NIGHT NURSE

Route of Administration Oral To be taken at bedtime Maximum daily dose:

Only one dose should be taken per night. 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.

Adults and children 16 years and over:

One 20 ml measured dose (or four 5 ml spoonfuls). Take just before going to bed. Maximum duration of continued use without medical advice: 3 days. Not to be given to children under 16 years except on medical advice.

Elderly:

The normal adult dose can be used.

The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, < 1/100), rare (≥1/10,000, < 1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

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 events is not known. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. **There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Dextromethorphan The following adverse events have been observed in published clinical studies and are likely to represent uncommon adverse reactions to dextromethorphan. Body system Undesirable effect Nervous system disorders Drowsiness, dizziness Gastrointestinal disorders Gastrointestinal disturbance, nausea, vomiting, abdominal discomfort Adverse reaction identified during post-marketing use with dextromethorphan are listed below.

The frequency of these reactions is unknown but likely to be very rare. g. 4) General disorders and administration site conditions Drug withdrawal syndrome Promethazine Adverse reactions which been observed in published clinical studies with promethazine and which are considered to be common or very common are listed below by MedDRA system Organ Class.

The frequency of other reactions identified during post-marketing use is not known, but these reactions are likely to be uncommon or rare. g. increased energy, irritability, restlessness, nervousness, sleep disturbance), hallucinations, aggression *The elderly are more susceptible to confusion, disorientation and paradoxical excitation **Children are more susceptible to paradoxical excitation Nervous system disorders Very common: Drowsiness Common: Psychomoto impairment, disturbance in attention, dizziness, headache.

Contains paracetamol. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines.

Medical advice must be sought before taking this product in people with: • Severe renal or hepatic impairment. Underlying liver disease increases the risk of paracetamol-related liver damage. The hazards of overdose are greater in those with non-cirrhotic liver disease.

• Chronic or persistant cough, such as occurs with asthma and emphysema, chronic bronchitis or where cough is accompanied by excessive secretions. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

g. atropine) 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 antihistamine.

Medical advice should be sought if symptoms persist, or are accompanied by high fever, skin rash or persistent headache. Patients with rare glucose-galactose malabsorption should not take this medicine. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose. Patients should be advised not to take other paracetamol-containing products or decongestant-containing medicines concurrently. If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Hypersensitivity to paracetamol, dextromethorphan, promethazine or any of the other constituents. g. those with chronic obstructive airways disease or pneumonia, or during an asthma attack or an exacerbation of asthma). Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks.