Panadol Cold and Flu

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Dostupné s:

GlaxoSmithKline Export Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC kód:

N02BE51

INN (Mezinárodní Name):

CHLORPHENAMINE MALEATE 2 mg PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Léková forma:

TABLET

Složení:

CHLORPHENAMINE MALEATE 2 mg PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Druh předpisu:

OTC

Terapeutické oblasti:

ANALGESICS

Stav Autorizace:

Withdrawn

Datum autorizace:

2007-02-09

Informace pro uživatele

Site for batch Release: Consolidated Packaging Limited, Valletta Road,
Qormi, Malta

Charakteristika produktu

 
Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 
1. 
NAME OF THE MEDICINAL PRODUCT 
Panadol Cold & Flu 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each Panadol Cold & Flu tablet contains Paracetamol 500 mg,
pseudoephedrine hydrochloride 
30 mg, chlorpheniramine maleate 2mg 
For a full list of excipients, see section 6.1 

3. PHARMACEUTICAL 
FORM 
Tablet. 

4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Panadol Cold  & Flu is indicated for temporary relief of sinus and
headache pain, nasal 
decongestion associated with sinusitis or due to cold, hay fever or
other upper respiratory allergies.  
It also temporarily relieves runny nose, sneezing, itching of nose
and throat and itchy, watery eyes 
due to hayfever or other upper respiratory allergies. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
For oral use. 
ADULTS, INCLUDING THE ELDERLY AND CHILDREN 12 YEARS AND OVER: 
Two tablets up to four times daily as required for relief of symptoms.
 The dose should not be 
repeated more frequently than every four hours nor should more than
four doses be given in any 
24 hour period. 
4.3 CONTRAINDICATIONS 
Hypersensitivity to paracetamol, pseudoephedrine, chlorpheniramine or
any of the other 
constituents. 
Not to be used by patients taking monoamine oxidase inhibitors
(MAOI’s) or for two weeks after 
stopping the MAOI drug. 

Page 2 of 6 
4.4 
SPECIAL WARNING AND PRECAUTIONS FOR USE 
Care is advised in the administration of Panadol Cold & Flu
to patients with renal or hepatic 
impairment, cardiovascular disease, hypertension, hyperthyroidism,
prostatic hypertrophy, diabetes 
mellitus or glaucoma, breathing difficulties such as emphysema or
chronic bronchitis, epilepsy or 
thyrotoxicosis.  Do not exceed the stated dose. Chlorpheniramine may
cause drowsiness, dizziness, 
blurred vision and psychomotor impairment, which can seriously hamper
the patients' ability to 
drive and operate machinery. 

Patients should be advised