Lasonil 220 mg - anti-inflammatory and anti-rheumatic 12 coated tablets

Product Description

Lasonil 220 mg: coated tablets

Indicated for the symptomatic treatment of headache, back pain, joint and muscle pain, toothache, and colds. It is also indicated for menstrual cramps and minor pain in arthritis.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. History of asthma, urticaria, or allergic-type reactions following the intake of acetylsalicylic acid or other analgesics, antipyretics, or nonsteroidal anti-inflammatory drugs. Severe renal insufficiency (creatinine clearance less than 20 ml/min). Severe cardiac insufficiency. Liver cirrhosis and severe hepatitis. Those undergoing intensive therapy with diuretics. Gastric and duodenal ulcers. Subjects with active or risky bleeding. During treatment with anticoagulants as it synergizes their action. Pregnancy and breastfeeding. Adolescents under 16 years of age. 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).

Dosage

The film-coated tablet should be taken orally with a glass of water, on a full stomach. Adults and adolescents over 16 years of age: 1 tablet every 8 - 12 hours. Greater benefit may be obtained by starting with 2 tablets followed by 1 tablet every 12 hours, as needed. The maximum daily dose is 3 tablets. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not use for more than 12 hours. For more than 7 days for the symptomatic treatment of pain and for more than 3 days for colds without medical supervision. Elderly: Use the minimum dosage. Patients with renal, hepatic, or cardiac insufficiency: In patients with renal and/or cardiac insufficiency and/or severe hepatic insufficiency, a dosage reduction may be necessary. Paediatric population: Safety and efficacy in children under 16 years of age have not yet been established.

Warnings

The product is not indicated for gastrointestinal pain. Use should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Anaphylactic/anaphylactoid reactions: Analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs can cause potentially fatal hypersensitivity reactions, including anaphylactic (anaphylactoid) reactions, even in individuals with no history of hypersensitivity following exposure to these drugs. These reactions may occur in individuals with a history of angioedema, altered bronchial reactivity (asthma), rhinitis, nasal polyps, allergic conditions, chronic respiratory conditions, or sensitivity to acetylsalicylic acid. This may also occur in patients who have experienced allergic reactions (skin reactions, urticaria) to naproxen or other NSAIDs. Worsening of asthma is possible following administration of analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs. 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. Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of 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. 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: Gastrointestinal bleeding, ulceration, and perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing doses of NSAIDs. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low-dose 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 receiving concomitant medications which 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. If 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. Sodium and fluid retention in cardiovascular disease and peripheral edema. Caution is required before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID therapy. Cardiovascular and cerebrovascular effects: The use of coxibs and some NSAIDs may increase the risk of cerebrovascular accidents. be associated with a modestly increased 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 on the effects of low-dose naproxen (220 to 660 mg) to draw firm conclusions about possible thrombotic risks. Hepatic effects: Serious liver reactions, including jaundice and hepatitis (some fatal) have been reported with the use of naproxen sodium or other nonsteroidal anti-inflammatory drugs. Cross-reactivity has also been reported. Precautions regarding fertility: Use is not recommended in women attempting to conceive due to effects on ovulation, which are reversible upon discontinuation of treatment. Administration should be suspended in women who have fertility problems or who are undergoing fertility investigations. Patients with coagulation disorders must be carefully monitored since naproxen inhibits platelet aggregation and may prolong bleeding time. In case of hepatic insufficiency, concomitant treatment with other drugs, such as other analgesics, steroids, or intensive diuretic therapy, or in case of previous side effects with analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs, the product should be administered with caution. One tablet contains approximately 20 mg of sodium. Taking the maximum daily dose of 3 tablets results in a maximum sodium intake of approximately 2.6 mmol/day. This should be taken into account in patients with reduced renal function or on a low-sodium diet.

