1. Name Of The Medicinal Product
Night Nurse Capsules
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsule
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of colds, chills and influenza at night.
4.2 Posology And Method Of Administration
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
Adults and children aged 12 years and over:
Take two capsules just before bedtime.
Not to be given to children under 12 years except on medical advice.
Elderly:
The normal adult dose can be used.
Only one dose should be taken per night.
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.
Maximum duration of continued use without medical advice: 3 days.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents. Hepatic or renal impairment.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. 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 reach of children.
May cause drowsiness. If affected, do not drive or operate machinery. Alcohol should be avoided.
In patients with asthma or other respiratory disorders, epilepsy, glaucoma, urinary retention, prostatic hypertrophy, hepatic impairment or cardiovascular problems, the product should only be taken after consulting a doctor.
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Promethazine may potentiate the action of alcohol and other centrally-acting depressants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines. Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs including tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy tests to produce false results.
Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.
4.6 Pregnancy And Lactation
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
There are also no known contraindications to the use of promethazine and dextromethorphan during pregnancy and lactation. However, as with all medicines, the advice of a doctor should be sought before use of the product in pregnancy and lactation, and it should only be used when considered essential by the doctor.
4.7 Effects On Ability To Drive And Use Machines
This product may cause drowsiness. If affected do not drive or operate machinery.
4.8 Undesirable Effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Drowsiness, psychomotor impairment, antimuscarinic effects (such as urinary retention, dry mouth, blurred vision), disorientation, restlessness and gastrointestinal disturbances may occasionally occur with promethazine. Hypersensitivity reactions including rash, and photosensitivity reactions have been reported.
Adverse effects with dextromethorphan are rare, but gastrointestinal disturbances and dizziness have been reported occasionally.
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
or
b) Regularly consumes ethanol in excess of recommended amounts.
or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Promethazine Hydrochloride
Symptoms
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children. Coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon.
Management
Treatment is supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anti-convulsants.
Dextromethorphan
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol - an analgesic and antipyretic.
Promethazine hydrochloride – an antihistamine with anticholinergic activity.
Dextromethorphan hydrobromide - an antitussive.
5.2 Pharmacokinetic Properties
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, but undergoes extensive first pass metabolism in the liver, with only 25% of the oral dose reaching the systemic circulation unchanged. After oral therapy therapeutic effects are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours. Estimates of terminal half life in blood plasma are in the range of 4-6 hours. It is extensively plasma protein bound. It is eliminated mainly as metabolites, predominantly by the faecal (via biliary) route, with < 1% of the parent compound and ca. 10% as the sulphoxide metabolite being excreted in the urine over a 72 hour period.
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 and urine.
5.3 Preclinical Safety Data
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.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose, dimeticone, colloidal anhydrous silica, gelatin, patent blue V (E131), quinoline yellow (E104) and titanium dioxide (E171).
6.2 Incompatibilities
None known
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
The capsules are contained in a strip consisting of opaque blisters of PVC 250µm / aluminium foil 30µm. The strips are packed in boxboard cartons. Packs contain 10 or 20 capsules (1 or 2 blister strips), or 2 capsules (trial size pack).
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administration Details
7. Marketing Authorisation Holder
Beecham Group plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, U.K.
8. Marketing Authorisation Number(S)
PL 00079/0220
9. Date Of First Authorisation/Renewal Of The Authorisation
11 February 1985 / 04 March 2009
10. Date Of Revision Of The Text
11/11/2011
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