Perrigo Cold & Flu powder for oral solution Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine hydrochloride 10 mg

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Tilgjengelig fra:

Chefaro Ireland DAC

ATC-kode:

N02BE; N02BE51

INN (International Name):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosering :

500mg/200mg/10 milligram(s)

Legemiddelform:

Powder for oral solution

Terapeutisk område:

Anilides; paracetamol, combinations excl. psycholeptics

Autorisasjon dato:

2018-02-16

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
Perrigo Cold & Flu Powder for Oral Solution
Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine 10 mg
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 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 3 days.
WHAT IS IN THIS LEAFLET
1.
What is Perrigo Cold & Flu Powder for Oral Solution and what it is
used for
2.
What you need to know before you take Perrigo Cold & Flu Powder for
Oral Solution
3.
How to take Perrigo Cold & Flu Powder for Oral Solution
4.
Possible side effects
5.
How to store Perrigo Cold & Flu Powder for Oral Solution
6.
Contents of the pack and other information
1.
WHAT IS PERRIGO COLD & FLU POWDER FOR ORAL SOLUTION AND WHAT IT IS
USED FOR
Perrigo Cold & Flu Powder for Oral Solution contains the following
active substances:
•
Paracetamol which is a pain reliever (analgesic) effective against
aches and 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.
Perrigo Cold & Flu Powder for Oral Solution is used for the short-term
relief of the
symptoms of colds and flu, including aches and pains, such as headache
and sore throat, nasal
congestion, chills and feverishness (high temperature). Loosens
stubborn mucus (phlegm)
and provides relief from chesty coughs, in adults and adol

Preparatomtale

Health Products Regulatory Authority
14 August 2023
CRN00CQNL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu powder for oral solution Paracetamol 500 mg,
Guaifenesin 200 mg, Phenylephrine hydrochloride 10 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
ACTIVE SUBSTANCE MG/SACHET
Paracetamol 500
Guaifenesin 200
Phenylephrine hydrochloride 10
Excipients of known effect:
- Sucrose 2077 mg
- Aspartame (E951) 12 mg
- Sodium citrate (E331) 500 mg (contains 117.3 mg sodium)
- Sodium cyclamate (E952) 100 mg (contains 11.5 mg sodium)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
An off-white powder with a characteristic citrus/menthol odour.
The reconstituted solution is opalescent yellow with a characteristic
citrus/menthol odour.
4 CLINICAL PARTICULARS
Each sachet contains:
ACTIVE SUBSTANCE
MG/SACHET
Paracetamol
500
Guaifenesin
200
Phenylephrine hydrochloride
10
Excipients of known effect:
- Sucrose 2077 mg
- Aspartame (E951) 12 mg
- Sodium citrate (E331) 500 mg (contains 117.3 mg sodium)
- Sodium cyclamate (E952) 100 mg (contains 11.5 mg sodium)
For the full list of excipients, see section 6.1.
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic relief of colds and flu including aches
and pains, headache, blocked nose and sore throat,
chills and fever, and for relief from chesty coughs.
This medicine is indicated in adults, the elderly and adolescents aged
12 and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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14 August 2023
CRN00CQNL
Page 2 of 10
For all indications:
_Adults, the elderly and adolescents aged 12 years and over:_
One sachet every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.
Do not give to children under 12 years old.
Do not give to patients with hepatic or severe renal impairment (see
Section 4.3).
Medical advice should be sought if symptoms persist for more than 3
days.
The recommended daily dosage or the specif