Panadol Max Strength Fever and Congestion Hot Lemon Powder for Oral SolutionParacetamol 1000mgPhenylephrine hydrochloride 10mgAscorbic Acid 40mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Phenylephrine hydrochloride; Ascorbic acid

Available from:

Haleon Ireland Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Phenylephrine hydrochloride; Ascorbic acid

Dosage:

1000 mg/10 mg/40 milligram(s)

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:

1999-02-19

Patient Information leaflet

Page 1 of 3
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Panadol Max Strength Fever and Congestion Hot Lemon Powder for Oral
Solution
Paracetamol 1000mg
Phenylephrine hydrochloride 10mg
Ascorbic Acid 40mg
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for 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. This
includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Panadol Max Strength Fever and Congestion Hot Lemon is and what
it is used for
2.
What you need to know before you take Panadol Max Strength Fever and
Congestion Hot Lemon
3.
How to take Panadol Max Strength Fever and Congestion Hot Lemon
4.
Possible side effects
5.
How to store Max Strength Fever and Congestion Hot Lemon
6.
Contents of the pack and other information
1.
WHAT PANADOL MAX STRENGTH FEVER AND CONGESTION HOT LEMON IS AND WHAT
IT IS
USED FOR
Each sachet contains Paracetamol 1000mg, Phenylephrine hydrochloride
10mg and Ascorbic Acid
40mg as the active ingredients.
Paracetamol is an analgesic (pain killer) and antipyretic (it reduces
body temperature when you have
a fever). It is provided at the maximum dose. Phenylephrine
hydrochloride is a sympathiomimetic
decongestant, which unblocks your nose and sinuses helping you breathe
more easily. Ascorbic acid
is a common ingredient of ‘flu and cold products. It is included to
help replace the vitamin C which
may be lost in the initial stages of ‘flu and colds.
Panadol Max Strength Fever and Congestion Hot Lemon is a product for
the short term relief of the
symptoms of influenza (‘flu), colds and chills. These symptoms
include headache, shivers, aches and
pains, congested or blocked nose, painful sinuses and sore throat
pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANADOL MAX STRENGTH FEVER AND
CONGESTION HOT LEMON
CHECK BEFORE YOU TAKE THIS MEDICINE
Do

Summary of Product characteristics

Health Products Regulatory Authority
26 June 2023
CRN00DLHM
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Max Strength Fever and Congestion Hot Lemon Powder for Oral
SolutionParacetamol 1000mgPhenylephrine
hydrochloride 10mgAscorbic Acid 40mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains paracetamol 1000.0 mg, ascorbic acid 40.0 mg and
phenylephrine hydrochloride 10 mg.
Excipients: Contains Sucrose 3.7g and sodium 0.12g per sachet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
Off white free flowing powder with an odour of lemon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic relief of influenza, fever, chills and colds
including headache, sore throat pain, aches and pains, nasal
congestion, sinusitis and its associated pain and acute nasal catarrh.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DIRECTIONS FOR USE
Empty contents of sachet into a beaker. Half fill with very hot water.
Stir well. Add cold water as necessary and sugar if
desired.
RECOMMENDED DOSE
Adults (including the elderly) and children 16 years and over:
One sachet to be taken every four to six hours as necessary. Do not
exceed four doses per 24 hours. Not to be given to
children under 16 years except on medical advice.
Use the lowest amount needed for the shortest duration of treatment to
relieve symptoms. If symptoms persist or get worse,
consult your doctor.
The product should not be used continuously for more than seven days
without medical advice.
Renal impairment:
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician. See Table below:
Adults:
Glomerular filtration rate
Dose
10-50 ml/min
500mg every 6 hours
<10ml/min
500mg every 8 hours
Hepatic impairment:
In patients with hepatic impairment or Gilbert's Syndrome, the dose
should be reduced or the