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

Logo NOMOPAIN TABLETS
SCHEDULING STATUS
S2

PROPRIETARY NAME
(and dosage form):

NOMOPAIN TABLETS

COMPOSITION
Per tablet
Paracetamol         450 mg
Codeine phosphate         10 mg
Doxylamine succinate         5 mg
Caffeine         30 mg

PHARMACOLOGICAL CLASSIFICATION
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION
NOMOPAIN tablets have analgesic, antipyretic and antihistaminic actions.

INDICATIONS
For the relief of mild to moderate pain associated with tension.

CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients. Contra indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Contra-indicated in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Severe liver function impairment.
Safety in pregnancy and lactation has not been established.

WARNINGS
Nomopain tablets may lead to drowsiness and impaired concentration which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents. Dosages in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE
Adults and children 12 years and older:
One to two tablets every four to six hours as needed. Do not exceed eight tablets per day. Do not use continuously for longer than 10 days without consulting your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Products containing codeine should not be given for prolonged periods.
Consult your doctor if no relief is obtained with the recommended dosage.
Paracetamol: Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Paracetamol may cause sensitivity reactions resulting in reversible skin rash or blood disorders.
Codeine: Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, change in mood and miosis.
Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. 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, sedatives and phenothiazines. The prolonged use of high doses of codeine has produced dependence of the morphine type.
Caffeine: Side effects of caffeine include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretions and may cause gastric ulcerations. Caffeine should be given with care to patients with a history of peptic ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Paracetamol:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 24 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 arrhythmias 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. 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 your doctor or take the patient to the nearest hospital immediately.
Specialised treatment is essential as soon as possible.
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 I.V. as soon as possible.
Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
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: 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.
Codeine Phosphate:
Symptoms of overdosage with codeine phosphate 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.
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, naloxone hydrochloride, is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses. A dose of 0,4 to 2,0 mg is given IV, repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg. Naloxone may also be given by subcutaneous or intramuscular injection.

IDENTIFICATION
Yellow, round, flat tablet with bevelled edges scored on one side

PRESENTATION
20' in blister packs and 100' and 500’s in securitainers

STORAGE INSTRUCTIONS
Store below 25°C in a dry place and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
V/2.8/152

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hoechst Marion Roussel LTD
16th Road, Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 March 1994

        Pro-Print G 84/4

Updated on this site: June 2000

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