1. Name Of The Medicinal Product
Day & Night Nurse Capsules
2. Qualitative And Quantitative Composition
Day Nurse Capsules
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Night Nurse Capsules
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For excipients, see 6.1.
3. Pharmaceutical Form
Capsule, hard
The Day capsule has an orange cap and yellow body printed 'Day Nurse' in black ink on the cap and the body.
The Night capsule has an green cap and white body printed 'Night Nurse' in black ink on the cap and the body.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of colds, chills and influenza during the day.
For the symptomatic relief of colds, chills and influenza at night.
4.2 Posology And Method Of Administration
For oral administration.
Do not exceed the stated dose
Should not be used with other paracetamol-containing products; decongestants antihistamine containing products (including those used on the skin) or cough and cold medicines.
Not to be given to children under 12 years of age
Day Capsules
Adults and children aged 12 years and over
Two capsules every four hours, up to a maximum of three doses in any 24 hour period. Minimum dosing interval: 4 hours
Night Capsules
Adults and children aged 12 years and over
Two capsules just before bedtime. Only one dose should be taken at night. Allow at least 4 hours between taking last dose of Day capsules and the dose of Night capsules.
Elderly
There is no specific requirement for dosage reduction in the elderly. However. the product should not be taken by elderly patients with confusion. The elderly may be more susceptible to adverse effects including confusion and paradoxical excitation with this medicine.
Do not use for longer than 3 days without medical advice.
4.3 Contraindications
Hypersensitivity to any of the ingredients and hyperexcitability.
Not to be used by patients taking monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping the MAOI drug.
Avoid in patients with cardiovascular disease, hypertension, diabetes, epilepsy, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, severe liver or kidney disease and in patients with asthma, chronic bronchitis and bronchiectasis.
4.4 Special Warnings And Precautions For Use
Contains paracetamol.
Do not exceed the stated dose.
The night capsule may cause drowsiness. If affected, do not drive or operate machinery. Alcohol should be avoided.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Keep all medicines safely away from children.
Special label warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Special leaflet warnings
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. May diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients. May enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.
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.
Promethazine may potentiate the action of alcohol and other centrally-acting depressants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines. Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs including tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy tests to produce false results.
4.6 Pregnancy And Lactation
The use of the product during pregnancy or when breast feeding should be avoided.
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. The safety of pseudoephedrine and pholcodine during lactation has not been established and therefore the product should not be used during this period.
4.7 Effects On Ability To Drive And Use Machines
The night capsule may cause drowsiness. If affected do not drive or operate machinery.
4.8 Undesirable Effects
May cause nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, tinnitus, irritability, nightmares, anorexia, difficulty in micturition, tachycardia, tremors and skin rashes. Drowsiness, dizziness, psychomotor impairment, antimuscarinic effects (such as urinary retention, dry mouth, blurred vision), disorientation, restlessness. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Hypersensitivity reactions including rash and photosensitivity reactions have been reported.
Pholcodine has been associated with immune system disorders: hypersensitivity reactions, anaphylaxis.
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 Hydrocholride
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.
Promethazine Hydrochloride
Symptoms:
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children. Coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon.
Management:
Treatment is supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anti-convulsants.
Dextromethorphan/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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol - an analgesic and antipyretic.
Pseudoephedrine - a sympathomimetic agent with both direct and indirect effects on adrenergic receptors.
Pholcodine – an antitussive with little analgesic activity.
Promethazine hydrochloride – an antihistamine with anticholinergic activity.
Dextromethorphan hydrobromide - an antitussive.
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 absorbed 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 after 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.
Promethazine hydrochloride is readily absorbed from the gastrointestinal tract, but undergoes extensive first pass metabolism in the liver, with only 25% of the oral dose reaching the systemic circulation unchanged. After oral therapy therapeutic effects are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours. Estimates of terminal half life in blood plasma are in the range of 4-6 hours. It is extensively plasma protein bound. It is eliminated mainly as metabolites, predominantly by the faecal (via biliary) route, with < 1% of the parent compound and ca. 10% as the sulphoxide metabolite being excreted in the urine over a 72 hour period.
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted as demethylated metabolites including dextrorphan, and as a minor proportion of unchanged dextromethorphan. In a small proportion of individuals, metabolism proceeds more slowly and dextromethorphan predominates in blood and urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Day Nurse Capsules
Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate (E572)
Hard gelatin capsule
Quinoline yellow (E104)
Allura red (E 129)
Titanium dioxide (E171)
Printing Ink: Opacode black
(containing: shellac, iron oxide black (E172), propylene glycol)
Night Nurse Capsules
Lactose monohydrate
Dimeticone
Colloidal anhydrous silica
Gelatin
Patent blue V (E131)
Quinoline yellow (E104)
Titanium dioxide (E171).
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
Blisters: 250 μm PVC/40gsm PVDC blister tray with 30 μm aluminium foil lid. Each tray holds 6 Day Nurse capsules and 2 Night Nurse capsules.
Pack size: 24 capsules (3 trays) comprising 18 Day Nurse capsules and 6 Night Nurse capsules.
6.6 Special Precautions For Disposal And Other Handling
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, U.K.
8. Marketing Authorisation Number(S)
PL 00079/0387
9. Date Of First Authorisation/Renewal Of The Authorisation
18th July 2002
10. Date Of Revision Of The Text
11/11/2010
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