Numark Night Cold and Flu oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Available from:

Numark Ltd

INN (International Name):

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Dosage:

50mg/1ml ; 1mg/1ml ; 750microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Patient Information leaflet

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
This medicine is available without prescription, however, you still
need to take Numark Night Cold and Flu Oral Solution carefully to get
the best results from it.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after a few days.
What is in this leaflet:
1. What Numark Night Cold and Flu Oral Solution is and what it is used
for
2. What you need to know before you take Numark Night Cold and Flu
Oral Solution
3. How to take Numark Night Cold and Flu Oral Solution
4. Possible side effects
5. How to store Numark Night Cold and Flu Oral Solution
6. Contents of the pack and other information
1. What Numark Night Cold and Flu Oral Solution is and what it is used
for
Numark Night Cold and Flu Oral Solution provides night time relief
from cold and flu symptoms consisting of headache, shivers, sore
throat pain, runny nose,
tickly cough, aches and pains. It contains paracetamol to reduce
fever, promethazine to dry up a runny nose, aids restful sleep and
dextromethorphan which
relieves a dry irritating tickly cough.
2. What you need to know before you take Numark Night Cold and Flu
Oral Solution
Do not take Numark Night Cold and Flu Oral Solution
• if you are allergic (hypersensitive) to paracetamol, promethazine
hydrochloride, dextromethorphan hydrobromide or any of the other
ingredients of Numark
Night Cold and Flu Oral Solution (_Section 6 below_).
• if you suffer from lung disease.
• if you are taking, or have taken in the last two weeks, drugs for
depression known as Monoamine Oxidase Inhibitors (MAOI

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fedril Night Cold and Flu, Oral Solution
Lloyds Pharmacy Night Cold and Flu Relief, Oral Solution
Numark Night Cold and Flu, Oral Solution
Boots Night Cold & Flu Relief Oral Solution
Well Pharmaceuticals Night Cold & Flu Oral Solution
Care Night Cold & Flu Relief Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
mg/20 ml
Paracetamol
1000.0
Promethazine Hydrochloride
20.0
Dextromethorphan Hydrobromide
15.0
Excipients with known effect:
Each 20 ml of oral solution contains: 2916 mg of ethanol (18.08% v/v),
5180 mg of
propylene glycol, 12.9 g of liquid maltitol and 23.52 mg of sodium
(see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution
Clear green, mint flavoured, sugar free oral solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic night time relief of colds, chills and influenza
consisting of
headache, shivers, sore throat pain, tickly cough, runny nose, aches
and pains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
For oral use. To be taken at bedtime. Shake the bottle before use
Maximum daily dose: Only one dose should be taken per night.
Do not exceed the stated dose
Should
not
be
used
with
other
cough
or
cold
medicines,
or
any
other
antihistamine-containing products, including those used on the skin.
_Adults and children aged 16 years and over: _
One measured 20 ml dose to be taken just before going to bed.
_Children aged 12 to 15 years: _
A 10 ml to 15 ml dose to be taken just before going to bed.
Not to be given to children under 12 years.
_Elderly: _
The normal adult dose can be used.
Maximum duration of continued use without medical advice: 3 days.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, dextromethorphan, promethazine or any
of the other
excipients listed in Section 6.1
Hepatic or renal impairment.
With, or at risk of developing, respiratory failure (e.g. those with
chronic obstructive
airways disease