Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine Hydrochloride 10 mg, Powder for Oral Solution

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

から入手可能:

WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH

ATCコード:

N02BE; N02BE51

INN（国際名）:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

投薬量:

500/200/10 milligram(s)

医薬品形態:

Powder for oral solution

処方タイプ:

Product not subject to medical prescription

治療領域:

Anilides; paracetamol, combinations excl. psycholeptics

認証ステータス:

Not marketed

承認日:

2011-10-07

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCL 10 MG,
POWDER FOR ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR PHARMACIST
HAVE 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. This includes any
possible side effects not listed in
this leaflet. See section 4.
-
You must talk to your doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
:
1.
WHAT PARACETAMOL 500 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCL 10 MG,
POWDER FOR ORAL
SOLUTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL 500 MG, GUAIFENESIN
200 MG,
PHENYLEPHRINE HCL 10 MG, POWDER FOR ORAL SOLUTION
3.
HOW TO TAKE PARACETAMOL 500 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCL
10 MG, POWDER
FOR ORAL SOLUTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PARACETAMOL 500 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCL
10 MG, POWDER
FOR ORAL SOLUTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PARACETAMOL 500 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCL 10 MG,
POWDER FOR ORAL
SOLUTION IS AND WHAT IT IS USED FOR
Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine HCl 10 mg,
Powder for oral solution is
designed for the relief of symptoms of colds and flu.
It contains three active ingredients:
-
Paracetamol is a well known pain killer (analgesic). It is effective
against aches and pains
including headache and sore throat and can also reduce fever
(antipyretic).
-
Guaifenesin (an expectorant) loosens phlegm which helps relieve chesty
coughs.
-
Phenylephrine hydrochloride (a nasal decongestant) reduces swelling in
the passages of the nose
and so relieves a blocked nose.
You should only use Paracetamol 500 mg, Guaifenesin 200 mg,
Phenylephrine HCl 10 mg

製品の特徴

HealthProductsRegulatoryAuthority
22September2022
CRN00CXZX
Page1of8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol500mg,Guaifenesin200mg,PhenylephrineHydrochloride10mg,PowderforOralSolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Onesachetcontains:
500mgParacetamol
200mgGuaifenesin
10mgPhenylephrinehydrochloride
Excipientswithknowneffect:
Sucrose2000mg
Aspartame6mg
Sodium157mg
Forafulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Powderfororalsolution,sachet
Off-whitepowder
Appearanceafterreconstitution:Opalescentyellowcolouredsolutionwithcharacteristicscitrus/mentholodourandtaste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Shorttermsymptomaticreliefofmildtomoderatepain,fever,nasalcongestionwithanexpectoranteffectonchestycough,
associatedwithcolds,chillsandinfluenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults,theElderlyandchildrenaged12yearsandover:Onesachet
Repeateveryfourhoursasrequired,butdonotexceedfourdoses(sachets)inany24hours.
Donotgivetopatientswithhepaticorsevererenalimpairment(seeSection4.3).
Seekmedicaladviceifsymptomspersistformorethan3days
Paediatric population
Paracetamol500mg,Guaifenesin200mg,PhenylephrineHCl10mg,Powderfororalsolutioniscontraindicatedinchildren
under12yearsold(seesection4.3).

Method of administration:
Dissolvethecontentsofonesachetinastandardmugofhot,butnotboiling,water(approx.250ml).
Allowtocooltoa
drinkabletemperature.
4.3 CONTRAINDICATIONS
