Perrigo Cold & Flu powder for oral solutionParacetamol 500mgGuaifenesin 200mgPhenylephrine hydrochloride 10mg

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
30-07-2019
Shusha Tabia za bidhaa (SPC)
06-03-2018

Viambatanisho vya kazi:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Inapatikana kutoka:

Omega Pharma Ltd

ATC kanuni:

N02BE; N02BE51

INN (Jina la Kimataifa):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Kipimo:

500mg/200mg/10 milligram(s)

Dawa fomu:

Powder for oral solution

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Anilides; paracetamol, combinations excl. psycholeptics

Idhini hali ya:

Authorised

Idhini ya tarehe:

2018-02-16

Taarifa za kipeperushi

                                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 chil
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu powder for oral solution
Paracetamol 500mg
Guaifenesin 200mg
Phenylephrine hydrochloride 10mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
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
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 children aged 12
and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all indications:
_Adults, the elderly and children 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).
ACTIVE SUBSTANCE
MG/SACHET
Paracetamol
500
Guaifenesin
200
Phenylephrine hydrochloride
10
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