Descrizione Clinica
Anti-inflammatory Buscofokus 20cpr riv 200mg
BUSCOFOKUS 200 MG FILM-COATED TABLETS
active ingredients
Each film-coated tablet contains 200 mg of dexibuprofene. For the full list of excipients, see paragraph 6.1.Excellent
Compressed core: ipromellosa, microcrystalline cellulose, fleshy calcium, colloidal silica anidra, talco. Coating film material: ipromellose, titanium dioxide (E171), triacetin, talc, macrogol 6000.Therapeutic indications
Buscofokus is indicated in adults for the symptomatic treatment of short duration of acute pain from mild to moderate and inflammation as - musculoskeletal pain as, back pain, - dental pain, pain after dental extraction, - menstrual pain, - headache, - pain associated with cold and flu.Contraindications
Dexibuprofen should not be given to patients: - With hypersensitivity to the active ingredient, to any other NSAID or to any of the excipients listed in paragraph 6.1; - In which substances with a similar action (e.g. acetylsalicylic acid or other NSAIDs) trigger attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, hives or angioneurotic edema; - They have anamnesi of bleeding or gastrointestinal perforation, related to a previous therapy with NSAIDs; - With current or with history of peptic ulcer/recurring bleeding (two or more separate episodes of ulceration or proven bleeding); - With unclear haemopoietic disorders; - With cerebrovascular bleeding or other bleeding in progress; - With active Crohn disease or active ulcerative colitis; - With severe heart failure (Class IV of the New York Heart Association, NYHA) (see paragraph 4.4); - With severe renal dysfunction (GFR)Population
Population The dosage must be adjusted according to the severity of the disorder and the problems of the patient. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). The recommended maximum daily dose is 600 mg dexibuprofen, divided up to three single doses of 200 mg. The interval between one dose and the other should not be less than 6 hours. The maximum daily dose for no prescription is 600 mg dexibuprofene (3 tablets of Buscofokus) in 24 hours. Tablets can be divided into equal doses. The tablet must be placed on a rigid and pressed surface with two fingers, index or thumb, to be divided. Pediatric population Studies have not been conducted on the use of dexibuprofen in children and adolescents (Anziani Special modifications of the dosage are not required in the elderly. However, a reduction and evaluation of the individual dose must be taken into account due to the increased susceptibility of the elderly to adverse reactions of the gastrointestinal tract (GI) (see paragraph 4.4). Hepatic dysfunction Patients with mild to moderate liver dysfunction must start therapy at reduced doses and be strictly controlled. Renal dysfunction In patients with impaired kidney function, the initial dose must be reduced to moderate. Method of administration Tablets coated with movies can be taken with or without food (see paragraph 5.2). In general, NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with a meal to reduce gastrointestinal irritation, especially in case of chronic use. However, in some patients, delay in the onset of the action is expected when tablets are taken with meals or immediately after meals. Duration of treatment If conditions do not improve within 4 days (3 days if there is a fever), we recommend that you consult your doctor.Conservation
Do not store at temperature above 25 °C.Warnings
Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and GI and cardiovascular risks below). Caution is recommended in patients: - With systemic erythematosum lupus and different connective tissue diseases as there is a greater risk of developing aseptic meningitis (see paragraph 4.8); - Congenital pathology of porphyrinic metabolism (e.g. intermittent acute porphyria); - With history of gastrointestinal pathologies or chronic intestinal inflammatory pathologies ( ulcerative colitis and Crohn's disease) (see paragraph 4.8); - With high blood pressure and (or) mild to moderate heart failure since fluid retention and edema were reported in association with NSAID therapy; - With kidney damage as renal function may worsen further (see paragraphs 4.3 and 4.8); - With liver dysfunction (see paragraphs 4.3 and 4.8); - Immediately after important surgery; - With allergic rhinitis, nasal polyps or chronic pulmonary obstructive diseases, since there is a greater risk of allergic reactions. These may be asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Other Concurrent use of dexibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Seniors The elderly have a greater frequency of adverse reactions to