Boots Pharmacy Cold & Flu 24 Hour Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmacy Cold & Flu 24 Hour Capsules Boots 24 Hour Cold & Flu Relief Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nirolex Day Cold and Flu Capsules
Active ingredient mg/cap
Pseudoephedrine hydrochloride 30
Nirolex Night Cold and Flu Capsules
Active ingredient mg/cap
Pseudoephedrine hydrochloride 30
Diphenhydramine hydrochloride 12.5
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
The Day capsule has an orange cap and yellow body printed axially in black with ‘BOOTS’ on the cap and ‘0580’ on the body.
The Night capsule has a blue cap and purple body printed axially in white with 'BOOTS' on the cap and '0581' on the body.
CLINICAL PARTICULARS
4.
4.1. Therapeutic indications
For the relief of the major daytime symptoms of colds and influenza.
For the relief of the major night-time symptoms of colds and influenza, thus aiding restful sleep.
For oral administration.
4.2. Posology and method of administration
Day Capsules
For oral administration
Adults and children over 12 years: Two capsules every four hours, up to a maximum of three doses within any 24 hours period.
Children under 12 years: Not to be given to children under 12 years of age.
Do not use for longer than 7 days unless your doctor agrees.
Night Capsules
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.
For oral administration.
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 hyperexcitability, prostatic enlargement or liver failure.
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).
Patients taking beta-blockers - (see section 4.5).
Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.
Diphenhydramine should not be given to patients with asthma, narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction or bladder neck obstruction and porphyria.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
Paracetamol
Label:
Talk to a doctor at once if you take too much of this medicine, even if you feel well. Leaflet or combined label/leaflet:
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
Contains paracetamol.
. If you do not get better, talk to . If affected do not drive or
Do not take more medicine than the label tells you to your doctor.
Warning: The Night Capsules may cause drowsiness operate machinery.
Avoid alcoholic drink.
Asthmatics should consult their doctor before using this product.
If symptoms persist, consult your doctor.
Do not take anything else containing paracetamol while taking this medicine.
Do not take with other flu, cold or decongestant products.
Keep all medicines out of the sight and reach of children.
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 on 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.
Diphenhydramine
Caution is required if administered to patients with hepatic disease, glaucoma and urinary retention, myasthenia gravis or seizure disorders. Tolerance may develop with continuous use.
Side effects are more likely to occur in the elderly.
Information related specifically to the excipients in the formulation (see 6.1).
The colours Allura Red (E129) and Ponceau 4R (E124) may cause allergic reactions.
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
Pseuodephedrine may diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients
MAOIs and/or reversible inhibitors of monoamine oxidase A (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 on anticholinergic drugs (such as tricyclic antidepressants).
Paracetamol
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.
Diphenhydramine
Diphenhydramine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquillizers and tricyclic antidepressants) resulting in increased antimuscarinic and sedative effects. Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of Diphenhydramine.
4.6. Fertility, pregnancy and lactation
Pregnancy
This product should not be used in pregnancy.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosages.
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.
The safety of pholcodine during pregnancy has not been established, but there is no direct evidence of teratogenicity.
In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, its use during pregnancy should be avoided.
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. The safety of the combined ingredients in this product during lactation has not been established.
4.7 Effects on ability to drive and use machines
Patients should be warned not to drive or operate machinery if affected by dizziness.
The Night Capsules may cause drowsiness and patients should be warned not to drive or operate machinery.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called a ‘statutory defence’) if:
-The medicine has been prescribed to treat a medical or dental problem and -You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and -It was not affecting your ability to drive safely
4.8 Undesirable effects Diphenhydramine
The following side effects may be associated with the use of diphenhydramine:
Cardiovascular disorders: hypotension, palpitations, arrhythmias Eye disorders: blurred vision.
Gastrointestinal disorders: dryness of the mouth, gastrointestinal disturbances, nausea.
Immune system disorders: hypersensitivity reactions (including bronchospasm, angioedema and anaphylaxis).
Blood and lymphatic system disorders: thrombocytopaenia, blood disorders. Metabolism and nutrition disorders: liver dysfunction Nervous system disorders: drowsiness, dizziness, grogginess, tremors, headache, psychomotor impairment, antimuscarinic effects, extrapyramidal effects, tremors, convulsions, sweating, myalgia, paresthesia and hair loss Psychiatric disorders: nervousness, confusion, depression, sleep disturbances Skin and subcutaneous tissue disorders: rash, photosensitivity reactions, hair loss
Paracetamol
Immune system disorders: adverse effects of paracetamol are rare but anaphylaxis and cutaneous 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.
Respiratory, thoracic and mediastinal disorders: bronchospasm has been reported, this is more likely in asthmatics with aspirin or NSAID sensitivity Hepatobiliary disorders: hepatic dysfunction
Skin and subcutaneous tissue disorders: Very rare cases of serious skin reactions have been reported.
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 dizziness, excitation, confusion. Respiratory, thoracic and mediastinal disorders: sputum retention.
Skin and subcutaneous tissue disorders: skin reactions including rash.
Pseudoephedrine
Cardiovascular disorders: tachycardia, palpitations, dry mouth Gastrointestinal disorders: nausea and/or vomiting, diarrhoea or constipation, epigastric pain
Immune system disorders: hypersensitivity reactions including crosssensitivity
Metabolism and nutrition disorders: anorexia.
Nervous system disorders: dizziness, headache, tinnitus, tremor, anxiety, excitability, irritability, hallucinations, lassitude.
Psychiatric disorders: nightmares, nervousness, insomnia, blurred vision, agitation, restlessness, hallucinations (particularly in children), paranoid delusions, sleep disturbances.
Renal and urinary disorders: dysuria, difficulty in micturition including urinary retention.
Skin and subcutaneous tissue disorders: skin reactions including rash, sweating, allergic dermatitis.
Vascular disorders: hypertension.
Can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. Allura Red (E129) and Ponceau 4R (E124) may cause allergic type reactions.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Paracetamol
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 nalaxone.
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, restlessness, excitement, ataxia and respiratory depression.
Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In addition symptomatic and supportive therapy may be necessary, including the administration of the specific narcotic antagonist naloxone.
Other symptoms of overdosage may include headache, tachycardia, arrhythmias, urinary retention, hallucinations, coma, hyperreflexia, tremor and hypertension. Symptomatic and supportive therapy may be necessary, including the administration of a beta-blocker if supraventricular tachycardia supervenes.
Diphenhydramine
Symptoms: include CNS depression and CNS stimulation.
Management: Should be supportive, and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam
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.
Pharmacokinetic Properties
5.2.
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
Day Capsules
Sodium lauryl sulphate Magnesium stearate Sodium starch glycolate Hard gelatin capsule (size 0)
(containing; Quinoline yellow E104, Allura red E129, Titanium dioxide E171) Printing Ink:
(containing; Black iron oxide E172, Shellac, Propylene glycol)
Night Capsules
Sodium lauryl sulphate Magnesium stearate Sodium starch glycollate 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-resisrant push through pack of opaque 250 micron PVC/40gsm blisters heat sealed to 35 gsm Glassine paper/9 micron soft temper aluminium foil.
Pack size: 24 capsules comprising 18 Day Capsules and 6 Night Capsules.
6.6 Instructions for use/handling
Not applicable.
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom
Trading as: Boots Pharmacy
8. MARKETING AUTHORISATION NUMBER
PL 00014/0582
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
10 DATE OF REVISION OF THE TEXT
31/07/2015