Lemsip Cold & Flu Hot Lemon 500 mg Powder for Oral Solution

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Paracetamol

Tillgänglig från:

Reckitt Benckiser Ireland Ltd

ATC-kod:

N02BE; N02BE01

INN (International namn):

Paracetamol

Dos:

500 milligram(s)

Läkemedelsform:

Powder for oral solution

Receptbelagda typ:

Product not subject to medical prescription

Terapiområde:

Anilides; paracetamol

Bemyndigande status:

Marketed

Tillstånd datum:

1978-04-01

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP COLD & FLU
Hot Lemon 500mg
Powder for Oral solution
Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Lemsip Cold
& Flu Hot Lemon carefully to get the best results from it.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse 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, pharmacist or nurse.
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 3 days.
WHAT IS IN THIS LEAFLET:
1.
What Lemsip Cold & Flu Hot Lemon is and what it is used for
2.
What you need to know before you take Lemsip Cold & Flu Hot Lemon
3.
How to take Lemsip Cold & Flu Hot Lemon
4.
Possible side effects
5.
How to store Lemsip Cold & Flu Hot Lemon
6.
Contents of the pack and other information
1.
WHAT LEMSIP COLD & FLU HOT LEMON IS AND WHAT IT IS USED FOR
Each sachet of Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral
Solution contains
500mg paracetamol. Paracetamol has pain killing (analgesic) and fever
reduction
(antipyretic) properties. Lemsip Cold & Flu Hot Lemon can be used to
relieve the symptoms
of common cold or influenza such as headache, sore throat, fever, body
aches and pains.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP COLD & FLU HOT LEMON
DO NOT TAKE LEMSIP COLD & FLU HOT LEMON

If you are allergic (hypersensitive) to paracetamol or any of the
other ingredients
listed in section 6

If you are taking any other paracetamol containing products

If you are less than 12 years of age
TAKE SPECIAL CARE WITH LEMSIP COLD & FLU HOT LEMON

If you have been told by your doctor that you have an intolerance to
some sugars,

Produktens egenskaper

Health Products Regulatory Authority
12 January 2024
CRN00F208
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Cold & Flu Hot Lemon 500 mg Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
ACTIVE INGREDIENTS
​
MG/SACHET
​
Paracetamol
​
500.0
Excipients with known effects:
Aspartame - 22.5 mg/sachet
Sodium - 93.77 mg (4 mmol)/sachet
Sucrose - 3.04 g/sachet
Lactose* - 9.72 mg per sachet
* Present in curcumin powder
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Pale cream coloured homogenous powder with an odour and taste of
lemon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms associated with the common cold or
influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
POSOLOGY
Adults, the elderly and adolescents aged 16 years and over: 1 sachet
every 4 hours as required. Do not take more than 6
sachets in 24 hours.
In all patients over 16 years of age, the maximum daily dose of
paracetamol should not exceed 60 mg/kg/day (up to a
maximum of 2 g per day) in the following situations, unless directed
by a physician: (see section 4.4)

Weight less than 50kg

Dehydration

Malnutrition

Chronic alcoholism
Renal impairment
Paracetamol should be used with caution in patients with renal
impairment as a reduced dose and/or prolonged dosing
interval may be necessary (see section 4.4).
Hepatic impairment
Paracetamol should be used with caution in patients with hepatic
impairment as a reduced dose or prolonged dosing interval
may be necessary (see section 4.4).
Health Products Regulatory Authority
12 January 2024
CRN00F208
Page 2 of 6
The elderly
Experience has indicated that normal adult dosage of paracetamol is
usually appropriate. However, in frail, immobile elderly
subjects or in elderly patients with renal or hepatic impairment, a
reduc