Perrigo Cold & Flu Multi Relief Max Powder for Oral SolutionParacetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine 12.2 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Available from:

Wrafton Laboratories Ltd. t/a Perrigo

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosage:

1000/200/12.2 milligram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

2009-12-22

Patient Information leaflet

PATIENT INFORMATION LEAFLET
Perrigo Cold & Flu Multi-Relief Max Powder for Oral Solution,
Paracetamol 1000 mg,
Guaifenesin 200 mg,
Phenylephrine 12.2 mg
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 a 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 sachets are used for the relief of the symptoms of colds and flu
and the pain and
congestion of sinusitis, including aches and pains, headache, blocked
nose and sore
throat, chills and feverishness (high temperature). They can also
loosen stubborn
mucus (phlegm) and provide relief from 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 wit

Summary of Product characteristics

Health Products Regulatory Authority
06 December 2018
CRN008L7Y
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu Multi Relief Max Powder for Oral Solution
Paracetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine 12.2 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT MG/SACHET
Paracetamol 1000
Guaifenesin 200
Phenylephrine hydrochloride 12.2
This product also contains the excipients sucrose, aspartame and
sodium (as sodium
citrate) - see section 4.4.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Sachets containing the drug product, an off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu and the pain
and congestion
of sinusitis, including aches and pains, headache, blocked nose and
sore throat, chills,
lowering of temperature, and to loosen stubborn mucous and provide
relief from
chesty coughs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Dissolve the contents of one sachet in a standard mug of hot, but not
boiling water
(250 ml).
Allow to cool to a drinkable temperature.
FOR ALL INDICATIONS:
ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER:
One sachet every 4 to 6 hours when necessary to a maximum of 4 doses
in 24 hours.
Health Products Regulatory Authority
06 December 2018
CRN008L7Y
Page 2 of 13
CHILDREN UNDER 16 YEARS:
Do not give to children under 16 years of age.
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.
Hepatic or severe renal impairment, hypertension, hyperthyroidism,
diabetes, heart
disease or those taking tricyclic antidepressants or beta-blocking
drugs and those
patients who are taking or have taken, within the last two weeks,
monoamine oxidase
inhibitors (see section 4.5).
Phaeochromocytoma.
Prostatic enlargement or urinary retention