ANTINF 12CPR 220

ANTINFIAMMATORIO AND ANTIREUMATIO

active ingredients

ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO 220 mg granulated for oral solution A bag contains: Active ingredient: Naprossene sodium 220 mg Excipient: contains aspartame and sucrose For the full list of excipients, see paragraph 6.1 ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO 220 mg tablets coated with film One tablet contains: Active ingredient: Naprossene sodium 220 mg Excipient: contains monohydrate lactose For the full list of excipients, see paragraph 6.1

Excellent

Granulated oral solution Excipients: Acesulfame K, Aroma mint/liquerizia, Aspartame, Mannitolo, Polisorbato 20, Potassio Bicarbonato. Sucrose, Simeticone. Tablets covered with film Excipients: Core: Monohydrate lactose, pregelatinized starch, microcrystalline cellulose, Povidone (K30), Sodium Carbossimetilamido, Anidra colloidal Silice, Magnesium sterate. Coating: Ipromellose, Macrogol 400, Titanium Dioxide (E171), Talco.

Therapeutic indications

Syntomatic treatment of short duration of mild and moderate pains such as muscle and joint pain, headache, toothache and menstrual pain. ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO can also be used in the treatment of fever.

Contraindications

§ Hypersensitivity to the active ingredient or other substances closely related to the chemical or any of the excipients. The drug is also contraindicated in individuals with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAID) and/or anti-rheumatics II naprossene should not be administered in patients where such substances induce allergic reactions, such as as asthma, hives, nasalitis, angioedema and anaphylactic reactions. § Peptic ulcer in active phase and gastrointestinal inflammations. § The naprossene is contraindicated in patients with history of gastrointestinal hemorrhage or perforation related to previous treatments with non-steroidal anti-inflammatory drugs, active treatments or history of hemorrhage/peptic recurring ulcer (two or more distinct episodes of proven ulceration or bleeding) § Severe liver failure, § Severa cardiac failure, § Severe kidney failure (creainteinonic clearance)

Population

Adults and teenagers over 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. Senior patients and patients with mild or moderate kidney failure should not exceed 2 sachets or 2 tablets in 24 hours (see par. 4.3 and 4.4). ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO should be taken preferably after a meal. Do not use for more than 7 days for pain and for more than 3 days for fever. Patients should be informed to consult a doctor if pain and fever persist or worsen.

Conservation

Store in the original packaging to protect the medicine from light and moisture.

