ZERINOL FLA 12 Effervescent tablets
illustrative leaflet AIFA
An effervescent tablet contains: 300 mg paracetamol, Male Evil Chlorfenamine 2 mg, sodium ascorbate 280 mg corresponding to ascorbic acid (vitamin C) 250 mg. anhydrous citric acid, sodium bicarbonate, sodium carbonate, sorbitol, poveon, dimetic, aspartame, orange aroma, lemon aroma.
indications < /H3>
treatment of the symptoms of influence and colds in adults. Secondary
hypersensitivity to paracetamol, chlorfenamine or ascorbic acid, to any of the excipients or other substances closely related from a chemical point of view, in particular antihistamines of chemical structure similar to chlorfenamine; pregnancy and breastfeeding; Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and patients with severe hemolytic anemia; severe hepatocellular insufficiency (Child-Pugh C); Glaucoma, prostate hypertrophy, obstruction of the bladder neck, pyloric and duodenal stenosis or other traits of the gastrointestinal and urogenital system, due to the ancient effects; Patients in treatment with monoamine oxidase inhibitors (imao) or in the two weeks following this treatment. > Adults: 1 effervescent tablet twice a day.
pediatric population: safety and efficacy in patients of age of less than 18 years It has been established.
way of administration: oral use.
The effervescent tablet must be dissolved in about half a glass of water.
the medicine must be taken after the meals. br> duration of treatment: patients should be warned to contact the doctor if the fever persists or the symptoms do not improve after 3 days of treatment.
do not keep at sup temperature Eriore at the 25 degrees c.
do not administer for over 3 consecutive days without consulting the doctor.
if the fever persists for more than three days or if the symptoms do not improve and appear others within three days or are accompanied by high fever, Exanthem, excessive quantity of mucus and persistent cough, consult the doctor before continuing the administration.
paracetamolo: during the treatment check that it is not taken At the same time no other medicine containing paracetamol, since if the paracetamol is taken at high doses, you can not check serious adverse reactions. Contact the doctor before associating any other drug.
high or prolonged doses of the product can cause they are a high risk hepatopathy and alterations to be borne by the kidney and blood even serious.
in the case of reactions of acute hypersensitivity to paracetamol ( Eg
anaphylactic shock), the treatment must be interrupted and the necessary medical measures must be implemented according to the signs and symptoms.
malicious chlorfenamine to the common therapeutic doses, antihistamines have secondary reactions very variable from subject to subject and from compound compound.
the most frequent secondary effect is sedation that can manifest itself with sleepiness; Of this must be warned to those who can lead vehicles or wait for operations that require integrity of the degree of supervision. Ascorbic acid (vitamin C) must be used with caution from subjects suffering, or have suffered in the past, nefrolithiasis (renal calculation) and those affected by the deficit of G6PD (glucose-6-phosphate-de hydrogenase), emocromatosis, thalassemia o sideroblastic anemia.
patients with renal or liver failure: administering with caution in subjects with renal failure or liver. Span Style = "font-size: medium;"> elderly: particular attention must be paid to determine the dose in the elderly for their significant hours sensitivity towards the drug.
in elderly patients in treatment with antihistamine can occur with greater probability effects such as dizziness, sed Action, confusion and hypotension.
elderly patients are particularly sensitive to the anticholinergic secondary effects of antihistamines such as dry mouth and urinary retention (especially in men)
this medic inale contains one Source of phenylalanine.
it can be harmful if suffering from phenylchetonuria (lack of the enzyme phenilalanina hydroxylasi).
sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.
Sodium: an effervescent tablet contains 14.83 mmol of sodium.
to be taken into consideration in patients with reduced renal function or following a diet a low contain Sodium uteo.
paracetamolo: use with extreme caution and under strict control lasts the treatment Chronic with drugs that can determine the delay ion of liver monoxygenase or in the event of exposure to substances that may have this effect (for example rifampicin, cimetidine, ntiepileptics such as glutetimmide, phenobarbital, carbamazepine).
