BUSCOFENACT 20CPS 400MG

BUSCOFENACT 400 MG CAPSULE MOLLI

active ingredients

One soft capsule contains 400 mg of ibuprofen. Excipients with known effect: Sorbitol 95,94 mg/capsula (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

Content of the capsules: Macrogol 600 Potassium hydroxide Purified water Capsule wrapping : Gelatina Liquid Sorbitol Purified Water Printing Ink Ingredients of Opacode WB Black NS-78-17821: Black Iron oxide (E172) propylene glycol (E1520) Ipromellosa 6cP

Therapeutic indications

Syntomatic treatment of short duration of: - mild to moderate pain such as headache, toothache and menstrual pain; - fever and pain associated with the common cold. BuscofenAct is indicated in adults and adolescents with body weight of more than 40 kg (aged or older than 12 years).

Contraindications

BuscofenAct soft capsules is contraindicated in case of: - hypersensitivity to ibuprofene or any of the excipients listed in paragraph 6.1; - history of hypersensitivity (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); - hematologic disorders of unknown origin; - history of peptic ulcer/recurrent bleeding or in place (two or more separate episodes, of proven ulceration or bleeding); - history of gastrointestinal hemorrhage or perforation, related to a previous therapy with NSAID; - cerebrovascular hemorrhage or other bleeding episodes; - severe heart failure (IV NYHA class) (see also paragraph 4.4); - severe liver failure or severe kidney failure (see also paragraph 4.4); - patients at the third quarter of pregnancy (see paragraph 4.6); - teenagers with body weight below 40 kg and children under 12 years of age; - patients with severe dehydration (for vomiting, diarrhea or insufficient liquid intake).

Population

Population Adults and adolescents with body weight > 40 kg (aged or older than 12 years): initial dose of 400 mg of ibuprofen. If necessary, an additional 400 mg dose of ibuprofen can be taken. The interval between one dose and the other must be determined according to the observed symptoms and the maximum recommended daily dose, and should not be less than 6 hours. Do not take more than 1200 mg of ibuprofen in 24 hours. Only for short-term treatments. 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 4.4). If BuscofenAct soft capsules should be taken in adults for more than 3 days in case of fever or for more than 4 days for pain treatment or if symptoms worsen, it is recommended for the patient to consult the doctor. Full stomach intake is recommended for people with gastric disorders. If taken shortly after eating, the occurrence of the BuscofenAct effect can be delayed. If this happens do not take BuscofenAct more than recommended in paragraph 4.2 (posology) or until the correct interval between one dose and the other is over. Particular populations of patients Seniors No special modifications of the dosage are required. Due to possible side effects (see paragraph 4.4), older subjects must be carefully monitored. Renal insufficiency In patients with mild or moderate kidney function, special dose changes are not required (for patients with severe kidney failure, see paragraph 4.3). Hepatic insufficiency (see paragraph 5.2) In patients with mild or moderate liver function damage, special dose changes are not required (for patients with severe liver dysfunction, see paragraph 4.3). Pediatric population BuscofenAct is contraindicated in adolescents with body weight below 40 kg and in children under 12 years of age due to the high active substance content (see paragraph 4.3). In case the use of the medicinal product is necessary for more than 3 days in adolescents, or in case of worsening of the symptomatology the doctor must be consulted. Method of administration For oral use. Soft capsules should not be chewed.

