Ibuprofen 200mg Aurobindo Pharma 20 Coated Tablets

NAME
ZORENDOL 200 MG TABLETS COATED WITH FILM

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

ACTIVE PRINCIPLES
Ibuprofen.

EXCIPIENTS
Core of the tablet: microcrystalline cellulose; colloidal anhydrous silica; hydroxypropylcellulose; sodium lauryl sulfate; croscarmellose sodium; talc. Film coating [Opadry (white) 06B28499]: hypromellose; macrogol 400; titanium dioxide (E171).

INDICATIONS
Mild to moderate pain, such as headache, including migraine headache, toothache; primary dysmenorrhea; fever.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs; history of gastrointestinal bleeding or perforation, related to previous NSAID therapy; active peptic ulcer / haemorrhage or history of recurrence of the condition (two or more distinct episodes of ulceration or bleeding); severe hepatic or renal insufficiency; severe heart failure or coronary artery disease; last three months of pregnancy; significant dehydration (caused by vomiting, diarrhea or insufficient fluid intake); cerebrovascular or other active bleeding; dyshematopoiesis of unknown origin; children under the age of 6.

DOSAGE
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time needed to control symptoms. This medicine is indicated only for short-term treatments, not exceeding 7 days. If symptoms persist or worsen, see your doctor. The dose of ibuprofen depends on the age and body weight of the patient. Swallow the tablet with a glass of water during or after meals. >> Fever and mild to moderate pain. Adults and adolescents over 12 years of age (> = 40 kg): 200-400 mg administered in a single dose or 3-4 times a day at 4-6 hour intervals. The dosage in case of migraine headache is: 400 mg administered in a single dose, if necessary 400 mg at intervals of 4-6 hours. The maximum daily dose should not exceed 1200 mg. >> Children aged between 6-12 years (> 20 kg). Children aged 6-9 years (20-29 kg): 200 mg 1-3 times a day at intervals of 4-6 hours, according to the doctor's prescription. The maximum daily dose should not exceed 600 mg. Children aged between 10-12 years (30-40 kg): 200 mg 1-4 times a day at intervals of 4-6 hours, according to the doctor's prescription. The maximum daily dose should not exceed 800 mg. >> Primary dysmenorrhea. Adults and adolescents over 12 years of age: 200-400 mg 1-3 times daily at intervals of 4-6 hours, as needed. The maximum daily dose should not exceed 1200 mg. 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, ulcer or perforation. If treatment is considered necessary, the lowest dose should be given for the shortest period of time necessary to control symptoms. Treatment should be reassessed at regular intervals and discontinued if no benefit is observed or if intolerance develops. Renal impairment: in patients with mild to moderate impairment of renal function, the dose should be kept as low as possible for the shortest period necessary to control symptoms; renal function should be monitored. Impaired hepatic function: in patients with mild to moderate reduction in hepatic function, the dose should be kept as low as possible for the shortest period necessary to control symptoms; liver function should be monitored.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
Avoid using the drug concomitantly with NSAIDs, including selective cyclooxygenase 2 (Cox 2) inhibitors. Asthma patients should consult their doctor before taking ibuprofen. Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time needed to control symptoms. Patients treated with long-term NSAIDs should be placed under regular medical surveillance to monitor for adverse events. Under the following conditions, administer the drug only after carefully evaluating the risk / benefit ratio: systemic lupus erythematosus (SLE) or other autoimmune diseases; congenital disorder of porphyrin metabolism; first and second trimester of pregnancy; feeding time. Particular caution should be exercised in the following cases: gastrointestinal diseases, including chronic inflammatory bowel diseases; heart failure and hypertension; impaired renal function; liver dysfunction; disturbance of hematopoiesis; blood clotting defects; allergies, hay fever, chronic swelling of the nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma; immediately after major surgery. Gastrointestinal bleeding, ulceration or perforation, even fatal, has been reported at any time during treatment, with or without warning symptoms or a past history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is greater with higher NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should start treatment at the lowest available dose. For these patients and also for patients requiring coadministration of low dose acetylsalicylic acid or other medicinal products that may increase gastrointestinal risk, combination therapy with gastroprotective drugs should be considered. Patients with a history of gastrointestinal toxicity, particularly if elderly, should report any unusual abdominal symptoms especially in the initial stages of treatment. Caution should be exercised in patients treated with concomitant medications which could increase the risk of ulceration or bleeding. When gastrointestinal bleeding or ulceration develops in patients treated with the drug, discontinue treatment. Administer NSAIDs with caution to patients with a history of gastrointestinal disease because the pathology may be aggravated. For patients with a history of hypertension and / or mild to moderate congestive heart failure, appropriate monitoring and consultation are required because fluid retention, hypertension and edema have been reported in association with NSAID therapy. The results of clinical studies and epidemiological data suggest that the use of ibuprofen, particularly in high doses (2400 mg per day) and with long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events. In general, epidemiological studies do not suggest that low dose ibuprofen (i.e. <= 1200 mg per day) is associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, overt ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations must also be made before initiating longer-term treatment of patients with risk factors for cardiovascular events. Severe skin reactions, some fatal, have been reported very rarely. Patients appear to be most at risk of these reactions in the early stages of therapy because the onset of the reaction occurs in most cases in the first month of treatment. Discontinue the drug at the first sign of skin rash, mucosal lesion or any sign of hypersensitivity. Due to its effect on renal perfusion, ibuprofen can cause sodium, potassium and fluid retention in patients who have never previously suffered from renal disorders. This can cause edema or even lead to heart failure or hypertension in predisposed patients. Prolonged administration of ibuprofen to animals resulted in renal papillary necrosis and other pathological changes in the kidney. In humans, cases of acute interstitial nephritis with haematuria, proteinuria and sometimes nephrotic syndrome have been reported. 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 the formation of prostaglandins and, secondarily, in the renal blood flow which can precipitate an evident renal decompensation. Patients at greatest risk of developing this area are those with renal dysfunction, heart failure, hepatic dysfunction, taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID treatment is usually followed by recovery to the pre-treatment state. In patients who suffer or have suffered from bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases, bronchospasm, urticaria or angioedema can be precipitated. Ibuprofen can mask the signs or symptoms of an infection. During the use of long-term and high-dose analgesics, headache may occur which should not be treated with high doses of this medicinal product. In general, the habitual intake of analgesics, in particular the use in combination of different analgesic substances, can cause permanent renal damage and risk of renal failure. During treatment, some cases with symptoms of aseptic meningitis have been observed. Ibuprofen can temporarily inhibit platelet aggregation and prolong bleeding time. Therefore, place patients with coagulation defects or on anticoagulation therapy under close surveillance. In case of long-term treatment with ibuprofen, periodic monitoring of hepatic and renal function, as well as of the complete blood count, is necessary, particularly in high-risk patients. Alcohol consumption should be avoided. Patients treated with ibuprofen should report signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, rash, weight gain or edema.

INTERACTIONS
Concomitant use of ibuprofen with the following substances should be avoided. Low dose acetylsalicylic acid: experimental data suggest that, in case of concomitant administration, ibuprofen can inhibit the effect that low dose acetylsalicylic acid has on platelet aggregation. However, the limitations of these data and the uncertainties related to the extrapolation of the ex vivo data to the clinical situation make it impossible to draw firm conclusions for the regular use of ibuprofen and no clinically relevant effect is considered likely with occasional use. of the drug. Other NSAIDs: as a consequence of the synergistic effects, the concomitant use of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. Therefore, concomitant administration of ibuprofen with other NSAIDs should be avoided. Anticoagulants: NSAIDs can enhance the effects of anticoagulants, such as warfarin or heparin. In case of concomitant treatment, monitoring of coagulation status is recommended. Ticlopidine: NSAIDs should not be combined with ticlopidine due to the risk of an additional effect on the inhibition of platelet function. Methotrexate: NSAIDs inhibit tubular secretion of methotrexate and certain metabolic interactions may occur which result in decreased clearance of methotrexate. The administration of the drug 24 hours before or after the administration of methotrexate can 'cause a high concentration of methotrexate and an increase in its toxic effects. Therefore, concomitant use of NSAIDs and high doses of methotrexate should be avoided. In addition, the potential risk of interactions in low dose methotrexate treatment should be considered, particularly in patients with impaired renal function. In combination treatment, renal function should be monitored. Ibuprofen (like other NSAIDs) should only be taken with caution in combination with the following substances. Moclobemide: potentiates the effect of ibuprofen. Phenytoin, lithium: concomitant administration of the drug with preparations containing phenytoin or lithium may increase the serum level of these drugs. It is necessary to check the serum level of lithium and it is recommended to check the serum level of phenytoin. Cardiac glycosides (eg digoxin): NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum digoxin level is recommended. Diuretics and antihypertensives: diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs. NSAIDs 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 an angiotensin II antagonist with a medicinal product that inhibits cyclooxygenase may result in a further impairment of renal function and also acute renal failure. This effect is usually reversible. This combination should only be used with caution, particularly in elderly patients. Patients should be advised of the need to drink sufficient amounts of fluids; Periodic monitoring of renal function values should be considered in the period immediately following the initiation of combination therapy. Concomitant administration of the drug and potassium-sparing diuretics or ACE inhibitors can cause hyperkalaemia. Close monitoring of potassium levels is required. Captopril: experimental studies indicate that ibuprofen counteracts the effect of increased sodium excretion caused by captopril 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 renal damage caused by cyclosporine is increased by the concomitant administration of certain NSAIDs. This effect cannot be excluded even for the combination of cyclosporine and ibuprofen. Cholestyramine: Concomitant treatment with cholestyramine and ibuprofen results in a prolongation and reduction (25%) of the absorption of ibuprofen. These medicinal products should be administered at least one hour apart.Tacrolimus: high risk of nephrotoxicity. Zidovudine: There is evidence of an increased risk of haemarthrosis and hematoma in HIV positive haemophilia patients receiving concomitant treatment with zidovudine and ibuprofen. There may be an increased risk of haematotoxicity during concomitant use of zidovudine and NSAIDs. It is recommended that CBC be evaluated 1-2 weeks after initiation of concomitant treatment. Ritonavir: can 'increase plasma concentrations of NSAIDs. Mifepristone: NSAIDs given 8-12 days following mifepristone treatment may reduce its effect. Probenecide or sulfinpyrazone: can 'cause a delay in the elimination of ibuprofen. The uricosuric action of these substances is reduced. 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 case of concomitant treatment, blood glucose monitoring is recommended. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Antiplatelet agents (e.g. clopidogrel and ticlopidine): increased risk of gastrointestinal bleeding. Alcohol, bisphosphonates and oxpentifylline (pentoxifylline): can potentiate gastrointestinal side effects and the risk of bleeding and ulceration. Baclofen: high toxicity of baclofen.

