Ilmodol Anti-inflammatory And Antirheumatic 12 Sachets Granules 220mg

NAME
UNINAPRO

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

ACTIVE PRINCIPLES
Naproxen sodium.

EXCIPIENTS
Granules for oral solution: acesulfame K; mint / licorice flavor; aspartame; mannitol; polysorbate 20; potassium bicarbonate; sucrose; simethicone. Film-coated tablets. Core: lactose monohydrate; cornstarch; microcrystalline cellulose; povidone (K30); sodium carboxymethyl starch; anhydrous colloidal silica; magnesium sterate. Coating: hypromellose; macrogol 400; titanium dioxide (E171); talc.

INDICATIONS
Short-term symptomatic treatment of mild and moderate pain such as muscle and joint pain, headache, toothache and menstrual pain; it can also be used in the treatment of fever.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredient or to other substances closely related from a chemical point of view or to any of the excipients; hypersensitivity 'to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs) and / or antirheumatics Naproxen should not be administered in patients in whom these substances induce allergic reactions, such as asthma, urticaria, rhinitis, nasal polyps, angioedema and anaphylactic reactions and anaphylactoids, as severe anaphylactic-like reactions have been observed; active peptic ulcer and gastrointestinal inflammation; history of gastrointestinal haemorrhage or perforation related to previous treatments with non-steroidal anti-inflammatory drugs, active treatments history of haemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding); severe hepatic insufficiency; severe heart failure; severe renal insufficiency (CLcr <30 ml / min); angioedema; during intensive therapy with diuretics, in subjects with ongoing haemorrhage and at risk of haemorrhage during therapy with anticoagulants; third trimester of pregnancy and lactation; contraindicated in children <12 years.

DOSAGE
Adults and adolescents> 16 years: 1 sachet or 1 tablet every 8-12 hours If necessary, a better effect can be obtained by starting, on the first day, with 2 sachets or 2 tablets followed by 1 sachet or 1 tablet after 8-12 hours. Do not exceed 3 sachets or 3 tablets in 24 hours. Elderly patients and patients with mild or moderate renal insufficiency should not exceed 2 sachets or 2 tablets in 24 hours.The drug should preferably be taken after a meal. Do not use for more than 7 days for pain and more than 3 days for fever. Consult a doctor if pain and fever persist or worsen.

STORAGE
Store in the original package to protect the medicine from light and humidity.

WARNINGS
In children of 12-15 years, the drug can 'be used only after medical advice. The medicinal 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 needed to control symptoms. NSAIDs can cause hypersensitivity reactions', even serious, including those of the anaphylactic type. The risk is greater in subjects who have already presented these reactions after the use of other NSAIDs. Naproxen sodium should not be used at the same time as other naproxen-based drugs as they circulate in the blood in anionized form, as a naproxenate anion. The antipyretic and anti-inflammatory activity of naproxen can reduce fever and inflammation thus reducing the diagnostic utility of these symptoms. Bronchospasm may arise in patients with bronchial asthma or allergic diseases or who have suffered from it. Gastrointestinal Effects: Gastrointestinal bleeding episodes have been reported; in patients with previous gastrointestinal disease, naproxen should be administered under close medical supervision. In anti-inflammatory therapy, serious gastrointestinal side effects such as haemorrhage and perforation are possible; the risk appears to increase linearly with duration and with high doses. Gastrointestinal bleeding, ulceration and perforation, including fatal ones, have been reported during NSAID treatment at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Elderly: Increased frequency of adverse reactions, especially gastrointestinal bleeding and perforation, which can be fatal. In the elderly in patients with a history of ulcer the risk is higher with increased doses of NSAIDs; start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should also be considered for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Report any unusual gastrointestinal symptoms, particularly in the early stages of treatment. Caution should be exercised in patients taking concomitant medications that may 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. Caution is advised in habitual consumers of high doses of alcohol, as they are at risk of gastric bleeding. Cardiovascular and cerebrovascular effects: Adequate monitoring and appropriate instructions are required in case of a history of hypertension and / or mild to moderate congestive heart failure as fluid retention and edema have been reported. The use of coxibs and some NSAIDs may be associated with a modest increased risk of arterial thrombotic events; naproxen is associated with a lower risk, but some risks cannot be excluded. There are insufficient data on the effects of low dose naproxen on possible thrombotic risks. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated after careful consideration. Naproxen decreases platelet aggregation and prolongs bleeding time. This must be taken into account when bleeding times are determined. Patients suffering from coagulation disorders or who are on drug therapy that interfere with haemostasis should be carefully observed. Thus also the risk of bleeding must be considered increased in patients treated with anticoagulants. In these cases, the risk / benefit must be carefully weighed. Peripheral edema has been observed in a limited number of patients, therefore cardiac patients should be considered at high risk. Impaired renal function: naproxen is eliminated for the most part in the urine (95%), therefore it should be used with caution in patients with impaired renal function and serum creatinine and / or creatinine clearance should be monitored. . Administration of naproxen is not recommended in patients with a CLcr <20 ml / min. Renal function must be carefully monitored before and during treatment in patients with impaired renal blood flow, extracellular volume depletion, liver cirrhosis; sodium limitation, congestive heart failure and previous kidney disease. Elderly patients in whom limited renal function is expected should also be included among these patients. Consideration should be given to reducing the daily dose in order to avoid accumulation of naproxen metabolites. Impaired hepatic activity: in patients with chronic hepatic insufficiency of alcoholic origin, but also in cases of cirrhosis, the total plasma concentration of naproxen is reduced while that of naproxenelibero is increased; the cause of this behavior is not known; it is therefore prudent, in these patients, to use the drug at the lowest effective dose. Sporadic changes in laboratory tests were observed, however no changes in toxicity tests were observed. Skin Effects: Serious skin reactions including fatal skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely. The onset of the reaction occurs in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Naproxen can mask the symptoms of concomitant infectious diseases. In isolated cases an exacerbation of infectious inflammation (e.g. development of necrotizing fasciitis) has been reported. The medicine is not recommended in women who intend to become pregnant. The administration of the drug should be suspended in women who have fertility problems 'or who are undergoing investigation of fertility'. The tablets contain lactose. The granules contain aspartame, which is a source of phenylalanine and can be harmful to subjects suffering from phenylketonuria, and sucrose. If visual disturbances occur, treatment must be suspended.

