GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Night Nurse Capsules

Paracetamol 500 mg

Promethazine Hydrochloride 10 mg

Dextromethorphan Hydrobromide 7.5 mg

Each capsule contains:

Paracetamol 500.0 mg

Promethazine Hydrochloride 10.0 mg

Dextromethorphan Hydrobromide 7.5 mg

Excipients:

Lactose 60.04 mg per capsule

For a full list of excipients see section 6.1.

Hard Capsule.

No. 0 hard gelatin capsule with an opaque bright green cap and opaque white body, printed 'night nurse' in black on both halves and containing a white free-flowing powder.

For the night-time relief of the symptoms of colds, chills and influenza, including cough.

For oral administration only.

Adults aged 16 years and over:

Take two capsules just before bedtime.

Not to be given to children under 16 years of age except on medical advice.

Only one dose should be taken per night.

Elderly

The normal adult dose can be taken by the elderly.

Maximum duration of continued use without medical advice: 7 days.

Do not exceed the stated dose.

Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 4000mg (including this product) in any 24 hour period.

Allow at least four hours between taking any paracetamol-containing product and this product.

Should not be used with other cough or cold medicines, or any other antihistamine containing products, including those used on the skin.

If symptoms persist, consult a doctor.

• Known hypersensitivity to the active ingredients or to any of the excipients.

• Use in children under 16 years of age.

• Hepatic or renal impairment.

• Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.

• With, or at risk of developing, respiratory failure (e.g. those with chronic obstructive airways disease or pneumonia, or during an asthma attack or an exacerbation of asthma).

Concomitant use of other paracetamol or decongestant containing medicines or alcohol should be avoided.

Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with severe renal or severe hepatic impairment should seek medical advice before treatment with paracetamol. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Consult your doctor if you are taking warfarin.

In patients with asthma or other respiratory disorders, epilepsy, glaucoma, urinary retention, prostatic hypertrophy or cardiovascular problems the product should only be taken after consulting a doctor.

Night Nurse should only be used under medical supervision for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or where cough is accompanied by excessive secretions.

Medical advice should be sought before taking this product in people taking tricyclic antidepressants; selective serotonin reuptake inhibitors (SSRI); drugs which cause CNS depression, such as antipsychotics, hypnotics and anxiolytics, as concurrent use may cause an increase in sedative effects; or drugs with anticholinergic effects (e.g. atropine and tricyclic antidepressants)

Use with caution in the elderly, who are more likely to experience anticholinergic adverse effects including confusion and paradoxical excitation. Avoid use in elderly patients with confusion.

Children are more likely to experience paradoxical excitation with sedating antihistamines.

Medical advice should be sought if symptoms persist, or are accompanied by high fever, skin rash or persistent headache.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

If symptoms persist, please consult your doctor.

Patients who are taking other medication and/or are under the care of a physician, should consult their doctor before taking the product.

Do not exceed the recommended dose schedule.

Keep out of the reach and sight of children.

Potentially clinically significant drug interactions are listed below. Medical advice should be sought before taking paracetamol-promethazine-dextromethorphan in combination with these drugs:

Promethazine may interfere with immunologic urine pregnancy tests to produce false positive or negative results.

Pregnancy

This product should not be used during pregnancy without medical advice.

Human and animal studies with paracetamol have not identified any risk to pregnancy or embryo-foetal development.

No relevant data are available for products containing dextromethorphan.

Human and animal studies with promethazine are insufficient to establish the safety of this drug during pregnancy. It should only be used when considered essential by a doctor.

Lactation

This product should not be used whilst breast feeding without medical advice.

Human studies with paracetamol have not identified any risk to lactation or the breast-fed offspring. Paracetamol crosses the placental barrier and is excreted in breast milk, but not in a clinically significant amount.

No relevant data are available for dextromethorphan.

Promethazine may be excreted in breast milk. It should only be used when considered essential by a doctor.

May cause drowsiness, dizziness, blurred vision, cognitive and psychomotor impairment which can seriously affect the ability to drive and use machinery. Those affected should not drive or operate machinery.

Adverse events 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 considerer attributable are tabulated below by System Organ Class and frequency. Frequencies are defined as: very common (1/10); common (1/100 to <1/10); uncommon (1/1000 to <1/100); rare (1/10,000 to <1/1000); very rare (<1/10,000); not known (can not be estimated from the available data).

Paracetamol

Promethazine

Adverse events may occasionally occur with promethazine. Clinical data is insufficient to reliably determine event frequencies.

* The elderly are more susceptible to confusion, disorientation and paradoxical excitation

** Children are more susceptible to paradoxical excitation

The elderly are more susceptible to the anticholinergic effects of promethazine.

Dextromethorphan

Adverse events may occasionally occur with dextromethorphan. Clinical data is insufficient to reliably determine event frequencies.

Symptoms and Signs

Paracetamol

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.

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.

Promethazine

In children, promethazine overdose can cause CNS stimulation and antimuscarinic effects. In severe cases in both adults and children, CNS depression with coma and convulsions may occur. Additional symptoms may include delirium, agitation, hallucinations, dystonic reactions, hypotension and ECG changes. Large overdose may cause toxic psychosis, arrhythmias, coma and cardiorespiratory depression.

Dextromethorphan

Symptoms of dextromethorphan overdose would be dizziness, excitation, mental confusion and gastrointestinal disturbances, and at very high doses, respiratory depression. Following large overdoses, additional symptoms may include restlessness, nervousness and irritability, stupor, ataxia, dystonia, hallucinations, psychosis.

Treatment

Paracetamol

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.

Promethazine

Treatment should be supportive and directed towards specific symptoms, with attention to maintenance of adequate respiratory and circulatory status. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

Dextromethorphan

Supportive and symptomatic care should be provided as required. If overdose is severe, naloxone may be helpful, particularly for patients with respiratory depression.

ATC code/ pharmacotherapeutic group: NO2 BE51.

Paracetamol - an analgesic and antipyretic.

Promethazine - an antihistamine with anticholinergic activity.

Dextromethorphan hydrobromide - an antitussive.

Paracetamol: is readily absorbed from the upper gastrointestinal tract. It is metabolised predominantly in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Promethazine hydrochloride: is readily absorbed from the gastrointestinal tract, undergoes first pass metabolism in the liver and is excreted mainly as metabolites in the urine.

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 an urine.

Pre-clinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.

Powder Excipients

Lactose anhydrous

Dimeticone

Colloidal anhydrous silica

Capsule Shell

Patent blue V (E131)

Quinoline yellow (E104)

Titanium dioxide (E171)

Gelatin

Printing Ink

Shellac

Black iron oxide (E172)

Propylene Glycol

Not applicable.

3 years.

Do not store above 25°C. Store in the original package in order to protect from light.

The capsules are packed into opaque blister strips of polyvinylchloride backed with aluminium foil. The complete strip is contained in a boxboard carton containing 10 capsules.

No special requirements.

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 0678/021/001

Date of first authorisation: 08 February 1990

Date of last renewal: 08 February 2010

September 2011