LASONIL ANTINFIAMM * 12CPR 220MG

LASONIL ANTINFIAMM * 12CPR 220MG

Therapeutic indications

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

Dosage and method of use

Method of administrationThe film-coated tablet should be taken orally with a glass of water, on a full stomach.DosageAdults and adolescents over 16 years: 1 tablet every 8 - 12 hours. You may benefit most 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 reduced by using the lowest effective dose for the shortest possible duration of treatment to control symptoms (see section 4.4). Do not use for more than 7 days for symptomatic pain relief and for more than 3 days for colds without medical supervision.Pediatric populationThe safety and efficacy in children below the age of 16 have not yet been established (see section 4.3).Elderly peopleUse the lowest dosage.Patients with renal, hepatic or cardiac insufficiencyIn patients with renal and / or cardiac insufficiency and / or severe hepatic insufficiency a dose reduction may be necessary.

Contraindications

• Hypersensitivity to the active substance, or to any of the excipients, listed in section 6.1. • History of asthma, hives or allergic-type reactions following the intake of acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs. • Severe renal failure (creatinine clearance less than 20 ml / min) • Severe heart failure • Cirrhosis of the liver and severe hepatitis • During intensive therapy with diuretics • Gastric and duodenal ulcer • People with ongoing or at risk of bleeding of bleeding • During treatment with anticoagulants as they synergize their action • Pregnancy and lactation (see section 4.6) • Adolescents under 16 years • History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of haemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding).

Side effects

Cardiac disorders / vascular disordersEdema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke ) (see section 4.4).Gastrointestinal disordersThe most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Following administration of anti-inflammatory and antirheumatic Lasonil: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Gastritis has been observed less frequently.Skin and subcutaneous tissue disordersBullous 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 table below shows the undesirable 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,

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 ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:

Special warnings

The product is not indicated for pain in the gastrointestinal tract.General warningsThe use of anti-inflammatory and antirheumatic Lasonil 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 possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks).Anaphylactic / anaphylactoid reactionsAnalgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially fatal, including those of the anaphylactic (anaphylactoid) type, even in subjects with no history of hypersensitivity following exposure to this type of drug. These reactions can occur in subjects with a history of angioedema, altered bronchial reactivity (asthma), rhinitis, nasal polyposis, allergic diseases, chronic respiratory diseases or sensitivity to acetylsalicylic acid. This can also happen in patients who experience allergic reactions (skin reactions, hives) to naproxen or other NSAIDs. After administration of analgesics, antipyretics, non-steroidal anti-inflammatory drugs, worsening of asthma is possible. Anaphylactoid reactions, such as anaphylaxis, can be fatal.Skin reactionsSerious 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 signs of hypersensitivity.Gastrointestinal bleeding, ulceration and perforation:Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with 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 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 bleeding) particularly in the initial 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 acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking 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 edemaCaution is required before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.Cardiovascular and cerebrovascular effectsClinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest 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, a certain risk cannot be excluded. There are insufficient data regarding the effects of the low dose of naproxen 220 to 660 mg to arrive at precise conclusions on possible thrombotic risks. Naproxen can reduce the antiplatelet effect of acetylsalicylic acid. Patients should consult their physician if they are being treated with acetylsalicylic acid and intend to use naproxen sodium / naproxen (see section “Interactions with other medicinal products and other forms of interactions”).Hepatic effectsSerious hepatic reactions, including jaundice and hepatitis (including some fatal cases) have been reported with the use of naproxen sodium or other non-steroidal anti-inflammatory drugs. Cross-reactivity has also been reported.Special populations Elderly peopleElderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Women planning pregnancy Precautions regarding fertilityThe use of anti-inflammatory and antirheumatic Lasonil, as with any drug inhibiting 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 anti-inflammatory and antirheumatic Lasonil should be discontinued in women who have fertility problems or who are undergoing fertility investigations.Patients with additional medical historyIndividuals with the following additional medical histories should be carefully and adequately monitored when taking anti-inflammatory and antirheumatic Lasonil: - with bleeding disorders or taking medicinal products that affect haemostasis, as naproxen inhibits platelet aggregation and may prolong bleeding time . - with hepatic insufficiency - who have experienced previous undesirable effects with analgesics, antipyretics and non-steroidal anti-inflammatory drugs The product should be administered with caution in the 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 (23 mg) sodium per tablet, ie essentially "sodium-free". The intake of 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.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely 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 has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in 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 can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Breastfeeding Naproxen can pass into breast milk. The medicine is therefore contraindicated during breastfeeding. Fertility The use of naproxen caninterfere with fertility and female subjects and in particular women who have fertility problems or who are undergoing fertility investigations should be informed of this (see section 4.4).This effect is reversible upon discontinuation of treatment.

Expiration and retention

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

Interactions with other drugs

Cyclosporine : With the concomitant use of cyclosporine the concentration of the latter may be increased, increasing the risk of nephrotoxicity. Lithium : Lithium levels may be increased, which can 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 increased concentrations of methotrexate, 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 show that concomitant use of naproxen for more than one consecutive day may inhibit the effect of low dose acetylsalicylic acid on platelet activity and this inhibition may 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 acetisalicylic acid (see section “Special warnings and precautions for use). Corticosteroids : increased risk of gastrointestinal ulceration or bleeding (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 the bleeding time. This must be taken into account when determining the bleeding time. 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 further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking 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 monitoring of renal function should be considered after initiation of concomitant therapy. Clinically significant interactions with the following medicinal products are not expected in short-term use: • antacids • antidiabetics • hydantoins • probenecid • zidovudineInteractions with foodThe rate of absorption of naproxen can be slowed by the simultaneous intake of food.Interference with laboratory testsNaproxen sodium interferes with urinary 17-ketosteroid and 5-indolacetic acid assays.

Overdose

Dizziness, lethargy, heartburn, epigastric pain, digestive disturbances, nausea and vomiting, transient changes in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea and disorientation may occur as signs of overdose. Since naproxen sodium is rapidly absorbed, early elevated plasma levels are to be expected. Seizures 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 described. It is not known what the life-threatening dose of the drug is. In case of NSAID overdose, patients should be managed with symptomatic and supportive therapies. The stomach should be emptied and the usual supportive measures implemented. Prompt administration of an adequate amount of activated charcoal may reduce the absorption of the medicinal product. Hemodialysis does not decrease plasma naproxen concentrations due to high plasma protein binding. There is no specific antidote. Renal and hepatic function should be monitored.

Active principles

One film-coated tablet contains: 220 mg naproxen sodium, equivalent to 200 mg of naproxen. For the full list of excipients, see section 6.1.

Excipients

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