NAPROSYN OS 30BUST 250MG

NAPROSYN

active ingredients

Naprosyn 250 mg gastro-resistant tablets. Each gastrorous tablet contains 250 mg of excipient naprossene with known effects: Each gastro-resistant tablet contains 1,14 mg sodium. Naprosyn 500 mg gastro-resistant tablets. Each gastrorous tablet contains 500 mg of excipient naprossene with known effects: Each gastrorous tablet contains 2.29 mg of sodium. Naprosyn 500 mg presumed. Each suppository contains 500 mg of naprossene. Naprosyn 500 mg granulate for oral suspension. Each bag contains 500 mg of naprossene. Excipient with known effects: Each bag contains 1,65 g sucrose and 3,92 mg sodium. Naprosyn 250 mg granulate for oral suspension. Each bag contains 250 mg of naprossene. Excipients with known effects: Each bag contains 1,56 g sucrose and 18,24 mg sodium. Naprosyn 750 mg modified release tablets. Each modified release tablet contains 750 mg of naprossene. Excipient with known effects: each modified release tablet contains 0.64 mg of yellow sunset (E110). For the full list of excipients, see paragraph 6.1.

Excellent

500 mg Supposte: Semi-synthetic glycerides. 250 mg granulated oral suspension: Sodium chloride, Sodium diottilsolfosuccinato, Povidone, Aroma menta, Aroma liquirizia, Mannite, Sodio saccarinato, Saccarosio. 500 mg granulate for oral suspension: Mannite, Povidone, Acrylic Resin (Eudragit), Sodium saccharin, Aroma lemon, Citric Acid, Silice precipitate, Saccarosio. 750 mg modified release tablets: Ipromellosa, Magnesium stearate, Yellow sunset (E 110). 250 mg and 500 mg Gastro-resistant tablets: Povidone, Sodium croscarmellose, Magnesium stearate, Copolimer acid metacrilic, Talco, Sodium hydroxide, Trietylcitrate, Simeticone.

Therapeutic indications

Symptomatic treatment of the following conditions: rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, gothopathy and various forms of extraarticular rheumatism (lombosciatalgies, myalgies, neuralgies, radicular syndromes, periartriti, fibromyosites).

Contraindications

• Hypersensitivity to the active ingredient or other substances strictly related to the chemical or any of the excipients listed in the paragraph 6.1. • Gastroduodenal ulcer and peptic ulcer in place. • ulcerative elite. • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Severe heart failure. • Due to the possibility of cross-sensitivity, Naprosyn is contraindicated in patients where acetylsalicylic acid and/or other NSAIDs induce allergic manifestations such as asthma, hives, rhinitis, anaphylactic or anaphylactic reactions and have caused nasal polyps. • The use of the product is contraindicated in children under 2 years of age, since the safety of the product has not been established in this age group. • Pregnancy and nursing. • Renal insufficiency (creatiny clearance less than 20 ml/min).

