INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADCO-PARACETAMOL SYRUP

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ADCO-PARACETAMOL SYRUP

COMPOSITION:
Each 5 mL syrup contains:
  Paracetamol                 120 mg,
  Alcohol         9,6% v/v,
  Nipasept (as preservative) 0,1% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Adco-Paracetamol
Syrup has analgesic and anti-pyretic properties.

INDICATIONS:
For the symptomatic treatment of mild to moderate pain and fever in children.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol. Patients with severe liver function impairment.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Consult a doctor if no relief is obtained from the recommended dosage.
Do not use continuously for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the stated dose.
Not more than 4 doses daily.
Infants (3 months - 1 year):        ½- 1 medicine measure (2,5 - 5 mL) 3 - 4 times daily as required.
Children:
1-5 years: 1 - 2 medicine measures (5 - 10 mL) 3 - 4 times daily as required.
6-12 years: 2 - 4 medicine measures (10 - 20 mL) 3 - 4 times daily as required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pancreatitis, skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompained by fever and mucosal lesions. Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmia's have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may manifest on the second day (or later), initially by elevation of serum transaminase and lactic dehydrogenase activity, increase serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specialised therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered intravenously as soon as possible.
Acetylcysteine:
Aetylcysteine should be administered either intravenously or by mouth as soon as possible, preferably within 8 hours of overdosage.
Intravenously: An initial dose of 150 mg/kg body mass in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg body mass in 500 mL glucose injection over the next 4 hours, and then 100 mg/kg body mass in 1000 mL over the next 16 hours. The volume of intravenous fluid should be modified for children.
Orally: 140 mg/kg body mass as a 5% solution initially, followed by a 70 mg/kg body mass solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
A clear, green, syrup liquid having an odour of butterscotch and flavour of vanilla and peppermint.

PRESENTATION:
Bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in a well closed container. Protect from light.
Exposure to air should be minimum.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
U/2.7/118

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23/08/89

New addition to this site: April 2004
Source: Pharmaceutical Industry

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