LASONIL ANTI-INFLAMMATION 24CPR 220MG

LASONIL ANTINFIAMMATORIC AND ANTIREUMATIC 220 MG COMPRESSE RIVESTITE WITH FILM

active ingredients

A movie-coated tablet contains: sodium naprossene 220 mg, equivalent to 200 mg of naprossene. For the full list of excipients, see paragraph 6.1.

Excellent

Microcrystalline cellulose, povidone K 30, talc, magnesium stearate; coating film: Opadry Blue YS 1-4215.

Therapeutic indications

Symptomatic treatment of headaches, back pain, joint and muscle pain, toothache and cooling diseases. It is also indicated against menstrual pain and minor pain in arthritis and arthritis.

Contraindications

• Hypersensitivity to the active ingredient, or any of the excipients listed in the paragraph 6.1. • Anamnesi of asthma, hives or allergic reactions following the intake of acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. • Pregnancy of severe degree kidney (cancer of creatinine less than 20 ml/min) • Severe heart failure • Hepatic cirrhosis and severe hepatitis • Intensive treatment with diuretics • Gastric ulceration and duodenal • Subjects with hemorrhage in place or at risk of hemorrhaging • Pregnant treatment.

Population

Method of administration The film-coated tablet must be taken orally with a glass of water, on a full stomach. Population Adults and teenagers over 16 years: 1 tablet every 8 - 12 hours. It is possible that you have greater benefit starting with 2 tablets followed by 1 tablet every 12 hours, as needed. The maximum daily dose is 3 tablets. Undesirable effects can be reduced using the effective minimum dose, for the shortest possible duration of treatment to control symptoms (see paragraph 4.4.). Do not use for more than 7 days for symptomatic pain treatment and for more than 3 days for cooling diseases without medical control. Pediatric population Safety and effectiveness in children under 16 have not yet been established (see paragraph 4.3). Seniors Use the minimum dosage. Patients with kidney, liver or heart failure In patients with kidney and/or heart failure and/or severe liver failure, a reduction in dose may be required.

Conservation

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

Warnings

The product is not indicated for the pain of the gastrointestinal tract. General notices The use of anti-inflammatory and anti-reumatic Lasonil 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 below paragraphs on gastrointestinal and cardiovascular risks). Anaphylactic/anaphylactic reactions Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially fatal, including those of anaphylactic type (anaphylactoid), even in unprecedented subjects of hypersensitivity following exposure to this type of medication. These reactions can occur in subjects with history of angioedema, altered bronchial reactivity (asthma), rhinitis, nasal polyposi, allergic pathologies, chronic respiratory pathologies or sensitivity to acetylsalicylic acid. This can also happen in patients who experience allergic reactions (cutaneous reactions, hives) to naproxins or other NSAIDs. After administration of analgesic, antipyretic, non-steroidal anti-inflammatory, asthma worsening is possible. Anaphylactoid reactions, such as anaphylaxis, can be fatal. Skin reactions Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal 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 the reaction occurs in most cases within the first month of treatment. Anti-inflammatory and anti-reumatic lasonil must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Gastrointestinal bleeding, 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. 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 acetyllic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, particularly 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 medications that may 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 acetilsalicylic acid (see paragraph 4.5). When you experience hemorrhage or gastrointestinal ulceration in patients taking Lasonil anti-inflammatory and anti-rheumatic treatment should be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) as such conditions may be exacerbated (see paragraph 4.8). Sodium and liquid retention in cardiovascular disease and peripheral edema Caution is required before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure since retention of fluids, hypertension and edema were found in association with NSAIDs. Cardiovascular and cerebrovascular effects 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 risk may not be excluded. There is no sufficient data on the effects of low dose of naprossene from 220 to 660 mg to achieve precise conclusions on possible trombotic risks. Naprossene can reduce the pyastrinic anti-aggregating effect of acetylsalicylic acid. Patients should consult the doctor if they are in treatment with acetylsalicylic acid and intend to use sodium/naproxins (see “Interactions with other medicines and other forms of interaction”). Hepatitis effects Severe liver reactions, including jaundice and hepatitis (of which some fatal cases) were reported with the use of sodium naprossene or other non-steroidal anti-inflammatory drugs. It was also reported cross-reactivity. Special popularity 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). Women planning a pregnancy Precautions regarding fertility The use of anti-inflammatory and anti-reumatic Lasonil, as of any inhibitor drug of the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to start a pregnancy due to effects on ovulation, reversible to the interruption of treatment (see paragraph 4.6). The administration of anti-inflammatory and anti-reumatic Lasonil must be suspended in women who have fertility problems or who undergo fertility investigations. Patients with additional clinical history Subjects with the following additional clinical stories must be carefully and properly controlled when taking Lasonil anti-inflammatory and anti-rheumatic: - with coagulation disorders or taking medications that affect hemostasis, since naprossene inhibits pyastrinic aggregation and may prolong bleeding time. - with liver failure - that have manifested previous undesirable effects with analgesic, antipyretic and non-steroidal anti-inflammatory The product should be administered with caution in case of concomitant treatment with other drugs, such as other analgesics, steroids or intensive diuretic therapy. Sodium content This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "without sodium". Intake of the maximum daily dosage of 3 tablets entails a maximum intake of 60 mg of sodium equivalent to 3% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium per day for an adult.

