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

Logo DOLOROL® FORTE TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DOLOROL® FORTE TABLETS

COMPOSITION:
Each tablet contains:

  Paracetamol         500 mg
  Codeine Phosphate         8 mg
Preservative:
  Nipastat 0,200 % m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic Combinations.

PHARMACOLOGICAL ACTION:
Dolorol Forte has antipyretic and analgesic actions.

INDICATIONS:
Dolorol Forte is indicated for the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Patients who are sensitive to any of the ingredients.
Dolorol Forte is contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion and after operations on the biliary tract; in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised, during an attack of bronchial asthma or in heart failure secondary to lung disease.

WARNING:
Codeine should be given with extreme caution to patients taking monoamine oxidase inhibitors, or within 14 days of stopping such treatment.
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 only take paracetamol under medical supervision. Paracetamol should also be given with care to patients taking other drugs that affect the liver.
Consult your doctor if no relief is obtained from the recommended dosage.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children over 12 years.
One to two tablets every four to six hours with a maximum of 8 tablets daily. Do not use continuously for more than 10 days without consulting your doctor.

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 be accompanied by drug fever and mucosal lesions. In a few cases the use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia. The dose should be reduced in renal functional impairment.
Dosage in excess of those recommended may cause severe liver damage.
Do not use continuously for more than 10 days without consulting your doctor.
Store in a safe place out of the reach of children.
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an anti-diuretic effect. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Larger doses of codeine produce respiratory depression and hypotension, with circulatory failure and deepening coma.
Respiratory failure could result and, in infants and children, convulsions may occur.
The administration of codeine during labour may cause respiratory depression in the new born infant.
Codeine should be given with caution to patients with hypothyroidism, adreno-cortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. Opioid analgesics should be used with caution in patients with myasthenia gravis. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines.
The prolonged use of high doses of codeine has produced dependence.
Consult your doctor if no relief is obtained with the recommended dosage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most serious adverse effect of acute overdosage of paracetamol is dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycaemic coma may also occur. Paracetamol has caused thrombocytopenia. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the intoxication. Nausea, vomiting, anorexia and abdominal pain occur during the initial 24 hours and may persist for a week or more. Liver injury may become manifest on the second day, initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The hepatotoxicity may progress to encephalopathy coma and death. Both metabolic acidosis and metabolic alkalosis have been noted; cerebral oedema and nonspecific myocardial depression have also occurred. In non-fatal cases hepatic lesions are reversible over a period of weeks or months. In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Treatment of overdosage should be prompt, and vigorous supportive therapy is essential in severe intoxication. Since the hepatic injury is dose dependent and occurs early in the course of intoxication, procedures to limit continuing absorption of the medicine must be initiated promptly. Induction of vomiting or gastric lavage should be performed in all cases where the patient has ingested 7,5 g in the preceding 4 hours. Specific therapy with an antidote such as acetylcysteine or methionine is generally needed when the blood paracetamol concentration, lies above a line that is drawn between the 2 points, 200 mg/L at 4 hours, and 30 mg/L at 15 hours after the overdose is taken. Treatment is as follows:
Acetylcysteine:- can be given either intravenously, or by mouth.
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 1 litre over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally:- 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution ever 4 hours for 17 doses. Acetylcysteine is very effective if administered within 8 hours of overdosage.
Methionine: The usual dose is 2,5 g by mouth every 4 hours for 4 doses, but must be started within 10 hours of the overdosage.
As little as 10 g paracetamol can lead to fatal liver necrosis in the adult, especially in the malnourished. The signs of codeine intoxication are central nervous system depression, restlessness, excitement, respiratory depression, miosis and slow breathing, hypotension with circulatory failure and coma. Administration should be stopped immediately in cases of overdosage.
In acute poisoning by codeine taken by mouth, the stomach should be emptied by aspiration and lavage. A laxative may be given to aid peristalsis.
Intensive supportive therapy may be required to correct respiratory failure and shock. In addition, the specific antagonist naloxone hydrochloride is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of opioid analgesics. A dose of 0,4 to 2 mg is given intravenously, repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg.
Further treatment is supportive and symptomatic.
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
Dolorol Forte is a white, bisected tablet with bevelled edges.

PRESENTATION:
Packs of 20, 50, 100 and 500 tablets.

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

REGISTRATION NUMBER:
G/2.8/116

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3/75
                A270
        UNIPRINT-P

Updated on this site: May 2005
Source: Hospital Pharmacy

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