ZerinolFlu 20 effervescent tablets

ZerinolFlu 20 effervescent tablets is a medicine formulated for the treatment of flu and cold symptoms in adults. Each effervescent tablet contains paracetamol 300 mg , chlorphenamine maleate 2 mg and sodium ascorbate 280 mg , which corresponds to ascorbic acid (vitamin C) 250 mg . These active ingredients work synergistically to relieve common symptoms such as fever, muscle aches and nasal congestion. The effervescent formulation ensures rapid absorption and effective action. ZerinolFlu is ideal for those looking for rapid and targeted relief from flu-related discomfort.

ACTIVE INGREDIENTS

Active ingredients contained in ZerinolFlu 20 effervescent tablets - What is the active ingredient of ZerinolFlu 20 effervescent tablets?

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 effect: aspartame, sodium, sorbitol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of ZerinolFlu 20 effervescent tablets - What does ZerinolFlu 20 effervescent tablets contain?

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

DIRECTIONS

Therapeutic indications ZerinolFlu 20 effervescent tablets - Why is ZerinolFlu 20 effervescent tablets used? What is it used for?

Treatment of cold and flu symptoms in adults.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications ZerinolFlu 20 effervescent tablets - When should ZerinolFlu 20 effervescent tablets not be used?

Zerinolflu is contraindicated in the following cases: - hypersensitivity to paracetamol, chlorphenamine or ascorbic acid, to any of the excipients listed in paragraph 6.1 or to other closely related substances from a chemical point of view, in particular antihistamines with a similar chemical structure to chlorphenamine; - pregnancy and breastfeeding; - patients with manifest glucose-6-phosphate dehydrogenase insufficiency and patients with severe haemolytic anaemia; - severe hepatocellular insufficiency (Child-Pugh C); - glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or stenosis of other parts 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 (see paragraph 4.5).

DOSAGE

Quantity and method of taking ZerinolFlu 20 effervescent tablets - How to take ZerinolFlu 20 effervescent tablets?

Dosage Adults: 1 effervescent tablet twice daily. Paediatric population: the safety and efficacy of Zerinolflu in patients under 18 years of age have not been established. Method of administration Oral use. The effervescent tablet should be dissolved in approximately 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 (see section 4.4).

CONSERVATION

Storage ZerinolFlu 20 effervescent tablets - How to store ZerinolFlu 20 effervescent tablets?

Do not store above 25°C.

WARNINGS

Warnings ZerinolFlu 20 effervescent tablets - About ZerinolFlu 20 effervescent tablets it is important to know that:

Do not administer for more than 3 consecutive days without consulting your doctor. If the fever persists for more than three days or if the symptoms do not improve and new symptoms appear within three days or are accompanied by high fever, rash, excessive mucus and persistent cough, consult your doctor before continuing administration. Paracetamol During treatment with Zerinolflu, check that no other medicine containing paracetamol is taken at the same time, since if paracetamol is taken in high doses, serious adverse reactions may occur. Instruct the patient to contact their doctor before combining any other medicine. See also section 4.5. High or prolonged doses of the product can cause high-risk liver disease (see also section 4.9) and alterations to the kidney and blood, which may be serious. In case of acute hypersensitivity reactions to paracetamol (e.g. anaphylactic shock), treatment with Zerinolflu must be stopped and the necessary medical measures must be implemented based on the signs and symptoms. Chlorphenamine maleate At common therapeutic doses, antihistamines present side effects that vary greatly from subject to subject and from compound to compound. The most frequent side effect is sedation that may manifest itself with drowsiness; those who may drive vehicles or perform operations that require full alertness must be warned of this (see paragraph 4.7). Ascorbic acid Ascorbic acid (vitamin C) must be used with caution by subjects who suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and by those affected by G6PD (Glucose-6-phosphate dehydrogenase) deficiency, haemochromatosis, thalassemia or sideroblastic anaemia. Patients with renal or hepatic insufficiency Administer with caution in subjects with renal or hepatic insufficiency. Elderly Particular attention must be paid when determining the dose in the elderly due to their greater sensitivity to the drug. Elderly patients taking antihistamines are more likely to experience effects such as dizziness, sedation, confusion and hypotension. 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 medicinal product contains a source of phenylalanine. May 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 sodium. To be taken into consideration by patients with reduced kidney function or on a controlled sodium diet.