Interactions

Ciclosporin : With the concomitant use of cyclosporin the concentration of the latter can be increased, increasing the risk of nephrotoxicity. Litio : Lithium levels can be increased, which can induce nausea, polydipsia, polyuria, tremors and confusion. Metotress The use of anti-inflammatory and anti-rheumatic Lasonil in conjunction with metotressate (at doses greater than 15 mg/week) can lead to an increase in metotressate concentrations, with increased risk of toxicity of this substance. FANS : Do not administer the medicine in association with drugs based on naprossene, acetylsalicylic acid or other analgesic, antipyretic, anti-inflammatory drugs for increased risk of gastrointestinal bleeding. Acetylsalicylic acid Clinical pharmacodynamics data show that the concomitant use of naprossene for more than one consecutive day may inhibit the effect of acetylcylic acid at low doses on pyasternic activity and this inhibition may persist for a few days after the termination of treatment with naprossene. The clinical relevance of this interaction is not known. Treatment with sodium naproxin/naproxins in patients with increased cardiovascular risk may limit the cardiovascular protection of acetysalicylic acid (see “Special warnings and precautions of use). Courtesy : increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Antiagulants : NSAIDs can increase the effects of anticoagulants such as warfarin (increasing protrombine time and decreasing platelet aggregation) (see paragraph 4.4). Selective serotonin reuptake inhibitors and anti-aggregating agents (SSRIs) : increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Naprossene decreases platelet aggregation and prolongs hemorrhage time. This must be taken into account when the time of hemorrhage is determined. 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 Lasonil anti-inflammatory and anti-reumatic 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. In short term use, clinically significant interactions with the following medicines are not expected: • anti-diabetic acid • idantoinic • probenecid • zidovudine Food interactions The rate of absorption of naprossene can be slowed by the simultaneous intake of food. Interference with laboratory exams Sodium naprossene interferes with the analysis of 17-chetosteroids and 5-indolacetic urinary acid.

