Lemsip Cold & Flu Capsules with CaffeineParacetamol 500mg Caffeine 65mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Caffeine

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol; Caffeine

Dosage:

500mg/65 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2003-10-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP COLD & FLU
CAPSULES WITH CAFFEINE
PARACETAMOL 500MG,
CAFFEINE 65MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Always take this medicine exactly as described in this leaflet or as
your doctor,
pharmacist or nurse have 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 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 Capsules with Caffeine is and what it is used
for
2.
What you need to know before you take Lemsip Cold & Flu Capsules with
Caffeine
3.
How to take Lemsip Cold & Flu Capsules with Caffeine
4.
Possible side effects
5.
How to store Lemsip Cold & Flu Capsules with Caffeine
6.
Contents of the pack and other information
1.
WHAT LEMSIP COLD & FLU CAPSULES WITH CAFFEINE ARE AND
WHAT ARE THEY USED FOR?
Each Lemsip Cold & Flu Capsule with Caffeine contains 500mg
paracetamol and 65mg
caffeine. Paracetamol has pain killing (analgesic) and fever reduction
(antipyretic)
properties. Caffeine is a stimulant for relief of fatigue and
drowsiness. Lemsip Cold & Flu
Capsules with Caffeine can be used to relieve the symptoms of common
cold or influenza
such as headache, sore throat, body aches and pains, fatigue and
drowsiness and lowering of
temperature.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP COLD & FLU
CAPSULES WITH CAFFEINE
DO NOT TAKE THIS LEMSIP COLD & FLU CAPSULES WITH CAFFEINE

If you are allergic (hypersensitive) to paracetamol, caffeine or any
of the other
ingredients listed in section 6.

If you are taking any other paracetamol containing products

If you have a history of peptic ulcer

If you are less than 12 years of age
TAKE SPECIAL CAR

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2021
CRN009859
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Cold & Flu Capsules with Caffeine
Paracetamol 500mg
Caffeine 65mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains paracetamol 500 mg and caffeine 65 mg.
Excipients: Contains Tartrazine
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
A red and yellow hard gelatine capsule printed “Lemsip”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the common cold and
influenza, including relief of aches and pains, fever, sore
throat, headache, fatigue and drowsiness and lowering of temperature.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Duration of treatment should be limited to a maximum of 3 days. The
patient should consult a doctor if symptoms persist or
worsen, or if the product is required for more than 3 days.
Posology
Adults, the elderly and children aged 16 years and over: 2 capsules
every 4-6 hours as required. Do not take more than 8
capsules (4 doses) in 24 hours.
The product is particularly appropriate for day-time use.
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
14 December 2021
CRN009859
Page 2 of 6
The elderly
Experience has indicated that normal adult dosage of paracetamol is
usually appropriate. However, in frail, immobile