Interactions

Interactions with other medicinal products. Cyclosporin: Concomitant use of cyclosporin may increase cyclosporin concentrations, increasing the risk of nephrotoxicity. Lithium: Lithium levels may be increased, which may cause nausea, polydipsia, polyuria, tremors, and confusion. Methotrexate: Concomitant use with methotrexate (at doses greater than 15 mg/week) may lead to increased methotrexate concentrations, increasing the risk of methotrexate toxicity. NSAIDs: Do not administer the medicine in combination with naproxen-based drugs, acetylsalicylic acid, or other analgesics, antipyretics, or anti-inflammatories due to an increased risk of gastrointestinal bleeding. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs may increase the effects of anticoagulants such as warfarin (increased prothrombin time and decreased platelet aggregation). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding. Naproxen decreases platelet aggregation and prolongs bleeding time. This should be taken into account when determining bleeding time. Diuretics, ACE inhibitors, and angiotensin II antagonists: NSAIDs may 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), the coadministration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclooxygenase 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 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 initiating concomitant therapy. Clinically significant interactions are not expected with short-term use with the following medicinal products: antacids; antidiabetics; hydantoins; probenecid; zidovudine. Interactions with food: The rate of absorption of naproxen may be slowed by concomitant food intake. Interference with laboratory tests: Naproxen sodium interferes with urinary 17-ketosteroid and 5-indoleacetic acid analyses.

Undesirable Effects

Cardiac disorders/vascular disorders: Edema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Clinical trials and epidemiological data suggest that the use of coxibs and some NSAIDs (particularly at high doses and for long-term treatment) may be associated with a modestly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. Gastritis has been observed less frequently. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). The drug 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 lists the side effects observed with naproxen and naproxen sodium medicines. The frequency of possible side effects listed below is defined using the following convention: very common (>=1/10), common (>=1/100,<1/10), uncommon (>=1/1,000,<1/100), rare (>=1/10,000,<1/1,000), very rare (<10,000), not known. Immune system disorders. Very rare: anaphylaxis/anaphylactoid reactions, including shock with fatal outcome. Metabolism and nutrition disorders. Rare: hyperglycaemia, hypoglycaemia. Blood and lymphatic system disorders. Very rare: Haematopoietic disorders (leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, eosinophilia, haemolytic anemia). Psychiatric disorders. Very rare: Psychiatric disorders, depression, sleep disturbances, difficulty concentrating. Nervous system disorders. Common: dizziness, headache, lightheadedness; Uncommon: drowsiness, insomnia, somnolence; Very rare: aseptic meningitis, cognitive disorders, convulsions. Eye disorders. Very rare: visual disturbances, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema. Ear and labyrinth disorders. Uncommon: vertigo; Very rare: hearing loss, tinnitus, hearing disturbance. Cardiac disorders. Rare: tachycardia; Very rare: congestive heart failure, hypertension, pulmonary oedema, palpitations. Vascular disorders. Very rare: Vasculitis. Respiratory, thoracic, and mediastinal disorders. Very rare: Dyspnoea, asthma, eosinophilic pneumonia, alveolitis. Gastrointestinal disorders. Common: Dyspepsia, nausea, heartburn, abdominal pain; Uncommon: Diarrhea, constipation, vomiting; Rare: Peptic ulcer with or without haemorrhage or perforation, gastrointestinal haemorrhage, haematemesis, melaena; Very rare: Pancreatitis, colitis, aphthous ulcers, stomatitis, esophagitis, intestinal ulceration, crampy abdominal pain. Hepatobiliary disorders. Very rare: Hepatitis (including fatal cases), jaundice. Skin and subcutaneous tissue disorders. Uncommon: Rash, pruritus, 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. Renal and urinary disorders. Rare: Impaired renal function, glomerulonephritis; very rare: Interstitial nephritis, papillary necrosis, nephrotic syndrome, renal failure, nephropathy, haematuria, proteinuria. Pregnancy, puerperium, and perinatal conditions. Very rare: Induction of labor. Congenital, familial, and genetic disorders. Very rare: closure of the ductus arteriosus. Reproductive system and breast disorders. Very rare: infertility (in females). Systemic disorders and administration site conditions. Rare: peripheral edema, particularly in patients with hypertension or renal insufficiency, pyrexia (including chills and fever); very rare: edema, thirst, malaise. Diagnostic tests. Very rare: increased serum creatinine, abnormal liver function tests, hyperkalemia. Report any suspected adverse reactions via the national reporting system.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, 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 result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can 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 oligohydramnios; in the mother and newborn, at the end of pregnancy, possible prolongation of bleeding time and an antiplatelet effect that may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Naproxen may pass into breast milk. The medicine is therefore contraindicated during breastfeeding. The use of naproxen may interfere with fertility, and female subjects, particularly women with fertility problems or undergoing fertility investigations, should be informed of this. This effect is reversible upon discontinuation of treatment.