Population

Adults. As an attack therapy it is recommended to take 500-1000 mg daily, divided into two doses, at 12 hours interval (in the morning during breakfast and in the evening during dinner) or in one administration (during the noon meal or in the evening). For this purpose, a tablet of Naprosyn 750 mg is also indicated. The dose of 1000 mg (2 x 500 mg) per day in one administration is recommended: - in subjects with severe night pain and/or morning stiffness; - in patients already treated without success with other high dose anti-rheumatic drugs; - osteoarthritis when pain is the predominant symptom. As a maintenance therapy, depending on the attack dose, the severity of the disease and the algic component, a daily dose of 750-250 mg is indicated in a single administration or in two administrations at 12 hours of interval. In acute gout attacks it is recommended an initial dose of 500 mg, followed by doses of 250 mg every 8 hours in the first 24 hours, then passing to maintenance doses of 250 mg twice a day for 6-7 days. Seniors. In the elderly and generally in the most at risk the dose must be carefully established by the doctor who will have to assess a possible reduction of the dosages indicated above. Pediatric population. The use of the product is not provided in pediatric age, except, in the opinion of the doctor in cases of absolute necessity in children over 2 years. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). Patients with liver failure. In patients with compromised liver function, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. Such patients must be treated with the minimum effective dose (see paragraph 4.4). Patients with kidney failure. In patients with compromised kidney function, periodic monitoring of clinical and laboratory parameters should be required, especially in case of prolonged treatment. Chronic treatment with Naprosyn is contraindicated in patients with creatinine clearance less than 20 ml/minute (see paragraph 4.4). Naprosyn granulates for oral suspension (from 250 mg and 500 mg), properly dissolved in water, allow a faster absorption of the active substance and perform a more ready analgesic action; they are also more suitable for patients with swallowing difficulties and/or digestive disorders. Naprosyn gastro-resistant tablets is a gastro-protected formulation, so particularly indicated in all those patients where the dissolution of the drug in the stomach is not recommended. The use of Naprosyn gastro-resistant tablets should however be avoided in acute painful states where an analgesic action is required.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular risks). Particular caution should be taken in the treatment of patients with severely reduced heart, liver or kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. In particular, chronic treatment with Naprosyn is not recommended in patients with creatinine clearance less than 20 ml/minute. Patients with compromised liver function must be treated with the minimum effective dose. As with other NSAIDs, increases in liver function tests can occur, as a result of hypersensitivity rather than direct toxicity. Some serious liver reactions were reported, including jaundice and hepatitis, some of which with fatal outcome, following product administration, as well as other NSAIDs. Precaution is needed in patients with a history of hypertension and/or heart failure since, in association with NSAID therapy, water retention and edema have been reported. Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Naprosyn must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Like other non-steroidal anti-inflammatory drugs naprossene should be used with caution in patients with active allergic manifestations or anamnesis as it can determine bronchospasm and other allergic phenomena. Anaphylactic and anaphylactic reactions can also occur in patients with and without prior hypersensitivity to aspirin, other NSAIDs or other naproxin-based products. Anaphylactic and anaphylactic reactions may also occur in subjects with angioedema, bronchial reactivity (asthma), rhinitis or nasal polyps. Anaphylactic reactions, as well as anaphylatoids, can result fatally. Bronchospasm can be triggered in patients with pre- or ongoing allergy or asthma, or with acetylsalicylic acid hypersensitivity. As eye changes are detected during animal studies with non-steroidal anti-inflammatory drugs, it is recommended in case of prolonged treatments, to carry out periodic ophthalmologic controls. The use of Naprosyn must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Cardiovascular and cerebrovascular effects. Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure, as fluid and edema retention was found in association with NSAIDs. Clinical studies and epidemiological data suggest that the use of coxib and some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke). Although some data suggest that the use of naprossene (1000 mg/die) may be associated with a lower risk, some risks may not be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with naprossene only after careful evaluation. Analogue considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Seniors. Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. Patients with acute inflammatory affections of the gastrointestinal tract in place or anamnesi or who complained about gastrointestinal disorders as a result of other anti-rheumatic drugs, should only be treated under strict medical control. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Naprosyn treatment must be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Naprosyn can decrease piastrinic aggregation and prolong bleeding time. Care should be taken to treat patients with hemostasis disorders or in therapy with anticoagulants. Naproxin can decrease fever and inflammation, reducing its utility as diagnostic symptoms. The use of Naprosyn, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase is not recommended in women who intend to begin a pregnancy. The administration of Naprosyn should be suspended in women who have fertility problems or are subject to fertility investigations. Warnings on excipients. Naprosyn granulate for oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. Naprosyn 250 mg granulate for oral suspension contains 18.24 mg sodium per sachet equivalent to 0.91% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for adult

Interactions

Since interactions have been observed between non-steroidal anti-inflammatory drugs and highly protein-related drugs, such as idantoinics, sulphonluree, sulfamidic and juveniles, barbiturates, other NSAIDs and acetylsalicylic acid patients who receive Naprosyn at the same time and these medications must be observed in order to exclude overdose effects. In patients treated with other non-steroidal anti-inflammatory drugs and with cumarinic type anticoagulants, increased protrombine time and decreased piastrinic aggregation were observed. Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Diuretics, ACE inhibitors and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Naprosyn in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. A decrease in the natriuretic effect of furosemide was reported as a result of contemporary administration to some non-steroidal anti-inflammatory drugs. The association of such drugs with lithium leads to a decrease in renal clearance and consequently increased plasma concentration of the latter. Naprosyn, like other non-steroidal anti-inflammatory drugs, can reduce the antihypertensive effect of propanolol and other beta-blockers. Probenecid, administered simultaneously to Naprosyn, increases its plasma levels and considerably extends its half-life. The association with metotressate must be implemented with caution because, in animal models, it has been reported that the naprossene reduces the tubular secretion of metotressate. It is suggested that therapy with Naprosyn is temporarily suspended 48 hours before performing adrenal function tests since Naprosyn may interfere with some tests for 17-Ketogen steroids. Similarly Naprosyn may interfere with some evidence for urinary 5-hydroxyindolacetic acid. Avoid alcohol intake. Naproxins can decrease the effectiveness of intrauterine devices. It is not recommended to use non-steroidal anti-inflammatory drugs at the same time. Naprosyn should not be used simultaneously with its salt (sodium naprossene) or vice versa as both circulate in blood in anionic form. Acetylsalicylic acid: clinical pharmacodynamics data show that the concomitant use of naproxins for more than one consecutive day may inhibit the effect of acetylsalicylic acid at low doses on pyasternic activity and this inhibition may persist for a few days after the interruption of treatment with naproxin. The clinical relevance of this interaction is not known. We do not recommend the use at the same time as acetylsalicylic acid or other NSAIDs. Naprosyn can be used at the same time as gold and/or corticosteroid salts.

