Synflex 275mg Naproxen Sodium 30 Hard Capsules

NAME
SYNFLEX

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory / antirheumatic drugs, derivatives of propionic acid.

ACTIVE PRINCIPLES
Naproxen sodium.

EXCIPIENTS
CAPSULES: microgranular cellulose, lactose, magnesium stearate, purified water. Operculum: gelatin, titanium dioxide. TABLETS: microgranular cellulose, povidone, talc, magnesium stearate, purified water. Coating: hypromellose, macrogol 8000, titanium dioxide, E110 (lacquer) SUPPOSITORIES: solid semi-synthetic glycerides, calcium levulinate dihydrate. PEDIATRIC SUPPOSITORS: semi-synthetic glycerides. GRANULATE: cellulosamicrocrystalline, sodium chloride, sodium carboxymethylcellulose, povidone, citrus flavor, citric acid, fumaric acid, saccharin, avelo sugar.

INDICATIONS
Treatment of painful manifestations, due to musculoskeletal diseases or to surgical and dental interventions. Dysmenorrheae in migraines.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and / or to any of the excipients.Gastroduodenal ulcer and peptic ulcer in progress. Ulcerative colitis. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Severe heart failure. Patients in whom acetylsalicylic acid and / or other NSAIDs induce allergic manifestations, such as asthma, urticaria, rhinitis, anaphylactic or anaphylactoid reactions and have caused nasal polyps. Children under 2 years of age. Pregnancy and breastfeeding. Renal insufficiency (creatinine clearance less than 20 ml / min).

DOSAGE
Adults: 550 mg at the start; thereafter 275 mg every 6-8 hours or 550 mg every 12 hours. Elderly: the posology must be carefully established by evaluating a possible reduction in the dosages indicated above. Children: (limited to the painful manifestations of juvenile rheumatoid arthritis) older than 6 years 1 suppository of 275 mg once a day (from 6 to 11 years) or 2 times a day (children from 12 to 14 years) at a distance 12 hours, for a maximum period of 7 days. Hepatic insufficiency: it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. Such patients should be treated with the lowest effective dose. Renal insufficiency: periodic monitoring of clinical and laboratory parameters is advisable, especially in case of prolonged treatment. Chronic treatment is contraindicated in patients with creatinine clearance below 20 ml / minute. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

STORAGE
It does not require any special storage conditions.

WARNINGS
The use of the product should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Adequate monitoring and appropriate instructions are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). . Although some data suggest that the use of naproxen (1000 mg / day) may be associated with a lower risk, some risks cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with naproxen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular events. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Patients with current or previous inflammatory diseases of the gastrointestinal tract or who have complained of gastrointestinal disturbances following other antirheumatic drugs, should only undergo the treatment under strict medical supervision. In the elderly and in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. Concomitant use of protective agents (misoprostol or proton pump inhibitors) ) should 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. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Particular caution must be adopted in the treatment of patients with severely reduced cardiac, hepatic or renal function. In particular, chronic treatment is not recommended in patients with creatinine clearance below 20 ml / minute. Elevations of liver function tests may occur, which is a result of hypersensitivity rather than direct toxicity. Some serious hepatic reactions, including jaundice and hepatitis, some of which with fatal outcome, have been reported following administration of the product, as well as other NSAIDs. Fluid retention and edema have been reported. Serious skin reactions, some of them fatal, have been reported very rarely, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The onset of the reaction occurs in most cases within the first month of treatment. Naproxen sodium should be used with caution in patients with allergic manifestations in progress or in the anamnesis as it can cause bronchospasm and other allergic phenomena. Anaphylactic and aniphylactoid reactions may also occur in patients with and without a history of hypersensitivity to aspirin, other NSAIDs or other naproxen-based products. They can also occur in subjects with previous angioedema, bronchospasm, bronchial reactivity (asthma), rhinitis or nasal polyps. Bronchospasm can be triggered in patients with previous or current allergy or asthma, or with hypersensitivity to acetylsalicylic acids. The drug can decrease platelet aggregation and prolong bleeding time. It can reduce fever and inflammation, reducing their usefulness as symptoms for a diagnosis. It is not recommended for women intending to become pregnant. Administration should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

