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BOOTS NIGHT COLD & FLU RELIEF CAPSULES

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

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Pharmacy Cold & Flu Night Capsules
Boots Night Cold & Flu Relief Capsules

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Paracetamol
Pseudoephedrine hydrochloride
Pholcodine
Diphenhydramine hydrochloride.

3

mg/cap
500
30
5
12.5

PHARMACEUTICAL FORM
Capsule, hard (capsule)
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 before 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 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.
Do not take more medicine than the label tells you to. If you do not get better, talk to
your doctor. Warning: 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 colour 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
Pseudoephedrine 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 ertotism.
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 dosage.
Although there is no evidence to suggest that exposure to diphenydramine during
pregnancy is related to major malformations, there are 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 and a possible association between diphenhydramine
and foetal malformations, the use of this product, 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. 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
The product 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, paraesthesia 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.
Hepatobility 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 cross sensitivity.
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. (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 naloxone.
Pholcodine
It is thought to be of low toxicity, but the effects in overdosage will be potentiated by
simultaneous ingestion of alcohol and psychotripic 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 alpha-adrenoreceptor 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
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
Not applicable.

6.3.

Shelf Life
18 months.

6.4.

Special Precautions for Storage
Do not store above 25°C. Store in the original package.

6

PHARMACEUTICAL PARTICULARS

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.

Instruction for Use/Handling

Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
(Trading as Boots Pharmacy or BCM, Nottingham)
1 Thane Road West
Nottingham NG2 3AA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0581

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/03/2009

10

DATE OF REVISION OF THE TEXT
31/07/2015

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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.

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