SIDE EFFECTS
The most commonly observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, including fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and of Crohn's disease. Gastritis has been observed less frequently. Undesirable effects are predominantly dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. The results of clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high dose (2400 mg per day) and with long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g. example, myocardial infarction or stroke). Edema, hypertension and heart failure have been reported in association with NSAID treatment. Side effects are less frequent when the maximum daily dose is 1200 mg. Assessment of adverse reactions is generally based on the following frequency: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000 to <1/100); rare (> = 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000); not known. Diagnostic tests. Rare: increased blood urea nitrogen, serum transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased acid serum uric cardiac disorders. Very rare: 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, mouth surface ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding. Nervous system disorders. Common: headache, somnolence, dizziness, fatigue, agitation, dizziness, 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 bleeding 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, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be associated with renal insufficiency; very rare: renal papillary necrosis with 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 pathologies. Very rare: hypertension. Disorders of the immune system. Uncommon: hypersensitivity reactions', such as hives, itching, purpura and rash, as well as asthma attacks (sometimes with hypotension); rare: systemic lupus erythematosus; very rare: severe hypersensitivity reactions Symptoms may include: face edema, swelling of the tongue, internal swelling of the larynx with narrowing of the airways, dyspnoea, tachycardia, drop in blood pressure to the point of life-threatening shock. Hepatobiliary disorders. Very rare: hepatic dysfunction, liver damage, particularly with long-term use, liver failure, acute hepatitis, jaundice. Psychiatric disorders. Rare: depression, confusion, hallucinations.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo-fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increase in the incidences of various malformations, including cardiovascular ones, has been reported in animals treated with a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, the drug should not be administered unless strictly necessary. If the medicine is taken by a woman trying to conceive 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; renal dysfunction, which can lead to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; inhibition of uterine contractions resulting in a delay or prolongation of labor. Consequently, the drug is contraindicated during the last trimester of pregnancy. Ibuprofen is excreted in breast milk, but at therapeutic doses for short-term treatment, the risk of effects on the infant appears to be unlikely. If, however, prolonged treatment is prescribed, the possibility of early weaning should be considered. There is some evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by virtue of an effect on ovulation. This effect is reversible upon discontinuation of treatment.