INTERACTIONS
Due to the high plasma protein binding of naproxen, patients receiving concomitantly highly protein bound drugs such as hydantoin, anticoagulant barbiturates or sulfonamides should be carefully monitored to exclude overdose effects of these drugs. Beta blockers: Naproxen and other NSAIDs may reduce the antihypertensive effect of propanolol and other beta blockers. Lithium: inhibition of lithium elimination with consequent increase in its plasma concentration has also been reported. Probenecid: produces an increase in plasma levels of naproxen and considerably prolongs its plasma half-life. Methotrexate: caution is advised in the case of concomitant administration of methotrexate due to the possible increase in its toxicity caused by the reduction of tubular secretion. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage. Diuretics, ACE inhibitors and angiotensin II antagonists: 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 an further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking the drug concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. It is suggested to temporarily suspend the administration of naproxen 48 hours before carrying out adrenal function tests since it can artificially interfere with some tests for the determination of 17-ketosteroids. Similarly, naproxen can interfere with the search for urinary 5-hydroxyindolacetic acid.

SIDE EFFECTS
Systemic effects. Common: feeling of thirst; rare: anaphylactic reaction (possible symptoms of an anaphylactic reaction are: severe and sudden hypotension, rapid or slow heart rate, unusual tiredness or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty in breathing (from laryngeal obstruction or bronchospasm) or swallowing, generalized itching (especially of the soles of the feet or palms of the hands) hives with or without angioedema (swollen and itchy skin areas located more frequently in the extremities, external genitals and face, especially in the eyes and lips) redness of the skin (especially around the ears) cyanosis, profuse sweating, nausea, vomiting, crampy abdominal pain, diarrhea), fever, gastrointestinal effects. The most frequent are: nausea, vomiting, constipation, abdominal pain, heartburn, dyspepsia, esophagitis, stomatitis, diarrhea, epigastric pain. The most serious effects are gastrointestinal bleeding, peptic ulcer (sometimes with perforation and bleeding) and colitis. Rare effects are ulcerative stomatitis, pancreatitis. Gastric upset can be reduced by taking the drug on a full stomach. Dermatological effects: skin rash, urticaria and angioedema, bruising, sweating, purpura; rare: alopecia, photosensitivity dermatitis, Lyell's syndrome (toxic epidermal necrolysis), erythema multiforme, Stevens-Johnson syndrome, erythema nodosum. Allergic reactions to naproxen and naproxen sodium preparations, skin necrosis and photosensitivity including rare cases of pseudoporphyria or epidermolysis bullosa may also occur. Renal Effects: Renal reactions are not limited to glomerular nephritis but include interstitial nephritis, nephrotic syndrome, haematuria, papillary necrosis, fluid retention, hyperkalaemia and renal failure. Hepatic effects: Rare: abnormal liver function tests, jaundice; very rare: severe hepatitis. Effects on the central nervous system: headache, light-headedness, insomnia, convulsions, difficulty concentrating, confusion and lightheadedness; rare: depression, feeling of malaise, aseptic meningitis, cognitive disorders. Musculoskeletal and connective tissue effects: myalgia, muscle weakness. Hematological effects. Rare: agranulocytosis, eosinophilia, leukopenia, thrombocytopenia, granulocytopenia, aplastic anemia and haemolytic anemia. Cardiovascular effects. Common: palpitations; rare: congestive heart failure, vasculitis, tachycardia. Respiratory effects. Rare: pneumonia, eosinophilia, bronchospasm, alveolitis, edema of the larynx, asthma. Endocrine and metabolic effects. Rare: hyperglycemia, hypoglycemia. Others: visual disturbances, hearing loss, middle peripheral edema. Anaphylactic reactions to naproxen and naproxen sodium preparations have been reported in patients with or without prior hypersensitivity to non-steroidal anti-inflammatory drugs.

PREGNANCY AND BREASTFEEDING
Naproxen is contraindicated in the last trimester of pregnancy due to the risk of cardiopulmonary and renal toxicity to the fetus. It should not be used in the first and second months unless it is considered essential. In animals there was a delay in delivery (it is not known whether this effect also occurs in humans). Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported. in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the drug should not be administered except in strictly necessary cases. If the drug is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. 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 insufficiency with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, a possible prolongation of the bleeding time, and an antiplatelet effect that can occur even at very low doses, inhibition of uterine contractions resulting in delayed or prolonged labor Consequently, the drug is contraindicated during the third trimester of pregnancy. Naproxen has been found in breast milk, therefore the use of naproxen should be avoided in breastfeeding patients.