Johnson & Johnson Antalgil 200mg Ibuprofen 10 Tablets

NAME
ANTALGIL 200 MG TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory / antirheumatic drugs.

ACTIVE PRINCIPLES
Each tablet contains: ibuprofen 200 mg.

EXCIPIENTS
Maize starch, pregelatinised starch, hypromellose, microcrystalline cellulose, sodium starch glycolate, precipitated silica, sodium lauryl sulfate, E 104 aluminum lake, E 110 aluminum lake, titanium dioxide, propylene glycol, carnauba wax.

INDICATIONS
Symptomatic treatment of pain of various origins and nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscle pain).

CONTRAINDICATIONS / SECONDARY EFFECT
Children under 12 years old. Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and / or to any of the excipients. 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). Gastro-duodenal reactive ulcer or other gastropathies. Severe heart failure Last trimester of pregnancy and lactation. Severe renal or hepatic insufficiency.

DOSAGE
Adults and children 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 dose. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms This medicine is for short term use only and should not be longer than 3 days. treatment. If symptoms persist or worsen, a doctor should be consulted. If the drug is needed for more than 3 days or if symptoms worsen, or persist, it is necessary to consult your doctor. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of life-threatening gastrointestinal bleeding, ulceration or perforation. If treatment is considered necessary, the lowest dose should be used for the shortest duration necessary to control symptoms. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerances occur. Children: contraindicated in children younger 'less than 12 years. Renal insufficiency: in patients with mild or moderate renal impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. The drug is contraindicated in patients with severe renal insufficiency. Hepatic insufficiency: in patients with mild or moderate liver function impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. The drug is contraindicated in patients with severe hepatic insufficiency. Method of administration: the tablet should be swallowed with a glass of water during or after a meal.

STORAGE
No special storage precautions.

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms. It is advisable to take the drug on a full stomach. In asthmatic patients the product should be used with caution, consulting your doctor before taking the product. Avoid concomitant use of NSAIDs including selective COX-2 inhibitors. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported. In the elderly and in patients with a history of ulcer, 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 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 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 particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptakedel inhibitors or antiplatelet agents such as aspirin. When 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 can be exacerbated. Cardiovascular and cerebrovascular effects: caution should be exercised 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. NSAIDs can reduce the effect of diuretics, and other antihypertensive drugs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2,400 mg / day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (eg. myocardium or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations should be made before initiating longer-term treatment in patients with risk factors for cardiovascular events. Skin: 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. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Renal Effects: Ibuprofenep can cause sodium, potassium and water retention in patients who have never suffered from kidney disorders due to its effects on renal perfusion. This can cause edema or even lead to heart failure or hypertension in predisposed patients. Prolonged administration of ibuprofen in animals has led to renal papillary necrosis and other renal pathological changes. In humans, there have been reports of acute interstitial nephritis with hematuria, proteinuria, and nephrotic syndrome from time to time. Cases of renal toxicity have also been observed in patients in whom 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, secondarily, in renal blood flow, which can precipitate overt renal failure. Patients at greatest risk of suffering from this reaction are those with renal dysfunction, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment is generally followed by recovery of the pre-treatment state. Other Precautions: Bronchospasm, urticaria or angioedema may precipitate in patients with or with a previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases. Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling). Over the long term, the use of high doses of pain relievers for headaches not treated 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 renal damage and the risk of renal failure (analgesic nephropathy). During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed in patients with existing autoimmune disorders. Ibuprofen can temporarily inhibit platelet aggregation and prolong bleeding time. Therefore, patients with coagulation defects or on anticoagulation therapy should be carefully observed. In case of long-term treatment with ibuprofen, periodic monitoring of hepatic and renal function, as well as the blood count 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 central nervous system. Patients treated with the drug should report signs or symptoms of gastrointestinal ulcer or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema to their physician. The use is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations. In dehydrated adolescents there is a risk of impaired renal function.

