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

Logo DOLOROL® TABLETS

SCHEDULING STATUS:
Not scheduled:        Pack sizes of 25 tablets or less, containing 500 mg or less of paracetamol.
Schedule: 1        Pack sizes of more than 25 tablets

PROPRIETARY NAME:
(and dosage form):

DOLOROL® TABLETS

COMPOSITION:
Each tablet contains:
Paracetamol         500 mg
Preservative: Nipastat         0,2% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Antipyretic or antipyretic and anti-inflammatory agents.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic properties. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is about 2 hours after therapeutic doses.
It is distributed into most body tissues. It crosses the placenta and is present in breast milk.

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

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.
Severe liver function impairment.

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

DOSAGE AND DIRECTIONS FOR USE:
Adults:                1 to 2 tablets every 4 hours when necessary (maximum 8 tablets in 24 hours).
Children: 6-12 years: ½ to 1 tablet when necessary (maximum 4 tablets in 24 hours).
Children under 6 years: Dolorol tablets are not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, thrombocytopenia, pancytopenia and leucopenia. The dose should be reduced in renal functional impairment
Paracetamol should be given with care to patients with impaired kidney or liver f        unction. Paracetamol should be given with care to patients taking other drugs that affect the liver.
Interactions:
The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most serious adverse effects of acute overdosage of paracetamol is dose-dependent, potential fatal hepatic necrosis. In non-fatal cases, hepatic lesions are reversible over a period of weeks or months.
The consequences of overdosage can be extremely serious because of the narrow margin between therapeutic and toxic doses.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, lethargy, sweating, 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 arrythmias have been reported. Symptoms during the first two 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. Abdominal pain may be the first indication of liver damage.
Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased 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 7,5 g or more of paracetamol in the preceeding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible, preferably within 8 hours of overdosage.
ACETYLCYSTEINE
IV:        An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the 16 hours. The volume of intravenous fluid should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
A flat, white, bisected tablet with bevelled edges engraved "DOLOROL" on one side.

PRESENTATION:
Blister packs of 20 tablets.
Securitainer packs of 100 tablets.
Amber PVC packs of 500 and 1000 tablets.
Black HDPE packs of 5000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1186.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/1982
                        G494A
                KOHLER C&P P.E

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