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Zerinolflu 12 Effeverscent Tablets

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035191028
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WARNINGS
Do not administer for more than 3 consecutive days without consulting your doctor. If the fever persists for more 'than three days or if symptoms do not improve and others appear within three days or are accompanied by high fever, rash, excessive amount of mucus and persistent cough, consult your doctor before continuing administration. Paracetamol: during treatment check that no other medicines containing paracetamol are taken at the same time, as if paracetamol is taken at high doses, serious adverse reactions may occur. Instruct the patient to contact the physician before associating any other medication. High or prolonged doses of the product can cause high-risk liver disease and even severe changes in the kidney and blood. In case of acute hypersensitivity reactions to paracetamol (e.g. anaphylactic shock), treatment should be discontinued and necessary medical measures based on signs and symptoms should be implemented. Chlorphenamine maleate At common therapeutic doses, antihistamines exhibit highly variable secondary reactions from subject to subject and from compound to compound. The most frequent secondary effect is sedation which can manifest itself with drowsiness; those who may drive motor vehicles or attend to operations that require integrity of the degree of supervision must be warned of this. Ascorbic acid: ascorbic acid (vitamin C) should be used with caution by people who suffer, or have suffered in the past, from nephrolithiasis (calculosirenal) and by those with G6PD (Glucose-6-phosphate-dehydrogenase) deficiency, hemochromatosis, thalassemia or sideroblastic anemia. Patients with renal or hepatic insufficiency: administer with caution to subjects with renal or hepatic insufficiency. Elderly: particular attention should be paid to determining the dose in the elderly due to their greater sensitivity to the drug. In elderly patients treated with antihistamines, effects such as dizziness, sedation, confusion and hypotension may be more likely. Patients are particularly sensitive to the anticholinergic side effects of antihistamines such as dry mouth and urinary retention (especially in men). Contains: aspartame. This medicine contains a source of phenylalanine. It can be harmful if suffering from phenylketonuria (lack of the enzyme phenylalanine hydroxylase). Sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. Sodium: One effervescent tablet contains 14.83 mmol of sodium. To be taken into consideration in patients with impaired renal function or who follow a low sodium diet.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics, antipyretics.
STORAGE
Do not store above 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to paracetamol, to chlorphenamine or ascorbic acid, to any of the excipients or to other closely related substances from a chemical point of view, in particular antihistamines with a chemical structure similar to chlorphenamine; pregnancy and breastfeeding; patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and patients with severe haemolytic anemia; severe hepatocellular insufficiency (Child-Pugh C); glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or other tracts of the gastrointestinal and urogenital tract, due to anticholinergic effects; patients being treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment.
NAME
ZERINOLFLU EFFERVESCENT TABLETS
EXCIPIENTS
Anhydrous citric acid, sodium bicarbonate, sodium carbonate, sorbitol, povidone, dimethicone, aspartame, orange flavor, lemon flavor.
SIDE EFFECTS
Blood and lymphatic system disorders: thrombocytopenia, leukopenia, anemia, agranulocytosis, pancytopenia. Immune system disorders: hypersensitivity reactions' such as angioedema, larynx edema, anaphylactic shock. Nervous system disorders: drowsiness, asthenia, dizziness, headache, inability to concentrate. Eye disorders: blurred vision. Respiratory, thoracic and mediastinal disorders: thickening of bronchial secretions. Gastrointestinal disorders: dry mouth, nausea. Hepatobiliary disorders: impaired liver function and hepatitis. Skin and subcutaneous tissue disorders: skin reactions of various types and severity have been reported with the use of paracetamol, including cases of urticaria, erythema multiforme, very rare cases of severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). Photosensitization Renal and urinary disorders: renal disorders (acute renal failure, interstitial nephritis, haematuria, anuria), urinary retention Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
Contraindicated during pregnancy and lactation. No studies have been conducted to evaluate the effects on fertility in humans.
INDICATIONS
Treatment of flu and cold symptoms in adults.
INTERACTIONS
Paracetamol: use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine ). Normally harmless doses of acetaminophen can cause liver damage when taken together with these drugs. The same applies to potentially hepatotoxic substances and alcohol abuse. Habitual ingestion of anticonvulsant drugs or oral contraceptives can, with an enzyme induction mechanism, accelerate the metabolism of paracetamol. The use of the product is not recommended if the patient is being treated with anti-inflammatories. Intake of probenecid inhibits the binding of paracetamol to glucuronic acid, thereby reducing the clearance of paracetamol by about a factor of 2. Therefore, the dose of paracetamol should be reduced when given in combination with probenecid. Cholestyramine reduces the absorption of paracetamol when given within 1 h of taking paracetamol. It is not yet possible to establish the clinical relevance of interactions between paracetamol and oral anticoagulants. Therefore, the prolonged use of paracetamol in patients being treated with oral anticoagulants is advisable only under medical supervision. The combination of paracetamol with chloramphenicol can 'prolong the half-life of chloramphenicol, increasing the risk of toxicity'. Concomitant use of paracetamol and zidovudine increases the latter's tendency to reduce the number of leukocytes (neutropenia). Therefore, the drug should be taken together with zidovudine only under medical supervision. Medicines that slow down gastric emptying, such as propantheline, reduce the rate of absorption of paracetamol and delay the onset of its effect. Medicines instead that accelerate gastric emptying, such as metoclopramide, lead to an increase in the rate of absorption. Interference with laboratory tests The administration of paracetamol can interfere with the determination of uric acid (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). Chlorphenamine maleate: other substances with anticholinergic action should not be taken at the same time as the drug, as these can cause significant interactions. The product is contraindicated in patients treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment as these may prolong and intensify the anticholinergic and central nervous system (CNS) depressant effects of chlorphenamine maleate. The product can interact with alcohol, tricyclic antidepressants, neuroleptics or other drugs with a depressive action on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics. These products should not be taken during therapy with the medicine as they can cause an increase in the sedative effect. It can mask the first signs of ototoxicity of certain antibiotics. Chlorphenamine inhibits phenytoin metabolism and can cause phenytoin toxicity. Ascorbic Acid: Ascorbic acid (vitamin C) reduces amphetamine levels by inhibiting gastrointestinal absorption. Vitamin C increases the bioavailability of iron by chelation with deferoxamine. Estrogen can increase the elimination of vitamin C.
DOSAGE
Adults: 1 effervescent tablet twice a day. Pediatric population: the safety and efficacy in patients less than 18 years of age has not been established. Method of administration: oral use. The effervescent tablet should be dissolved in about half a glass of water. The medicine should be taken after meals. Duration of treatment: Patients should be advised to contact their doctor if fever persists or symptoms do not improve after 3 days of treatment.
ACTIVE PRINCIPLES
One effervescent tablet contains: paracetamol 300 mg, chlorphenamine maleate 2 mg, sodium ascorbate 280 mg corresponding to ascorbic acid (vitamin C) 250 mg.

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Zerinolflu 12 Effeverscent...

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