Effects

Alterations of blood and lymphatic system: sporadically there have been alterations such as thrombocytopenia, granulocytopenia, leucopenia, heosinophilia, aplastic anemia or hemolytics. Alterations of the immune system: as for other non-steroidal anti-inflammatory, anaphylactic or anaphylactoid type reactions can occur even severe in patients with or without a previous exposure to drugs belonging to this class. Alterations of metabolism and nutrition: hyperkaliemia. Psychiatric disorders: depression, insomnia, abnormal dreams. Alterations of the nervous system: dizziness, disorientation, retrobulbing optic neuritis, seizures, headache, drowsiness, cognitive dysfunction, difficulty of concentration, aseptic meningitis. Ocular disorders: sight turbes, corneal opacity, papylitis, papilloedema. Alteration of the hearing apparatus and labyrinth: vertigo, turbe dell’udito, ronzii auricolari, tinnito. Heart rate: palpitations, tachycardia, congestive heart failure. Edema, hypertension and heart failure were reported in association with treatment with FANS.Patologie vasculars: hypertension, vasculitis. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Alterations of the respiratory system, chest and mediastinum: dispnea, pulmonary edema, asthma, eosinophilous pneumonia, bronchospasm, larynx edema. Alterations of the gastrointestinal apparatus: the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). After administration of Naprosyn were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal and epigastric pain, gastric pyrosis, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4), esophagitis and pancreatis. Less frequently gastritis were observed. Alterations of the hepatobiliary system: hepatitis (some cases were fatal), jaundice. Alteration of the skin and subcutaneous tissue: rashes, itching, ecchimosis, hives, angioedema, multiform erythema, nodous erythema, fixed erythema from medicaments, lichen planus, purple, bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis (very rarely), photosensitivity reactions, alopecia. Alterations of the musculoskeletal system and connective tissue: myalgia, muscle weakness. Kidney and urinary tract alterations: hematuria, interstitial nephritis, nephrosic syndrome, reduction of kidney function, kidney failure, renal papillar necrosis. Disorders of reproductive system and breast: female infertility. General disorders and alteration of the administration site: mild peripheral edema, excessive thirst, fever and chills, malaise. Diagnostic investigations: alteration of liver function test, hypercreatinemia. With the supposed formulation, local side effects of mild amount have also been reported, such as rectal pain and irritation, burning and itching. There were also isolated cases of rectal hemorrhage, tense and proctitis. However, the incidence of these effects is low. 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 www.aifa.gov.it/content/segnalazioni- reactions-adverse.

Overdosing

As signs of overdose may occur dizziness, harrow status, abdominal disorders, epigastric pain, nausea or vomiting, transient alterations of liver and kidney function, hypoprotrombinemia, metabolic acidosis, apnea, disorientation. Gastrointestinal bleeding may occur. In case of ingestion of a strong amount of naproxins, accidental or voluntary, gastric emptiness must be performed and the normal measures required in these cases must be implemented. Treatment is symptomatic and there is no specific antidote. The prompt administration of an adequate amount of activated carbon can significantly reduce the absorption of the drug. Forced diuresis, hemodialysis or hemoperfusion are probably useless because naproxin strongly binds to plasma proteins.

The use of Naprosyn, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenases is not recommended in women who intend to start a pregnancy. The administration of Naprosyn should be suspended in women who have fertility problems or who are subject to fertility surveys (see paragraph 4.4). The product is contraindicated (see paragraph 4.3) during pregnancy and nursing. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. 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 in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. The use of the drug near the childbirth determines the delay of childbirth; moreover, the drug may cause, if administered during this period, alterations to the hemodynamics of the small circle of the nascituro, with serious consequences for breathing.

Source: Farmadati