Day Nurse Capsules Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg Pholcodine 5mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Pholcodine

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Pholcodine

Dosage:

500 mg/30 mg/5 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

2003-11-04

Patient Information leaflet

INFORMATION FOR THE USER
DAY NURSE CAPSULES
PARACETAMOL 500MG
PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
PHOLCODINE 5MG
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Day Nurse capsules carefully
to get the best results from them.
•
Keep this leaflet, you may need to read it again.
•
If you have any further questions, ask your pharmacist.
IN THIS LEAFLET:
1.
What Day Nurse capsules are and what they are used for
2.
Check before you take Day Nurse capsules
3.
How to take Day Nurse capsules
4.
Possible side effects
5.
How to store Day Nurse capsules
6.
Further information
1.
WHAT DAY NURSE CAPSULES ARE AND WHAT THEY ARE USED FOR
DAY NURSE CAPSULES ARE USED FOR THE RELIEF OF THE MAJOR SYMPTOMS OF
COLD AND FLU INCLUDING FEVER,
PAINS, COUGHING AND NASAL CONGESTION.
Day Nurse capsules contain three active ingredients. Paracetamol is a
painkiller and reduces your
temperature when you have a fever. Pseudoephedrine Hydrochloride is a
decongestant that unblocks
your nose and sinuses helping you to breathe more easily. Pholcodine
is a cough suppressant that helps
relieve dry or tickly coughs.
2.
CHECK BEFORE YOU TAKE DAY NURSE CAPSULES
[X]
DO NOT TAKE DAY NURSE CAPSULES:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to paracetamol, pseudoephedrine hydrochloride,
pholcodine or any of the other ingredients (listed in Section 6).
•
if you have ever developed a
SEVERE
SKIN RASH
or skin that
PEELS, BLISTERS OR SORES
IN THE
MOUTH
after taking Day Nurse capsules or other pseudoephedrine or
pholcodine-containing
medicinal products.
•
if you have
HIGH BLOOD PRESSURE
or
HEART DISEASE.
•
if you have
SEVERE KIDNEY DISEASE.
•
if you have
DIFFICULTY BREATHING
or
LUNG PROBLEMS.
•
if you are taking
APPETITE SUPPRESSANTS
or
STIMULANT DRUGS
called amphetamines (sometimes
used to treat ADHD).
•
if you have taken
MONOAMINE OXIDASE INHIBITORS
(MAOIs) in the last two weeks.
•
if you are
UNDER 16 YEARS.
•
if you are taking an antib

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2022
CRN00CY3S
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Day Nurse Capsules Paracetamol 500mg Pseudoephedrine Hydrochloride
30mg Pholcodine 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Quantity mg/cap
Paracetamol
500
Pseudoephedrine hydrochloride
30
Pholcodine
5
Also contains Allura Red (E129).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (Capsule)
The capsule has an orange cap and yellow body, printed with an
identifier in black ink. It contains a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the major symptoms of colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only. To be taken during the day.
Adults and children aged 16 years and over: Two capsules every four to
six hours, up to a maximum of 4 doses (8 capsules) in
24 hours if needed. Other products containing paracetamol may be taken
at night, but the total daily dose of paracetamol
must not exceed 4000mg (including this product) in any 24 hour period.
Maximum daily dose: 8 capsules for a total of 4000 mg Paracetamol, 240
mg Pseudoephedrine, 40 mg Pholcodine
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. Maximum duration of continued use without
medical advice: 7 days. Minimum dosing interval: 4 hours.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
Should not be used with other paracetamol containing products,
decongestants or cough and cold medicines. If symptoms
persist consult a doctor.
Hepatic Impairment: Patients who have been diagnosed with hepatic
impairment must seek medical advice before taking this
medication.
Renal Impairment: Pseudoephedrine is primarily excreted renally. This
product should not be used by those with severe renal
impairment