Perrigo Cold & Flu Tablets Paracetamol 250 mg Guaifenesin 100 mgPhenylephrine 5 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Guaifenesin; Paracetamol; Phenylephrine hydrochloride

Available from:

Wrafton Laboratories Ltd. t/a Perrigo

ATC code:

N02BE; N02BE51

INN (International Name):

Guaifenesin; Paracetamol; Phenylephrine hydrochloride

Dosage:

250/100/5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

2010-07-21

Patient Information leaflet

Perrigo Cold & Flu Tablets
Paracetamol 250 mg,
Guaifenesin 100 mg,
Phenylephrine 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.
This medicine is available without prescription, however, you still
need to use this
product carefully to get the best results from it. Keep this leaflet
as you may need to
read it again. Ask your pharmacist if you need more information or
advice.
1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
THIS MEDICINE CONTAINS:

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 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. 2. IS THIS MEDICINE SUITABLE FOR YOU?
DO NOT TAKE THIS MEDICINE IF YOU:

are ALLERGIC to paracetamol, guaifenesin, phenylephrine or any of the
other
ingredients

have a serious heart condition or cardiovascular disorder(s)

have high blood pressure (hypertension)

have diabetes

have an overactive thyroid

have glaucoma

have difficulty passing urine, an enlarged prostate or other prostate
problems

have phaeochromocytoma (a rare tumour of adrenal gland tissue)

suffer from liver or kidney problems

have porphyria, which is a type of blood disorder that causes skin or
nervous
system problems

are pregnant or breastfeeding

are taking tricyclic antidepressants such as imipramine or
amitriptyline

are taking antidepressant drugs called monoamine oxidase inhibitors
(MAOI’s), or
have taken them within the last 14 days - these are medicines such as
phenelzine,
isocarboxazid and tranylcypromine

are currently taking other decongestant drugs (e.g. ephedrine and
xylometazoline)
or stim

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu Tablets
Paracetamol 250 mg
Guaifenesin 100 mg
Phenylephrine 5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
MG/TABLET
Paracetamol
250
Guaifenesin
100
Phenylephrine Hydrochloride
5
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Take tablets with water. Swallow whole, do not chew.
For all indications:
Adults, the elderly and children aged 12 years and over:
Two tablets every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.
Children under 12 years:
Not to be used unless recommended by a doctor.
Dosage should not be continued for longer than 3 days without
consulting a doctor.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol, guaifenesin or phenylephrine or any
of the other ingredients.
Hypertension (high blood pressure), hyperthyroidism, diabetes, serious
heart disease, cardiovascular disorders or those
patients receiving or within two weeks of stopping therapy with
monoamine oxidase inhibitors (see Section 4.5).
Those taking tricyclic anti-depressant drugs (see Section 4.5).
Phaeochromocytoma.
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