Perrigo Cold & Flu Tablets Paracetamol 250 mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 mg

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Disponible desde:

Chefaro Ireland DAC

Código ATC:

N02BE; N02BE51

Designación común internacional (DCI):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosis:

250/100/5 milligram(s)

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

Anilides; paracetamol, combinations excl. psycholeptics

Estado de Autorización:

Marketed

Fecha de autorización:

2010-07-21

Información para el usuario

Perrigo Cold & Flu Tablets
Paracetamol 250 mg,
Guaifenesin 100 mg,
Phenylephrine hydrochloride 5 mg
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION YOU NEED TO KNOW.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have told you.
- Keep this leaflet as 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 Perrigo Cold & Flu Tablets is and what it is used for
2. What you need to know before you take Perrigo Cold & Flu Tablets
3. How to take Perrigo Cold & Flu Tablets
4. Possible side effects
5. How to store Perrigo Cold & Flu Tablets
6. Contents of the pack and other information
1.
WHAT PERRIGO COLD & FLU TABLETS IS AND WHAT IS IT USED
FOR?
PERRIGO COLD & FLU TABLETS CONTAINS THE FOLLOWING ACTIVE SUBSTANCES:
•
PARACETAMOL
which is a pain reliever (analgesic) and helps reduce your
temperature when you have a fever
•
GUAIFENESIN
which is an expectorant to help loosen phlegm
•
PHENYLEPHRINE
HYDROCHLORIDE
which is a decongestant to reduce swelling in the
passages of the nose to help you breathe more easily.
These tablets are used for the relief of symptoms of colds and flu,
including aches and
pains, headache, blocked nose, sore throat, chills and chesty coughs.
This medicine can be used by adults, the elderly and adolescents aged
12 years and
over.
You must talk to a doctor if symptoms persist for more than 3 days,
get worse or
other symptoms occur.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERRIGO COLD &
FLU TABLETS
DO NOT TAKE PERRIGO COLD & FLU TABLETS IF YOU:
•
are
ALLERGIC
to paracetamol, guaifenesin, phenylephrine hydrochloride or
any of the other ingredi

Ficha técnica

Health Products Regulatory Authority
26 October 2022
CRN00CVW1
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu Tablets Paracetamol 250 mg Guaifenesin 100 mg
Phenylephrine hydrochloride 5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT MG/TABLET
Paracetamol
250
Guaifenesin
100
Phenylephrine Hydrochloride
5 (corresponding to 4.1 mg phenylephrine base)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White capsule shaped tablet, embossed with “PGP”, free from specks
and blemishes.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu, including
aches and pains, headache, blocked nose and sore throat,
chills and chesty cough.
This medicine is indicated in adults, the elderly and adolescents aged
12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults, the elderly and adolescentsaged 12 years and over:
Two tablets every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.
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 medication. It is
recommended, when giving paracetamol to patients with renal failure,
to reduce the dose and to increase the minimum
interval between each administration to at least 6 hours. The
restrictions related to the use of paracetamol products in patients
with renal impairment are primarily a consequence of the paracetamol
content of the drug (see section 4.4).
Hepatic impairment
Patients who have been diagnosed with hepatic impairment or Gilbert's
Syndrome must seek medical advice before taking this
medication. The medicinal product should be used with caution in
patients with mild or moderate hepatic impairment (see
section 4.4). The medicinal product is contraindicated in patients
with severe hepatic impairm