the NSAIDs, especially bleeding and gastrointestinal perforation that can be fatal. Gastrointestinal hazards Hemorrhage, ulceration and gastrointestinal perforation, sometimes fatal, were reported, at any stage of treatment, with the use of all NSAIDs, with or without prodromic symptoms or a history of serious gastrointestinal events. The risk of ulceration or perforation or gastrointestinal hemorrhage increases with higher doses of NSAIDs, in patients with ulcer history, especially if complicated by hemorrhage or perforation (see paragraph 4.3), alcoholism and elderly patients. These patients must begin treatment with the lowest dose available. A concomitant therapy with protective agents (e.g. misoprostol or protonic pump inhibitors) must be taken into account for these patients and also for patients taking low doses of acetylicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with gastrointestinal toxicity anamnesis, especially when elderly, must report any abdominal symptoms (especially gastrointestinal hemorrhage), especially in the early stages of treatment. It is recommended caution in patients in concomitant treatment with drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, oral or parental anticoagulants (e.g. heparin or its derivatives, antagonists of vitamin K, such as acenocumarol or warfarin and non-vitamin K oral anticoagulants, such as reservoxabanids. When bleeding or gastrointestinal ulceration occurs in patients taking Buscofokus, the treatment must be suspended. NSAIDs should be given with caution to patients with history of inflammatory gastrointestinal disease ( ulcerative colitis, Crohn's disease) as their condition may worsen (see paragraph 4.8). Hypersensitivity As with other NSAIDs, allergic reactions can occur, including anaphylactic/anaphylactic reactions, even in the absence of previous exposure to the drug. Severe reactions from acute hypersensitivity (e.g. anaphylactic shock) occur very rarely. At the first signs of a reaction of hypersensitivity after taking ibuprofen, the therapy must be suspended. Medical measures required on the basis of symptoms must be carried out by experienced personnel. Respiratory effects In patients suffering from or with early history of bronchial asthma or allergic diseases may occur bronchospasm. Cardiovascular and cerebrovascular effects For patients with anamnesi of hypertension and/or mild to moderate congestive heart failure, adequate monitoring and advice is required, since in combination with NSAID therapy fluid retention and edema were reported. Clinical studies suggest that the use of ibuprofen especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg per day) are associated with 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/die) is similar to that associated with high-dose ibuprofen (2400 mg/die). Patients suffering from uncontrolled hypertension, congestive heart failure (NYHA II-III), proven ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular disease should be treated with dexibuprofen only after careful evaluation and high doses (1200 mg/die) should be avoided. You should also be careful before you start the long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoke), especially if high doses of dexibuprofen (1200 mg/die are required). Kidney and hepatitis effects It is necessary to pay attention to patients suffering from liver and kidney disease; it is necessary to take into account the risk of fluid retention, edema and deterioration of kidney function. In case of treatment of these patients with dexibuprofen, the lowest possible dose must be used and kidney function must be regularly controlled. As with other NSAIDs, dexibuprofen may be associated with adverse effects on the kidney system, which can lead to glomerulonephritis, interstitial nephritis, kidney papillar necrosis, nephrosic syndrome and acute kidney failure (see paragraphs 4.2, 4.3 and 4.5). As with all NSAIDs, dexibuprofen can increase azotemia and creatininemia values. As with other NSAIDs, dexibuprofen may cause slight transient increases in certain hepatic parameters and also significant increases in SGOT and SGPT levels. In the event of a substantial increase in these parameters, therapy must be interrupted (see paragraphs 4.2 and 4.3). In general, the usual use of analgesics, in particular the combination of several analgesic drugs, can lead to lasting kidney injuries with the risk of kidney failure (nephropathy from analgesics). Therefore, associations with ibuprofen or other NSAIDs must be avoided (including self-medication products and selective COX-2 inhibitors). Severe skin reactions Severe skin reactions, some of which lethal, including exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at greater risk of these reactions at the beginning of therapy, as the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. The administration of dexibuprofen should be interrupted to the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections Buscofokus can mask the symptoms of infection, which could 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 Buscofokus 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. It is advisable to avoid the use of dexibuprofen in case of chickenpox. Coagulation Similarly to other NSAIDs, dexibuprofen can severely inhibit piastrinic aggregation and function and prolong bleeding time. Care should be taken in patients with hemorrhagic diathesis and other clotting disorders and when dexibuprofen is administered simultaneously to oral anticoagulants (see paragraph 4.5). Preclinical studies suggest that the inhibition of piastrinic aggregation determined by low doses of acetylsalicylic acid can be altered if FANS are administered simultaneously as dexibuprofen. This interaction could reduce the cardiovascular protective effect. Therefore, in the case of concomitant administration of acetylical acid at low doses, special attention should be paid if the duration of treatment exceeds the short term (see paragraphs 4.5 and 5.1). Cephalea from excessive use of medicinal products Prolonged use of any type of analgesic for headache can make it worse. If this situation is present or suspected, consult your doctor and stop treatment. Diagnosis of headache caused by excessive use of medicine (Medication Overuse Headache, MOH) must be suspected in patients with frequent or daily headaches despite (or due to) regular use of cephalea medications. Additional warnings and precautions Patients in long-term treatment with dexibuprofen should be monitored as a precautionary measure (renal, hepatic and hematological/hematological function).Interactions
The information of this section is also based on previous experience with dexibuprofen and other NSAIDs. In general, NSAIDs must be used with caution with other drugs that may increase the risk of gastrointestinal ulceration or gastrointestinal bleeding or kidney damage. Contemporary use is not recommended with: Other NSAIDs and salicylates (acetylsalicylic acid as painkiller) Avoid concurrent use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, since simultaneous administration of different NSAIDs can increase the risk of gastrointestinal ulceration and hemorrhage (see paragraph 4.4). Acetylsalicylic acid (such as antiplatelet treatment) Concurrent administration of dexibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen could 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, it cannot be excluded the possibility that the long-term regular use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. Clinical effects are not likely to be relevant to the occasional use of ibuprofen (see paragraph 5.1). Although there is no data available for dexibuprofen, it is reasonable to assume that there is a similar interaction between dexibuprofene (= S(+)-ibuprofene) (which is the pharmacologically active enantiomer of ibuprofene) and acetylyl acid at low doses. 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 kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of ACE inhibitors, beta receptor blockers or antagonists of angiotensin- II and agents inhibiting cyclooxygenase may cause further deterioration of kidney function, including possible acute kidney failure, which is generally reversible. Therefore, the combination should be given with caution, especially in the elderly. Patients should be properly hydrated and should be taken into account the monitoring of kidney function after the start of concomitant therapy, and subsequently at regular intervals. Diuretics can increase the risk of NSAID nephrotoxicity. Antibiotics aminoglycosidic, cyclosporin, tacrolimus and sirolimus Concurrent administration with NSAIDs can increase the risk of nephrotoxicity due to the reduced synthesis of prostaglandins in the kidney. During combined treatment, kidney function must be strictly controlled, especially in the elderly. Courtesy Increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Antiagulants NSAIDs can increase the effects of anticoagulants, such as heparine or its derivatives, vitamin K antagonists, such as acenocumarol or warfarin, and non-vitamin K oral anticoagulants such as Rivaroxaban, apixaban or dabigatran (see paragraph 4.4). Digoxin, phenytoin, lithium Concurrent use of dexibuprofen with digoxin, phenytoin or lithium preparations can increase the serum levels of these medicines. Monitoring of the serum levels