INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
NUCOPAIN (TABLETS)

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

NUCOPAIN (TABLETS)

COMPOSITION:
Each tablet contains:

Paracetamol	320 mg
Codeine Phosphate	8 mg
Caffeine anhydrous	32 mg
Meprobamate	150 mg

Preservative:

Nipastat

0,025% m/m

Contains no TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
NUCOPAIN tablets have analgesic and skeletal muscle - relaxing properties.

INDICATIONS:
Pain and pain associated with tension.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of NUCOPAIN tablets during pregnancy should be avoided. Asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, acute alcoholism, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.

WARNINGS:
The use of this medicine leads to drowsiness, which is aggravated by the simultaneous intake of alcohol, and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with this product. Paracetamol administration in excess of the recommended dosage may cause severe liver damage.

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
Not recommended for children, under the age of 12 years.
Adults:        Two tablets every 6 to 8 hours.

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. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Caffeine may cause headache, nausea, insomnia, restlessness, excitement and muscle tremor. Caffeine increases gastric secretion and may cause gastric ulceration.
Meprobamate may cause drowsiness, nausea, vomiting, diarrhoea, paraesthesia, hypotension, tachycardia, cardiac arrhythmias, weakness and central effects such as headaches, excitement, dizziness, ataxia and disturbances of vision. Hypersensitivity reactions such as skin rashes, urticaria and purpura may occur or may be more severe with angioneurotic oedema, bronchospasm or anuria.
Erythema multiforme and exfoliative or bullous dermatitis has been reported. Blood disorders such as agranulocytosis, eosinophilia, leucopenia, thrombocytopenia and aplastic anaemia have been reported. Symptoms of porphyria may be exacerbated. Meprobamate may lower tolerance to alcohol and other central nervous system depressants. It may include the hepatic microsomal enzymes involved in drug metabolism.
Due to the dependence potential, Meprobamate should be gradually withdrawn after long-term treatment.
Codeine may cause respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo, flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm, and an antiduiretic effect.
PRECAUTIONS:
Codeine should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock.
It should be used with caution or in reduced doses in patients with adrenocortical insufficiency and hypothyroidism.
Dosages should be reduced in debilitated and in elderly patients.

INTERACTIONS:
Codeine may affect the activity of the other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.
Meprobamate may lower the tolerance to alcohol and other central nervous system depressants.
Meprobamate may enhance the metabolism of oral contraceptives, corticosteroids, phenytoin, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include the following: nausea, vomiting, restlessness, sensory disturbances, muscle tremor, diuresis, palpitations, stupor, shock, central stimulation with exhilaration, convulsions, drowsiness, respiratory depression, hypotension with circulatory failure, respiratory collapse, cyanosis and coma.
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay 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 alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of 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 is limited 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 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 1 000 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.
Codeine phosphate: In acute poisoning the stomach should be emptied by aspiration and lavage. Intensive supportive therapy may be necessary to correct respiratory failure and shock. The specific antagonist nalaxone may be used to counteract severe respiratory depression
Meprobomate: Symptoms of overdosage are mainly due to the depressant effect on the central nervous system. See also “Side effects and special precautions”.
Following recent ingestion of an overdose the stomach may be emptied by gastric lavage and aspiration. Patients should be managed with intensive symptomatic and supportive therapy, with particular attention being paid to the maintenance of cardiovascular, respiratory and renal functions, and to the maintenance of the electrolyte balance.

IDENTIFICATION:
Green, round, biconvex tablet, bisected on the one side

PRESENTATION:
Packaged in push-through blister packs of 10 tablets, in containers of 20 and 100 tablets, and in plastic bottles of 500 and 1000 tablets

STORAGE INSTRUCTIONS:
Store in a dry place below 25ºC. Protect from strong light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/2.8/27

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

www.gulfdrug.co.za

DATE AND PUBLICATION OF THIS PACKAGE INSERT:
10 January 1991

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