1. Name Of The Medicinal Product
Boots Night Time Cough Syrup 2 Years +
2. Qualitative And Quantitative Composition
|
|
|
|
|
|
3. Pharmaceutical Form
A clear or almost clear, colourless viscous liquid with characteristic odour and taste.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of dry, ticklish and unproductive coughs.
4.2 Posology And Method Of Administration
Children 2 to 5 years: 5ml 3 times daily and at bedtime.
Children 6 to 12 years: 10ml 3 times daily and at bedtime.
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Patients with renal or hepatic failure.
4.4 Special Warnings And Precautions For Use
Cough suppressants may depress respiration and cause sputum retention, which may be harmful in patients with chronic bronchitis and bronchiectasis.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Not recommended for children under 2 years.
May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
Do not give with any other cough or cold products.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May interact with alcohol and other CNS depressants.
4.6 Pregnancy And Lactation
The safety of this product during pregnancy and lactation has not been established. There has been a slight suggestion of an association between inguinal hernia or genitourinary malformations and first trimester exposure to diphenhydramine. Use of pholcodine during pregnancy has not revealed any direct evidence of teratogenicity.
The levels of diphenhydramine in breast milk are considered not to be high enough after therapeutic doses to affect the breast fed infant. There is no information available as to whether pholcodine is excreted in breast milk but it is unlikely to be harmful to the breast fed infant. However, use of the product should be carefully assessed by consideration of the small benefits versus potential risks to the foetus or neonate.
4.7 Effects On Ability To Drive And Use Machines
May cause drowsiness. If affected, do not drive or operate machinery.
4.8 Undesirable Effects
May occasionally cause nausea, vomiting, drowsiness, skin rashes and anticholinergic side effects such as dryness of the mouth, sputum retention and constipation. May also cause elation or depression.
Immune system disorders: hypersensitivity reactions, anaphylaxis.
4.9 Overdose
Symptoms of overdosage may include nausea, vomiting, drowsiness, restlessness, excitement, ataxia, respiratory depression and occasionally convulsions and hyperpyrexia.
In cases of severe overdosage, the stomach should be emptied by aspiration and lavage. The patient should be kept quiet to minimise excitation which occurs particularly in children. The specific narcotic antagonist naloxone may be used to reverse any respiratory depression. Convulsions may be controlled with intravenous diazepam. Otherwise treatment should be symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pholcodine is a cough suppressant with mild sedative but little analgesic action.
Diphenhydramine is an antihistamine with anticholinergic and sedative properties.
5.2 Pharmacokinetic Properties
Pholcodine is readily absorbed from the gastrointestinal tract, maximum plasma concentrations being achieved 4-8 hours after an oral dose. Pholcodine has a high volume of distribution. The elimination half life ranges from 32 to 43 hours. Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide or sulphate. Very little or no metabolically derived morphine is produced from pholcodine.
Diphenhydramine hydrochloride is well absorbed from the gastrointestinal tract, though high first pass metabolism appears to affect systemic availability. Peak plasma concentrations are achieved about 1-4 hours after administration. Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. Diphenhydramine is highly bound to plasma proteins. Metabolism is extensive. Diphenhydramine is excreted mainly in the urine as metabolites, with little being excreted as unchanged drug. Excretion is almost complete within 24 hours of administration.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maltitol liquid
Glycerin
Hydroxyethylcellulose (Natrosol 250 HX)
Citric acid monohydrate
Sodium citrate
Acesulfame K
Alcohol 96%
Salt pure vacuum dried
Apple flavour 11042-33
Redcurrant flavour 500661E
Sorbic acid
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
Do not refrigerate or freeze.
6.5 Nature And Contents Of Container
An amber coloured polyethylene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner packed in a cardboard carton.
Pack sizes: 100ml and 150ml.
6.6 Special Precautions For Disposal And Other Handling
None known.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL00014/0383
9. Date Of First Authorisation/Renewal Of The Authorisation
9 October 1989 / 26 January 2004
10. Date Of Revision Of The Text
March 2008
