ANTALGIL 10CPR 200MG

ANTALGIL 200 MG COMPRESENT

active ingredients

Each tablet contains: Active Principle: Ibuprofen 200 mg For full list of excipients, see section 6.1

Excellent

Corn starch, pregelatinized starch, ipromellosa, microcrystalline cellulose, sodium glyculate starch, silica precipitate, sodium laurilsulfate, E 104 aluminum lacquer, E 110 aluminum lacquer, titanium dioxide, propylene glycol, carnauba wax.

Therapeutic indications

Syntomatic treatment of pains of various origin and nature (headache, toothache, nerves, menstrual pains, osteoarticocular and muscle pain).

Contraindications

Children under 12 years (see Section 4.2). Hypersensitivity to the active ingredient or other substances closely related to a chemical point of view and/or any of the excipients. History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). Active gastro-duodenal ulcer or other gastropathies. Severe heart failure (IV class NYHA). Last trimester of pregnancy and nursing (see section 4.6). Severe kidney or liver failure (see Section 4.2).

Population

Adults and boys over 12 years: 1-2 tablets 2-3 times a day. Do not exceed the dose of 6 tablets per day. Do not exceed the recommended doses. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4) This medicine is only for short-term use and should not exceed 3 days of treatment. If the symptoms persist or worsen it is necessary to consult a doctor. If Antalgil is necessary for more than 3 days or if symptoms worsen, or persist, you must consult your doctor. Seniors: nSAIDs must be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal hemorrhage, ulceration or perforation (see paragraph 4.4). If the treatment is considered necessary, the lowest dose should be used for the shortest duration necessary for the control of symptoms (see section 4.4). Treatment should be revised at regular intervals and interrupted if no benefit is seen or if intolerance is required. Children: ANTALGIL is contraindicated in children under the age of 12 (see section 4.3). Renal insufficiency: in patients with mild or moderate reduction of kidney function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. ANTALGIL is contraindicated in patients with severe kidney failure (see section 4.3) Hepatic insufficiency: in patients with mild or moderate reduction of liver function, the dosage must be kept as low as possible for the shortest duration necessary to control symptoms and liver function must be monitored. ANTALGIL is contraindicated in patients with severe liver failure (see section 4.3) Methods of administration: The tablet must be swallowed with a glass of water during or after a meal.

Conservation

No special precaution for conservation.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration that is required to control symptoms (see Section 4.2 and Gastrointestinal and cardiovascular hazards below) It is recommended to take the drug on a full stomach. In asthmatic patients the product must be used with caution, consulting the doctor before taking the product. The use of Antalgil must be avoided in conjunction with NSAIDs including selective COX-2 inhibitors. Masking the symptoms of underlying infections Antalgil can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Antalgil is administered for the relief of fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Seniors : 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). 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 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-aggragant agents such as aspirin (see section 4.5) When bleeding or gastrointestinal ulceration occurs in patients taking Antalgil the treatment must be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see section 4.8) Cardiovascular and cerebrovascular effects Precaution is needed in patients with a history of hypertension and/or heart failure since, in association with NSAID therapy, water retention, hypertension and edema were reported. NSAIDs can reduce the effect of diuretics, and other antihypertensive drugs. (see section 4.5) Clinical studies suggest that the use of ibuprofen, especially at high doses (2,400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1,200 mg/die) are associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Severe skin reactions Some of which fatal, including exfoliatory 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 higher risk: the onset of reaction occurs in most cases within the first month of treatment. Antalgil must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Serious skin reactions have been reported, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity Renal effects Ibuprofen can cause sodium, potassium and water retention in patients who have never suffered kidney disorders due to its effects on kidney perfusion. This can cause edema or even lead to heart failure or hypertension in predisposed patients. As with other NSAIDs, prolonged administration of ibuprofen in animals led to kidney papillar necrosis and other kidney pathological variations. In humans, there have been reports of acute interstitial nephritis with hematuria, proteinuria and nephrosic syndrome from time to time. Renal toxicity cases were also observed in patients where prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, the administration of NSAIDs can cause a dose-dependent reduction in prostaglandin production and, secondly, kidney blood flow, which can precipitate a conclaimed kidney failure. Patients at greater risk of suffering from this reaction are those with kidney dysfunction, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. The suspension of treatment with NSAIDs is generally followed by recovery of the pre-treatment state.Other precautions Broncospasm, hives or angioedema can precipitate in patients suffering from or with previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases. Hybuprofen can mask signs or symptoms of infection (fever, pain and swelling). During the long term, the use of high doses of analgesics for non-treated cephaleses with high doses of the drug may occur. In general, the habitual intake of analgesics, in particular the use in combination of different analgesic substances, can cause permanent kidney damage and the risk of kidney failure (nephropathy from analgesics). During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as torcicollo, headache, nausea, vomiting, fever or disorientation were observed in patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). Hybuprofen can temporarily inhibit piastrinic aggregation and prolong bleeding time. Therefore, patients with clotting defects or anticoagulant therapy should be carefully observed. In case of long-term treatment with ibuprofen, periodic monitoring of liver and kidney function, as well as hemochrome is necessary, especially in high-risk patients. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially if it affects the gastrointestinal tract or the central nervous system. Patients treated with Antalgil should report to their doctor signs or symptoms of gastro-intestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema. The use of Antalgil, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase is not recommended in women who intend to begin a pregnancy. The administration of Antalgil should be suspended in women who have fertility problems or who are subject to fertility surveys. In dehydrated adolescents there is a risk of alteration of kidney function.

