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DAY NURSE CAPSULES

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Day Nurse Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Paracetamol
Pseudoephedrine Hydrochloride
Pholcodine

mg/cap
500
30
5

For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Capsule, hard
The Capsule has an orange cap and yellow body printed axially in black ink ‘Day
Nurse’ on the cap and the body.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of the symptoms of colds and influenza.
For oral administration.

4.2.

Posology and Method of Administration
Take during the day.
Should not used with other paracetamol-containing products,
decongestants or cough and cold medicines
Adults and Children over 16 years
Two capsules 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-time
paracetamol-containing product is taken before bedtime. Minimum dosing interval:
4 hours. Do not exceed the stated dose.

Children under 16 years
Not to be given to children under sixteen years of age.
Elderly: There is no specific requirement for dosage reduction in the
elderly.

4.3

4.4

Contraindications
This product is contraindicated in patients with:


Hypersensitivity to any of the ingredients or excipients.



Severe hypertension or severe coronary artery disease.,



Severe renal impairment.



Hyperexcitability



With or at risk of developing, respiratory failure (e.g. those with chronic
obstructive airways disease or pneumonia) or those with bronchiolitis or
bronchiectasis due to sputum retention.



Who are receiving other sympathomimetics (such as decongestants, appetite
suppressants and amphetamine-like psychostimulants).



Who are receiving Monoamine Oxidase Inhibitors (MAOIs) or for two weeks
after stopping a MAOI drug.

Special warnings and precautions for use
Should be given with caution to patients with mild to moderate kidney
impairment and in those with impaired liver function. The hazard of overdose
is greater in those with non-cirrhotic alcoholic liver disease.
There have been rare cases of posterior reversible encephalopathy
(PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with
sympathomimetic drugs, including pseudoephedrine. Symptoms reported
included sudden onset of severe headache, nausea, vomiting, and visual
disturbances. Most cases improved or resolved within a few days following
appropriate treatment. Pseudoephedrine should be discontinued immediately
and medical advice sought if signs/symptoms of PRES/RCVS develop.
Caution should also be exercised in patients with cardiovascular disease,
arrhythmias, hypertension, hyperthyroidism, prostatic enlargement, diabetes,

glaucoma, phaeochromocytoma, or in those with chronic or persistent cough,
asthma, or where cough is accompanied by excessive secretions.
Pholcodine may enhance the CNS effects of alcohol and other CNS
depressants.
Use with caution in patients taking beta-blockers and other antihypertensives
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this
product
Contains paracetamol.
Warning: Do not exceed the stated dose.
Asthmatics should consult their doctor before using this product.
Do not use for longer than 7 days unless your doctor agrees.
If symptoms persist, consult your doctor.
Do not take with any other paracetamol-containing products.
Do not take with any other flu, cold or decongestant products.
Keep out of reach and sight of children.
Label
Immediate medical advice should be sought in the case 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.

4.5

Interaction with other medicinal products and other forms of interaction
Should not be given to patients being treated with monoamine oxidase
inhibitors or within 14 days of stopping such treatment as this may lead to a
hypertensive crisis.
Pseuodephedrine may diminish the antihypertensive effects of hypotensive
drugs and increase the possibility of arrhythmias in digitalised patients.
Pholcodinemay enhance the sedative effect of central nervous system
depressants including alcohol, barbiturates, hypnotics, narcotic analgesics,
sedatives and tranquillisers. Pholcodine may also predispose patients to
developing anaphylaxis with neuromuscular blocking agents.
Concomitant use of this medication with sympathomimetic agents (such as
decongestants, appetite suppressants and amphetamine-like psychostimulants)

which interfere with the catabolism of sympathomimietic amines, may
occasionally cause a rise in blood pressure.

The speed of absorption of paracetamol may be increased by metoclopramide
or domperidone and absorption reduced by colestryramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular daily use of paracetamol with increased risk of bleeding,
occasional doses have no significant effect.

4.6

Fertility, Pregnancy and lactation
Safe use of pseudoephedrine and pholcodine in pregnancy has not been
established despite widespread use over many years. Caution should therefore
be exercised by balancing the potential benefit of treatment to the mother
against any possible hazards to the developing foetus.
In view of the possible association of foetal abnormalities with first trimester
exposure to pseudoephedrine this product should not be used in pregnancy
without medical advice.
Pseudoephedrine is excreted in breast milk in small amounts but the effect of
this on breast fed infants is unknown. The safety of the ingredients during
lactation has not been established and therefore the product should not be used
whilst breastfeeding without medical advice.

4.7

Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by
dizziness.

