Increased risk of haematological toxicity when NSAIDs are administered with zidovudine. There is evidence of an increased risk of haemarthrosis and hematoma in HIV (+) haemophiliacs receiving concomitant treatment with zidovudine and ibuprofen. Probenecid and sulfinpyrazone Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. Baclofen Baclofen toxicity can develop after ibuprofen use. Pemetrexed High doses of NSAIDs can increase the concentration of pemetrexed. In patients with mild to moderate renal impairment (creatinine clearance 45 to 79 ml / min), concomitant use of high-dose dexibuprofen should be avoided two days before and two days after administration of pemetrexed. Alcoholic Excessive alcohol consumption during NSAID therapy may increase gastrointestinal adverse effects.

Overdose

Dexibuprofen exhibits low acute toxicity and some patients have survived after single doses of up to 54 g of ibuprofen (equivalent to approximately 27 g of dexibuprofen). Most overdoses are asymptomatic. There is a risk of symptoms at doses> 80-100 mg / kg of ibuprofen. The onset of symptoms usually occurs within 4 hours. Mild symptoms are more common, including abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nystagmus, tinnitus, and ataxia. Rarely, moderate or severe symptoms include gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, renal impairment, coma, adult respiratory distress syndrome, and transient apnea episodes (in very young children following high ingestion ). In case of severe poisoning, metabolic acidosis may arise. Treatment is symptomatic and there is no specific antidote. Quantities that do not produce symptoms (less than 50 mg / kg dexibuprofen) can be diluted with water to minimize gastrointestinal upset. If a significant amount is ingested, administer activated charcoal. Stomach emptying by emesis can only be considered if the procedure can be undertaken within 60 minutes of ingestion. Gastric lavage should not be considered unless a patient has ingested a life-threatening amount of the drug and the procedure can be undertaken within 60 minutes of ingestion. Forced diuresis, hemodialysis or hemoperfusion are of little use because dexibuprofen is strongly bound to plasma proteins.

Active principles

Each film-coated tablet contains 200 mg of dexibuprofen. For the full list of excipients, see section 6.1.

Excipients

Tablet core:hypromellose, microcrystalline cellulose, carmellose calcium, anhydrous colloidal silica, talc.Coating film material:hypromellose, titanium dioxide (E171), triacetin, talc, macrogol 6000.