Panadol Cold & Flu 500mg / 30mg film-coated Tablets

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Disponible desde:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

Código ATC:

N02BE51

Designación común internacional (DCI):

PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg PARACETAMOL 500 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg PARACETAMOL 500 mg

tipo de receta:

OTC

Área terapéutica:

ANALGESICS

Estado de Autorización:

Authorised

Fecha de autorización:

2014-03-14

Información para el usuario

PAGE 1
of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANADOL COLD & FLU 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 Cold & Flu is and what it is used for
2.
What you need to know before you take Panadol Cold & Flu
3.
How to take Panadol Cold & Flu
4.
Possible side effects
5.
How to store Panadol Cold & Flu
6.
Contents of the pack and other information
1.
WHAT PANADOL COLD & FLU
IS AND WHAT IT IS USED FOR
Panadol Cold & Flu 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 COLD & FLU
DO NOT TAKE PANADOL COLD & FLU:
•
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, overactive thyroid gland, enlarged
prostate, heart
problems, glaucoma (excessive pr

Ficha técnica

_SUMMARY OF PRODUCT CHARACTERISTICS _
1.
NAME OF THE MEDICINAL PRODUCT
Panadol Cold & Flu 500mg / 30mg Film Coated Tablets
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 Cold & Flu 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 Cold & Flu 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 with severe renal impairment GFR <30 mL/min (see section 4.3)
and should
be used with caution in those with moderate renal impairment GFR 30-59
m