ZERINOLFLU * 12CPR EFF

ZERINOLFLU * 12CPR EFF

Therapeutic indications

Treatment of flu and cold symptoms in adults.

Dosage and method of use

Dosage. Adults:1 effervescent tablet twice a day.Pediatric population:the safety and efficacy of Zerinolflu in patients below 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 physician if fever persists or symptoms do not improve after 3 days of treatment (see section 4.4).

Contraindications

Zerinolflu is contraindicated in the following cases: - hypersensitivity to paracetamol, chlorphenamine or ascorbic acid, to any of the excipients listed in section 6.1 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 tracts, due to anticholinergic effects; - patients being treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment (see section 4.5).

Side effects

Following the use of Zerinolflu, the following side effects may occur. The frequency of these undesirable effects cannot be estimated from the available data.Disorders of the blood and lymphatic system:- thrombocytopenia, leukopenia, anemia, agranulocytosis, pancytopenia.Immune system disorders:- hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock.Nervous system disorders:- sleepiness, 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:- changes in liver function and hepatitis.Skin and subcutaneous tissue disorders:- Skin reactions of various types and severities 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 pustulosis generalized acute exanthematous (AGEP). Photosensitization.Renal and urinary disorders:- renal alterations (acute renal failure, interstitial nephritis, haematuria, anuria), urinary retention.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Special 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 a high fever, rash, excessive mucus and persistent cough, consult your doctor before continuing administration.Paracetamol:During treatment with Zerinolflu ensure that no other medicines containing paracetamol are taken at the same time, as if paracetamol is taken in high doses, serious adverse reactions can occur. Instruct the patient to contact the physician before associating any other medication. See also section 4.5. High or prolonged doses of the product can cause high-risk liver disease (see also section 4.9) and even severe changes in the kidney and blood. In case of acute hypersensitivity reactions to paracetamol (e.g. anaphylactic shock), treatment with Zerinolflu should be stopped and necessary medical measures based on the signs and symptoms.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 as drowsiness; those who may drive motor vehicles or attend to operations that require integrity of the degree of supervision must be warned of this (see paragraph 4.7).Ascorbic acid:Ascorbic acid (vitamin C) should be used with caution by people who suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and those with G6PD (Glucose-6-phosphate-dehydrogenase) deficiency, hemochromatosis, thalassemia or sideroblastic anemia.Patients with renal or hepatic insufficiency:Administer with caution in subjects with renal or hepatic insufficiency.Elderly people:Particular attention should be paid to determining the dose in the elderly due to their greater sensitivity to the drug. Effects such as dizziness, sedation, confusion and hypotension are more likely to occur in elderly patients being treated with antihistamines. Elderly patients are particularly sensitive to the anticholinergic side effects of antihistamines such as dry mouth and urinary retention (especially in men).Zerinolflu effervescent tablets contain: Aspartame:This medicine contains a source of phenylalanine. It can be harmful if you have 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 on a low sodium diet.

Pregnancy and breastfeeding

Pregnancy and breastfeeding:Zerinolflu is contraindicated during pregnancy and lactation.Fertility:Studies with Zerinolflu have not been conducted to evaluate the effects on human fertility.

Expiration and retention

Do not store above 25 ° C.

Interactions with other drugs

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, by an enzyme induction mechanism, accelerate the metabolism of paracetamol. It is not recommended to use the product 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 a factor of approximately 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 the 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 its risk of toxicity. Concomitant use of paracetamol and zidovudine increases the latter's tendency to reduce the number of leukocytes (neutropenia). Therefore, Zerinolflu 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 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 uricaemia (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 Zerinolflu, 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 (see section 4.3) 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 Zerinolflu as they can cause an increase in the sedative effect. Like all preparations containing antihistamines, Zerinolflu can mask the first signs of ototoxicity of certain antibiotics. Chlorphenamine inhibits the metabolism of phenytoin 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.

Overdose

SymptomsIn case of overdose, marked depressive or stimulating effects on the central nervous system, somnolence, lethargy, respiratory depression are generally observed. In case of overdosing, the paracetamol contained in Zerinolflu can cause hepatic cytolysis which could evolve towards massive necrosis.TherapyN-acetylcysteine, administered in the hours immediately following paracetamol ingestion, is effective in limiting liver damage. It is recommended that the usual measures be used to remove unabsorbed material from the gastrointestinal tract by inducing vomiting or possibly by gastric lavage; keep the patient under observation by practicing supportive therapy. Further measures will depend on the severity, nature and course of the clinical symptoms and should follow standard intensive care protocols.

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. Excipients with known effects: aspartame, sodium, sorbitol. For the full list of excipients, see section 6.1.

Excipients

Anhydrous citric acid, sodium bicarbonate, sodium carbonate, sorbitol, povidone, dimethicone, aspartame, orange flavor, lemon flavor.