Lasonil anti-inflammatory and antirheumatic 220mg 12 coated tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

- Hypersensitivity to the active substance, or to any of the excipients, listed in paragraph 6.1. - History of asthma, urticaria or allergic reactions following the intake of acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. - Severe renal insufficiency (creatinine clearance less than 20 ml/min) - Severe cardiac insufficiency - Liver cirrhosis and severe hepatitis - Under intensive therapy with diuretics - Gastric and duodenal ulcer - Subjects with current bleeding or at risk of bleeding - Under treatment with anticoagulants as they synergize their action - Pregnancy and breastfeeding (see section 4.6) - Adolescents under 16 years of age - History of gastrointestinal bleeding or perforation related to previous active treatment or history of recurrent peptic hemorrhage/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding).

WARNINGS AND PRECAUTIONS FOR USE

The product is not indicated for pain in the gastrointestinal tract. General warnings The use of anti-inflammatory and antirheumatic Lasonil should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Anaphylactic/anaphylactoid reactions Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially fatal hypersensitivity reactions, including those of the anaphylactic (anaphylactoid) type, even in subjects without a history of hypersensitivity following exposure to this type of drugs. These reactions may occur in subjects with a history of angioedema, altered bronchial reactivity (asthma), rhinitis, nasal polyposis, allergic pathologies, chronic respiratory pathologies or sensitivity to acetylsalicylic acid. This may also happen in patients who experience allergic reactions (skin reactions, hives) to naproxen or other NSAIDs. After administration of analgesics, antipyretics, non-steroidal anti-inflammatories, worsening of asthma is possible. Anaphylactoid reactions, such as anaphylaxis, can be fatal. Skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Lasonil anti-inflammatory and antirheumatic should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking the anti-inflammatory and antirheumatic Lasonil, 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 (see section 4.8). Sodium and fluid retention in cardiovascular diseases and peripheral edema Caution is required before starting treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Cardiovascular and cerebrovascular effects 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 risk cannot be excluded. There are insufficient data regarding the effects of low doses of naproxen from 220 to 660 mg to reach precise conclusions on possible thrombotic risks. Naproxen can reduce the antiplatelet effect of acetylsalicylic acid. Patients should consult their doctor if they are being treated with acetylsalicylic acid and intend to use naproxen sodium/naproxen (see the section “Interactions with other medicinal products and other forms of interactions”). Hepatic effects Serious hepatic reactions, including jaundice and hepatitis (including some fatal cases) have been reported with the use of naproxen sodium or other nonsteroidal anti-inflammatory drugs. Cross-reactivity has also been reported. Special Populations Elderly Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Women planning a pregnancy Precautions regarding fertility The use of anti-inflammatory and antirheumatic Lasonil, as with any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant due to effects on ovulation, reversible upon discontinuation of treatment (see section 4.6). The administration of the anti-inflammatory and antirheumatic Lasonil must be suspended in women who have fertility problems or who are undergoing fertility investigations. Patients with additional medical history Subjects with the following additional medical histories should be carefully and adequately monitored when taking the anti-inflammatory and antirheumatic Lasonil: - with coagulation disorders or taking medicines that affect haemostasis, since naproxen inhibits platelet aggregation and may prolong bleeding time. - with hepatic insufficiency - who have experienced previous side effects with analgesics, antipyretics and non-steroidal anti-inflammatory drugs. 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 medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'. Taking the maximum daily dosage of 3 tablets results in 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 of sodium per day for an adult.

INTERACTIONS

Cyclosporine: with the concomitant use of ciclosporin the concentration of the latter can be increased, increasing the risk of nephrotoxicity. Lithium: lithium levels may be increased, which may induce nausea, polydipsia, polyuria, tremors and confusion. Methotrexate: the use of anti-inflammatory and antirheumatic Lasonil concomitantly with methotrexate (at doses higher than 15 mg/week) can lead to an increase in methotrexate concentrations, with an increased risk of toxicity of this substance. NSAIDs: do not administer the medicine in combination with drugs based on naproxen, acetylsalicylic acid or other analgesics, antipyretics, anti-inflammatories due to increased risk of gastrointestinal bleeding. Acetylsalicylic acid Clinical pharmacodynamic data highlight that the concomitant use of naproxen for more than one consecutive day can inhibit the effect of low-dose acetylsalicylic acid on platelet activity and this inhibition can persist for a few days after discontinuation of treatment with naproxen. The clinical relevance of this interaction is unknown. Treatment with naproxen/naproxen sodium in patients with increased cardiovascular risk may limit the cardiovascular protection of acetylsalicylic acid (see “Special warnings and precautions for use” section). Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). Anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin (increased prothrombin time and decreased platelet aggregation) (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). Naproxen decreases platelet aggregation and prolongs bleeding time. This must be taken into account when determining the bleeding time. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking the anti-inflammatory and antirheumatic Lasonil 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 consideration should be given to monitoring renal function after initiation of concomitant therapy. In short-term use, no clinically significant interactions are to be expected with the following medicinal products: • antacids, • antidiabetics, • hydantoins, • probenecid, • zidovudine. Interactions with foods The rate of absorption of naproxen can be slowed down by concomitant food intake. Interference with laboratory tests Naproxen sodium interferes with urinary 17-ketosteroid and 5-indoleacetic acid assays.

