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BOOTS NIGHT COLD & FLU RELIEF is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the symptomatic night time relief of colds, chills and influenza consisting of headache, shivers, sore throat pain, tickly cough, runny nose, aches and pains.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration For oral use. To be taken at bedtime.
Shake the bottle before use Maximum daily dose:
Only one dose should be taken per night. Do not exceed the stated dose 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 aged 16 years and over:
One measured 20 ml dose to be taken just before going to bed.
Children aged 12 to 15 years:
A 10 ml to 15 ml dose to be taken just before going to bed. Not to be given to children under 12 years.
Elderly:
The normal adult dose can be used. 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 to <1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to < 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 is not known. Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition disorders High anion gap metabolic acidosis with frequency “Not known”# *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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 are not known. 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 ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.
g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin 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.
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. There have been no specific studies of this product in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.
Underlying liver disease increases the risk of paracetamol-related liver damage. This product should not be taken with any other cough and cold medicine. Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
This product should be used with caution in atopic children due to histamine release. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose. Always use the measuring cup supplied with the pack. Patients should be advised not to take other paracetamol-containing products or decongestant-containing medicines concurrently. If symptoms persist consult your doctor.
Keep all medicines out of sight and reach of children.
1 Hepatic or renal impairment. 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.
Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure. 5). Not to be used in children under the age of 12 years.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acetaminophen in United Kingdom.
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4) Nervous System Disorders Not known Not known Not known Not known Convulsion Dizziness Psychomotor hyperactivity Somnolence Respiratory, thoracic and mediastinal Disorders Not known Respiratory depression Gastrointestinal Disorders Not known Not known Not known Not known Not known Abdominal pain Diarrhoea Gastrointestinal disturbance Nausea Vomiting 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 Nervous system disorders Very common: Drowsiness Common: Psychomotor 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 confusion, disorientation and paradoxical excitation **Children are more susceptible to paradoxical excitation 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.
Warning:
May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink. 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.
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. 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.
’ Serotonin Syndrome 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 this medicine should be discontinued. 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.
Special label warnings Do not take with any other paracetamol-containing 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.
Excipients:
Ethanol, Propylene glycol, Sodium and Maltitol. 08 v/v %. 1 mg/100 ml. 0 mg/100 ml. For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be […]