Conservation

This medicine does not require any special storage temperature.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment, necessary to obtain control of symptoms (see below paragraphs dedicated to gastrointestinal and cardiovascular risks). It requires caution in patients with certain clinical conditions, which could worsen: - patients with systemic erythematous lupus and various pathologies of connective tissue have a greater risk of developing aseptic meningitis (see paragraph 4.8); - congenital pathology of porphyrinic metabolism (e.g. intermittent acute porphyria); - gastrointestinal pathologies and chronic intestinal inflammatory pathologies ( ulcerative colitis, Crohn's disease) (see paragraph 4.8); - hypertension and/or cardiac impairment as renal function may worsen (see paragraphs 4.3 and 4.8); - kidney damage (see paragraphs 4.3 and 4.8); - hepatic dysfunction (see paragraphs 4.3 and 4.8); - immediately after important surgery; - in patients who have allergic reactions to other substances, since for such patients there is a greater risk of hypersensitivity reactions also following the use of BuscofenAct; - in patients suffering from hay fever, nasal polyps or chronic obstructive diseases of the respiratory tract since for such patients there is a greater risk of allergic reactions. Such reactions may occur as asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Gastrointestinal effects The use of BuscofenAct soft capsules in association with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse reactions and must be avoided. Seniors Older subjects have a greater frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal (see paragraph 4.2). Gastrointestinal bleeding, ulceration or drilling Gastrointestinal hemorrhage, ulceration or 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 gastrointestinal events. If bleeding or gastrointestinal ulceration occurs in patients taking ibuprofen, the treatment must be suspended. The risk of gastrointestinal hemorrhage, ulceration or perforation increases with higher doses of NSAIDs, in patients with ulcer history, especially if complicated by hemorrhage or perforation (see paragraph 4.3), and in 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 history of gastrointestinal toxicity, especially the elderly, must report any unusual abdominal symptoms (especially gastrointestinal hemorrhage), especially in the early stages of treatment. Caution should be used in patients in concomitant treatment with drugs that may increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregants such as acetyl acid (see paragraph 4.5). NSAIDs should be given with caution to patients with history of gastrointestinal pathologies ( ulcerative colitis, Crohn's disease) as their conditions may worsen (see paragraph 4.8). Strict skin reactions Very rarely have been reported, in association with the use of NSAIDs (see paragraph 4.8), severe skin reactions, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients seem to be at greater risk for these reactions in the early stages of therapy; in fact, in most cases, the reaction arises in the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. The administration of BuscofenAct soft capsules should be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Exceptionally the chickenpox can be the origin of severe skin infections and complications at the expense of soft tissues. It is recommended not to use BuscofenAct soft capsules in course of chickenpox. Masking the symptoms of underlying infections BuscofenAct soft capsules can mask the symptoms of infection, which may delay the start of proper treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When BuscofenAct soft capsules 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. Cardiovascular and cerebrovascular effects It requires caution (discuss with your doctor or pharmacist) before you begin treatment in patients with anamnesi of hypertension and/or heart failure, since in association with NSAID therapy fluid, hypertension and edema were found. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg per day) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg per day). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg per day) are required of ibuprofen. Other warnings and precautions Severely severe acute reactions of hypersensitivity have been observed (p.es. anaphylactic shock). To the first signs of a reaction of hypersensitivity following the intake/administration of BuscofenAct soft capsules, the therapy must be suspended. The medical measures required must be carried out by experienced personnel. The ibuprofene, the active ingredient of BuscofenAct soft capsules, can temporarily inhibit the pyasternic function (platelet aggregation). Therefore, patients with platelet disorders must be carefully monitored. In case of prolonged treatment with ibuprofen, it is necessary to regularly check hepatic and kidney parameters, as well as the blood picture. Prolonged use of any headache analgesic can make it worse. If you experience or suspect this situation, you should consult your doctor and stop treatment. Diagnosis of headache from excessive use of drugs (MOH) must be suspected in patients with frequent or daily headaches, despite (or due to) regular use of headache medications. In general, the usual use of analgesics, in particular the association of different active ingredients, can lead to permanent kidney injuries with the risk of kidney failure (nephropathy from analgesics). This risk can be increased under physical effort associated with loss of salts and dehydration. Therefore this must be avoided. In case of concomitant consumption of alcohol during the use of NSAIDs, adverse events related to the active ingredient, especially those with gastrointestinal tract or central nervous system, can increase. Pediatric population In dehydrated adolescents there is a risk of alteration of kidney function. Sorbitol BuscofenAct contains 95.94 mg of sorbitol in each capsule. Patients with a hereditary intolerance to fructose, a rare genetic disease, should not take this medicine.