INTERACTIONS

Interactions ZerinolFlu 20 effervescent tablets - Which medicines or foods can modify the effect of ZerinolFlu 20 effervescent tablets?

Paracetamol Use with extreme caution and under close supervision 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 paracetamol can cause liver damage if taken together with these drugs. The same applies to potentially hepatotoxic substances and in case of alcohol abuse. The habitual ingestion of anticonvulsant drugs or oral contraceptives can, with an enzymatic induction mechanism, accelerate the metabolism of paracetamol. It is not advisable to use the product if the patient is being treated with anti-inflammatory drugs. 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 if administered in combination with probenecid. Cholestyramine reduces the absorption of paracetamol if administered within 1 h of paracetamol intake. The clinical relevance of interactions between paracetamol and oral anticoagulants has not yet been established. Therefore, prolonged use of paracetamol in patients receiving oral anticoagulants is advisable only under medical supervision. The combination of paracetamol with chloramphenicol may prolong the half-life of chloramphenicol, increasing the risk of toxicity. Concomitant use of paracetamol and zidovudine increases the tendency of the latter to reduce the number of leukocytes (neutropenia). Therefore, Zerinolflu should only be taken with zidovudine under medical supervision. Medicines that slow 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 may interfere with the determination of uric acid (using the phosphotungstic acid method) and blood sugar (using the glucose-oxidase-peroxidase method). Chlorphenamine maleate Other substances with anticholinergic action should not be taken at the same time as Zerinolflu, as they may cause significant interactions. The product is contraindicated in patients being treated with monoamine oxidase inhibitors (MAOIs) or within two weeks of 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 may interact with alcohol, tricyclic antidepressants, neuroleptics or other drugs with a depressant action on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics. These products should not be taken during therapy with Zerinolflu as they may cause an increase in the sedative effect. Like all preparations containing antihistamines, Zerinolflu may mask the first signs of ototoxicity of certain antibiotics. Chlorphenamine inhibits the metabolism of phenytoin and may 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. Estrogens may increase the elimination of vitamin C.

SIDE EFFECTS

Like all medicines, ZerinolFlu 20 effervescent tablets can cause side effects - What are the side effects of ZerinolFlu 20 effervescent tablets?

Following the use of Zerinolflu, the following undesirable effects may occur. The frequency of these undesirable effects cannot be estimated from the available data. Blood and lymphatic system disorders : - thrombocytopenia, leukopenia, anaemia, agranulocytosis, pancytopenia. Immune system disorders : - hypersensitivity reactions such as angioedema, laryngeal 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 : - alterations in 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. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose ZerinolFlu 20 effervescent tablets - What are the risks of ZerinolFlu 20 effervescent tablets in case of overdose?

Symptoms In case of overdose, marked depressive or stimulating effects on the central nervous system, drowsiness, lethargy, respiratory depression are generally observed. In case of overdose, the paracetamol contained in Zerinolflu can cause hepatic cytolysis that could evolve into massive necrosis. Therapy N-acetylcysteine, administered in the hours immediately following the ingestion of paracetamol, is effective in limiting liver damage. It is recommended to use the usual measures to remove unabsorbed material from the gastrointestinal tract by inducing vomiting or possibly with 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 must follow standard intensive care protocols.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking ZerinolFlu 20 effervescent tablets.

Pregnancy and breastfeeding Zerinolflu is contraindicated during pregnancy and breastfeeding. Fertility No studies have been conducted with Zerinolflu to evaluate the effects on fertility in humans.

DRIVING AND USE OF MACHINERY

Take ZerinolFlu 20 effervescent tablets before driving or using machinery - Does ZerinolFlu 20 effervescent tablets affect driving or using machinery?

Patients should be advised that Zerinolflu may cause drowsiness. Those who drive vehicles or perform operations requiring an intact state of alertness should be aware of this.