VACUDOL SYRUP

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

VACUDOL SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

VACUDOL SYRUP

COMPOSITION:
Each 5 mL syrup contains:

Paracetamol	120 mg
Codeine phosphate	5 mg
Promethazine Hydrochloride	6,5 mg
Preservatives:
Methylparaben	0,10% m/v
Propylparaben	0,01% m/v
Alcohol content	12,5% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Special analgesic combination.

PHARMACOLOGICAL ACTION:
VACUDOL SYRUP has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
For the relief of mild to moderate pain, associated with fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol, opiates or phenothiazines. During an attack of bronchial asthma; respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, heart failure secondary to chronic lung disease, liver or kidney damage, head injuries and where intracranial pressure is raised. Acute alcoholism. Premature neonates and infants.

WARNINGS:

1.	If the patient does not respond, a doctor should be consulted.
2.	Do not use continuously for more than 10 days without consulting a doctor.
3.	This medicine may cause drowsiness and impaired concentration, which is increased by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against performing potentially hazardous activities/duties where loss of concentration may lead to accidents.
4.	Patients should be examined periodically for abnormal skin pigmentation or eye changes.
5.	Should be used with extreme caution in patients recieving monoamine-oxidase inhibitors.
6.	Dosages in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS:

2 to 5 years:	One medicine measureful (5 mL) three times a day.
6 to 12 years:	One to two medicine measuresful (5 to 10 mL) three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS FOR USE:
Do not administer to patients with liver or kidney damage. If taken in excess this medicine may cause liver damage which may be fatal.
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 occurence of neutropenia, pancytopenia and leucopenia.
Side-effects from codeine that may occur are nausea, respiratory depression, abnormally slow pulse rate, circulatory failure, low blood pressure, drop in blood pressure when standing up, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, flushing, abnormally low body temperature, increased intracranial pressure, miosis, dry mouth, muscle rigidity, vomiting, constipation, itching, urticaria, sweating; urinary retention, uteric and biliary spasm, and decreased excretion of urine. The following side-effects have been reported with promethazine: agranulocytosis, allergic reactions, lack of appetite, convulsions, diarrhoea, dizziness, epigastric pain, epileptiform seizures and euphoria which may lead to dependence.
Extrapyramidal effects, gastro-intestinal effects, haemolytic anaemia, headache, low blood pressure, inco-ordination; insomnia, lack of energy, leucopenia, dry mouth, skeletal muscle weakness, nausea, nervousness, sensitization of the skin to light, sedation varing from slight drowsiness to deep sleep, increased rate of heart beat, tinnitus, tremor, vomiting and angioedema.
Precautions:
Should be used with caution or in reduced doses in patients with adrenocortical insufficiency, obstructive bowel disorders and hypothyroidism. Dosage should be reduced in debilitated patients. Should be used with caution in patients with liver impairment, myasthenia gravis, impaired renal function shock, cardiovascular disease, glaucoma and urinary retention.
Prolonged use of high doses of codeine may lead to dependence. The positive result of a skin allergy test may be suppressed.
Interactions:
The anticholinergic effects of agents with anticholinergic properties may be enhanced. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Monoamine oxidase inhibitors may enhance the anticholinergic effects. The warning signs of damage caused by ototoxic agents may be masked. May effect the activity of other medicines by delaying their absorption.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhytmias 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.
Prompt treatment is essential. Any patient who has ingested about 7,5 g 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.
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 1000 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. Symptoms of overdosage of promethazine may be fatal, especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia (loss of muscle co-ordination), excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face, abnormally high body temperature and respiratory collapse. Death may occur from respiratory failure. Drowsiness and low blood pressure may occur. Overdosage symptoms that may arise from codeine are excitement, convulsions and respiratory failure that may result in death.

IDENTIFICATION:
Mauve to maroon-coloured clear syrup with a distinctive flavour of blackcurrant.

PRESENTATION:
Amber plasic bottles containing 100 mL of syrup.

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

REGISTRATION NUMBER:
27/2.8/0229

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

13/4/93	93E0693
	P1338