Interactions

Concurrent use of ibuprofen and the following substances should be avoided: A i'm sorry acetylsalicy . Concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be ruled out the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Other : as a result of synergistic effects, the concomitant use of several NSAIDs can increase the risk of gastrointestinal ulcers and bleeding. Concurrent administration of ibuprofen with other NSAIDs must therefore be avoided (see paragraph 4.4). Anti- clots: NSAIDs can increase the effects of anticoagulants, such as warfarin or heparin (see paragraph 4.4). In case of concomitant treatment, monitoring of the coagulation status is recommended. Ticlopidine: NSAIDs should not be combined with ticlopidine due to a risk of an additive effect in the inhibition of the pyastrinic function. Methodology: NSAIDs inhibit the tubular secretion of metotrexate and some metabolic interactions can occur with reduced metotrexate clearance. The administration of Ibuprofen within 24 hours before or after the administration of metotrexate may lead to a high concentration of metotrexate and an increase in its toxic effects. Therefore, the concomitant use of NSAIDs and high doses of metotrexate should be avoided. In addition, the potential risk of interactions in low dose treatment with metotrexate should be considered, particularly in patients with impaired kidney function. In combined treatment, renal function must be monitored. Ibuprofen (like other NSAIDs) must be taken with caution in combination with the following substances: Moclobemide: increases the effect of ibuprofen. Fenitoin , lithium: concomitant administration of ibuprofen and phenytoin or lithium preparations may increase the serum levels of these medicines. Control of the lithium level in the serum is necessary and it is recommended to check the serum levels of phenytoin. Glycosides heart rate (e.g. digoxin): NSAIDs can exacerbate heart failure, reduce glomerular filtration speed and increase plasma levels of cardiac glycosides. It is recommended to monitor sierica dygoxin. Diuretics and antihypertensive: diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs. NSAIDs can reduce the effect of diuretics and antihypertensives including ACE inhibitors and beta-blockers. In patients with reduced kidney function (e.g. dehydrated patients or elderly patients with reduced kidney function), the concomitant use of an ACE inhibitor and angiotensin II antagonist with a drug-inhibition of cyclooxygenase can lead to further deterioration of the kidney function which includes a possible acute kidney failure, generally reversible. This combination should therefore be used with caution, especially in elderly patients. Patients should be trained to drink sufficient liquid and periodic monitoring of renal values should be considered for the time immediately after the start of the combination therapy. Concurrent administration of ibuprofen and diuretic potassium or ACE inhibitors can cause hyperkaliemia. Careful monitoring of potassium levels is necessary. Captopril: experimental studies indicate that ibuprofen contrasts the effect of captopril to an increase in sodium excretion. Aminoglycosides: NSAIDs can slow down the elimination of aminoglycosides and increase their toxicity. Inhibitions selective serotonin recaptation (SSRIs): increased risk of gastrointestinal bleeding (see paragraph 4.4). Ciclosporin: the risk of kidney damage from cyclosporin is increased by the concomitant administration of some NSAIDs. This effect cannot be excluded for the combination of cyclosporin and ibuprofen. Colestiramine: the concomitant treatment with choleramine and ibuprofen is prolonged and reduced (25%) absorption of ibuprofen. Drugs should be administered at least one hour interval. Tacrolimus: high risk of nephrotoxicity. Zidovudina: there are evidence of an increased risk of hematoma and hematoma in positive HIV hemophiliacs who had received concomitant treatment of zidovudine and ibuprofen. There may be an increase in the risk of hematotoxicity during the concomitant use of zidovudine and NSAIDs. Hematological examination is recommended 1-2 weeks after starting use together. Ritonavir: may increase plasma concentrations of NSAIDs. Mifepristone: if NSAIDs are used within 8-12 days after mifepristone administration can reduce the effect of mifepristone. Probenecid or on the ground: may cause delay in the elimination of ibuprofen. The uricreal action of these substances has decreased. Antibiotics chinolo: Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. Sulfaniluree: NSAIDs can increase the hypoglycemic effect of sulphonluree. In the case of simultaneous treatment, it is recommended to monitor blood glucose levels. Courtesy: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Agents anti-platelet aggregation (e.g. clopidogrel and ticlopidine): increase the risk of gastrointestinal bleeding (see paragraph 4.4). Other , biphosphonate and oxpentifilline (pentoxyflline): can enhance gastrointestinal side effects and the risk of bleeding and ulcer. Baclofen: high toxicity baclofen.