Warnings

In children aged 12 to 15 years can only be used after consulting the doctor The use of ANTINFIAMMATORIO AND ANTIREUMATICO ILMODOL must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. 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 Section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks). Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious, including those of anaphylactic type, even in individuals not previously exposed to this type of medication. The risk of hypersensitivity reactions after taking naproxene is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (see contraindications). Sodium naproxene should not be used simultaneously with other drug based on naproxene as both circulate in blood in ionized form, such as naproxenate anion. Antipyretic and anti-inflammatory activity of naproxene can reduce fever and inflammation thus reducing the diagnostic utility of these symptoms. Broncospasm may arise in patients with bronchial asthma or allergic diseases or who have suffered from it. Gastrointestinal effects Episodes of gastrointestinal bleeding have been reported in patients treated with naproxene; therefore, in patients with previous gastrointestinal pathology, naproxene must be administered under strict medical control. In the course of anti-inflammatory therapy it is possible to develop serious side effects at gastro-intestinal level such as hemorrhage and perforation; the risk of such eventuality seems to increase linearly with the duration of treatment and is probably associated with the use of the highest doses of these drugs. 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. Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see Section 4.2). In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see section 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 section 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 section 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking ANTINFIAMMATORIO and ANTIREUMATICO ILMODOL the treatment must be suspended. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions may be exacerbated (see section 4.8 Undesirable effects). It is recommended caution in regular consumers of high doses of alcohol, as at risk of gastric bleeding. The use of the product must be avoided in cases of gastrointestinal pain. 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, since in association with the treatment with NSAIDs, fluid and edema retention was found. 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 (e.g. myocardial infarction 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 esclusi.Non there are sufficient data on the effects of low dose of naprossene (600 mg/die) to achieve precise conclusions on possible trombotic risks. 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). Naproxene decreases piastrinic aggregation and prolongs bleeding time. This effect must be taken into account when bleeding times are determined. Patients who suffer from clotting disorders or who are in therapy with drugs that interfere with hemostasis, must be carefully observed if you administer them naproxene. Thus also the risk of bleeding must be considered increased in patients in anticoagulant therapy (e.g. heparine or warfarina). (In these cases the risk/benefit must be carefully assessed). In a limited number of patients, in naproxene therapy, peripheral edema was observed, therefore, cardiopathic patients should be considered at high risk in the case of drug administration. Use in patients with compromised kidney function . Since naproxene is eliminated for the most part through urine (95%) must be used with great caution in patients with compromised kidney function and in these patients must be monitored serum creatinine and/or creatinine clearance. Naproxene administration is not recommended in patients with a lower basal creatinine clearance of 20 ml/minute. Before and during treatment with naproxene renal function should be carefully controlled in cases of patients with compromised kidney blood flow, depletion of extracellular volume, liver cirrhosis; sodium limitation, heart congestive failure and previous kidney disease. Among these patients, the elderly should also be included in which limited kidney function is foreseeable. In these patients should be taken into account the reduction of the daily dose in order to avoid the accumulation of naproxene metabolites. Use in patients with impaired liver activity In patients with chronic hepatic insufficiency of alcohol but also in cases of cirrhosis, the total plasma concentration of naproxene is reduced while the free naproxene concentration is increased; the cause of such behaviour is not known; it is therefore prudent, in these patients, to use the drug at the least effective dose. Spooradic changes were observed in laboratory tests (e.g. tests of liver function) in patients in naproxene therapy however no modification of toxicity tests was observed. Skin effects 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 section 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. ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Naprossene, like any other NSAID, can mask the symptoms of concomitant infectious diseases. In isolated cases, in temporal connection with the use of NSAIDs, an exacerbation of infectious inflammations (e.g. the development of necrotizer fascites). Effects on fertility The use of ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase is not recommended in women who intend to start a pregnancy. The administration of ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO should be suspended in women who have fertility problems or who are subject to fertility surveys. Tablets contain lactose: patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. The granulate contains aspartame which is a source of phenylalanine, therefore it can be harmful to individuals suffering from phenylchetonuria. The granulate also contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or sucrasis-isomaltasis failure, should not take this medicine. If visual disturbances arise the treatment with naprossene should be suspended. As for associations with other drugs that require caution, see section 4.5.

Interactions

Due to the high bond of naproxene with plasma proteins, patients who receive high-protein drugs such as idantoinics, anti-agulent or sulfamidic barbiturics must be carefully monitored in order to exclude overdosing effects of these drugs. Beta blockers Naproxene and other non-steroidal anti-inflammatory drugs can reduce the antihypertensive effect of propanolol and other beta-blockers. Litio The inhibition of the elimination of lithium was also reported, resulting in an increase in its plasma concentration. Probenecid Probenecid, administered simultaneously, produces an increase in plasma levels of naproxene and considerably extends its plasma half-life. Methodology Prudence is recommended in the case of concomitant administrations of metotrexate for the possible increase of its toxicity caused by the reduction of the tubular secretion. Courtesy: Increased risk of gastrointestinal ulceration or hemorrhage (see section 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants such as warfarin (see section 4.4). Selective serotonin reuptake inhibitors and anti-aggregating agents (SSRIs): increased risk of gastrointestinal hemorrhage (see section 4.4). Diuretics, ACE inhibitors and Angiotensin Antagonists 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 can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking ANTINFIAMMATORIO AND ANTIREUMATICO ILMODOL 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. It is suggested to temporarily suspend the administration of naproxene 48 hours before carrying out adrenal function tests since it can artificially interfere with some tests for the determination of 17-chetosteroids. Similarly, naproxene may interfere with the research of 5-hydroxyindolacetic urinary acid.

