IBUPROFENE ZENT IT 12CPR 400MG

IBUPROFECT ZENTIVA ITALIA 400 MG COMPRESSE RIVESTITES WITH FILM

active ingredients

Each film-coated tablet contains 400 mg of ibuprofen. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core Cellulose microcrystalline Silice colloidal anidra Hydroxypropylcellulose Sodium laurilsulfate Croscarmellosa sodica Talco Coating with film [Opadry (bianco) 06B28499] Ipromellosa Macrogol 400 Titanium Dioxide (E171)

Therapeutic indications

Mild to moderate pain, such as headache, including migraine headache, toothache. Primary disorder. Fever.

Contraindications

IBUPROFECT ZENTIVA ITALY 400 mg is contraindicated in patients with: - hypersensitivity to the active ingredient or any of the excipients of IBUPROFENE ZENTIVA ENGLISH 400 mg. - previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylcylic acid or other NSAIDs - bleeding anamnesis or gastrointestinal perforation, in correlation to previous treatment with NSAIDs - peptic ulcer/active bleeding or anamnesia of recurrence.

Population

Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). This medicine is indicated only for short-term treatments, not more than 7 days. If symptoms persist or worsen, consult your doctor. The dose of ibuprofen depends on the age and body weight of the patient. To swallow the tablet with a glass of water during or after meals. Fever and mild to moderate pain Adults and teenagers over 12 years (≥ 40 kg): 200-400 mg administered in a single dose or 3-4 times a day at intervals of 4-6 hours. 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. Primary disorder Adults and teenagers over 12 years old: 200-400 mg 1-3 times a day at intervals of 4-6 hours, in need. The maximum daily dose should not exceed 1200 mg. Teenagers In case the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of the symptomatology the doctor must be consulted. Seniors NSAIDs must be used with particular caution in elderly patients who are more subject to adverse events and are more at risk of hemorrhage, ulcer or potentially lethal gastrointestinal perforation (see paragraph 4.4). If the treatment is considered necessary, it is necessary to administer the minimum dose for the shortest period of time necessary to control the symptoms. Treatment should be reassessed at regular and suspended intervals if no benefit is observed or if intolerance develops. Compromise of kidney function In patients with mild to moderate renal function reduction, the dose must be kept at the lowest possible level for the shortest period necessary to control symptoms; renal functionality must be monitored. (For patients with severe kidney failure, see paragraph 4.3). Compromise of liver function In patients with mild to moderate liver function reduction, the dose must be kept at the lowest possible level for the shortest period necessary to control symptoms; the liver function must be monitored. (For patients with severe liver failure, see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation.

