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PARACETAMOL 120 mg/ 5 mlPediatric Elixir

FORMULA:

Each 5 ml (ore spoon) contains 120 mg paracetamol, ,perfume framboise, ponceau 4 R, methylparaben, propyl paraben, sodium cyclamate, sodium sakarin and ethyl alcoholPHARMACOLOGICAL PROPERTIES:Paracetacol shows analgesic and antipyretic effect with a similar mechanism by salicylates,increases pain treshold and effects the thermo-regulatiun center in hypotalamusIts antiinflammatory effect poor.Paracetamol is absorbed fast and full, from the gastointestinal tract afteringestion. Maximum plasma concentetion is reached in 30-90 minutes .Distributed throughout most body fluids fast.Plasma half life is 1-3 hours. Metabolized by the microzomal enzyme system in lver, excreted inurine 1-3 % as unchanged paracetamol, 80 % as inactive glucuronide or suplhate compounds.INDICATIONS:Paracetamol pediatric Elixir is indicated symptomatic relief of mild to moderate fever and pain inchildren.CONTRAINDICATIONS:

Paracetamol is contraindicated in patients with hypersensitivity to paracetamol and liver and renalinsufficiency

WARNINGS/PRECAUTIONS:Paracetamol should be used in patients with impaired liver and renal function under supervision ofa medical doctor It should be used in patients with caution who have heart,lung diseases and whohave anemia. Paracetamol should not be given to children who have pain longer than 5 days ofduration, fever more than 39.5 C or 3 days of duration or intermittant fever. Hepatic necrosis is acomplication of paracetamol over dosis.Liver enzymes may be incresed in 12-48 hours, protrombin time may be prolonged.The clinicalsymptoms may not appear 1-6 after the ingestion of paracetamol.Toxicity symptoms may appearafter ingestion of more than 10grams of paracetamol.

ADVERSE REACTIONS:

Urticaria, itching, maculopapular erythema are rare, Prolonged treatment with high dosis maycause thrombositopenia, leucopenia and pansitopenia. Neutropenia, hemolytic anemiathrombocytopenic,purpura and agranulocytosis are reported very rarelyCONSULT YOUR PHYSICIAN IN CASE OR UNEXPECTED EFFECT

INTERACTIONS:A serious hypothermia should be kept in mind in patients with concomitant treated withparacetamol, phanothiazine and antipyretic treatment. Prolonged and high dose treatmentparacetamol increases the effect of anticoagulant medication. Prolonged and high dose treatmentof paracetamol, may interact with coumarin indantoin derivaties, phenotiazines. Alcohol,barbiturates, tricyclic antidepresants may increse hepatotoxicity of paracetamol

EFFECTS TO LABORATORY TESTS:

Paracetamol may cause a faLSE positive IAA (5-Hydroxy indol acetic acid) test is urineADMINISTRATION AND DOSAGE:Recommended paracetamol syrup dosage is:3 moths-1 year 3-4 times spoons/day(60mg) maximum dosage 10 ml/240 mg/day1 year -4 years 3-4 times spoon/ day(120 mg) 20ml/480 mg/day4 years -8 years 3-4 times 1.5-2 spoons/day (180-240mg) 40 960 mg/day8 years -12 years 3-4 times 2 spoons (240 mg) 40 960 mg/day

Dosage should be adjusted on age and weight4 hours of interval should be kept between administrations Minimum doses should be gven inprolonged treatments.If not recommended by physician, paracetamol should not be gven more than 4 times in 24hours.

OVERDOSAGE:A heath center should be consulted in suspect of overdosage.

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Nausea, vomiting, abdominal pain may occur in 2-3 hours after ingestion of toxic doses.Treatment of acute paracetamol toxicity is a symptomatic and supportive Vomiting, gashicaspiration or lavage application may be applied after a short period of time after ingestion. Acetylcystein is recommended as antidote. 150 mg /1 g after the frst 8-10 hours N Acetyl cystein isinfused in 15 mnutes. Prothrombin time, BUN, blood sugar, SGOT ,SGPT, bilirubin ,kreatinin, andelectrolytes must be monitored.Fluid electrolyte balance should be maintaired. Hypoglycemia if present shold be treated.Laboratory tests should be repeated until reaching normal levels. If liver and renal insulliciecyappears hemodialysis and hemoperfusion may help. Peritoneal dialysis and hemoperfusion mayhelp. Peritoreal dialysis is not effective

STORAGE:Keep at room temperature below 25 CKeep in package and out of the reach of children

PACKAGINGn 150 ml bottles (with a spoon 5 ml)

Registration date and number: 24.4.1974-118/37

Manufacturing place: Munir Sahin Ilac San ve Tic A.S.Kartal-IstanbulHolder of Registration: Saba Ilac San.ve Tic. A.S.

Halkal Merkez Mah.Basn Ekspres Cad.No:1 Kat:1Kkekmece /stanbul

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