Flucolidex ® (Flucoldex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceParacetamol + ChlorphenamineParacetamol + Chlorphenamine
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  • Flucolidex ®
    syrup inwards 
    Outline Pharma Pvt. Ltd.     India
    • Dosage form: & nbspsyrup for children
    Composition:

    Each 5 ml contains:

    paracetamol-125 mg

    chlorphenamine maleate - 2 mg

    Excipients:

    sodium methylpentrahydroxybenzoate, sodium propyl parahydroxybenzoate, sodium benzoate, disodium edetate, carmellose sodium (sodium carboxymethylcellulose), aspartame, citric acid, propylene glycol, sorbitol (70% solution), raspberry flavor, pink flavor, azorubine dye (E122), glycerol (glycerol), water for injection.

    Description:

    Dense viscous opalescent liquid of dark pink color with a raspberry smell.

    Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic + H1-histamine receptor blocker)
    ATX: & nbsp

    N.02.B.E   Anilides

    N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Combined drug. Paracetamol has antipyretic and analgesic effect: reduces pain syndrome, which is observed in catarrhal conditions - sore throat, headache, muscle and joint pain, reduces heat. Chlorphenamine - a blocker of H1 - histamine receptors.Has anti-allergic effect: it removes the itch of the eyes, nose and throat, swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, reduces exudative manifestations. Has an overwhelming effect on the central nervous system.

    Indications:

    Symptomatic treatment of "cold" diseases, flu, ARVI (febrile syndrome, pain syndrome, rhinorrhea).

    Contraindications:Hypersensitivity to paracetamol and other components that make up the drug; reception of other medicinal products containing substances included in preparation; expressed violations of the liver or kidney function, phenylketonuria, deficiency of glucose-6-phosphate dehydrogenase, children under 3 years old.

    Carefully:

    Carefully - Severe atherosclerosis of the coronary arteries, arterial hypertension, diseases of the blood system, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), alcoholism, zakratougolnaya glaucoma, prostatic hyperplasia, pregnancy, lactation.

    Pregnancy and lactation:Carefully.
    Dosing and Administration:

    Inside.Children from 3 to 5 years - 5 ml 2 times a day; children from 6 to 10 years - 5 ml 3-4 times a day; children from 10 to 15 years - 10 ml 3 times a day; Children from 16 years and adults - 10 ml to 4-6 times a day.

    The duration of treatment without a doctor's consultation is up to 5 days.

    Side effects:

    In therapeutic doses, the drug is usually well tolerated. Sometimes there are allergic reactions (skin rash, itching, hives, angioedema). Possible dizziness, nausea, agitation, sleep disturbance, tachycardia, arrhythmia, epigastric pain, mydriasis, paresis of accommodation, increased intraocular pressure, dry mucous membrane of the mouth, nose, throat; retention of urine. With prolonged use in large doses - hepatotoxic effect, hemolytic or aplastic anemia, methemoglobinemia, thrombocytopenia, agranulocytosis, pancytopenia; nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis).

    Overdose:

    Signs of acute poisoning caused by paracetamol - pallor of the skin, decreased appetite, nausea, vomiting, stomach pain, signs of liver damage are determined in 1-2 days.In severe cases, hepatonecrosis develops (the severity of necrosis, due to intoxication directly depends on the degree of overdose), hepatic insufficiency, encephalopathy and coma, death. Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: increasing the activity of "liver" transaminases, increasing prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis). Chlorpheniramine may be associated with dizziness, dry mouth, nausea, depression of the central nervous system.

    Treatment: should be done rinsing of the stomach during the first 4 hours of poisoning, appoint adsorbents, introduce agents that increase the formation of glutathione ( methionine - 8-9 hours after an overdose, acetylcysteine - in the first 12 hours). Detoxification can be done by hemodialysis. Along with these measures, symptomatic therapy should be provided.

    Interaction:

    Nonsteroidal anti-inflammatory drugs, non-narcotic analgesics and drugs that depress the central nervous system can increase the side effect of the drug.

    The risk of developing a hepatotoxic effect increases with the simultaneous administration of barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine, phenylbutazone, tricyclic antidepressants and other inducers of microsomal liver enzymes, while consuming alcohol. With simultaneous use with levomitsetinom (chloramphenicol) excretion of the latter slows down and toxicity increases. Speed suction of paracetamol increases with metoclopramide or domperidone, the slowing of absorption occurs when combined with colestyramine.

    Long-term use of barbiturates reduces the effectiveness of paracetamol.

    Ethanol promotes the development of acute pancreatitis.

    Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

    Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

    Myelotoxic drugs increase the manifestation of hematotoxicity of the drug. Long-term use Flukoldeks syrup withanticoagulants of indirect action should be under constant medical supervision, tk. increases the effect of the latter.

    Inductors of microsomal oxidation in the liver (phenytoite, ethanol, barbiturates, rifampicin, phenylbutazone, triktsiklicheskie antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.

    Paracetamol reduces the effectiveness of uricosuric drugs and increases the effect of indirect anticoagulants.

    Special instructions:

    Against the background of the use of Flukoldex syrup Syrup for children, you should not take other non-narcotic analgesics or non-steroidal anti-inflammatory drugs, as well as drugs that depress the central nervous system. Avoid excessive consumption of tea, coffee and other products containing methylxanthines.

    With prolonged (more than a week) application of the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

    Because of the possible sedative effect of chlorphenamine is not recommended when using the drug to perform work that requires increased attention (driving vehicles, management mechanisms, etc.).

    With a febrile syndrome that lasts more than 3 days, and more than 5 days, a doctor's consultation is required. Paracetamol distorts the indicators of laboratory studies in quantitative determination of sugar and uric acid in the plasma.

    Form release / dosage:Syrup for children.
    Packaging:

    For 60, 100 ml of preparation in brown polyethylene bottles with a screw cap. The bottle, together with a measuring cup and instructions for use, is placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N009866
    Date of registration:15.12.2008
    The owner of the registration certificate:Outline Pharma Pvt. Ltd.Outline Pharma Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC
    Information update date: & nbsp09.09.2015
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