Warnings

IBUPROFENE use must be avoided ZENTIVA ITALY 400 mg in conjunction with NSAIDs, including selective cycloxygenase 2 inhibitors (Cox 2). Asthmatic patients should consult the doctor before taking ibuprofen (see below). Undesirable effects can be minimized by taking the lowest effective dose for the shortest period of time needed to control symptoms (see paragraph 4.2 and GI and cardiovascular risks below). Patients treated with long-term NSAIDs must be placed under regular medical surveillance to monitor adverse events. Please find in the following conditions: ZENTIVA ITALY 400 mg should be administered only after carefully evaluating the risk/benefit ratio: - Systemic erythematosum lupus (LES) or other autoimmune diseases - congenital disorder of porphyrin metabolism (i.e. acute intermittent porphyria) - first and second trimester of pregnancy - Breasting In the following cases special caution should be given: - gastrointestinal pathologies, including chronic intestinal inflammatory diseases ( ulcerative colitis, Crohn's disease) - heart failure and hypertension - reduced kidney function - hepatic dysfunction - hematopoiesic disorder - blood clotting defects - allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive disease of respiratory tract. Blood, ulceration and gastrointestinal perforation With all NSAIDs, at any time during treatment, bleeding, ulceration or gastrointestinal perforation, even lethal, with or without premonitory symptoms or remote anamnesi of serious gastrointestinal events. The risk of bleeding, ulceration or gastrointestinal perforation is greater with higher doses of NSAIDs, in patients with ulcer anamnesis, especially if complicated by hemorrhage or perforation (see paragraph 4.3) and in the elderly. These patients must begin treatment at the minimum dose available. For these patients and also for patients requiring concomitant administration of low dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk, it is necessary to take into account the therapy of association with gastroprotective drugs (e.g. misoprostol or protonic pump inhibitors) (see below and paragraph 4.5.) Patients with gastrointestinal toxicity anamnesis, especially if elderly, must report any unusual abdominal symptoms (especially gastrointestinal bleeding) especially in the early stages of treatment. Caution should be given in patients treated with concomitant drugs that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin or heparine, selective inhibitors of serotonin recaptation or antiplastrine such as acetylsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration develops in patients treated with IBUPROFENE ZENTIVA ITALY 400 mg, treatment must be suspended. NSAIDs should be given with caution to patients with gastrointestinal disease anamnesis ( ulcerative colitis, Crohn's disease) because pathology can be aggravated. (See paragraph 4.8) Teenagers In dehydrated adolescents there is a risk of alteration of kidney function. Seniors The elderly show a greater frequency of adverse reactions to the NSAIDs, in particular bleeding and gastrointestinal perforation, even lethal (see paragraph 4.2). Cardiovascular and cerebrovascular effects For patients with anamnesi of hypertension and/or mild to moderate congestive heart failure, appropriate monitoring and consultation are required because in association with NSAID therapy water retention, hypertension and edema were reported. Clinical studies suggest that diibuprofen use, especially at high doses (2400 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. ≤1200mg/die) are associated with increased 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. Skin reactions Very rarely have serious skin reactions, some lethal, 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 more at risk of these reactions in the early stages of therapy because the onset of reaction occurs in most cases in the first month of treatment. IBUPROFECT ZENTIVA ITALY 400 mg must be interrupted to the first sign of skin rash, mucosa lesion or any sign of hypersensitivity. Renal effect Due to its effect on renal perfusion, ibuprofen can cause sodium, potassium and liquid retention in patients who have never previously suffered kidney disorders. This can cause edema or even determine heart failure or hypertension in predisposed patients. As with other NSAIDs, prolonged administration of ibuprofen to animals has resulted in kidney papillar necrosis and other pathological alterations of the kidney. In humans, cases of acute interstitial nephritis with hematuria, proteinuria and sometimes nephrotic syndrome have been reported. Cases of kidney toxicity have also been 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 formation and, secondly, kidney blood flow that can precipitate a renal breakdown. Patients who have the greatest risk of developing this reaction are those with kidney dysfunction, heart failure, liver dysfunction, taking diuretics and ACE inhibitors and the elderly. The suspension of treatment with NSAIDs is generally followed by a pre-treatment recovery. Other precautions In patients suffering or suffering from bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases, bronchospasm, hives or angioedema may be precipitated. Ibuprofen can mask the signs or symptoms of an infection (fever, pain and swelling). During the use of long-term analgesics and high doses, cephalea cannot be treated with high doses of this medicine. In general, the habitual intake of analgesics, in particular the use in association of different analgesic substances, can cause permanent kidney damage and risk of kidney failure (nephropathy from analgesics). During treatment with ibuprofen, some cases have been observed with symptoms of aseptic meningitis, such as stiffening of the neck, headache, nausea, vomiting, fever or disorientation, in patients suffering from pre-existing autoimmune diseases (such as systemic erythematous lupus, mixed connective tissue disease). Hybuprofen can temporarily inhibit piastrinic aggregation and prolong bleeding time. Therefore, patients with clotting defects or anticoagulant therapy must be placed under careful surveillance. In case of long-term treatment with ibuprofen, periodic monitoring of liver and kidney function is required, as well as hemochrome, especially in high-risk patients. Alcohol consumption should be avoided, which could intensify the undesirable effects of NSAIDs, especially if it is dependent on the gastrointestinal tract or the central nervous system. Patients treated with ibuprofen should report to the doctor signs or symptoms of gastrointestinal ulceration or bleeding, blurred sight or other symptoms at the expense of the eyes, rash, weight gain or edema.

