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

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FEVAPAR SYRUP

COMPOSITION:
Each 5 mL of syrup contains:

	Paracetamol	120 mg
	Codeine phosphate	5 mg
	Promethazine hydrochloride	6,5 mg

Preservatives:

	Methylparaben	0,10% m/v
	Propylparaben	0,0 1% m/v
	Alcohol content	12,5% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Special analgesic combinations.

PHARMACOLOGICAL ACTION:
FEVAPAR 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 infants or neonates.

WARNINGS:

1.	If the patient does not respond, a doctor should be consulted.
2.	Do not take continuously for more than 10 days without consulting a doctor.
3.	This medicine may cause drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.
	Patients should be warned against performing potentially hazardous activities 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 receiving monoamine-oxidase inhibitors.
6.	Dosages of paracetamol in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:

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

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.
Side-effects from codeine that may occur are respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo (dizziness), flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm and an antidiuretic effect.
Should be used with caution or in reduced doses in patients with adrenocortical insufficiency, and hypothyroidism. Should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, impaired renal function or shock.
Dosage should be reduced in debilitated patients. Promethazine and codeine should be used with caution in patients with liver impairment. Prolonged use of high doses of codeine may lead to dependence.
The following side-effects with promethazine have been reported: dizziness, lassitude, hypotension, muscular weakness and inco-ordination, nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. It may also produce headache, hallucinations, blurred vision, tinnitus, elation or depression, irritability, anorexia, difficulty in mictruition, dryness of the mouth, tightness of the chest and weakness of the hands. Large doses may precipitate fits in epileptics.
Blood dyscrasias, including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenic purpura have been reported. Idiosyncracy and angioedema have been reported.
Other side-effects are polyuria, tiredness and weakness, lowering of temperature (occasionally pyrexia), increase in heart rate, restlessness, insomnia, photosensitivity and skin rash. Extrapyramidal dysfunction. Deposition of pigment in the eyes, corneal and lens opacities.
Jaundice of the obstructive type and a lupus erythematous-like syndrome have been reported.
Promethazine should be used with caution in patients with cardiovascular disease, glaucoma, liver impairment and urinary retention. The positive results of skin allergy tests 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 affect the activity of the 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 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 2 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 non-specific 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 about 7,5 g of paracetamol in the preceding 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 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.

Promethazine:
Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia, respiratory collapse. Death may occur from respiratory failure. Drowsiness and hypotension may occur. Treatment is symptomatic and supportive.
Codeine:
Symptoms of overdosage that may arise include excitement, convulsions and respiratory failure.
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 naloxone may be used to counteract severe respiratory depression.

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

PRESENTATION:
Amber plastic bottles containing 100 mL or 500 mL of syrup

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

REGISTRATION NUMBER:
28/2.8/0385

NAME AND BUSINESS ADDRESS OF APPLICANT:
Xeragen Laboratories (Pty) Ltd.
8-11 Glen Park Industrial
Highdale Road
GLEN ANIL
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 2002

PFE0121/6-02

New addition to this site: March 2004
Source: Pharmaceutical Industry
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