Lemsip Max Sinus & Flu Hot Lemon Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

0 percent volume/volume

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

1996-05-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP MAX SINUS & FLU
HOT LEMON
POWDER FOR ORAL SOLUTION
Paracetamol 1000mg
Pseudoephedrine Hydrochloride 60mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told
you

Keep this leaflet. You many need to read it again

Ask your pharmacist if you need more information or advise

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 Max Sinus & Flu Hot Lemon is and what it is used for
2. What you need to know before you take Lemsip Sinus & Flu Hot Lemon
3. How to take Lemsip Sinus & Flu Hot Lemon
4. Possible side effects
5. How to store Lemsip Sinus & Flu Hot Lemon
6. Contents of the pack and other information
1.
WHAT LEMSIP MAX SINUS & FLU HOT LEMON IS AND WHAT IT IS USED FOR?
Each sachet of Lemsip Max Sinus & Flu Hot Lemon Powder for Oral
Solution contains 1000mg paracetamol and
60mg pseudoephedrine hydrochloride. Paracetamol has pain killing
(analgesic) and fever reducing
(antipyretic) properties. Pseudoephedrine Hydrochloride is a
decongestant to relieve blocked or runny nose.
Lemsip Max Sinus & Flu Hot Lemon can be used to relieve the symptoms
of sinusitis and common cold & flu,
such as headache and congestion in the nose and sinuses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP MAX SINUS & FLU HOT LEMON
DO NOT TAKE LEMSIP MAX SINUS & 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 taking monoamine oxidase inhibitors (MAOIs) or have done so
in the past 14 days

if you suffer from hypertension or s

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2024
CRN00F208
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Max Sinus & Flu Hot Lemon Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains Paracetamol 1000mg.
Pseudoephedrine hydrochloride 60mg.
Excipient(s) with known effect:
Aspartame: 62.5mg/sachet
Sodium: 121.91 mg (5.3 mmol)/sachet
Sucrose: 2.19 mg/sachet
Lactose*: 9.72mg per sachet (present in curcumin powder)
For thefull list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
A pale yellow powder with a lemon odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms of sinusitis, common cold and influenza,
such as headache and nasal and sinus congestion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
Adults only: The usual dose is one sachet up to three times daily. A
maximum dose of three sachets per 24 hours should not
be exceeded.
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
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 impairme