Day Nurse
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Day Nurse
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient per 30 ml
Paracetamol 1000mg
Pseudoephedrine Hydrochloride 60mg
Pholcodine 10mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Oral Solution Clear orange liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of the symptoms of colds and influenza. For oral administration.
4.2 Posology and method of administration
Take during the day.
It is important to shake the bottle for at least 10 seconds before use
Should not used with other paracetamol-containing products, decongestants or cough and cold medicines.
Adults and children 16 years and over 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.
Minimum dosing interval: 4 hours. Do not exceed the stated dose
Children under 16 years
Not to be given to children under sixteen years of age.
Elderly
There is no specific requirement for dosage reduction in the elderly.
4.3 Contraindications
This product is contraindicated in patients with:
• Hypersensitivity to any of the ingredients or excipients.
• Severe hypertension or severe coronary artery disease.,
• Severe renal impairment.
• Hyperexcitability
• With or at risk of developing, respiratory failure (e.g. those with chronic obstructive airways disease or pneumonia) or those with bronchiolitis or bronchiectasis due to sputum retention.
• Who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
• Who are receiving Monoamine Oxidase Inhibitors (MAOIs) or for two weeks after stopping a MAOI drug.
4.4. Special Warnings and Precautions for Use
For oral use only.
Always use the measuring cup supplied with the pack.
Should be given with caution to patients with mild to moderate kidney impairment and in those with impaired liver function. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported included sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or
resolved within a few days following appropriate treatment. Pseudoephedrine should be discontinued immediately and medical advice sought if signs/symptoms of PRES/RCVS develop.
Caution should also be exercised in patients with cardiovascular disease, arrhythmias, hypertension, hyperthyroidism, prostatic enlargement, diabetes, glaucoma, phaeochromocytoma, or in those with chronic or persistent cough, asthma, or where cough is accompanied by excessive secretions.
Pholcodine may enhance the CNS effects of alcohol and other CNS depressants.
Use with caution in patients taking beta blockers and other antihypertensives,
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Glycerol may cause headache, upset stomach and diarrhoea
This product contains 5 vol% ethanol (alcohol), i.e up to 1.2g per 30ml dose, equivalent to 30ml beer, 12.5ml wine per dose (normally calculated assuming 5% vol and 12% vol ethanol for beer and wine respectively). This could be harmful for those suffering from alcoholism. This should also be taken into consideration in pregnant or breastfeeding women and children and high risk groups such as patients with liver disease or epilepsy.
Contains 28.75mg of sodium per 30ml dose. To be taken into consideration by patients on a controlled sodium diet.
Contains paracetamol.
Warning: Do not exceed stated dose.
Asthmatics should consult their doctor before using this product.
As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist 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 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.
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 as this may lead to a hypertensive crisis.
Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Pholcodine may also predispose patients to developing anaphylaxis with neuromuscular blocking agents.
Pseudoephedrine may diminish the antihypertensive effects of antihypertensive drugs and increase the possibility of arrhythmias in digitalised patients.
Concomitant use of this medication with sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.
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.
4.6 Fertility, pregnancy and lactation
Safe use of pseudoephedrine and pholcodine in pregnancy has not been established despite widespread use over many years. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.
In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, this product should not be used in pregnancy without medical advice .
Pseudoephedrine is secreted into breast milk in small amounts but the effect of this on breast fed infants is unknown. This product should not be used whilst breast-feeding without medical advice.
Effects on ability to drive and use machines
4.7
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable effects
The following convention has been utilised or the classification of undesirable effects: very common (>/=1/10), common (>=1/100. <1/10), uncommon (<=1/1000,<1/100), rare (<=1/10000, <1/1000), very rare (1</10000).
Paracetamol
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. The frequency of these adverse is not known (cannot be estimated from available data).
|
Body System |
Undesirable effect |
Frequency |
|
Blood and lymphatic system disorders |
Thrombocytopaenia |
Very rare |
|
Immune System Disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema, and Stevens Johnson syndrome |
Very rare |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm in patients sensitive to aspirin and other NSAIDs |
Very rare |
|
Hepatobiliary disorders |
Hepatic dysfunction |
Very rare |
Pseudoephedrine
The frequency of reactions identified during post-marketing use is not known.
|
Body System |
Undesirable effect |
Frequency |
|
Psychiatric disorders |
Nervousness, insomnia |
Common |
|
Blurred Vision |
Unknown | |
|
Agitation, restlessness |
Uncommon |
|
Hallucinations (particularly in children) |
Rare | |
|
Nightmares |
Unknown | |
|
Nervous System Disorders |
Dizziness |
Common |
|
Headache, tinnitus, irritability, tremor |
Unknown | |
|
Cardiac Disorders |
Tachycardia, palpitations |
Rare |
|
Vascular Disorders |
Increased blood pressure* |
Rare |
|
Gastrointestinal Disorders |
Vomiting, dry mouth, nausea |
Common |
|
Diarrhoea or constipation; epigastric pain, anorexia |
Unknown | |
|
Skin and subcutaneous tissue disorders |
Rash, allergic dermatitis** |
Rare |
|
Sweating |
Unknown | |
|
Renal and Urinary Disorders |
Dysuria, urinary retention*** |
Uncommon |
|
Micturition difficulty |
Unknown |
*Increases in systolic blood pressure have been observed. At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant. **A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine
***Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.
Pholcodine
The frequency of reactions identified during post-marketing use is not known.
|
Body System |
Undesirable effect |
Frequency |
|
Immune System disorders |
Hypersensitivity reactions including skin rashes, angioedema, anaphylaxis |
Rare |
|
Gastrointestinal Disorders |
Nausea vomiting |
Common |
|
Respiratory, thoracic and mediastinal disorders |
Sputum retention |
Unknown |
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 coingested, 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.
5 PHARMACOLOGICAL PROPERTIES
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.
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.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS 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
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25 °C
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.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK
8 MARKETING AUTHORISATION NUMBER
PL 00079/0378
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/2001 / 25/02/2009
10 DATE OF REVISION OF THE TEXT
20/02/2013