Day Nurse Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PHOLCODINE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

N02BE51

INN (International Name):

PHOLCODINE 10/30 mg/ml PARACETAMOL 1000 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60/30 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

PHOLCODINE 10/30 mg/ml PARACETAMOL 1000 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60/30 mg/ml

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-05-29

Patient Information leaflet

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 carefully to get the best results from it.
•
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 does
2. Check before you take Day Nurse
3. How to take Day Nurse
4. Possible side effects
5. How to store Day Nurse
6. Further information
1. What Day Nurse does
DAY NURSE IS USED FOR THE DAY-TIME RELIEF OF THE MAJOR SYMPTOMS OF
COLDS, CHILLS
AND FLU. The medicine contains three active ingredients. Paracetamol
is a painkiller and reduces your temperature when you have a fever.
Pseudoephedrine hydrochloride is a decongestant which unblocks your
nose and
sinuses helping you breathe more easily. Pholcodine is a cough
suppressant that
helps relieve dry or tickly coughs. Day Nurse also helps relieve a
sore throat.
2. Check before you take Day Nurse
DO NOT TAKE DAY NURSE:
•
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 high BLOOD PRESSURE or HEART DISEASE
•
if you have KIDNEY DISEASE or HYPEREXCITABILITY
•
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) prescribed for
DEPRESSION in the LAST TWO WEEKS.
DO NOT TAKE WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS.
DO NOT TAKE WITH ANY OTHER FLU, COLD OR DECONGESTANT PRODUCT.
TAKE SPECIAL CARE WITH DAY NURSE:
•
Do not drive if the medicine makes you dizzy
•
Avoid drinking alcohol whilst taking this medicine
•
Day Nurse contains 5% v/v ethanol (ALCOHOL). i.e. up to 1.2g per dose,
equivalent to 30 ml beer, 12.5 ml wine. This could be harmful if you
suffer
from ALCOHOLISM. This should also be considered if you are PREGNANT or

Summary of Product characteristics

P
age 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Day Nurse
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Paracetamol
Pseudoephedrine Hydrochloride
Pholcodine
per 30 ml
1000 mg
60 mg
10 mg
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Oral Solution
Clear orange liquid
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.
It is important to SHAKE THE BOTTLE for at least 10 seconds before use
Should not used with other paracetamol-containing products,
decongestants or
cough and cold medicines.
Adults and children 16 years and over
30 ml 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.
P
age 2 of 10
Elderly
There is no specific requirement for dosage reduction in the elderly.
4.3.
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.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For oral use only.
Always use the measuring cup supplied with the pack.
Should be given with caution to patients with mild to moderate kidney
impairment and in