GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Day Nurse Capsules

Paracetamol 500mg

Pseudoephedrine Hydrochloride 30mg

Pholcodine 5mg

Also contains Allura Red (E129)

For a full list of excipients see section 6.1.

Capsule, hard (Capsule)

The capsule has an orange cap and yellow body, printed with an identifier in black ink. It contains a white powder.

For the relief of the major symptoms of colds and influenza.

Take during the day.

Adults and children over 12 years: Two capsules every four hours, up to a maximum of 4 doses in 24 hours if needed.

Children under 12 years: Not to be given to children under 12 years of age.

Elderly: There is no specific requirement for dosage reduction in the elderly.

Do not use for longer than 7 days unless your doctor agrees.

For oral administration.

Hypersensitivity to any of the ingredients and hyperexcitability. Avoid in patients with cardiovascular disease, hypertension, diabetes, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, severe kidney disease or liver failure and in patients with chronic bronchitis and bronchiectasis.

Do not give to children under 12 years of age.

Should be given with caution to patients with impaired kidney or liver function.

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 irreversible, serious liver damage.

Contains paracetamol.

Warning: Do not exceed the stated dose.

Asthmatics should consult their doctor before using this product.

If symptoms persist, consult your doctor.

Do not take with any other paracetamol-containing medicines.

Keep all medicines out of the reach of children.

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 tranquilisers.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

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 the ingredients of this medicine during lactation has not been established and therefore the product should not be used during this period.

No adverse effects known.

May cause nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, irritability, anxiety, restlessness, insomnia, nightmares, anorexia, difficulty in micturition, tachycardia, tremors and skin rashes. Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Hallucinations have been reported rarely in association with pseudoephedrine, particularly in children.

Immediate medical attention (in-hospital, if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12 g paracetamol (24 standard 500 mg tablets) or more than 150 mg paracetamol per kg bodyweight (9 g paracetamol in a 60 kg individual), whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose.

Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.

Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

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.

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.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Capsule contents

Sodium lauryl sulphate

Sodium starch glycollate

Magnesium stearate

Hard gelatin capsule

(containing: Gelatin, Quinoline yellow (E104), Allura red (E129), Titanium dioxide (E171).)

Black print ink

(containing: Shellac, Iron oxide black (E172), propylene glycol.)

Not applicable.

3 years

Do not store above 25°C. Store in the original package.

PVC/PVdC blister tray with aluminium foil lid.

Pack sizes: 8, 10, 12, 16, 20 or 24 tablets.

Not all pack sizes may be marketed

Not applicable.

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/100/1

Date of first authorisation: 04 November 2003

Date of last authorisation: 04 November 2008

August 2011