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

Logo GULF PARACETAMOL (TABLETS)

SCHEDULING STATUS:
Schedule 0 - 10's and 20's
Schedule 1 - S1 –100’s, 500's,1 000'S, 5 000's, 10 000's and 20 000's

PROPRIETARY NAME
(and dosage form):

GULF PARACETAMOL (TABLETS)

COMPOSITION:
Each tablet contains
       
Paracetamol 500 mg
Preservatives
        Nipastat 0,097% m/m
        Benzoic acid 0.065% m/m

PHARMACOLOGICAL CLASSIFICATION:
A. 2 7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesic.

PHARMACOLOGICAL ACTION:
GULF PARACETAMOL has analgesic and anti-pyretic action

INDICATIONS:
For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Severe liver function impairment.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor. Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetarno1 under medical supervision. Consult your doctor ifno relief is obtained with the recommended dosage. In the event of overdosage or suspected overdose and not withstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

DOSAGE AND DIRECTIONS FOR USE:
DO NOT EXCEED THE RECOMMENDED DOSE
Children under 6 years: Not recommended
Children 6
- 12 years: Half to one tablet every hours
Adults and children over 12 years: One to two tablets every four to six hours, up to a maximum of eight (8) tablets daily

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may beaccompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of leucopenia, neutropenia and pancytopenia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. Adelay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 - 10 g/day) of paracetamol for several days, in chronic a1coholism, chronic liver disease, AIDS, malnutrition, and with the useof drugs that induce liver microsomal oxidation such as barbiturates isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported
Treatment for Paracetamol overdosage:
Although evidence islimited it is recommended that any adult person who has ingested 5 - 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed b an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1 000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by a 70 mg/kg solution every 4 hours for 17 doses.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the normogram below
Those whose plasma paracetamol levels are above the "normal treatment line", should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the "high risk treatment line". Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety six hours.

IDENTIFICATION:
A flat, round, white tablet with breakline on one side.

PRESENTATION:
Blisters in strips of: 10 tablets.
Plastic vial containing 10 or 20 tablets.
Plastic bottles containing10, 20, 100, 500 and 1 000 tablets.
Plastic bucket with a white lid containing 5 000, 10 000 or 20 000 tablets.

STORAGE INSTRUCTIONS:
Store in a cool dry place, in well-closed containers, below 25ºC. Protect from light. KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
28/2.7/0511

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Gulf Drug Company (Pty) Ltd.
22 Burnside Drive, Old Mill Industrial Park, Mount Edgecombe4300

www.gulfdrug.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 January 1997.

P/280511/3

New addition to this site: July 2010
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2010