Zerinol 300mg + 2mg 20 coated tablets

INDICATIONS

Treatment of flu and cold symptoms in adults.

ACTIVE INGREDIENTS

One coated tablet contains: paracetamol 300 mg, chlorphenamine maleate 2 mg. Excipient with known effects: sucrose. For the full list of excipients, see section 6.1.

EXCIPIENTS

Corn starch; microcrystalline cellulose; povidone; magnesium stearate; carmellose sodium; talc; sucrose; jelly; macrogol 6000; calcium carbonate; water-soluble chlorophyll; gum arabic; carnauba wax.

CONTRAINDICATIONS AND SIDE EFFECTS

Zerinol is contraindicated in the following cases: - hypersensitivity to paracetamol or chlorphenamine, to other antihistamines of similar chemical structure or to any of the excipients listed in paragraph 6.1; - pregnancy and breastfeeding; - patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and patients suffering from severe hemolytic 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 system, due to anticholinergic effects; - patients being treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment (see section 4.5).

DOSAGE

Dosage Adults: 1 coated tablet, twice a day. Pediatric population: The safety and effectiveness of Zerinol in patients under 18 years of age have not been established. Method of administration Oral use. The tablet should be taken with water 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

This medicinal product does not require any special storage conditions.

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 the 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 the administration. Paracetamol During treatment with Zerinol, 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. Invite the patient to contact the doctor before combining any other drug. See also paragraph 4.5. High or prolonged doses of the product can cause high-risk liver disease (see also section 4.9) and even serious alterations in the kidney and blood. In case of acute hypersensitivity reactions to paracetamol (e.g. anaphylactic shock), treatment with Zerinol should be discontinued and necessary medical measures should be implemented based on the signs and symptoms. Chlorphenamine maleate At common therapeutic doses, antihistamines present secondary reactions that vary greatly from subject to subject and from compound to compound. The most frequent side effect is sedation which can manifest itself with drowsiness; Those who may drive motor vehicles or carry out operations that require integrity of the level of supervision must be warned of this (see paragraph 4.7). Patients with renal or hepatic insufficiency Administer with caution in subjects with renal or hepatic insufficiency. Elderly people Particular attention should be paid when determining the dose in the elderly due to their greater sensitivity towards the drug. In elderly patients treated with antihistamines, effects such as dizziness, sedation, confusion and hypotension may be more likely to occur. Elderly patients are particularly sensitive to the anticholinergic side effects of antihistamines such as dry mouth and urinary retention (especially in men). Sucrose Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or insufficiency of the sucrose-isomaltase enzyme should not take this medicine.

INTERACTIONS

Paracetamol Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). Normally harmless doses of acetaminophen can cause liver damage if taken together with these drugs. The same applies to potentially hepatotoxic substances and in case of alcohol abuse. Habitual ingestion of anticonvulsant drugs or oral contraceptives can, through an enzymatic induction mechanism, accelerate the metabolism of paracetamol. The use of the product is not recommended if the patient is being treated with anti-inflammatories. Taking 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 acetaminophen if administered within 1 hour of acetaminophen administration. It is not yet possible to establish the clinical relevance of the interactions between paracetamol and oral anticoagulants. Therefore, prolonged use of paracetamol in patients being treated with oral anticoagulants is advisable only under medical supervision. Combining acetaminophen with chloramphenicol may prolong the half-life of chloramphenicol, increasing the risk of toxicity. The concomitant use of paracetamol and zidovudine increases the tendency of the latter to reduce the number of leukocytes (neutropenia). Therefore, you should only take Zerinol together with zidovudine under your doctor's supervision. Medicines that slow gastric emptying, such as propantheline, reduce the speed of absorption of paracetamol and delay the onset of its effect. However, medicines that accelerate gastric emptying, such as metoclopramide, lead to an increase in the speed of absorption. Interference with laboratory tests The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method). Chlorphenamine maleate Other substances with anticholinergic action should not be taken at the same time as Zerinol, as these can cause significant interactions. The product is contraindicated in patients being 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 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 Zerinol as they can cause an increase in the sedative effect. The use of antihistamines can mask the first signs of ototoxicity of certain antibiotics. Chlorphenamine inhibits the metabolism of phenytoin and may cause phenytoin toxicity.

SIDE EFFECTS

Following the use of Zerinol, the following side effects may occur. The frequency of these side effects cannot be estimated from the available data. Pathologies of the blood and lymphatic system: - thrombocytopenia, leukopenia, anemia, 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 pathologies: - blurred vision. Respiratory, thoracic and mediastinal disorders: - thickening of bronchial secretions. Gastrointestinal disorders: - dry mouth, nausea. Hepatobiliary disorders: - alterations in liver function and hepatitis. Pathologies of the skin and subcutaneous tissue: - 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 serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). Photosensitization. Renal and urinary disorders: - renal alterations (acute renal failure, interstitial nephritis, hematuria, anuria), urinary retention. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.

OVERDOSE

Symptoms In case of overdose, marked depressive or stimulant effects on the central nervous system, drowsiness, lethargy, respiratory depression are generally observed. In case of overdose, paracetamol, contained in Zerinol, can cause hepatic cytolysis which could evolve towards massive necrosis. Therapy N-acetylcysteine, administered in the hours immediately following ingestion of paracetamol, is effective in limiting liver damage. It is recommended to use usual measures to remove unabsorbed material from the gastrointestinal tract; keep the patient under observation by practicing supportive therapy. Further measures will depend on the severity, nature and course of clinical symptoms and should follow standard intensive care protocols.

PREGNANCY AND BREASTFEEDING

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

EFFECTS ON DRIVING ABILITY

Patients should be warned that Zerinol may cause drowsiness. Patients who may drive vehicles or who may be carrying out operations requiring an intact state of vigilance must be warned of this.