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

Logo COLCAPS* CHILDREN'S SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

COLCAPS* CHILDREN'S SYRUP

COMPOSITION:
Each 5 mL contains:

Paracetamol         120 mg
Codeine Phosphate         5 mg
Promethazine HCl         6,5 mg
Pseudoephedrine HCl         25 mg
Alcohol 10% v/v        
Preservatives:        
Methyl Hydroxybenzoate 0,06% m/v
Propyl Hydroxybenzoate 0,03% m/v
TARTRAZINE FREE.

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
COLCAPS * CHILDREN'S SYRUP
has analgesic, antipyretic, antihistaminic and antitussive properties.

INDICATIONS:
The symptomatic relief of colds and flu associated with cough.

CONTRA-INDICATIONS:
Hypersensitivity to any of the stated ingredients.
Severe liver function impairment.
Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of its termination.
Safety in pregnancy and lactation has not been established.
Do not use in children under six months old.

WARNINGS:
Do not use continuously for more than ten days without consulting your doctor.
Patients suffering from liver or kidney disease should take paracetamol containing preparations under medical supervision.
Dosage in excess of those recommended may cause severe liver damage.
Should be used with caution in patients with hyperthyroidism; cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms; diabetes mellitus; closed-angle glaucoma and prostatic enlargement.
This medicine 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 about taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Do not use this product without consulting a doctor or pharmacist if you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension.

DOSAGE AND DIRECTIONS FOR USE:
6 months - 1 year: Half a medicine measureful (2,5 mL) three times a day.
1 year - 5 years: One medicine measureful (5,0 mL) three times a day.
5 years - 12 years: One to two medicine measurefuls (5,0 mL - 10,0 mL) three times a day.
Do not exceed the stated dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Side effects of paracetamol are usually mild though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported. Pancreatitis, skin rashes and other allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.
Codeine Phosphate:
May cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of moods and miosis. Micturition may be difficult and there may be ureteric or billiary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Give 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.
Promethazine HCl:
The most common side-effects are: sedation, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands may occur.
In infants and children it may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
Promethazine HCl has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy.
Drug Interactions:
The effects of atropine and tricyclic antidepressants may be enhanced by promethazine HCl.
Warning symptoms of damage caused by ototoxic drugs may be masked and the metabolism of drugs in the liver may be affected. The sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers may be enhanced.
Pseudoephedrine HCl:
Central nervous system:
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur.
Cardiovascular system:
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of B1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness, fainting and flushing may occur. Anginal pain may be precipitated in patients with anginal pectoris.
Other Effects:
May include difficulty in micturition and urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogentated anaesthetics as they may induce ventricular fibrillation. An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Drug Interactions:
Reversal of the action of antihypertensive agents may occur and therefore special care is advisable in patients receiving antihypertensive therapy. Interaction with alpha- and beta- blocking drugs may be complex. Interactions possible with guanethidine, reserpine, tricyclic antidepressants, digoxin and alpha-methyldopa. Aluminium hydroxide mixture may increase the absorption rate of pseudoephedrine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.
Paracetamol:
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 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 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 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.

Codeine phosphate:
Following large doses of codeine, excitement and convulsions may occur. Treatment is symptomatic and supportive.

Promethazine HCl:
Overdosage may be fatal especially in infants and children. It is associated with antimuscarinic, extrapyramidal, gastro-intestinal and CNS effects. In infants and children CNS stimulation predominates over CNS depression, causing ataxia, excitement, tremors, psychoses, hallucinations, and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults, CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse. Treatment is symptomatic and supportive.

Pseudoephedrine HCl:
Overdosage with the pseudoephedrine component will result in the excessive stimulation of the central nervous system causing an increase in the severity of the CNS side effects mentioned.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear orange syrup, orange flavour.

PRESENTATION:
Bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store in safe place, below 25°C. Protect from light. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
D/5.8/54

NAME AND ADDRESS OF THE APPLICANT:
Adcock Ingram Ltd
17 Harrison Avenue, Bryanston Ext 77
Private Bag X69, Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 January 1995

* Registered Trade Mark

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

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