1. Name Of The Medicinal Product
Boots Pharmacy Cold & Flu Night Capsules
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsule, hard
The capsule has a blue cap and purple body printed axially in white ink 'BOOTS' on the cap and '0581' on the body.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of the major night time symptoms of colds and influenza thus aiding restful sleep.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 12 years: Two capsules to be taken at bedtime only.
Children under 12 years: Not to be given to children under 12 years of age.
Elderly: There is no specific requirement for dosage reduction in the elderly.
Do not use for longer than 7 days unless your doctor agrees.
4.3 Contraindications
Hypersensitivity to any of the ingredients and hyperexcitability. Avoid in patients with cardiovascular disease, hypertension, diabetes, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, severe liver or kidney disease and in patients with chronic bronchitis and bronchiectasis.
4.4 Special Warnings And Precautions For Use
Label:
Immediate advice should be sought in the event of an overdose, even if you feel well.
Leaflet or combined label/leaflet:
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.
Contains paracetamol.
Warning: Do not exceed the stated dose.
Warning: May cause drowsiness. If affected do not drive or operate machinery.
Avoid alcoholic drink.
Asthmatic should consult their doctor before using this product.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Keep all medicines out of the reach of children.
Information related specifically to the excipients in the formulation (see 6.1).
The colour Ponceau 4R (E124) may cause allergic reactions.
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 cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. The effects of anticholinergic drugs such as atropine and tricyclic antidepressants may also be enhanced. May diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients.
4.6 Pregnancy And Lactation
Pregnancy
This product should not be used in pregnancy.
Although there is no evidence to suggest that exposure to diphenhydramine during pregnancy is related to major malformations, there are slight suggestions of an association between diphenhydramine use and inguinal hernia or genitourinary malformations. Accordingly diphenhydramine is considered to be contraindicated during pregnancy.
In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, its use during pregnancy should be avoided.
The safety of pholcodine during pregnancy has not been established, but there is no direct evidence of teratogenicity.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosages.
Lactation
The use of this medicine during lactation is not recommended.
Diphenhydramine is excreted into human breast milk but levels have not been reported. Although the levels are not thought to be high, the drug is considered to be contraindicated during lactation.
Paracetamol is excreted in breast milk but not in a clinically significant amount and amounts of pseudoephedrine secreted into breast milk are considered to be too small to be harmful.
There is no information available as to whether pholcodine is excreted in breast milk, but it is unlikely to be harmful to the infant.
4.7 Effects On Ability To Drive And Use Machines
The product may cause drowsiness and patients should be warned not to drive or operate machinery.
4.8 Undesirable Effects
Hallucinations have been reported rarely, in association with pseudoephedrine, particularly in children.
May occasionally cause drowsiness, lassitude, dizziness and muscular weakness. Other side effects include nausea, vomiting, diarrhoea or constipation, epigastric pain, headache, blurred vision, tinnitus, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tachycardia, tremors and skin rashes. Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Immune system disorders: hypersensitivity reactions, anaphylaxis.
4.9 Overdose
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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Other symptoms of overdosage may include drowsiness, headache, tachycardia, arrhythmias, urinary retention, hallucinations, stupor, coma, hyperreflexia, tremor, excitement and hypertension, dry mouth, disorientation, staggering gait, nystagmus hyperthermia, convulsions and respiratory depression.
Immediate treatment is essential in the management of overdosage. Patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested the equivalent of 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after overdosage, may be required. In addition symptomatic and supportive therapy may be necessary including the administration of a beta-blocker if supraventricular tachycardia supervenes and the administration of the specific narcotic antagonist naloxone.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol has analgesic and antipyretic actions. Pseudoephedrine is a sympathomimetic agent with both direct and indirect effects on adrenergic receptors. Pholcodine is a cough suppressant with little analgesic activity.
Diphenhydramine is an antihistamine with anticholinergic properties.
5.2 Pharmacokinetic Properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours.
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism and is excreted largely unchanged in the urine. It has a half life of several hours but elimination is enhanced and half life shortened in acid urine.
Pholcodine is rapidly absorbed after oral administration and maximum plasma concentrations are attained at about 4-8 hours. The elimination half life ranges from 32 to 43 hours. The drug has a large volume of distribution and is only 23.5% protein bound. Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and sulphate.
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 to 4 hours after administration by mouth. Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. Diphenhydramine is highly protein bound. Metabolism is extensive and diphenhydramine is excreted mainly in the urine as metabolites, 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
Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate
Hard gelatin capsule (size 0)
(containing; Brilliant blue E133, Black iron oxide E172, Titanium dioxide E171, Ponceau 4R E124)
Printing Ink:
(containing; Titanium dioxide (E171), Shellac, Propylene glycol)
6.2 Incompatibilities
None stated
6.3 Shelf Life
18 months
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.
Pack sizes: 8/ 10/ 12/ 16/ 20/ 24
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Trading as: BCM
Trading as: Boots Pharmacy
8. Marketing Authorisation Number(S)
PL 00014/0581
9. Date Of First Authorisation/Renewal Of The Authorisation
First authorisation: 12 January 2000
10. Date Of Revision Of The Text
June 2010
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