Effects

The undesirable effects observed with naproxene are generally common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. The most frequently reported side effects are: constipation, gastric pyrosis, abdominal pain, nausea, headache, dizziness, drowsiness, itching, tinnitus, edema and dispnea. As with other analgesics, antipyretics, non-steroidal anti-inflammatory drugs, also with naproxene have been reported serious undesirable effects such as bleeding (ematemesis, melena) or gastrointestinal perforation, gastrointestinal ulcerations, nephrotoxicity, hepatotoxicity and hypersensitivity reactions (such as skin rashes, angioedema or bronchospasm). The most commonly observed adverse events are of gastrointestinal nature, peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see section 4.4). After administration of ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 Special warnings and precautions for use). Less frequently gastritis were observed. In combination with NSAID treatment, edema, hypertension and heart failure were reported. Bollose reactions, including Stevens- Johnson syndrome and epidermal toxic necrolysis (very rarely). Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at 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 section 4.4). Systemic effects. Common: feeling thirsty.Rare: anaphylactic reaction (possible symptoms of an anaphylactic reaction are: sudden severe low blood pressure, rapid or slow heartbeat, unusual tiredness or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty breathing (due to laryngeal obstruction or bronchospasm) or swallowing, generalised itching (especially on the soles of the feet or palms of the hands), urticaria with or without angioedema (swollen and itchy areas of the skin most frequently located on the extremities, external genitals and face, especially in the region of the eyes and lips), redness of the skin (especially around the ears), cyanosis, profuse sweating, nausea, vomiting, crampy abdominal pain, diarrhoea).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 hemorrhages) and colitis.Rare effects are ulcerative stomatitis, pancreatitis.Gastric disorders can be reduced by taking the drug on a full stomach. Dermatory effects Skin rash, urticaria and angioedema, ecchymosis, 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, nephrosic syndrome, hematuria, papillar necrosis, water retention, hyperpotassiemia and kidney failure. Hepatitis effects Rare effects are: alteration of liver function tests, jaundice. Very rare: severe hepatitis. Effects on the central nervous system Headache, feeling of empty head, insomnia, seizures, difficulty of concentration, confusion and stun. Rares: depression, sense of malaise, aseptic meningitis, cognitive disorders. Musculoskeletal effects and connective tissue Myalgia, muscle weakness Ematologic effects Rarely, the following may occur: agranulocytosis, eosinophilia, leukopenia, thrombocytopenia, granulocytopenia, aplastic anemia and haemolytic anemia. Cardiovascular effects Common: palpitations.Rare: congestive heart failure, vasculitis, tachycardia. Respiratory effects Rare: eosinophilic pneumonia, bronchospasm, alveolitis, laryngeal edema, asthma. Endocrine and metabolic effects Rare: hyperglycaemia, hypoglycaemia. Others Visus disorders, decreased hearing, average periphery edema. Anaphylactic reactions to naproxene and sodium naproxene preparations have been reported in patients with or without prior hypersensitivity to non-steroidal anti-inflammatory drugs. If other side effects are not described and related to the use of the drug, please inform your doctor or pharmacist.

Overdosing

Symptoms of overdose are: drowsiness, heartburn, dyspepsia, nausea, vomiting. In the case of intake,high levels of naproxene must proceed to emptying the stomach and adopt normal support measures. The immediate administration of adequate amounts of coal tends to significantly reduce the absorption of the drug.

Pregnancy Naproxene is contraindicated in the last trimester of pregnancy due to the risk of cardiopulmonary and kidney toxicity for the fetus. It should not be used in the first and second month unless it is considered essential by the attending physician. In animals there has been a delay in childbirth (it is not known if this effect is manifested also in man). 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 first and second trimester of pregnancy, ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO should not be administered if not in strictly necessary cases. If ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must 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 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 Consequently, ILMODOL ANTINFIAMMATORIO AND ANTIREUMATICO is contraindicated during the third trimester of pregnancy. Nursing:Naproxene was found in breast milk, so the use of naproxene should be avoided in breast-feeding patients.

Source: Farmadati