Panadol Fever and Congestion Film-coated Tablets Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Haleon Ireland Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

500 mg/30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

2003-11-28

Patient Information leaflet

PACKAGE LEAFLET : INFORMATION FOR THE USER
PANADOL FEVER AND CONGESTION 500 MG / 30 MG FILM COATED
TABLETS PARACETAMOL AND PSEUDOEPHEDRINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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. 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 5 days.
WHAT IS IN THIS LEAFLET:
1.
What Panadol Fever and Congestion is and what it is used for
2.
What you need to know before you take Panadol Fever and Congestion
3.
How to take Panadol Fever and Congestion
4.
Possible side effects
5.
How to store Panadol Fever and Congestion
6.
Contents of the pack and other information
1.
WHAT PANADOL FEVER AND CONGESTION IS AND WHAT IT IS USED FOR
Panadol Fever and Congestion is used for the relief of nasal
congestion when combined with fever
and/or pain such as sore throat, sinus pain or headache in the common
cold or flu. The medicine
contains two active ingredients. Paracetamol is a painkiller and
reduces your temperature
when you have a fever. Pseudoephedrine hydrochloride is a decongestant
which
unblocks your nose and sinuses helping you breathe more easily without
drowsiness.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANADOL FEVER AND CONGESTION
DO NOT TAKE PANADOL FEVER AND CONGESTION:
•
If you are allergic to paracetamol, pseudoephedrine hydrochloride or
any of
the other ingredients in the product (listed in section 6).
•
If you are taking other sympathomimetics (such as decongestants,
tricyclic
antidepressants).
•
If you have high blood pressure, over

Summary of Product characteristics

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Fever and Congestion Film-coated Tablets Paracetamol 500mg
Pseudoephedrine Hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg and pseudoephedrine
hydrochloride 30 mg. For the full list of excipients see section
6.1.
3 PHARMACEUTICAL FORM
Form: Film coated tablet.
Description: A bilayer (white/blue) film coated capsule shaped tablet.
The tablet is debossed with the number 2 in a circle on
one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Panadol Fever and Congestion is indicated in adults and adolescents
aged 12 to 18 years.
Symptomatic relief of nasal congestion when combined with fever and/or
pain such as sore throat, sinus pain or headache in
the common cold or influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
_ADULTS, INCLUDING THE ELDERLY_
Two tablets up to three times daily as required for relief of
symptoms.
The dose should not be repeated more frequently than every four hours
nor should more than three doses be given in any 24
hour period.
_PAEDIATRIC POPULATION _
_ _
_ADOLESCENTS AGED 16 TO 18 YEARS OLD_
One to two tablets up to three times daily as required for relief of
symptoms.
The dose should not be repeated more frequently than every four hours
nor should more than three doses be given in any 24
hour period.
_ADOLESCENTS AGED 12 TO 15 YEARS OLD_
One tablet up to three times daily as required for relief of symptoms.
The dose should not be repeated more frequently than every four hours
nor should more than three doses be given in any 24
hour period.
_ _
Panadol Fever and Congestion is contraindicated in children aged under
12 years and below (see section 4.3).
_Patients with renal impairment_
Pseudoephedrine is primarily excreted renally. Pseudoephedrine should
not be used by those wi