Night Nurse Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE 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):

PARACETAMOL 1000 µg/dose DEXTROMETHORPHAN HYDROBROMIDE 15 µg/dose PROMETHAZINE HYDROCHLORIDE 20 µg/dose

Pharmaceutical form:

ORAL SOLUTION

Composition:

PARACETAMOL 1000 µg/dose DEXTROMETHORPHAN HYDROBROMIDE 15 µg/dose PROMETHAZINE HYDROCHLORIDE 20 µg/dose

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2006-01-10

Patient Information leaflet

Page 1 of 1

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE
MEDICINAL
PRODUCT
Night Nurse
2
QUALITATIVE
AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG/20 ML
Paracetamol
Ph Eur
1000.0
Promethazine hydrochloride
Ph Eur
20.0
Dextromethorphan hydrobromide
Ph Eur
15.0
3
PHARMACEUTICAL
FORM
Oral solution
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of colds, chills and influenza at night.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration
Oral
To be taken at bedtime
Maximum daily dose: Only one dose should be taken per night.
Do not exceed the stated dose
Other products containing paracetamol may be taken during the day but
the
total daily dose of paracetamol must not exceed 4000mg (including this
product) in any 24 hour period. Allow at least four hours between
taking any
paracetamol-containing product and this product.
Should not be used with other cough or cold medicines, or any other
antihistamine-containing products, including those used on the skin.
Page 2 of 13
Adults and children 12 years and over:
One 20 ml measured dose (or four 5 ml spoonfuls). Take just before
going to
bed.
Maximum duration of continued use without medical advice: 3 days.
Not to be given to children under 12 years except on medical advice.
Elderly:
The normal adult dose can be used.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, dextromethorphan, promethazine or any
of
the other constituents.
With, or at risk of developing, respiratory failure (e.g. those with
chronic
obstructive airways disease or pneumonia, or during an asthma attack
or an
exacerbation of asthma).
Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in
the
last two weeks.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical advice must be sought before taking this product in people
with:

Hepatic or renal impairment. Underlying liver disease increases the
risk of paracetamol-related liver damage.

Chronic or persistant cough, such as occurs with asthma and
emphysema, or where cough is accom