Interactions

Concurrent use of ibuprofen should be avoided with the following substances : Acetylsalicylic acid 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, concurrent use of multiple NSAIDs can increase the risk of gastrointestinal ulcers and bleeding. Therefore, it is necessary to avoid concurrent administration of ibuprofen with other NSAIDs (see paragraph 4.4). Antiagulants: NSAIDs can enhance 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:The NSAIDs should not be associated with ticlopidine due to the risk of additional effect on inhibition of pyastrinic function. Methodology:The NSAIDs inhibit the tubular secretion of the metotrexate and certain metabolic interactions can occur that determine a reduction of metotrexate clearance. IBUPROFENE administration ZENTIVA ITALY 400 mg 24 hours before or after the administration of metotrexate can determine a high concentration of metotrexate and an increase of its toxic effects. Therefore, it is necessary to avoid the concomitant use of NSAIDs and high doses of metotrexate. In addition, the potential risk of interactions in low dose treatment of metotrexate should be taken into account, particularly in patients with renal impairment. In the treatment of association it is necessary to monitor the kidney function. Hybuprofen (such as other NSAIDs) should only be taken with caution in association with the following substances : Moclobemide: enhances the effect of ibuprofen. Fenitoine, lithium:the concurrent administration of IBUPROFENE ZENTIVA ITALY 400 mg with preparations containing phenytoin or lithium can increase the serum level of these medicines. It is necessary to check the serum level of lithium and it is recommended to check the serum level of phenytoin. Heart glycosides (e.g. digoxin): NSAIDs can exacerbate heart failure, reduce glomerular filtration speed and increase plasma levels of cardiac glycosides. It is recommended to monitor the serum level of digoxin. Diuretics and antihypertensives: diuretics and inhibitors can increase the nephrotoxicity of NSAIDs. NSAIDs can reduce the effect of diuretics and antihypertensives, including 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 an antagonist of angiotensin II with a medicine that inhibits cycloxygenase can cause further impairment of kidney function and also acute kidney failure. This effect is usually reversible. This association should only be used with caution, especially in elderly patients. Patients should be informed of the need to drink sufficient amounts of liquids; periodic monitoring of renal function values must be taken into account in the period immediately after the beginning of association therapy. Concurrent administration of IBUPROFENE ZENTIVA ITALY 400 mg and diuretics potassium or ACE inhibitors can cause hyperkaliemia. Careful monitoring of potassium levels is required. Captopril: experimental studies indicate that ibuprofen contrasts with the increase in sodium excretion caused by captopril. Aminoglycosides:The NSAIDs can slow down the elimination of aminoglycosides and increase their toxicity. Selective serotonin reuptake inhibitors (SSRI): increased risk of gastrointestinal bleeding (see paragraph 4.4). Ciclosporin: the risk of kidney damage caused by cyclosporin is increased by the concomitant administration of certain NSAIDs. This effect cannot be excluded even for the association of cyclosporin and ibuprofen. Colestiramine: concurrent treatment with cholesteramine and ibuprofen causes an extension and reduction (25%) of the absorption of ibuprofen. These medicines must be administered at least one hour interval. Tacrolimus: high risk of nephrotoxicity. Zidovudina: there is evidence of an increase in the risk of hematoma and hematoma in positive HIV hemophiliacs treated with zidovudine and ibuprofen. An increase in the risk of hematotoxicity may occur during the concomitant use of zidovudine and NSAIDs. It is recommended to evaluate the hemochrome 1-2 weeks after the start of the concomitant treatment. Ritonavir:can increase plasma concentrations of NSAIDs. Mifepristone: NSAIDs administered in the 8-12 days following mifepristone treatment can reduce their effect. Probenecid or Finpirazone: may cause delay in the elimination of ibuprofen. The uricreal action of these substances is reduced. Chinolonic antibiotics: patients taking NSAIDs and kinolones can present an increase in the risk of convulsion development. On the phone: NSAIDs can increase the hypoglycemic effect of sulphonluree. In case of concomitant treatment, blood glucose monitoring is recommended. Courtesy: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Anti-platelet aggregators (e.g. clopidogrel and ticlopidine): greater risk of gastrointestinal bleeding (see paragraph 4.4). Alcohol, biphosphonate and oxpentifilline (pentoxifilline): can enhance the unwanted gastrointestinal effects and the risk of bleeding and ulceration. BaclofeneHigh toxicity of baclofene.

