Skip to Content

BOOTS 24 HOUR COLD & FLU RELIEF CAPSULES

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / PHOLCODINE / PSEUDOEPHEDRINE HYDROCHLORIDE / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / PHOLCODINE / PSEUDOEPHEDRINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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

Paracetamol

500

Pseudoephedrine hydrochloride

30

Pholcodine

5

Nirolex Night Cold and Flu Capsules

3

Active ingredient

mg/cap

Paracetamol

500

Pseudoephedrine hydrochloride

30

Pholcodine

5

Diphenhydramine hydrochloride

12.5

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.

4.

CLINICAL PARTICULARS

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 16 years: Two capsules every four hours, up to a maximum of three
doses within any 24 hours period.
Children under 16 years: Not to be given to children under 16 years of age. Do not use for
longer than 7 days unless your doctor agrees.
Night Capsules
Adults and children over 16 years: Two capsules to be taken at bedtime only.
Children under 16 years: Not to be given to children under 16 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
Care is advised in the administration of paracetamol to patients with severe renal or hepatic
impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic

liver disease.
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.
Do not take more medicine than the label tells you to. If you do not get better, talk to your
doctor.
Warning: The Night Capsules may cause drowsiness. If affected do not drive or 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
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 odema 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 overdosage. 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 the 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) but results should not delay initiation of treatment beyond 8
hours after ingestion, as 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 of hospital.
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
Pseudoephedrine
Symptoms: symptoms of overdosage include abdominal discomfort, excitation, confusion,
hallucinations, ataxia, irritability, restlessness, palpitations, hypertension, difficulty in
micturition and thirst.
Management: In severe overdosage gastric lavage and aspiration should be performed.
Symptomatic and supportive measures should be undertaken, particularly with regard to the
cardiovascular and respiratory systems. Chlorpromazine may be used to control marked
excitement and hallucinations. Severe hypertension may need to be treated with an alphaadrenoreceptor blocking drug such as phentolamine. A beta-blocker may be required to
control cardiac 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.
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
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.

7.

MARKETING AUTHORISATION HOLDER
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
28/04/2017

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide