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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

可用日期:

Procter & Gamble (Health & Beauty Care) Ltd

ATC代码:

R05X

INN（国际名称）:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

剂量:

500/200/10 milligram(s)

药物剂型:

Powder for oral solution

处方类型:

Medicinal product not subject to medical prescription

治疗领域:

OTHER COLD PREPARATIONS

授权状态:

Not marketed

授权日期:

2011-10-07

资料单张

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

产品特点

Health Products Regulatory Authority
14 December 2018
CRN008L4J
Page 1 of 10
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:
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).
Health Products Regulatory Authority
14 December 2018
CRN008L4J
Page 2 of 10
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

Hypersensitivity to paracetamol, guaifenesin, phenylephrine
hydrochloride
or any of the other ingredients

Hepatic or severe renal impairment

Hypertension

Hyperthyroidism

Diabetes

Heart disease

Narrow-angle glaucoma

Porphyria

Use in patients taking tricyclic antidepressants

Use in patients who are curr