of lithium, serum levels of digoxin and serum levels of phenytoin are generally not required with proper use (3 days at most). Methodology There is evidence of a potential increase in plasma levels of metotrexate. The administration of dexibuprofen within 24 hours before or after the administration of metotrexate may lead to high metotrexate concentrations and an increase in its toxic effect. On the phone Clinical investigations have shown interactions between NSAIDs and antidiabetics (sulphonluree). Although interactions between ibuprofen or dexibuprofene and sulphonluree have not been described, glycemic values control is recommended, as well as precaution during concurrent use. Chinolonic Antibiotics Animal data indicates that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have a greater risk of developing seizures. CYP2C9 inhibitors Concurrent administration of dexibuprofen with CYP2C9 inhibitors can increase exposure to dexibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors an increase in exposure to S(+)-ibuprofen of about 80-100% was demonstrated. The reduction of dexibuprofen dose should be taken into account when administering powerful CYP2C9 inhibitors simultaneously, especially when high dose dexibuprofen is administered with voriconazole or fluconazole. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRI) Increased risk of gastrointestinal bleeding (see paragraph 4.4). Diuretic potassium savers Concurrent administration of ibuprofen and potassium-saving diuretics can cause hyperkaliemia (serious control of serum potassium is recommended). Zidovudina (azidotimidina) Increased risk of hematological toxicity when NSAIDs are administered with zidovudine. There is evidence of an increase in the risk of hematoma and hematoma in HIV (+) hemophiliacs in treatment at the same time with zidovudine and ibuprofen. Probenecid and the Finpirazone Drugs containing probenecid or finpirazone may delay the excretion of ibuprofen. Baclofene Baclofen toxicity can develop after use of ibuprofen. Pemetrex High doses of NSAIDs can increase the concentration of pemetrexed. In patients suffering from mild to moderate kidney failure (cancer from 45 to 79 ml/min), the concomitant use of high dose dexibuprofen should be avoided two days before and two days after the administration of pemetrexed. Alcohol Excessive alcohol consumption during NSAID therapy can increase gastrointestinal adverse effects.Effects
a. Summary of security profile Clinical experience has shown that the risk of undesirable effects induced by dexibuprofen is widely comparable to that of racemic hybuprofen, see also section 5.1. The most common adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). Adverse events are mainly dependent on dose and vary individually, especially the risk of occurrence of undesirable gastrointestinal effects depends on dose interval and duration of treatment. Some of the side effects are less frequent when the maximum daily dose is 600 mg dexibupropfen if you compare high dose therapy to long-term therapy, e.g. in rheumatic patients.| Very common | (≥1/10); |
| Town | (from ≥1/100 to |
| Not common | (from ≥1/1,000 to |
| Rare | (from ≥1/10.000 to |
| Very rare | ( |
| Notable | (frequency cannot be defined on the basis of available data). |
| Infections and infestations | Very rare | The aggravation of infection-related inflammations (e.g. the development of necrotizing fascites) was described during the use of NSAID1. |
| Emolinfopoietic system pathologies | Very rare | Hemopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis)2. |
| Immune system disorders | Not common | Hypersensitivity reactions with skin rashes and itching sensation, as well as as asthma attacks (with possibility of blood pressure reduction)3; |
| Very rare | Severe reactions of general hypersensitivity. They may vary from facial edema, tongue swelling, internal larynx swelling with airway constriction, tired breathing, tachycardia and blood pressure reduction up to dangerous shock for life. Asthma aggravated3. | |
| Psychiatric disorders | Very rare | Psychic reaction, depression. |
| Diseases of the nervous system | Not common | Central nervous disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue; |
| Very rare | Synthetic Meningitis4. | |
| Pathologies of the eye | Not common | Visual disturbances. |
| Ear and labyrinth pathologies | Rare | Tinnitus, hearing compromised after a longer treatment. |
| Heart disease | Very rare | Edema, palpitations, heart failure5. |
| Vascular diseases | Very rare | Arterial hypertension, vasculitis. |
