1. NAME OF THE MEDICINAL PRODUCT
Day Nurse
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
per 30 ml
Paracetamol
1000 mg
Pseudoephedrine Hydrochloride
60 mg
Pholcodine
10 mg
For excipients, see 6.1
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3. PHARMACEUTICAL FORM
Oral Solution
Clear orange liquid
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4. CLINICAL PARTICULARS
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4.1 Therapeutic indications
For the relief of the symptoms of colds and influenza.
For oral administration.
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4.2 Posology and method of administration
Take during the day.
Adults and Children over 12 years
30 ml every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of
three doses within any 24 hour period if a night-time paracetamol-containing product is taken
before bedtime.
Children under 12 years
Not to be given to children under twelve years of age.
Elderly
There is no specific requirement for dosage reduction in the elderly.
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4.3 Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease,
hypertension, hyperexcitability, diabetes, hyperthyroidism, phaeochromocytoma, closed angle
glaucoma, prostatic enlargement and liver failure.
.
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4.4 Special warnings and precautions for use
Should be given with caution to patients with impaired kidney or liver function, and in patients with
chronic bronchitis and bronchiectasis.
Contains paracetamol.
Warning: Do not exceed stated dose.
Asthmatics should consult their doctor before using this product.
Do not use this product for longer than 7 days unless your doctor agrees.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Do not take with any other flu, cold or decongestant products.
Keep all medicines out of the reach and sight of children.
Label
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Leaflet or combined Label/Leaflet
Immediate medical advice should be sought in the event of an overdose, even if you feel well,
because of the risk of delayed, serious liver damage.
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4.5 Interaction with other medicinal products and other forms of interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days
of stopping such treatment. Theoretically may enhance the sedative effect of central nervous
system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and
tranquillisers. May diminish the antihypertensive effects of antihypertensive drugs and increase the
possibility of arrhythmias in digitalised patients.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone
and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other
coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of
bleeding, occasional doses have no significant effect.
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4.6 Pregnancy and lactation
In view of the possible association of foetal abnormalities with first trimester exposure to
pseudoephedrine, the use of the product during pregnancy should be avoided. In view of the
significant amounts of pseudoephedrine secreted into breast milk, use of product during lactation
should be avoided.
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4.7 Effects on ability to drive and use machines
No adverse effects known.
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4.8 Undesirable effects
May cause nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision,
tinnitus, irritability, nightmares, anorexia, difficulty in micturition, tachycardia, tremors, skin rashes,
sputum retention an sweating.
Pholcodine has been associated with immune system disorders: hypersensitivity reactions,
anaphylaxis.
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4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or
more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone,
rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation,
cachexia.
Symptoms:
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. In severe poisoning,
hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema,
and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain,
haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac
arrhythmias and pancreatitis have been reported.
Management:
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of
significant early symptoms, patients should be referred to hospital urgently for immediate medical
attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of
overdose or the risk of organ damage. Management should be in accordance with established
treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1
hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion
(earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24
hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8
hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required
the patient should be given intravenous N-acetylcysteine, in line with the established dosage
schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote
areas, outside hospital. Management of patients who present with serious hepatic dysfunction
beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Pseudoephedrine Hydrochloride
Symptoms:
As with other sympathomimetics pseudoephedrine overdose will result in symptoms due to central
nervous system and cardiovascular stimulation e.g. excitement, irritability, restlessness, tremor,
hallucinations, hypertension, palpitations,arrhythmias and difficulty with micturition. In severe
cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels
may be low due to extracellular to intracellular shifts in potassium.
Management:
Treatment should consist of standard supportive measures. Beta-blockers should reverse the
cardiovascular complications and the hypokalaemia.
Pholcodine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and
psychotropic drugs.
Symptoms:
Central nervous system depression, including respiratory depression, may develop but is unlikely
to be severe unless other sedative agents have been co-ingested, including alcohol, or the
overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common.
Hypotension and tachycardia are possible but unlikely.
Management:
This should include general symptomatic and supportive measures including a clear airway and
monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one
hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist
and has a short half-life, so large and repeated doses may be required in a seriously poisoned
patient. Observe for at least four hours after ingestion, or eight hours if a sustained release
preparation has been taken.
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5. PHARMACOLOGICAL PROPERTIES
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5.1 Pharmacodynamic properties
Paracetamol has analgesic and antipyretic actions. Pseudoephedrine is a sympathomimetic agent
with both direct and indirect effects on adrenergic receptors. Pholcodine is a cough suppressant
with little analgesic activity.
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5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations
occurring about 30 minutes to 2 hours after oral administration. Paracetamol is distributed into
most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is
negligible at usual therapeutic concentrations. Paracetamol is metabolised predominantly in the
liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10%
as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination
half life varies from about 1 to 4 hours.
Pseudoephedrine is absobed from the gastrointestinal tract. It is resistant to metabolism and is
excreted largely unchanged in the urine. It has a half life of several hours but elimination is
enhanced and half life shortened in acid urine. Pholcodine is rapidly absorbed afetr oral
administration and maximum plasma concentrations are attained at about 4-8 hours. The
elimination half life ranges from 32 to 43 hours. The drug has a large volume of distribution and is
only 23.5% protein bound.
Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and
sulphate.
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5.3 Preclinical safety data
Not applicable.
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6. PHARMACEUTICAL PARTICULARS
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6.1 List of excipients
Acesulfame K
Citric Acid Monohydrate
Sodium Benzoate
Sodium Citrate
Levomenthol
Propylene Glycol
Alcohol 96%
Glycerol
Liquid Sugar
Liquid Glucose
Peach Flavour 17.40.3109
Pear Drop Flavour 17.40.3848
Lime Flavour 17.42.5408
Riboflavin-5-Phosphate Sodium (E101)
Purified water
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6.2 Incompatibilities
Not applicable
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6.3 Shelf life
36 months
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6.4 Special precautions for storage
Do not store above 25°C.
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6.5 Nature and contents of container
Bottle of amber polyethylene terephthalate fitted with a child resistant cap closure of polypropylene
with expanded polyethylene liner and measuring cup.
Pack size: 210ml, 240ml, 300ml. Not all pack sizes may be marketed.
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6.6 Special precautions for disposal and other handling
Not applicable.