Lemsip Decongestant & Flu Capsules with CaffeineParacetamol 500mgPhenylephine Hydrochloride 6.1mgCaffeine 25mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Phenylephrine Hydrochloride; Caffeine anhydrous

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Phenylephrine Hydrochloride; Caffeine anhydrous

Dosage:

500 mg/6.1 mg/25 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

2007-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP DECONGESTANT & FLU
CAPSULES WITH CAFFEINE
Paracetamol 500mg
Phenylephrine Hydrochloride 6.1mg
Caffeine 25mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
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 or pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse after
five days.
WHAT IS IN THIS LEAFLET
1.
What Lemsip Decongestant & Flu Capsules with Caffeine is and what it
is used
for
2.
What you need to know before you take Lemsip Decongestant & Flu
Capsules
with Caffeine
3.
How to take Lemsip Decongestant & Flu Capsules with Caffeine
4.
Possible side effects
5.
How to store Lemsip Decongestant & Flu Capsules with Caffeine
6.
Contents of the pack and other information
1. WHAT LEMSIP DECONGESTANT & FLU CAPSULES WITH CAFFEINE IS AND WHAT
IT IS
USED FOR
Paracetamol has pain killing (analgesic) and fever reducing
(antipyretic) properties.
Caffeine is a stimulant to relieve fatigues and phenylephrine
hydrochloride is a
decongestant to relieve blocked or runny nose.
Lemsip Decongestant & Flu capsule with caffeine can be used to relieve
symptoms of
sinusitis, common cold and influenza, such as headaches, body aches &
pains, nasal
& sinus congestion and lowers temperatures in adults & children (over
12 years).
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP DECONGESTANT & FLU
CAPSULES
WITH CAFFEINE
DO NOT TAKE LEMSIP DECONGESTANT & FLU CAPSULE WITH CAFFEINE:
-
WITH ANY OTHER PARACETAMOL PRODUCTS
-
if you allergic to paracetamol, phenylephrine hydrochloride, caffeine
or any of

Summary of Product characteristics

Health Products Regulatory Authority
07 September 2021
CRN00CDNT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Decongestant & Flu Capsules with Caffeine
Paracetamol 500mg
Phenylephrine Hydrochloride 6.1mg
Caffeine 25mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/CAPSULE
Paracetamol
500
Caffeine anhydrous
25
Phenylephrine hydrochloride
6.1
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Red/blue hard gelatin capsules with 'Lemsip' written axially down the
capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the pain and congestion of
sinusitis, including relief of aches and pains, headache,
nasal congestion and lowering of temperature.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lemsip Decongestant & Flu Capsules with caffeine is contraindicated in
children under the age of 12 years (see section 4.3).
The patient should consult a doctor, if symptoms worsen or persist for
up to 3 days. Paracetamol-containing products 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: Two
capsules every 4 hours to a maximum of four doses in any 24
hours.
Do not exceed eight capsules in any 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 P