Effects

The most commonly observed adverse effects are gastrointestinal. Peptic ulcers, perforation or gastrointestinal bleeding may occur, even lethal, especially in the elderly (see paragraph 4.4). After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis was observed. The side effects are predominantly dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. For other known risk factors, see paragraph 4.4. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). In association with the treatment with NSAIDs were reported edema, hypertension and heart failure. Side effects are less frequent when the maximum daily dose is 1200 mg. The evaluation of adverse reactions is generally based on the following frequency: Very common (≥ 1/10) Common (≥ 1/100, Diagnostic examinations Rare: increased urethic nitrogen in blood, sieric transaminases and alkaline phosphates, decreased hemoglobin and heatocrite values, inhibition of piastrinic aggregation, prolongation of bleeding time, decrease in serum calcium, increase in serum uric acid Heart disease Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema Emolinfopoietic system pathologies Very rare: hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first symptoms or signs may include: fever, sore throat, ulcers at the surface of the mouth, flu-like symptoms, severe fatigue, nasal bleeding and skin Diseases of the nervous system Town: headache, drowsiness, dizziness, fatigue, agitation, dizziness, insomnia, irritability Very rare: aseptic meningitis Pathologies of the eye Not common: Rare view disorders: toxic ambliopia Ear and labyrinth pathologies Very rare: tinnitus Respiratory, chest and mediastinic pathologies Not common: rhinitis, bronchospasm Gastrointestinal diseases Very common: gastrointestinal disorders, such as pyrosis, dyspepsia, abdominal pain and nausea, vomiting, flatulence, diarrhea, stipsi Town: gastrointestinal ulcers, sometimes with bleeding and perforation (see paragraph 4.4), loss of occult blood that can lead to anemia, melena, ematemesis, ulcerative stomatitis, colitis, exacerbation of intestinal inflammatory diseases, complications of colon diverticula (perforation, fistola) Not common: gastritis Very rare: esophagitis, pancreatis, intestinal stenosis. Kidney and urinary pathologies Not common: development of edema, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that may be associated with kidney failure Very rare: renal papillar necrosis with long-term use (see paragraph 4.4) Pathologies of skin and subcutaneous tissue Not common: photosensitivity Very rare: severe forms of skin reactions (mulform erythema, exfoliative dermatitis, bollose reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotizing fascites Notable: Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome). Vascular diseases Very rare: hypertension Immune system disorders Not common: hypersensitivity reactions, such as hives, itching, purple and esantema, as well as as asthma attacks (sometimes with hypotension) Rare: systemic erythematosum lupus Very rare: severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the tongue, internal swelling of the larynx with narrowing of the respiratory tract, dispnea, tachycardia, decrease in blood pressure to the point of potentially lethal shock Hepatobiliary diseases Very rare: hepatic dysfunction, liver damage, especially with 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 workers are required to report any suspected adverse reaction via the national reporting system at the address 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 will 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. 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. In cases of severe poisoning, it is possible that metabolic acidosis occurs. 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 The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo-fetal development. The data obtained from epidemiological studies suggest an increase in the risk of miscarriage and heart and gastroschisis malformation after the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy. The absolute risk of cardiovascular malformation was increased from less than 1% to about 1.5%. It is believed that the risk increases according to dose and duration of therapy. In animals, the administration of an inhibitor of the synthesis of prostaglandins showed an increase in pre- and post-plant loss and embryo-fetal mortality. In addition, an increase in the incidences of various malformations, including cardiovascular ones, has been reported in animals treated with an inhibitor of the synthesis of prostaglandins during the organogenetic period. During the first and second trimester of pregnancy, IBUPROFENE ZENTIVA ITALY 400 mg should not be administered if not strictly necessary. If IBUPROFENE ZENTIVA ITALY 400 mg is taken by a woman who is trying to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept at the minimum possible level. 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 evolve in kidney failure with oligoidramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions that determines a delay or extension of labor. As a result, IBUPROFENE ZENTIVA ITALY 400 mg is contraindicated during the last trimester of pregnancy. Food Hybuprofen is excreted in breast milk, but at therapeutic doses for short-term treatment, the risk of lactating effects seems to be unlikely. If, however, prolonged treatment is prescribed, the possibility of premature weaning should be assessed. Fertility There are some evidence that medicines that inhibit cycloxygenase/synthesis of prostaglandins can cause a compromise of female fertility due to an effect on ovulation. This effect is reversible with the suspension of treatment.

Source: Farmadati