INTERACTIONS
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. A decrease in the natriuretic effect of furosemide has been reported following co-administration with some non-steroidal anti-inflammatory drugs. The association of these drugs with lithium leads to a decrease in renal clearance and consequent increase in the plasma concentration of the latter. May reduce the antihypertensive effect of propranolol and other beta-blockers. Probenecid, given at the same time, increases its plasma levels and considerably prolongs its half-life. The association with methotrexate should be used with caution as naproxen sodium has been reported to reduce tubular secretion of methotrexate in animal models. It is suggested that naproxen sodium therapy be temporarily suspended 48 hours before adrenal function tests, as it may interfere with some tests for the determination of 17-ketogenic steroids. Similarly, Synflex can interfere with some tests for urinary 5-hydroxyindolacetic acid. It should not be used at the same time as its acid (naproxen) or vice versa as both circulate in the blood in anionic form. In patients treated with other non-steroidal anti-inflammatory drugs and with coumarin-type anticoagulants, increased prothrombin time and decreased platelet aggregation have been observed. NSAIDs can increase the effects of blood thinners, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Due to the high binding of medicianal to plasma proteins, patients receiving concomitant hydantoin or sulfonamides, sulphonylureas, coumarin anticoagulants, barbiturates, other NSAIDs and acetylsalicylic acid should be monitored for overdose effects. Naproxen sodium can be used simultaneously with gold salts and / or corticosteroids. Use at the same time as acetylsalicylic acid or other NSAIDs is not recommended. Avoid alcohol intake. Naproxen sodium can decrease the effectiveness of intrauterine devices. The use of non-steroidal anti-inflammatory drugs at the same time as quinolone drugs is not recommended.

SIDE EFFECTS
Blood and lymphatic system disorders: There have been sporadic cases of changes such as thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, aplastic or haemolytic anemia. Alterations of the immune system: anaphylactic or anaphylactoid reactions, including severe ones, have been observed in patients with or without previous exposure to drugs belonging to the class of non-steroidal anti-inflammatory drugs. Alterations of metabolism and nutrition: hyperkalaemia. Psychiatric disorders: abnormal dreams, depression, insomnia. Alterations of the nervous system: dizziness, disorientation, convulsions, headache, somnolence, retrobulbar optic neuritis, cognitive dysfunction, difficulty concentrating, aseptic meningitis. Ocular disorders: papillitis, papilloedema, visual disturbances, corneal opacity. Alteration of the auditory system: hearing disturbances, ringing in the ears, tinnitus, vertigo. Cardiac alterations: palpitations, tachycardia, congestive heart failure, hypertension, vasculitis. Edema, hypertension and heart failure have been reported in association with NSAID treatment. The use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke). Alterations of the respiratory system, thorax and mediastinum: dyspnoea, asthma, eosinophilic pneumonia, pulmonary edema, edema of the larynx, bronchospasm. The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal and epigastric pain, heartburn, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, esophagitis and pancreatitis have been reported. Gastritis was observed less frequently. Alterations of the hepatobiliary system: jaundice, hepatitis (some cases have been fatal). Skin and subcutaneous tissue disorders: rash, pruritus, ecchymosis, urticaria, angioedema, erythema multiforme, erythema nodosum, fixed drug erythema, lichen planus, purpura, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely ), photosensitivity reactions, alopecia. Alterations of the musculoskeletal system and connective tissue: myalgia, muscle weakness. Renal and urinary disorders: haematuria, decreased renal function, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis. Disorders of the reproductive system and breast: female infertility. General disorders and administration site alteration: edema, excessive thirst, fever and chills, malaise. SUPPOSITORIES. Mild local side effects have also been reported, such as pain and rectal irritation, burning and itching. There have also been isolated cases of rectal haemorrhage, tenesmus and proctitis. Diagnostic investigations: abnormal liver function test, hypercreatinemia.

PREGNANCY AND BREASTFEEDING
As with any drug that inhibits the prostaglandin synthesis of cyclooxygenase, it is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems 'or who are undergoing investigation of fertility'. It is contraindicated during pregnancy and breastfeeding. Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose: the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, a possible prolongation of the bleeding time, and an antiplatelet effect which can occur even at very low doses and inhibition of uterine contractions resulting in delay or prolongation of labor. The use of the drug in proximity of the birth determines the delay of the birth itself; moreover the drug can cause, if administered in this period, alterations to the haemodynamics of the small circulation of the unborn child, with serious consequences for breathing.