< Span Style = "Font-Size: Medium;"> Dosi n Hormally Innocue of Paracetamol can cause liver damage if AS Sunte together with these drugs.
The same applies to potatoxic potential substances and in case of alcohol abuse.
the usual ingestion of unconventional drugs or oral contraceptives can, With a me ccanism of enzymatic induction, accelerate the metabolism of the tamolo parace.
the use of the for Eight if the patient is in trat tamento with anti-inflammatory.
the intake of probenecid inhibits the egame of paracetamol with glucuronic acid, reducing In this way, the clearance of the paracetamol of a factor of about 2.
therefore, the dose of paracetamol must be reduced, if administered in the associate to probenecid.
cholestiramine reduces the absorption of parace tamolo if administered within 1 h from the intake of paracetamol. it is not yet possible to establish the clinical relevance of the interactions between paracetamol and oral anticoagulants.
Therefore, the proluns of paracetamol extension in patients in treatment with anticoagulants now is advisable to them only under medical supervision.
the association PA RACET Amolo with chloramfenicolo can prolong the half-life of chloramfeni colo, increasing the risk of toxicity.
concomitant use of par acetamol and zidovudine increases The tendency of the latter to reduce the number of leukocytes (neutropenia).
therefore, the drug should be taken together with zidovudine only under control of the doctor.
media icinals that slow down gastric emptying, such as for example, reduce the speed of absorption of paracetamol and n and delay the onset of the effect.
medicines instead of acceleran or gastric emptying, such as metoclopramide, lead to an increase in the absorption speed.
interference with laborato exams rio the administration of paracetamol can interfere with the determination d Ella Uricemia (through the phosphotong acid method) and with that of blood sugar (through the method of glucose-oxida si-peroxidase).
chlorfenamine Maleato: other anticholinergic substances should not be taken on the drug, since these can cause significant interactions. Patients in treatment with MON Oaminoxidase inhibitors (IMAO) or in the two weeks following this treatment to these can prolong and intensify the anti -olinergic and depressive effects of the central nervous system (snc) of the chlorf Enamine Maleato. br> the product can interact with alcohol, antidepressiv the tricyclic, neuroleptics or other depressive action drugs on the central nervous system such as barbiturates, sedatives, tranquilizers, ipn otic.
these products should not be taken during the therapy with the icinal MEDs since they can cause an increase in the sedative effect. > It can mask the first signs of ototoxicity of certain antibiotics.
the orfenamine cl Fenitoine.
ascorbic acid: ascorbic acid (vitamin C) reduces amphetamine levels for inhibition of gastro ointarous absorption.
vitamin C increases the bioavailability of iron for chelation with deferoxamine.
Estrogen can increase the elimin action of vitamin C.
pathologies of the emolinfopoietic system: trombocytopenia, leukopenia, in Neemia, agranulocytosis, pantychopenia.
disorders of the immune system: hypersensitivity reactions such as Angioedama, edema of the larynx, an anaphylactic s Hock. br> pathologies of the nervous system: sleepiness, asthenia, dizziness, headache, incapacita 'to concentrate.
Pathologies of the Acqua o: blurred vision.
respiratory pathologies, chest and mediastinich e: thickening of bronchial secretions. br> gastrointestine pathologies li: dryness of the jaws, nausea.
hepatobiliary diseases: changes of the Hepatic and hepatitis functionality.
pathologies of the skin and subcutaneous ssuto: with the use of paracetamol, skin reactions of various types have been reported and gravity including cases of urticaria, Erit Ema Multiform, cases mo LTO rare of serious skin reactions such as Sinndro Me by Stevens-Johnson (SJS), Toxic epidermal necrolysis (Ten) and generalized acute exanthematical pust (agep).
kidney and urinary pathologies: renal alterations (acute renal failure, interstitial nephritis, hematuria, anuria), urinary retention.
report any suspect adverse reaction through the nal system of reporting. p> contraindicated during pregnancy and breastfeeding.
no studies have been conducted for Evaluate the effects on fertility in humans.