Effects

The following spontaneous adverse events have been reported using ibuprofen tablets, and within each organ or system class, are collected by frequency, using the following convention: Very common (>1/10); Common (>1/100, 1/ 1,000, 1/10,000, Laboratory examinations. Rare : increase in azotemia, sieric transaminasis and alkaline phosphatease, decrease in hemoglobin and hematocrite values, inhibition of piastrinic aggregation, prolongation of bleeding time, decrease in sieric calcium, increase in sieric uric acid. Heart disease . . Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema. System pathologies emolinfopoietico. . Very rare: hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first symptoms or signs may include: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal bleeding and skin. Diseases of the nervous system. . Town: headache, drowsiness, dizziness, fatigue, agitation, insomnia, irritability; very rare: aseptic meningitis. Eye pathologies. Not common: Visual disturbances; rare: toxic ambliopia. Ear pathologies and the maze. Very rare: tinnitus. Respiratory diseases , thoracic and mediastinic. Not common: rhinitis, bronchospasm. Gastrointestinal diseases. . Very common: gastrointestinal disorders, such as heartburn, dyspepsia, abdominal pain and nausea, vomiting, flatulence, diarrhea, constipation; common: gastrointestinal ulcers, sometimes with hemorrhage and perforation (see paragraph 4.4), loss of occult blood, which can lead to anemia, melena, hematitis, ulcerative stomatitis, colitis, exacerbation of intestinal inflammatory disease, complications of diverticula of the colon (perforation, fistola); not common: gastritis; very rare: esophagitis, pancreatis, intestinal stenosis. Kidney and urinary disorders. . Not common: development of edema especially in patients with arterial hypertension or kidney failure, nephrosic syndrome, interstitial nephritis that may be associated with kidney failure; very much rare: renal papillar necrosis in long term use (see paragraph 4.4). Skin pathologies and of subcutaneous tissue. Not common: photosensitivity; very rare: severe forms of skin reactions (multiform erythema, exfoliative dermatitis, boiling reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fascites; do not note: reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome) generalized acute acute exantematic Pustolosis (PEAG). Disturbation vasculars. Very rare: hypertension. System disturbances immune. Not common: reactions of hypersensitivity such as hives, itching, purple and esantema as well as as asthma attacks (sometimes with hypotension); rare: The lupus erythematous syndrome; very rare : severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the tongue, internal larynx, swelling with the constriction of airways, dispnea, tachycardia, fall of blood pressure to the point of life-threatening shock. Alterations of the hepatobiliary system. Very rare: liver dysfunction, liver damage, especially in long term use, liver failure, acute hepatitis, jaundice. Psychiatric disorders. Rare: depression, confusion, hallucinations. Reporting of suspicious adverse reactions: The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the Italian Pharmaco Agency, Website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. Children can also develop myoclonic cramps. In cases of severe poisoning it is possible that metabolic acidosis occurs. Rarely, nistagm, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea, and depression of SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy

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-system 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, ANTALGIL should not be administered if not in strictly necessary cases. If ANTALGIL 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 - ANTALGIL is subsequently contraindicated during the third trimester of pregnancy. It is also not recommended to use the product during lactation.

Food

Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influence on the newborn seems unlikely. If, instead, treatment is longer term, premature weaning should be considered.

Fertility

There is some evidence that medicines that inhibit cyclo-oxygenase/prostaglandin synthesis may cause female fertility impairment due to ovulation. This is reversible with the suspension of treatment.

Source: Farmadati