4.8

Undesirable effects
The following convention has been utilised or the classification of undesirable
effects: very common (>/=1/10), common (>=1/100. <1/10), uncommon
(<=1/1000,<1/100), rare (<=1/10000, <1/1000), very rare (1
Paracetamol
Adverse events of paracetamol from historical clinical trial data are both
infrequent and from small patient exposure. Accordingly, events reported from
extensive post-marketing experience at therapeutic/labelled dose and
considered attributable are tabulated below by system class. The frequency of
these adverse is not known (cannot be estimated from available data).

Body System
Blood and lymphatic
system disorders
Immune System
Disorders

Respiratory, thoracic
and mediastinal
disorders
Hepatobiliary disorders

Undesirable effect
Thrombocytopaenia

Frequency
Very rare

Very rare
Anaphylaxis
Cutaneous
hypersensitivity reactions
including skin rashes,
angiodema, and Stevens
Johnson syndrome
Bronchospasm in patients Very rare
sensitive to aspirin and
other NSAIDs
Hepatic dysfunction
Very rare

Pseudoephedrine
The frequency of reactions identified during post-marketing use is not known.

Body System
Psychiatric disorders

Nervous System
Disorders

Cardiac Disorders
Vascular Disorders
Gastrointestinal
Disorders

Skin and subcutaneous
tissue disorders
Renal and Urinary
Disorders

Undesirable effect
Nervousness, insomnia
Blurred Vision
Agitation, restlessness
Hallucinations
(particularly in children)
Nightmares
Dizziness

Frequency
Common
Unknown
Uncommon
Rare

Headache, tinnitus,
irritability, tremor
Tachycardia,
palpitations
Increased blood
pressure*
Vomiting, dry mouth,
nausea
Diarrhoea or
constipation; epigastric
pain, anorexia
Rash, allergic
dermatitis**
Sweating
Dysuria, urinary
retention***
Micturition difficulty

Unknown

Unknown
Common

Rare
Rare
Common
Unknown

Rare
Unknown
Uncommon
Unknown

*Increases in systolic blood pressure have been observed. At therapeutic doses,
the effects of pseudoephedrine on blood pressure are not clinically significant.
**A variety of allergic skin reactions, with or without systemic features such as
bronchospasm and angioedema have been reported following use of
pseudoephedrine
***Urinary retention is most likely to occur in those with bladder outlet
obstruction, such as prostatic hypertrophy.

Pholcodine
The frequency of reactions identified during post-marketing use is not known.

Body System
Immune System
disorders

Gastrointestinal
Disorders
Respiratory, thoracic
and mediastinal
disorders

4.9

Undesirable effect
Hypersensitivity
reactions including skin
rashes, angioedema,
anaphylaxis
Nausea vomiting

Frequency
Rare

Sputum retention

Unknown

Common

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 oedema, 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 overdose. 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 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). Treatment with Nacetylcysteine may be used up to 24 hours after ingestion of paracetamol, however,
the maximum protective effect is obtained up to 8 hours post-ingestion. 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 hospital. Management of patients who present with serious
hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or
a liver unit.
Pseudoephedrine Hydrochloride
Symptoms:
As with other sympathomimetics pseudoephedrine overdose will result in symptoms
due to central nervous system and cardiovascular stimulation e.g. excitement,
irritability, restlessness, tremor, hallucinations, hypertension, palpitations,arrhythmias
and difficulty with micturition. In severe cases, psychosis, convulsions, coma and
hypertensive crisis may occur. Serum potassium levels may be low due to
extracellular to intracellular shifts in potassium.
Management:
Treatment should consist of standard supportive measures. Beta-blockers should
reverse the cardiovascular complications and the hypokalaemia.
Pholcodine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol
and psychotropic drugs.
Symptoms:
Central nervous system depression, including respiratory depression, may develop but
is unlikely to be severe unless other sedative agents have been co-ingested, including
alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and
vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management:
This should include general symptomatic and supportive measures including a clear
airway and monitoring of vital signs until stable. Consider activated charcoal if an
adult presents within one hour of ingestion of more than 350 mg or a child more than
5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive
antagonist and has a short half-life, so large and repeated doses may be required in a
seriously poisoned patient. Observe for at least four hours after ingestion, or eight
hours if a sustained release preparation has been taken.

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
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 E572
Hard gelatin capsule
(containing: Quinoline yellow E104, Allura red E 129, Titanium dioxide
E171)
Printing Ink: Opacode black

(containing: shellac, isopropyl alcohol, iron oxide black (E172), propylene
glycol (E1520), ammonium hydroxide (E527) and n-butyl alcohol).

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 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
250μm PVC/60gsm PVDC blister tray with 30μm aluminium foil lid in a cardboard
carton containing 8, 10, 12, 16, 20, 24 or 32 tablets. Not all pack sizes may be
marketed.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 44673/0069

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/09/2001 / 25/02/2009

10

DATE OF REVISION OF THE TEXT
05/06/2017

Expand Transcript

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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