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NIGHT NURSE is a brand name for Dextromethorphan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the symptomatic relief of colds, chills and influenza at night.
Verbatim from this product's MHRA label. Tap a section to expand.
RouteofAdministration Oral Do not exceed the stated dose To be taken at bedtime Maximum daily dose: Only one dose should be taken per night.
Adults and children aged 16 years and over:
Take two capsules just before bedtime. Not to be given to children under 16 years except on medical advice.
Elderly:
The normal adult dose can be used. Only one dose should be taken per night. Do not take if you have already taken 4 doses of a paracetamol-containing product during the day. Other products containing paracetamol may be taken during the day but for adults 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. Maximum duration of continued use without medical advice: 3 days.
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. Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Metabolism and nutrition disorders High anion gap metabolic acidosis * Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients).
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. 4) General disorders and administration site conditions Drug withdrawal syndrome 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. rash, urticaria, angiodema) Nervous system disorders Serotonin syndrome (with changes in mental status, restlessness, myoclonus, hyperreflexia, diaphoresis, shivering, tremor and hypertension) has been reported when dextromethorphan has been taken concurrently with MAOIs or serotonergic drugs such as SSRIs 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.
Contains paracetamol. Do not use with any other paracetamol- containing products. The concomitant use with other products containing paracetamol may lead to an overdose. 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 hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 reach and sight 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dextromethorphan in United Kingdom.
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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.
Not known:
Neuroleptic malignant syndrome, psychomotor hyperactivity Eye disorders Common: Blurred vision Cardiac disorders Not known : QT prolongation, Torsade de pointes Gastrointestinal disorders Common: Dry mouth Not Known: Gastrointestinal disturbance Renal and urinary disorders Not known: Urinary retention The elderly are more susceptible to anticholinergic effects of promethazine.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
Avoid alcoholic drink. Cases of dextromethorphan abuse and dependence have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Drug withdrawal syndrome The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.
Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Night Nurse should be discontinued. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6.
The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan.
5). Promethazine may interfere with immunologic urine pregnancy tests to produce false positive or negative results. Special label warnings Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well. 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.
QT interval As phenothiazines can prolong the QT interval, caution is advised in treated patients with pronounced bradycardia, cardiovascular disease, with a hereditary form of prolongation of the QT interval and concomitant use with other products leading to QT prolongation.