Night Nurse oral solution

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Navodilo za uporabo Navodilo za uporabo (PIL)
01-06-2020
Lastnosti izdelka Lastnosti izdelka (SPC)
08-07-2020
Javno poročilo o oceni Javno poročilo o oceni (PAR)
20-04-2020

Aktivna sestavina:

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Dostopno od:

DE Pharmaceuticals

Koda artikla:

N02BE51

INN (mednarodno ime):

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Odmerek:

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

Farmacevtska oblika:

Oral solution

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Never Valid To Prescribe As A VMP

Povzetek izdelek:

BNF: 04070100

Navodilo za uporabo

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
NIGHT NURSE HOT LEMON MENTHOL
Powder for Oral Solution
_PARACETAMOL, DEXTROMETHORPHAN, PROMETHAZINE_
_ _
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE. This medicine is
available without prescription, but you still need to use this
medicine 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 does this medicine do
2.
Check before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Further information
1.
WHAT DOES THIS MEDICINE DO
NIGHT NURSE HOT LEMON MENTHOL POWDER FOR ORAL SOLUTION IS USED FOR THE
NIGHT-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. Promethazine
hydrochloride is an antihistamine which dries up a runny nose and aids
restful sleep.
Dextromethorphan hydrobromide is a cough suppressant that helps
relieve dry or tickly coughs. This
medicine also helps to relieve a sore throat.
2.
CHECK BEFORE YOU TAKE THIS MEDICINE CONTAINS PARACETAMOL.
TAKING TOO MUCH PARACETAMOL CAN CAUSE SERIOUS HARM TO YOUR LIVER. DO
NOT TAKE ANYTHING ELSE
CONTAINING PARACETAMOL WITHIN FOUR HOURS OF TAKING THIS PRODUCT. DO
NOT TAKE WITH OTHER
ANTIHISTAMINE-CONTAINING PREPARATIONS, INCLUDING TOPICAL
ANTIHISTAMINES AND COUGH AND COLD
MEDICINES.
<_X SYMBOL_>
DO NOT TAKE THIS MEDICINE:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, promethazine
hydrochloride,
dextromethorphan hydrobromide or to any of the other ingredients
(listed in Section 6).
•
if you have a CHEST INFECTION, WORSENING ASTHMA or SEVERE RESPIRATORY
PROBLEMS.
•
if you are taking or have taken MONOAMINE OXIDASE INHIBITORS (MAOIs)
prescribed for
DEPRESSION in the LAST TWO WEEKS.
<_! SYMBOL> _
TAKE SPECIAL CARE WITH THIS MEDICINE

This medicine can lead to
                                
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Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Night Nurse Hot Lemon Menthol Powder for Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituents
mg/sachet
Paracetamol
1000.0
Promethazine hydrochloride
20.0
Dextromethorphan hydrobromide
Excipients
Aspartame
15.0
mg/sachet
35.0
Sodium (as sodium citrate dihydrate)
117.3
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for 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
Adults and children 16 years and over:
Empty contents of one sachet into a mug. Half fill with very hot
water. Stir
well. Add cold water as necessary.
One sachet to be taken just before going to bed.
Not to be given to children under 16 years except on medical advice.
Maximum daily dose: Only one sachet should be taken per night.
Do not exceed the stated dose
Maximum duration of continued use without medical advice: 3 days.
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.
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
Contains paracetamol. Paracetamol overdose may cause liver failure
which may
require liver transplant or lead to death.
Avoid use of othe
                                
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