Interactions

Concurrent use of ibuprofen with:	Possible effects:
Other NSAs, including salicylates	Concurrent administration of several NSAIDs can increase the risk of gastrointestinal hemorrhage and ulcers due to a synergistic effect. Therefore the concomitant use of ibuprofen with other NSAIDs must be avoided (see paragraph 4.4).
Digoxin	Concurrent use of BuscofenAct soft capsules with drugs containing digoxin, can increase the serum levels of digoxin. Usually, if the digoxin is used correctly (for a maximum of 4 days) it is not necessary to control the serum levels.
Courtesy	Corticosteroids may increase the risk of adverse reactions, particularly gastrointestinal tract (gastrointestinal bleeding or ulceration) (see paragraph 4.4).
Anti-platelet agents	Increased risk of gastrointestinal hemorrhage (see paragraph 4.4).
Acetylsalicylic acid	Concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two medicines are administered simultaneously. Although there are uncertainties regarding the extrapolation of this data to the clinical situation, the possibility that regular use, long-term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1).
Antiagulants	NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4).
Fenitoin	Concurrent use of BuscofenAct and phenytoin-based preparations can increase serum levels of phenytoin. Usually, if used correctly (for a maximum of 4 days) it is not necessary to check the serum levels of phenytoin.
Selective serotonin reuptake inhibitors (SSRI)	Increased risk of gastrointestinal hemorrhage (see paragraph 4.4).
Litio	Concurrent use of BuscofenAct with lithium preparations can increase the serum levels of lithium. Usually, if used correctly (for a maximum of 4 days) it is not necessary to control the serum levels of lithium.
Probenecid and the Finpirazone	Drugs containing probenecid and sulfinpirazone may delay the elimination of ibuprofen.
Diuretics, ACE inhibitors, beta-blockers and antagonists of angiotensin II	NSAIDs can reduce the effect of diuretics and other antihypertensive medicines. In some patients with impaired kidney function (especially dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE, beta-blocker or antagonists of angiotensin II and agents that inhibit cyclo-oxidase can cause further worsening of kidney function, including a possible acute kidney failure, usually reversible. Therefore, these associations must be administered with caution especially in elderly patients. Patients should be properly hydrated and renal function monitoring should be taken into account at the beginning of concomitant therapy and subsequently on a periodic basis.
Diuretic potassium savers	Concurrent intake of BuscofenAct and potassium-saving diuretics can lead to hyperkaliemia.
Methodology	BuscofenAct administered in 24 hours before or after taking metotrexate may increase its concentrations and therefore toxicity.
Ciclosporine	The risk of kidney damage caused by cyclosporins may be increased by the concomitant use of some NSAIDs. This effect cannot be excluded in the event of a contemporary intake of cyclosporins and ibuprofene.
Tacrolimus	The risk of nephrotoxicity increases in case of concurrent administration of ibuprofene and tacrolimus.
Zidovudina	In case of concurrent administration of ibuprofen and zidovudine, there is evidence of an increase in the risk of hematomas and hematomas in positive HIV hemophiliacs.
On the phone	Clinical researches have shown that there are interactions between non-steroidal anti-inflammatory drugs and anti-diabetic drugs (sulfoniluree). Although interactions between ibuprofen and sulphonluree have not yet been described, in case of concomitant use of these two drugs it is recommended to control blood sugar.
Chinolonic Antibiotics	Animal studies indicate that NSAIDs can increase the risk of convulsions associated with the use of kinolonic antibiotics. Patients taking NSAIDs and kinolonics may have an increased risk of developing seizures.
CYP2C9 inhibitors	Concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. You should consider reducing the dose of ibuprofen when concurrently administering strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole and fluconazole.
Mifepristone	NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Effects

