Panadol Cold & Flu 500mg / 30mg Film-Coated Tablets

Страна: Мальта

мова: англійська

Джерело: Malta Medicines Authority

Активний інгредієнт:

PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE

Доступна з:

GlaxoSmithKline Consumer Health-care UK Trading Limited

Код атс:

N02BE51

ІПН (Міжнародна Ім'я):

PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE

Фармацевтична форма:

FILM-COATED TABLET

Склад:

PARACETAMOL 500 mg; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Тип рецепту:

OTC

Терапевтична области:

ANALGESICS

Статус Авторизація:

Authorised

інформаційний буклет

Page 1 of 5
PACKAGE LEAFLET : INFORMATION FOR THE USER
PANADOL COLD AND 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 and Flu is and what it is used for
2.
What you need to know before you take Panadol Cold and Flu
3.
How to take Panadol Cold and Flu
4.
Possible side effects
5.
How to store Panadol Cold and Flu
6.
Contents of the pack and other information
1.
WHAT PANADOL COLD AND FLU IS AND WHAT IT IS USED FOR
Panadol Cold and 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 AND FLU
DO NOT TAKE PANADOL COLD AND FLU:

If you are allergic to paracetamol, pseudoephedrine hydrochloride or
other
sympathomimetics (such as decongestants, appetite suppressants or
stimulant drugs
called amphetamines), or any of the other ingredients (listed in
section 6).

If you have high blood pressure, overactive thyroid gland, enlarged
prostate, heart
problems, gl

Характеристики продукта

Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol Cold and 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 and 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
_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 12 to 18 years old_
Page 2 of 10
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.
Panadol Cold and 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 (see section 4.3) and should be used with
caution in those with
moderate renal impairment (see sections 4.4 and 5.2).
Method of administration For oral use.
Patients should be advised not to use this product for more than 5
days and to seek medical advice
if symptoms persist.
Do not exceed the stated dose.
The tablets should be taken with water.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, pseudoephedrine, sympathomimetic