ZERINOL 20CPR RIV 300MG+2MG

ZERINOL 300 MG + 2 MG STATEMENTS

active ingredients

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

Excellent

Corn starch; microcrystalline cellulose; povidone; magnesium stearate; sodium carmellose; talc; sucrose; gelatin; macrogol 6000; calcium carbonate; hydrosoluble chlorophyll; arabic rubber; carnauba wax.

Therapeutic indications

Treatment of symptoms of flu and cold in adults.

Contraindications

Zerinol is contraindicated in following cases: - hypersensitivity to paracetamol or chlorfenamine, to other antihistamines of similar chemical structure or to any of the excipients listed in paragraph 6.1; - pregnancy and nursing; - patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and patients with severe hemolytic anemia; - severe hepatocellular insufficiency (Child-Pugh C); - glaucoma, prostate hypertrophy, vescic neck obstruction, pyloric and duodenal stenosis or other traits of gastroenteric and urogenital apparatus, due to anti-linergical effects; - patients treated with monoaminoxydase inhibitors (IMAO) or in the next two weeks (see paragraph 4.5).

Population

Population Adults: 1 tablet covered, twice a day. Pediatric population: zerinol’s safety and effectiveness in patients under 18 years of age has not been established. Method of administration Oral use. The tablet must be taken with water after meals. Duration of treatment Patients should be advised to contact the doctor if the fever persists or symptoms do not improve after 3 days of treatment (see paragraph 4.4).

Conservation

This medicine does not require any special condition of conservation.

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 appear another within three days or are accompanied by high fever, exantema, excessive amount of mucus and persistent cough, consult your doctor before continuing administration. Paracetamol During treatment with Zerinol, check that no other medicine containing paracetamol is not taken at the same time, as if the paracetamol is taken at high doses, severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication. See also paragraph 4.5. High or prolonged doses of the product may result in a high-risk hepatopathy (see also paragraph 4.9) and serious alterations to the kidney and blood. In case of acute hypersensitivity reactions to the paracetamol (e.g. anaphylactic shock), treatment with Zerinol must be stopped and the necessary medical measures must be implemented according to signs and symptoms. Malfunctional Clorfenamin At the common therapeutic doses, antihistamines have very variable secondary reactions from subject to subject and compound to compound. The most frequent secondary effect is the sedation that can manifest with drowsiness; of this must be warned those who can conduct motor vehicles or wait for operations requiring integrity of the degree of supervision (see paragraph 4.7). Patients with kidney or liver failure Carefully administer in subjects with kidney or liver failure. Seniors Particular attention should be placed in determining the dose in the elderly for their greater sensitivity to the drug. In older patients in treatment with antihistamines, more likely effects such as dizziness, sedation, confusion and hypotension can occur. Older patients are particularly sensitive to the secondary anti-inflammatory effects of antihistamines such as mouth dryness and urinary retention (especially in men). Sucrose Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or saccarosio-isomaltase enzyme failure should not take this medicine.

Interactions

Paracetamol Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). Doses normally harmless of paracetamol can cause hepatitis damage if taken along with these drugs. The same applies to potentially hepatotoxic substances and in case of alcohol abuse. The usual ingestion of anticonvulsant drugs or oral contraceptives can, with an enzyme induction mechanism, accelerate the metabolism of paracetamol. It is not recommended to use the product if the patient is in treatment with anti-inflammatory drugs. The intake of probenecid inhibits the binding of the paracetamol with glucuronic acid, thereby reducing the clearance of the paracetamol of a factor about 2. Therefore, the dose of paracetamol should be reduced, if administered in association with probenecid. Colestramine reduces the absorption of paracetamol if administered within 1 h from the administration of paracetamol. 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 treated with oral anticoagulants is recommended only under medical control. Paracetamol association with chloramphenicol can prolong the half-life of chloramphenicol, increasing the risk of toxicity. Concurrent use of paracetamol and zidovudine increases the tendency of the latter to reduce the number of leukocytes (neutropenia). Therefore, you should take Zerinol together with zidovudine only under medical supervision. Medicines that slow gastric emptying, such as propanine, reduce the absorption rate of the paracetamol and delay the onset of the effect. Medicines instead of accelerating gastric emptying, such as metoclopramide, lead to an increase in absorption rate. Interference with laboratory exams Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Malfunctional Clorfenamin Other anti-linergical substances should not be taken at the same time as Zerinol, since these can cause significant interactions. The product is contraindicated in patients treated with monoaminoxydase inhibitors (IMAO) or in the two weeks following such treatment (see paragraph 4.3) since these can prolong and intensify the anti-linergical and depressive effects of the central nervous system (SNC) of malato chlorphenamine. The product can interact with alcohol, antidepressants triceclic, neuroleptic or other depressive drugs on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics. These products should not be taken during therapy with Zerinol since they can cause increased sedative effect. The use of antihistamines can mask the first signs of ototoxicity of certain antibiotics. Chlorphenamine inhibits the metabolism of phenytoin and can cause toxicity from phenytoin.

Effects

Following the use of Zerinol, the undesirable effects indicated below may occur. The frequency of such unwanted effects cannot be defined on the basis of the available data. Emolinfopoietic system pathologies: - thrombocytopenia, leucopenia, anemia, agranulocytosis, pancitopenia. Immune system disorders: - hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock. Diseases of the nervous system: - drowsiness, astenia, dizziness, headache, inability to concentrate. Pathologies of the eyeBlurred vision. Respiratory, chest and mediastinic pathologies: - thickening of bronchial secretions. Gastrointestinal diseasesDry mouth, nausea. Hepatobiliary diseases: - alterations of liver and liver function. Pathologies of skin and subcutaneous tissue: - with the use of paracetamol skin reactions of various types and severity included cases of hives, multiform erythema, very rare cases of serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and generalized acute acute acute acute acute acute acute acute acute acute acute acute acute acute (AGEP). Awareness photos. Kidney and urinary pathologies: - kidney alterations (acute kidney failure, interstitial nephritis, hematuria, watermelon), urinary retention. 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: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Synonyms In case of overdose, depressive or stimulating effects are generally observed on the central nervous system, drowsiness, letargy, respiratory depression. In case of hyperdosage, the paracetamol, contained in Zerinol, can cause liver cytolysis that could evolve towards the massive necrosis. Therapy N-acetylcysteine, administered immediately after paracetamol ingestion is effective in limiting liver damage. It is recommended to resort to the usual measures to remove from the gastrointestinal tract the unabsorbed material; keep the patient under observation by practicing a support therapy. Further measures will depend on the severity, nature and course of clinical symptoms and will have to follow standard intensive therapy protocols.

Pregnancy and nursing

Zerinol is contraindicated during pregnancy and nursing.

Fertility

Studies have not been conducted with Zerinol to assess the effects on fertility in man.

Source: Farmadati