The list of side effects listed below refers to all the side effects that have occurred during treatment with ibuprofen, including those observed during long-term treatment and high doses in patients with rheumatic pathologies. The declared frequencies, which occur with a higher incidence than very rare cases, refer to the short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for the oral dosage form and a maximum of 1800 mg for the supposed. It should be taken into account that the following side effects are basically dose-dependent and vary from individual to individual. The most commonly observed unwanted events are gastrointestinal. Peptic ulcer, perforation or gastrointestinal hemorrhage may occur, even with fatal outcome, especially in the elderly (see paragraph 4.4). As a result of administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, worsening of the colitis and Crohn's disease (see paragraph 4.4). Gastritis has been observed less frequently. The risk of gastrointestinal hemorrhage depends on the dose and duration of treatment. In association with the treatment with NSAIDs were reported edema, hypertension and heart failure. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Patients should be informed to immediately stop taking BuscofenAct and consult the doctor if a serious adverse reaction occurs. The adverse reactions are listed below by classification for systems and organs, and by frequency, according to the following categories: Very common (≥1/10) Common (≥1/100, Infections and infestations Very rare In conjunction with the use of non-steroidal anti-inflammatory drugs a worsening of infectious inflammations (e.g. development of necrotizing fascites). This is probably associated with the mechanism of action of non-steroidal anti-inflammatory drugs. During treatment with ibuprofen, symptoms of aseptic meningitis with nuke stiffness, headaches, nausea, vomiting, fever or clouding of consciousness were observed. Patients with autoimmune diseases (LES, mixed connective tissue disease) seem to be predisposed. Emolinfopoietic system pathologies Very rare Hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first signs can be: fever, sore throat, superficial wounds in the mouth, flu-like symptoms, strong fatigue, epistaxis and skin bleeding. In a long-term therapy, the blood count must be checked regularly. Immune system disorders Not common Hypersensitivity reactions with rashes, and itching, asthma attacks (with possible decrease in blood pressure). Very rare Severe generalized reactions of hypersensitivity, whose signs can be facial edema, swelling of the tongue, swelling of the larynx with constriction of the respiratory tract, respiratory distress, tachycardia, decrease of blood pressure, up to dangerous mortal shock for life. If one of these symptoms occurs, and this may also happen at first use, immediate medical assistance is required. Psychiatric disorders Very rare Psychic reactions, depression. Diseases of the nervous system Not common Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability or fatigue. Pathologies of the eye Not common Visual disturbances. Ear and labyrinth pathologies Rare Tinnitus. Heart disease Very rare Palpitations, heart failure, myocardial infarction. Vascular diseases Very rare Arterial hypertension, vasculitis. Gastrointestinal diseases Town Gastrointestinal disorders, such as pyrosis, abdominal pain, nausea, dyspepsia, vomiting, flatulence, diarrhea, constipation, slight blood losses at the gastrointestinal level that in exceptional cases involve anemia. Not common Gastrointestinal ulcer with potential hemorrhage and perforation. Ulcerative symptoms, worsening of the colitis and Crohn's disease (see paragraph 4.4), gastritis. Very rare Esophagitis, pancreatis, formation of diaphragmatic intestinal stenosis. If you experience severe pain in the upper part of the abdomen or if you experience melena or ematemesis, you should immediately inform your doctor and stop taking the medicine. Hepatobiliary diseases Very rare Hepatic dysfunction, liver damage, especially in case of prolonged therapy, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue Not common Different rashes. Very rare Bollose reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis ( Lyell syndrome), alopecia. In exceptional cases, severe skin infections, and soft tissues during chickenpox infection (see also "Infections and infestations"). Notable Generalized acute exantelosis (PEAG). Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome). Photosensitivity reactions Kidney and urinary pathologies Rare Rarely, damage to the kidney tissue (papillary necrosis) and high concentrations of uric acid in the blood may also be observed. Very rare Formation of edema, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which can be accompanied by acute kidney failure. The kidney function must be checked regularly. If necessary, patients should be adequately advised to stop treatment with BuscofenAct and consult a doctor immediately if any of the following conditions occur: - severe gastrointestinal disturbances, heartburn or abdominal pain; - haematemesis;- melaena or blood in the urine;- skin reactions, such as itchy rashes;- respiratory distress and/or swelling of the face or larynx;- fatigue associated with loss of appetite;- sore throat, associated with aphthous ulcers, fatigue and fever;- severe nosebleeds and skin bleeding;- abnormal tiredness associated with reduced urinary excretion;- swelling of the feet or legs;- chest pain;- visual disturbances. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms in case of overdose Symptoms of overdose may include central nervous system symptoms such as headache, dizziness, light-headedness and loss of consciousness (myoclonic convulsions even in children), abdominal pain, nausea, vomiting, gastrointestinal bleeding and liver and kidney dysfunction, hypotension, respiratory depression and cyanosis.In cases of severe poisoning, metabolic acidosis may occur. Therapeutic measures in case of overdose There is no specific antidote.If within one hour of ingestion the patient has potentially toxic levels of the drug, resort to oral administration of activated charcoal.

Pregnancy

The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increase in the risk of miscarriage, heart malformation and gastroschisis, after the use of an inhibitor of prostaglandin synthesis at the beginning of pregnancy. The absolute risk of cardiovascular malformations increased from less than 1%, up to about 1.5%. The risk is believed to increase dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has resulted in an increase in pre- and post-plant loss and embryo mortality. Moreover, an increase in the incidence of malformations, including cardiovascular ones, has been reported in animals treated with an inhibitor of the synthesis of prostaglandins during the period of organogenesis. During the first and second quarter of pregnancy, ibuprofen should only be administered if absolutely necessary. If ibuprofen is used in women who intend to conceive or during the first and second trimester of pregnancy the dose must be kept as low as possible and the duration of treatment must be as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus at the risk of: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can worsen up to kidney failure with oligo-hydroamniosis. At the end of pregnancy, the mother and the newborn to: - possible extension of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions that may result in delay or extension of labor at the time of childbirth. Consequently, the administration of ibuprofen is contraindicated during the third trimester of pregnancy.

Food

Hybuprofen and its metabolites can pass in low concentrations in breast milk. Until now, there are no known deleterious effects on infants. Therefore, for a short-term treatment of pain and recommended dose fever, it should not generally be necessary to stop breastfeeding.

Fertility

There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation.Once treatment with ibuprofen is stopped, the effect is reversible.

Source: Farmadati