SIDE EFFECTS

Cardiac diseases / vascular diseases Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. 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) (see section 4.4). Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). After administration of the anti-inflammatory and antirheumatic Lasonil the following have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Pathologies of the skin and subcutaneous tissue Bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (very rarely). Lasonil anti-inflammatory and antirheumatic causes a modest transient, dose-dependent increase in bleeding time. However, these values ​​often do not exceed the upper limit of the reference range. The following table shows the side effects observed with medicines containing naproxen and naproxen sodium. The frequency of possible side effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to < 1/10), Uncommon (≥1/1000 to < 1/100), Rare (≥1/10,000 to < 1/1,000), Very rare <10,000), Not known (cannot be estimated from the available data).

Classification by systems and organs | Frequency | Side effects

Immune system disorders | Very rare | Anaphylaxis/anaphylactoid reactions, including shock with fatal outcome

Metabolism and nutrition disorders | Rare | Hyperglycemia, hypoglycemia

Pathologies of the blood and lymphatic system | Very rare | Hematopoiesis disorders (leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia)

Psychiatric disorders | Very rare | Psychiatric disorders, depression, sleep disorders, difficulty concentrating

Nervous system disorders | Municipality | Dizziness, headache, lightheadedness

Uncommon | Drowsiness, insomnia, drowsiness

Very rare | Aseptic meningitis, cognitive disorders, convulsions

Eye pathologies | Very rare | Visual disturbances, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Ear and labyrinth disorders | Uncommon | Vertigo

Very rare | Hearing loss, tinnitus, hearing disorders

Cardiac diseases | Rare | Tachycardia

Very rare | Congestive heart failure, hypertension, pulmonary edema, palpitations

Vascular pathologies | Very rare | Vasculitis

Thoracic and mediastinal respiratory disorders | Very rare | Dyspnea, asthma, eosinophilic pneumonia, alveolitis

Gastrointestinal disorders | Municipality | Dyspepsia, nausea, heartburn, abdominal pain

Uncommon | Diarrhea, constipation, vomiting

Rare | Peptic ulcer with or without hemorrhage or perforation, gastrointestinal hemorrhage, hematemesis, melena

Very rare | Pancreatitis, colitis, aphthous ulcers, stomatitis, esophagitis, intestinal ulcerations, crampy abdominal pain

Hepatobiliary disorders | Very rare | Hepatitis, (including fatal cases), jaundice

Pathologies of the skin and subcutaneous tissue | Uncommon | Rash, itching, urticaria

Rare | Angioedema

Very rare | Alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, bullous reactions including Steven's-Johnson syndrome and toxic epidermal necrolysis, erythema nodosum, fixed erythema, lichen planus, pustules, rash, Systemic Lupus Erythematosus, photosensitivity reactions including porphyria cutanea tardi (“pseudoporphyria”) or epidermolysis bullous, ecchymosis, purpura, sweating

Pathologies of the musculoskeletal system and connective tissue | Rare | Myalgia, muscle weakness

Renal and urinary disorders | Rare | Impaired renal function, glomerulonephritis

Very rare | Interstitial nephritis, papillary necrosis, nephrotic syndrome, renal failure, nephropathy, haematuria, proteinuria

Congenital, familial and genetic pathologies | Very rare | Closure of the ductus arteriosus

Reproductive system and breast disorders | Very rare | Infertility (in women)

Systemic pathologies and conditions relating to the administration site | Rare | Peripheral edema, particularly in hypertensive patients or patients with renal insufficiency, pyrexia (including chills and fever)

Very rare | Edema, thirst, malaise

Diagnostic tests | Very rare | Increased serum creatinine, abnormal liver function tests, hyperkalaemia

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-re azione-avversa.