Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg capsules, hard

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Boleh didapati daripada:

Chefaro Ireland DAC

Kod ATC:

N02BE51

INN (Nama Antarabangsa):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dos:

500 milligram(s)

Borang farmaseutikal:

Capsule, hard

Kawasan terapeutik:

paracetamol, combinations excl. psycholeptics

Status kebenaran:

Not marketed

Tarikh kebenaran:

2021-09-10

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG/GUAIFENESIN 100 MG/PHENYLEPHRINE HYDROCHLORIDE 6.1
MG/CAPSULE,
HARD
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
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 symptoms persist for more than 3 days,
get worse or other
symptoms occur.
WHAT IS IN THIS LEAFLET
1.
What is Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine
hydrochloride 6.1mg
capsules, hard and what it is used for
2.
What
you
need
to
know
before
you
take
Paracetamol
500mg/Guaifenesin
100mg/Phenylephrine hydrochloride 6.1mg capsules, hard
3.
How to take Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine
hydrochloride
6.1mg capsules, hard
4.
Possible side effects
5.
How to store Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine
hydrochloride
6.1mg capsules, hard
6.
Contents of the pack and other information
1.
WHAT IS PARACETAMOL 500MG/GUAIFENESIN 100MG/PHENYLEPHRINE
HYDROCHLORIDE
6.1MG CAPSULES, HARD AND WHAT IT IS USED FOR
Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg
capsules, hard
contains the following active substances:
•
Paracetamol which is a pain reliever (analgesic) for pains including
headache and sore
throat, and also helps reduce your temperature when you have a fever
(antipyretic).
•
Guaifenesin which is an expectorant to help loosen mucus (phlegm) when
you have a
chesty cough.
•
Phenylephrine hydrochloride which is a decongestant used to reduce
swelling in the
passages of the nose to help you breathe more easily.
This medicine is used for the short-term relief of the symptoms colds
and flu including mild
to moderate

Ciri produk

Health Products Regulatory Authority
09 November 2022
CRN00D7L6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg
capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active Ingredient mg/capsule
Paracetamol 500
Guaifenesin 100
Phenylephrine hydrochloride 6.1 (corresponding to 5mg phenylephrine
base)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Capsule with translucent green body and opaque blue cap, 21mm long,
filled with an off-white powder free from large
aggregates and particulate contamination.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic relief of colds and flu including mild
to moderate pains, headache, blocked nose and sore
throat, chills and fever, and for relief from chesty coughs.
Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg
capsules, hard is indicated in adults, the elderly
and adolescents aged 16 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and adolescents aged 16 years and over_
2 capsules every 4 to 6 hours as needed to a maximum of 3 doses in 24
hours.
No more than 6 capsules (3g paracetamol) should be taken in any 24
hour period.
Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg
capsules, hard should not be used in adults, the
elderly and adolescents aged 16 years and over, who weigh less than 50
kg.
_Paediatric population_
Paracetamol 500mg/Guaifenesin 100mg/Phenylephrine hydrochloride 6.1mg
capsules, hard is not intended for use in children
and adolescents under 16 years of age.
_Elderly patients_
Elderly patients, especially those who are frail or immobile, may
require a reduced dose or frequency of dosing.
_ _
_Renal impairment_
Patients who have been diagnosed with kidney impairment must seek
medical advice before taking this medicine. It is
recommended, when giving paracetamol to patients with renal failu