Effects

Heart disease / vascular disease In association with the treatment with the NSAIDs were reported edema, hypertension and heart failure. 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) (see paragraph 4.4). Gastrointestinal diseases 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 anti-inflammatory and anti-rheumatic Lasonil have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. Pathologies of skin and subcutaneous tissue Bollose reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (very rarely). Anti-inflammatory and anti-rheumatic lasonil causes a modest transitory increase, dependent dose, of bleeding time. However, these values often do not exceed the upper limit of the reference range. The following table shows the undesirable effects observed with medicines based on naproxin and sodium naproxin. The frequency of possible side effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100, Classification for systems and organs Frequency Undesirable effects Immune system disorders Very rare Anaphylaxis/Anaphylactoid reactions, including fatal shock Disorders of metabolism and nutrition Rare Hyperglycemia, hypoglycemia Emolinfopoietic system pathologies Very rare Hemopoiesis disorders (leucopenia, thrombocytopenia, agranulocytosis, aplastic anemia, heosinophilia, hemolytic anemia) Psychiatric disorders Very rare Psychiatric disorders, depression, sleeping disorders, difficulty concentrating Diseases of the nervous system Town Chief, headache, dismay Not common Sober, insomnia, drowsiness Very rare Aseptic meningitis, cognitive disorders, seizures Pathologies of the eye Very rare Visual disturbances, corneal opacity, papillite, retrobulb optic neuritis, papyledema Ear and labyrinth pathologies Not common Vertigo Very rare Easy hearing, tinnitus, hearing disorders Heart disease Rare Tachycardia Very rare Congestive heart failure, hypertension, pulmonary edema, palpitations Vascular diseases Very rare Vasculitis Thoracic and mediastinic respiratory pathologies Very rare Dispnea, asthma, eosinophilic pneumonia, alveolites Gastrointestinal pathologies Town Dispepsia, nausea, pirosis, abdominal pain Not common Diarrhea, constipation, vomiting Rare Peptic ulcer with or without hemorrhage or perforation, gastrointestinal hemorrhage, hematemesis, melena Very rare Pancreatitis, colitis, aftous ulcers, stomatitis, esophagitis, intestinal ulcerations, abdominal cramps Hepatobiliary diseases Very rare Hepatitis (including fatal cases), jaundice Pathologies of skin and subcutaneous tissue Not common Exanthema (rash), itching, urticaria Rare Angioedema Very rare Alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema nodosum, fixed erythema, lichen planus, pustules, rash, systemic lupus erythematosus, photosensitivity reactions including porphyria cutanea tarda (“pseudoporphyria”) or epidermolysis bullosa, ecchymosis, purpura, sweating Musculoskeletal and connective tissue disorders Rare Myalgia, muscle weakness Kidney and urinary pathologies Rare Impaired renal function, glomerulonephritis Very rare Interstitial nephritis, papillary necrosis, nephrotic syndrome, renal failure, nephropathy, hematuria, proteinuria Congenital, family and genetic pathologies Very rare Closure of the ductus arteriosus Pathologies of the reproductive apparatus and of the breast Very rare Infertility (in woman) Systemic pathologies and conditions for administration Rare Peripheral edema, especially in hypertensive patients or kidney failure, pyrexia (including chills and fever) Very rare Edema, thirst, malaise Diagnostic tests Very rare Increased serum creatinine, abnormal liver function tests, hyperkalemia Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 through the national reporting system: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-re adverse action.

Overdosing

Signs of overdose may include dizziness, lethargy, heartburn, epigastric pain, indigestion, nausea and vomiting, transient changes in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea and disorientation.Since naproxen sodium is rapidly absorbed, early elevated plasma levels are to be expected.Convulsions have been reported in some patients but it is unclear whether these were related to naproxen overdose.A few cases of reversible acute renal failure have been reported.The life-threatening dose of the drug is not known.In the event of NSAID overdose, patients should be managed with symptomatic and supportive care.The stomach should be emptied and usual supportive measures should be implemented.Prompt administration of an adequate amount of activated charcoal may reduce absorption of the drug.Hemodialysis does not decrease plasma concentrations of naproxen due to high plasma protein binding.There is no specific antidote.Renal and hepatic function should be monitored.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development.Results of epidemiological studies suggest an increased risk of miscarriage and of 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%, up 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 result in 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 third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect which may occur even at very low doses;- inhibition of uterine contractions resulting in delayed or prolonged labor.Breastfeeding Naproxen may pass into breast milk.The medicinal product is therefore contraindicated during breastfeeding.Fertility The use of naproxen, may

interfere with fertility and female subjects, particularly women who have fertility problems or who are undergoing investigation of fertility, should be informed of this (see section 4.4).

This effect is reversible upon discontinuation of treatment.

Source: Farmadati