| Gastrointestinal diseases | Town | Gastrointestinal disorders such as abdominal pain, nausea, dyspepsia, diarrhea, flatulence, constipation, heartburn, vomiting and mild gastrointestinal hematic losses that can cause anemia in exceptional cases6; |
| Not common | Gastrointestinal ulcer, perforation or gastrointestinal hemorrhage, gastritis, ulcerative stomatitis, aggravation of Crohn's colitis and disease (see paragraph 4.4); | |
| Very rare | Esophagitis, pancreatis, formation of intestinal stenosis similar to diaphragms. | |
| Pathologies of skin and subcutaneous tissue | Not common | Skin rashes; |
| Very rare | Multiform erythema, alopecia, photosensitivity reactions, bollose reactions including Stevens-Johnson syndrome, acute toxic epidermal necrolysis ( Lyell syndrome); | |
| Not known | Drug reaction with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute hexantholysis (PEAG). | |
| Respiratory, chest and mediastinic pathologies | Very rare | Broncospasm (predominantly in asthmatic patients), aggravation of asthma. |
| Kidney and urinary pathologies | Rare | Renal dynasty (paillar necrosis), high concentrations of urea in the blood and high concentrations of uric acid in the blood; |
| Very rare | Edema formation, especially in patients with arterial hypertension or kidney failure, interstitial nephritis, nephrosic syndrome or kidney damage. The kidney function must be regularly checked during prolonged treatment. | |
| Hepatobiliary diseases | Rare | Alterations of liver functions (usually reversible); |
| Very rare | Hepatic dysfunction, liver damage, especially during long-term treatment, liver failure, acute hepatitis and jaundice. |
Overdosing
Dexibuprofen has a low acute toxicity and some patients survived after single doses up to 54 g of ibuprofen (equivalent to about 27 g of dexibuprofen). Most overdose is asymptomatic. There is a risk of symptoms at doses > 80-100 mg/kg of ibuprofen. The onset of symptoms usually takes place within 4 hours. The mild symptoms are more common, including abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nistagm, tinnitus and ataxia. Rarely, moderate or severe symptoms include gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, convulsive crisis, impairment of kidney function, coma, adult respiratory suffering syndrome and transient episodes of apnea (in very small children following high ingestion). In case of severe poisoning it can develop metabolic acidosis. Treatment is symptomatic and there is no specific antidote. The quantities that do not produce symptoms (less than 50 mg/kg dexibuprofen) can be diluted with water to minimize gastrointestinal disorders. In case of ingestion of a significant amount, administer activated carbon. Emptying the stomach by means of hemesis can only be considered if the procedure can be undertaken within 60 minutes of ingestion. Gastric washing should not be taken into account unless a patient has ingested a potentially lethal amount of the drug and the procedure can be undertaken within 60 minutes of ingestion. Forced diuresis, hemodialysis or hemoperfusion are not useful because dexibuprofen is strongly linked to plasma proteins.Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Epidemiological studies suggest an increase in the risk of miscarriage, heart malformation and gastroschisis after the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1%, up to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, it has been shown that the administration of an inhibitor of the synthesis of prostaglandins increases a pre- and post-system loss and embryo-fetal lethality. In addition, increased incidences of various malformations were reported, including cardiovascular disease, in animals that received an inhibitor of prostaglandin synthesis during the organogenetic period (see paragraph 5.3). During the first and second quarter of pregnancy, NSAIDs should not be administered unless strictly necessary. If the NSAIDs are used during the first and second trimester of pregnancy, you should use the minimum dose 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress to kidney failure with oligo-hydroamniosis and can expose the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, dexibuprofene is contraindicated during the third trimester of pregnancy.Food
Ibuprofen is slightly excreted in human milk. Breastfeeding is possible with dexibuprofen if the dosage is low and the treatment period is short.Fertility
Drugs known in the inhibition of the synthesis of prostaglandins/cyclooxygenases can reversibly compromise fertility and are not recommended in women who are trying to conceive. In women who have difficulty in conceiving or who are under investigation of infertility, it is necessary to consider the interruption of dexibuprofen.Source: Farmadati
