1. Name Of The Medicinal Product
Boots Day Cold & Flu Relief Oral Solution
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Oral solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Combination product for the relief of the symptoms of colds and influenza. Decongestant for the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold. Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infection. Analgesic for the relief of aches, pains and fever associated with colds and influenza.
For oral administration.
4.2 Posology And Method Of Administration
Take during the day.
Adults and children over 12 years: 30ml every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night liquid is taken before bedtime.
Elderly: There is no specific requirement for dosage reduction in the elderly.
Children 6 to 12 years: 15ml every four hours, up to a maximum of 3 doses in 24 hours, if needed.
This medicine is contraindicated in children under 6 years of age (see section 4.3).
Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Warning: Do not exceed the stated dose.
Keep all medicines out of the sight and reach of children.
4.3 Contraindications
Hypersensitivity to the active substances or any of the excipients.
Severe renal impairment.
Cardiovascular disease including hypertension and peripheral vascular disease.
Diabetes mellitus.
Phaeochromocytoma.
Hyperthyroidism.
Closed angle glaucoma.
Avoid in patients with prostatic enlargement or liver failure.
Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Concomitant use of other sympathomimetic decongestants.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).
Beta-blockers – (see section 4.5).
Not to be used in children under the age of 6 years.
4.4 Special Warnings And Precautions For Use
Pholcodine
Should be used with caution by patients with liver or renal disease.
Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma or are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.
Do not take with any other cough and cold medicine.
Use of pholcodine with alcohol or other CNS depressants may increase the effects of the CNS and cause toxicity in relatively smaller doses.
Pseudoephedrine
If any of the following occur, this medicine should be stopped
Hallucinations
Restlessness
Sleep disturbances
Caution in moderate to severe renal impairment.
Paracetamol
Should be given with caution to patients with impaired renal or hepatic function. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Contains paracetamol.
Warning: Do not exceed the stated dose.
Do not use this product for longer than 5 days unless your doctor agrees.
If symptoms persist consult your doctor.
Do not take with any other paracetamol-containing products.
Label:
Immediate medical 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.
May be harmful to people on a low sodium diet. (Sodium)
Warning: this product contains 4.8% by volume of ethanol.
Each 30ml dose contains up to 1.16g of alcohol.
Harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. May modify or increase the effect of other medicines. (Alcohol)
This medicinal product contains 42.75g of sucrose.
When taken according to the dosage recommendations each 30ml dose supplies up to 5.34g of sucrose.
Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. (Sucrose)
This medicinal product contains 14.37g of glucose.
When taken according to the dosage recommendations each dose supplies up to 1.8g of glucose. (Glucose)
Harmful in high doses. Can cause headache, upset stomach and diarrhoea. (Glycerin)
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Pholcodine
Not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect.
Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
Pseudoephedrine
MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.
Moclobemide: risk of hypertensive crisis.
Antihypertensives: (including adrenergic neurone blockers, diuretics & beta-blockers): this medicine may block the hypotensive effects.
Cardiac glycosides: increased risk of dysrhythmias.
Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.
Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.
Oxytocin: risk of hypertension.
Enhances effects of anticholinergic drugs (such as TCAs).
Paracetamol
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The antigoagulant 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.
4.6 Pregnancy And Lactation
In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided.
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.
Although the safety of this product during lactation has not been established, data on the individual ingredients suggests that the product may be used during this period.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
Amounts of pseudoephedrine secreted into breast milk are considered 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
No adverse effects known.
4.8 Undesirable Effects
Paracetamol
Immune system disorders: Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.
Blood and lymphatic system disorders: Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Pholcodine
The following side effects may be associated with the use of pholcodine:
Gastrointestinal disorders: Gastrointestinal disturbances (nausea and constipation), vomiting, diarrhoea, upset stomach, epigastric pain.
Immune system disorders: Hypersensitivity reactions and anaphylaxis.
Nervous system disorders: Occasional drowsiness, dizziness, excitation, confusion.
Respiratory, thorasic and mediastinal disorders: Sputum retention.
Skin and subcutaneous tissue disorders: Skin reactions including rash.
Pseudoephedrine
Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Blurred vision.
Gastrointestinal disorders: nausea and/or vomiting, anorexia.
General disorders and administration site conditions: Irritability.
Immune system disorders: Hypersensitivity reactions including cross-sensitivity that may occur with other sympathomimetics.
Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.
Psychiatric disorders: Sleep disturbance, nightmares.
Renal and urinary disorders: Difficulty in micturition including urinary retention.
Skin and subcutaneous tissue disorders: Skin reactions including rash, sweating.
Vascular disorders: Hypertension.
Harmful in high doses. Can cause headache, stomach upset and diarrhoea. (Glycerin)
4.9 Overdose
Immediate treatment is essential in the management of paracetamol overdosage.
Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested the equivalent of 7.5g 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 overdose, may be required. In addition symptomatic and general supportive therapy must be available, including the administration of a beta-blocker if supraventricular tachycardia supervenes and the administration of the specific narcotic antagonist naloxone.
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.
Pholcodine
It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.
Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In cases of severe poisoning the specific narcotic antagonist nalaxone may be used.
Information for children:
Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.
Other symptoms of overdosage may include headache, tachycardia, urinary retention, hallucinations, coma, hyperreflexia, tremor, hypertension and arrhythmias.
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.
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.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Acesulfame K
Citric Acid Monohydrate
Sodium Benzoate
Sodium Citrate
Levomenthol
Propylene Glycol
Alcohol 96%
Glycerol
Liquid Sugar
Liquid Glucose
Peach Flavour
Pear drop Flavour
Lime Flavour
Riboflavin-5-Phosphate Sodium (E101)
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Bottle of amber polyethylene terephthalate fitted with a child resistant closure of polypropylene with expanded polyethylene liner.
Pack size: 210ml, 240ml, 300ml.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
Nottingham NG2 3AA
Trading as BCM
Trading as Boots Pharmacy
8. Marketing Authorisation Number(S)
PL 00014/0565
9. Date Of First Authorisation/Renewal Of The Authorisation
17 September 1997
10. Date Of Revision Of The Text
December 2010
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