Indication:
Analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache.. backache, rheumatic and muSele Pah% dInMetleffth0a0, sore throat, and Sot reeving the fever, aches and pains of colds and flu. Also recommender/lot the symptomatic relief of pain due to non-serious aWnntis.
00,1Qe Br Administration:
Adults:
One to two tablets every 4 to 6 hours up to tour times daily as required. Maximum daily dose is 4000 mg. On not exceed the slated dose. banal take more than 8 tablets in 24 hours. Do not take more frequently than every four hours
Children: Children should not be given Abonol fOr more than 3 days without consulting a doctor. No more than 4 doses to be taken in any 24 hour period The maximum daily dose is 6Orng/kg
6 - 12 years: Half to one tablet three or four times daily as required.
1 - 6 years: 5 to 10 Int of the liquid suspension (120 to 240 mg of paracetamol). Dose may he repeated after 4 hours.
3 months to less than 1 year: 2.5 to 5 ml of tht liquid suspension (60 to 120 mg of paracetamol). Dose may be repeated
after 4 hours.
Less than) months; 2.5m1 of the liquid suspension may be administered to infants who devtlop pyrexia after vaccination at
2 months Al age. If necessary, a second dose can be given 4-6 hours later. If uremia persists after the second dose, medical attention is required.
For all other indicatiOns in this age group, use only under medical supervision.
Abimol should not be used with Other paracetamol containing products.
Contra-Indications:
Abimol is contraindicated in patients with a previous history Al hypersensitivity to paracetamol or exeipients.
Side Effects:
Paracetamol has been widely used and, when taken at the usual recommended dosage, ode effects are mild and infrequent and reports of adverse reactions are rare.
Skin rash and other allergic reactions, such as angioedema occur rarely.
In patients sensitive to aspinn or other NSAIDs. aggravation of bronchospastn has been reported.
Most reports of adverse Tactions to paracetamol relate to overdose with the drug
Isolated cases of blood dyscrasia, thromboeytopenic purputa. haemolytic anaemia and agranulocytosrs have been recorded. Chronic hepatic necrosis has been reported in a patient who look daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A feN4CW of a group of patients with chronic active aepatitiS faded to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
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Nephrotoxic effects Maoism therapeutic doses of paracetamol are uncommon. Papillary necrosis nas ban reported alter prolonged administration
Over dose & tre Olsen
Potentially fatal nerd age is litchi in adults who have taken 15g or more of paracetamol. As little as lOg may lead 10 liver necrosis Patients taking enzyme-inducing drugs of with a history of alcoholism may have an increased susceptibility. Ills considered that xcess q antities of a toxic metabolite (usually adequately detoxified by glutathione amen normal doses of paracetamol are mployed), become irreversibly bound to liver tissue.
Symptoms of paracetarn I over dosage in the first 24 hours are pallor, nausea, vomiting, diarrhoea. anorexia, abdominal pain and increased sweating, liver damage may become apparent 12 10 46 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopa thy, coma, and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmia, have been reported.
Prompt treatment is essential in the management of paracetamol ovetdosage. Any patient who has ingested abcmt 2.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavagc or induced ernesis. Specific therapy with an antidote such as acetyleyst err or methioninc may be necessary. Actrykysteine may be given either intravenoody of by mouth or methionine may be given by mouth within 10 -12 hours of ingestion of the overdose. Generally treatment is required if the blood-paracetamol concentration is higher than a line (the '200' line) drawn on semi‑
log/linear paper joining the points 200 mg/litre (1.32 mmofflitre) at 4 IMMS and 30 mg/litre (0.20 rnmolflitre) 01 15 henna following Ingestion
Determination of the concentration before 4 hours is not considered to give a reliable measurement. Administration of oral methionine or intravenous N-aectylcystone which may have a beneficial effect up coal least 48 hours after the overdose. may be required. General supportive measures most be available. Liver function tests should be performed at 14 hour intervals for at least 96 hours post-ingestion if the plasma paracetamol concentration indicates a potential for hepatotoxicity. Renal and cardiac function should be monitored and supportive,aceatmen1 should be directed at maintaining fluid and electrolyte balance and correc t nig hypo. itlycaernia. Haemodialysis and haeihoperfusion have been used with some success but peritoneal dialysis is met Incline
Drug Interaction:
the an: ire:mid:int effect of warta !I rid other coumarins may be e77411e VrorsIlljed minter daily use 01 paracetamol with increased. tisk of hired. ..aceaSlonal doses have no significant el rect.
Human and an mat studies have not osk to pregnancy or embryofoetal devetopment. Human studies have not identified any risk In lactation or the theasl-led offspring. Paracetamol crosses the placental barrier and is excreted in breast milk
Precaution & Warnings: , s. • . •
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is g tea ter In those with non-cirrhotic alcoholic liver disease. Patients who are taking other potentially hepatotoxic drugs are at increased risk of paracetamol-induced hepatoluxicity
Package & Storage:
Tablets, Strips of 10 tablets in packs of 2 strips. Store below 30 C
Syrup: Bottle of 125ml
Suppository: Box of 5 suppositories.
Storage: See outer pack.
Instruction to Patient:
On not exceed the stated dose.
Do not to take other paracetamol-containing products concurrently.
If symptoms persist consult your doctor.
If you have been diagnosed With liner or kidney impairment seek medical advice before taking this medication
KEEP ALL MEDICAMENTS OUT OF THE REACH OF CHILDREN
For tablets & Syrup: Manufactured by GlaxoSmithKline SA.E.- El Salam city-Cairo- Egypt.
For Suppositories: Manufactured by SmithKline Beecham - Elharam-Giza for GlaxoSmithKline SAE. - Egypt
Abimol is a trade mark of GlaxoSmithKlinc SA.E SBCOCIaxoSmithKline
Produced by SIGMA Pharmaceutical industries. Egypt S.A.E. 0412701