Flukoldeks-C - instructions for use, doses, side effects, contraindications

Excipients: starch 1000 mg, aspartame 1,500 mg, calcium gluconate 2 mg, citric acid 200 mg, lactose 1416.5 mg, lemon flavor 60 mg, quinoline yellow dye 1.5 mg.

Description:Loose heterogeneous powder of light yellow color with the smell of lemon. When dissolved in water, a solution of light yellow color with the smell of lemon is formed.

Pharmacotherapeutic group:Remedy for elimination of symptoms of acute respiratory disease and "colds" (analgesic non-narcotic remedy + alpha-adrenomimetic + vitamin).

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 the pain syndrome observed when catarrhal conditions - sore throat, headache, muscle and joint pain, reduces heat. Phenylephrine has a vasoconstrictive effect - reduces edema and hyperemia of the mucous membranes of the upper respiratory tract and accessory sinuses of the nose. Ascorbic acid (vitamin C) replenishes the increased need for vitamin C for "colds" and flu, especially at the initial stages of the disease.

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; simultaneous reception of other drugs containing substances that are part of Flukoldkodex ®-C, simultaneous administration of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (MAO), incl. within 14 days after their cancellation; pregnancy, lactation, expressed aortic stenosis, acute myocardial infarction, tachyarrhythmia, hypertension, hyperthyroidism (including hyperthyroidism), diabetes and galactose intolerance, lactase deficiency or glucose-galactose malabsorption (b.p. formulation contains lactose) ; phenylketonuria (because the drug contains aspartame), prostatic hyperplasia, angle-closure glaucoma, children under 12 years old.

Carefully:Significant atherosclerosis of the coronary arteries, pheochromocytoma, bronchial asthma, chronic obstructive pulmonary disease, deficiency of glucose-6-phosphate dehydrogenase, blood diseases, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), hepatic and / or renal failure.

Dosing and Administration:

Pour the contents of 1 sachet into a cup, pour hot water, stir well until dissolved.

Adults: 1 sachet every 4-6 hours. Do not take more than 4 sachets in 24 hours. Children over 12 years: 1 sachet every 6 hours. Do not take more than 3 sachets in 24 hours.

If symptoms persist for 3-5 days, consult a physician. Do not exceed the indicated dose.

Side effects:

Allergic reactions (including skin rash, itching, urticaria, angioedema), dizziness, headache, disturbed sleep, increased excitability, mydriasis; increased blood pressure, tachycardia; nausea, vomiting, epigastric pain; dry mouth; urine retention, accommodation paresis,increased intraocular pressure; anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria; hepatotoxic effect, nephrotoxicity (papillary necrosis); bronchial obstruction.

Overdose:

Conditional, as a rule, paracetamol, appears after taking more than 10-15 g of the latter. Possible: pallor of the skin, anorexia, nausea, vomiting; hepatonecrosis; increased activity of liver transaminases, an increase in prothrombin time. When overdosing, it is urgent to see a doctor. Treatment: gastric lavage followed by the administration of activated charcoal; symptomatic therapy, the introduction of methionine after 8-9 hours after an overdose and N- acetylcysteine - after 12 h.

Interaction:

Strengthens the effects of MAO inhibitors, sedatives, ethanol.

Antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives - increase the risk of urinary retention, dry mouth, constipation. Glucocorticosteroids increase the risk of developing glaucoma. Paracetamol reduces the effectiveness of diuretic drugs. Tricyclic antidepressants strengthen the adrenomimetic effect of phenylephrine, the simultaneous administration of halothane increases the risk of ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine and the effectiveness of beta-blockers. Guanethidine increases the alpha-adrenostimulating activity of phenylephrine. With simultaneous appointment Fluxoldex®-C with barbiturates, ethanol, phenytoin, phenylbutazone, tricyclic antidepressants, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes increases the risk of hepatotoxic effects of paracetamol. Ascorbic acid increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Special instructions:

During treatment should refrain from taking alcohol, sleeping pills and anxiolytic (tranquilizers) medicines.Distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the plasma. Do not use other medicines containing paracetamol, as well as other non-narcotic analgesics, non-steroidal anti-inflammatory drugs (metamizol, ibuprofen and the like), barbiturates, antiepileptic drugs, rifampicin.

Excessive consumption of tea or coffee during the administration of Flukoldeks®-C may cause irritability and nervous tension. If the symptoms do not go away within 3 to 5 days, consult a doctor.

Effect on the ability to drive transp. cf. and fur:

Does not render (at reception in recommended doses).

Form release / dosage:

Powder for solution for oral administration.

Packaging:

For 5 g in paper bags with an inner coating of laminated aluminum foil or 5 grams in paper bags with an outer laminated PVC coating and an inner coating of laminated aluminum foil.

5 packs per pack of cardboard along with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C in a place protected from light and inaccessible to children.

Shelf life:

3 years.Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012732 / 01

Date of registration:25.12.2011

The owner of the registration certificate:Outline Pharma Pvt. Ltd.Outline Pharma Pvt. Ltd. India

Manufacturer: & nbsp

NABROS PHARMA, Pvt. Ltd. India

Representation: & nbspNPK Katren AONPK Katren AORussia

Information update date: & nbsp01.08.2012

Illustrated instructions

Instructions

Fluxoldex®-C (Flucoldex®-C)