INTERACTIONS
Concomitant use of ibuprofen and the following substances should be avoided. Low-dose acetylsalicylic acid: Ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen. Other NSAIDs: As a result of synergistic effects, concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. Concomitant administration of ibuprofen with other NSAIDs should therefore be avoided. Anti-coagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin or heparin. 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 inhibiting platelet function. Methotrexate: NSAIDs inhibit tubular secretion of methotrexate and some metabolic interactions may occur resulting in reduced clearance of methotrexate. Administration of ibuprofen within 24 hours before or after methotrexate administration may lead to an elevated concentration of methotrexate and an increase in its toxic effects. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. Furthermore, the potential risk of interactions in low dose methotrexate treatment must be considered, particularly in patients with impaired renal function. In combined treatment, renal function should be monitored. Ibuprofen (like other NSAIDs) should be taken with caution in combination with the following substances. Moclobemide: increases the effect of ibuprofen. Phenytoin, lithium: concomitant administration of ibuprofen and phenytoin or lithium preparations may increase the serum levels of these drugs. Monitoring of serum lithium level is necessary and monitoring of phenytoin serum levels is recommended. Cardiac glycosides (eg digoxin): NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum digoxin is recommended. Diuretics and antihypertensives: diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs. IFANS may reduce the effect of diuretics and antihypertensives including ACE inhibitors and beta-blockers. In patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of an ACE inhibitor and diangiotensin II antagonist with a cyclooxygenase inhibitor drug may lead to further deterioration of renal function which includes possible acute renal failure, which is generally reversible. This combination should therefore be used with caution, especially in elderly patients. Patients should be instructed to have sufficient fluid and periodic monitoring of renal values should be considered for the time immediately after initiation of combination therapy. Concomitant administration of ibuprofen and potassium-sparing diuretics or ACE inhibitors may cause hyperkalaemia. Careful monitoring of potassium levels is necessary. Captopril: Experimental studies indicate that ibuprofen counteracts the effect of captopril of increased sodium excretion. Aminoglycosides: NSAIDs can slow down the elimination of aminoglycosides and increase their toxicity. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Ciclosporin: The risk of cyclosporine-induced kidney damage is increased by concomitant administration of some NSAIDs. This effect cannot be excluded for the combination of cyclosporine and ibuprofen. Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen results in prolonged and reduced (25%) absorption of ibuprofen. Medicines should be administered with at least one hour interval. Tacrolimus: high risk of nephrotoxicity. Zidovudine: There is evidence of an increased risk of haemarthrosis and hematoma in HIV positive haemophilia patients who had received concomitant treatment of zidovudine and ibuprofen. There may be an increased risk of haematotoxicity during concomitant use of zidovudine and NSAIDs. A 1-2 week blood test is recommended after starting use together. Ritonavir: May 'increase plasma concentrations of NSAIDs. Mifepristone: If NSAIDs are used within 8-12 days after administration of mifepristone they may reduce the effect of mifepristone. Probenecid or sulfinpyrazone: May cause a delay in the elimination of ibuprofen. The uricosuric action of these substances is decreased. Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Sulfonylureas: NSAIDs may increase the hypoglycemic effect of sulfonylureas. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anti-platelet aggregation agents (e.g. clopidogrel and ticlopidine): increase the risk of gastrointestinal bleeding. Alcohol, bisphosphonates and oxpentifylline (pentoxyflline): can 'potentiate gastrointestinal side effects and the risk of bleeding and ulcer. Baclofen: high baclofen toxicity.

SIDE EFFECTS
Adverse reaction frequencies: very common (> 1/10), common (> 1/100, <1/100), uncommon (> 1 / 1,000, <1/100), rare (> 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000), with the inclusion of isolated reports Adverse effects are mostly dose-dependent. Especially the risk for the onset of gastrointestinal bleeding depends on the dosage range and duration of treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). . Edema, hypertension and heart failure have been reported in association with NSAID treatment. Laboratory tests. Rare: BUN, serum transaminases and alkaline phosphatase increased, hemoglobin and hematocrit decreased, platelet aggregation inhibition, bleeding time prolonged, serum calcium decrease, serum uric acid increase. Cardiac pathologies. Moltorari: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema. Disorders of the blood and lymphatic system. Very rare: haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms or signs may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding. Nervous system disorders. Common: headache, somnolence, dizziness, tiredness, agitation, insomnia, irritability; very rare: aseptic meningitis. Eye disorders. Uncommon: visual disturbances; rare: toxic amblyopia. Ear and labyrinth disorders. Very rare: tinnitus. Respiratory, thoracic and mediastinal disorders. Uncommon: rhinitis, bronchospasm. Gastrointestinal disorders. Very common: gastrointestinal disturbances, such as heartburn, dyspepsia, abdominal pain and nausea, vomiting, flatulence, diarrhea, constipation; common: gastrointestinal ulcers, sometimes with haemorrhage and perforation, occult blood loss, which can lead to anemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula); uncommon: gastritis; very rare: esophagitis, pancreatitis, intestinal strictures. Renal and urinary disorders. Uncommon: development of edema especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency; very rare: renal papillary necrosis in long-term use. Skin and subcutaneous tissue disorders. Uncommon: photosensitivity; very rare: severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fasciitis. Vascular disorders. Very rare: hypertension. Immune system disorders. Uncommon: reactions hypersensitivity such as hives, itching, purpura and rash as well as asthma attacks (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the tongue, internal larynx, swelling with constriction of the airways, dyspnoea, tachycardia, drop in blood pressure to the point of shock, life-threatening. Alterations in the hepatobiliary system. Very rare: hepatic dysfunction, liver damage, especially in long-term use , hepatic failure, acute hepatitis, jaundice Psychiatric disorders Rare: depression, confusion, hallucinations. suspected adverse reaction.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively 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 increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the medicine should not be administered except in strictly necessary cases. If the drug is used by a pregnant woman, or during the first and second trimester of pregnancy, the dose and duration of treatment should 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 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 can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor - Consequently it is contraindicated during the third trimester of pregnancy. Furthermore, the use of the product during breastfeeding is not recommended. Ibuprofen is excreted in the breast milk, but at therapeutic doses during short-term treatment, the risk of influenza in the newborn seems unlikely. If, on the other hand, the treatment is longer term, early weaning should be considered. There is some evidence that medicinal products that inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by effect on ovulation. This is reversible upon discontinuation of treatment.