PEDPAIN Syrup

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

PEDPAIN Syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PEDPAIN Syrup

COMPOSITION:
Each 5 mL of the syrup contains:

Paracetamol	120,0 mg
Codeine Phosphate	5,0 mg
Promethazine Hydrochloride	6,5 mg

Preservatives:

Sodium benzoate	0,1% (m/v)
Potassium sorbate	0,24% (m/v)

PHARMACOLOGICAL CLASSIFICATION:
2.9 Special Analgesic Combinations.

PHARMACOLOGICAL ACTION:
Pedpain has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
Pedpain is indicated for the relief of pain or pain associated with fever in children.

CONTRA-INDICATIONS:
Contra-indicated in patients hypersensitive to any of its ingredients.

WARNINGS:

1.	Pedpain syrup may cause sedation. Patients should therefore not operate machinery, drive cars, climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents. Other central nervous system depressants, such as narcotic analgesics, hypnotics sedatives and tranquillizers, if taken concomitantly, will enhance sedation.
2.	Do not use continuously for more than 10 days without consulting your doctor.
3.	Dosages in excess of those recommended may cause severe liver damage.
4.	Patients suffering from liver and kidney disease should take paracetamol under medical supervision. Paracetamol should also be given with care to patients taking other drugs that affect the liver.

DOSAGE AND DIRECTIONS FOR USE:
Three times daily or as prescribed.

6 months to 1 year:	2,5 mL
1 year to 5 years:	5,0 mL
5 years and older:	10,0 mL

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.

Codeine Phosphate:
Excitement and convulsions may occur after ingestion of large doses.
Nausea, vomiting, constipation, drowsiness and confusion may occur. Micturition may be difficult and there may be ureteric or biliary spasm. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, hallucinations and miosis is possible with high doses.
Due to its histamine releasing effect, reversible skin rashes and urticaria may develop.
Large doses produce respiratory depression and hypotension with circulatory failure and deepening coma.

Promethazine Hydrochloride:
Care should be observed when tricyclic anti-depressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly, as the antimuscarinic effect may be enhanced. Tachycardia, bradycardia and transient minor increases in bloodpressure may occur. Jaundice, blood dyscrasias and extrapyramidal effects is possible with high doses.
Sedation, inability to concentrate, with lassitude, dizziness and inco-ordination are common and may diminish after a few days of treatment.
Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors and rarely nightmares, hallucinations and convulsions. Dry mouth, tightness of the chest, blurred vision, urinary difficulty and retention and a reduction in tone and motility of the gastro-intestinal tract with constipation is possible. Apart from the constipation, gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or epigastric pain may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects"
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 nonspecific 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 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.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
A red, clear syrup with a sweet, raspberry odour and taste.

PRESENTATION:
Available in amber glass bottles of 100 mL or 2,5 litres.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
Q/2.9/245,

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd.
P.O. Box 7026, Bonaero Park, 1622.

PUBLICATION DATE:

7.04.94.	Britepak
	03/94