Solpa Cold & Flu Multi-Relief Capsules Paracetamol 500mg,Guaifenesin 100mg,Phenylephrine hydrochloride 6.1mg

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Beschikbaar vanaf:

Chefaro Ireland DAC

ATC-code:

N02BE; N02BE51

INN (Algemene Internationale Benaming):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosering:

500 mg/100 mg/6.1 milligram(s)

farmaceutische vorm:

Capsule, hard

Therapeutisch gebied:

Anilides; paracetamol, combinations excl. psycholeptics

Autorisatie-status:

Marketed

Autorisatie datum:

2009-02-20

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA COLD & FLU MULTI-RELIEF CAPSULES
PARACETAMOL 500MG, GUAIFENESIN 100MG, PHENYLEPHRINE HYDROCHLORIDE 6.1
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 symptoms persist for more than 3 days,
get worse or
other symptoms occur.
WHAT IS IN THIS LEAFLET:
1.
What Solpa Cold & Flu Multi-Relief Capsules is and what it is used for
2.
What you need to know before you take Solpa Cold & Flu Multi-Relief
Capsules
3.
How to take Solpa Cold & Flu Multi-Relief Capsules
4.
Possible side effects
5.
How to store Solpa Cold & Flu Multi-Relief Capsules
6.
Contents of the pack and other information
1
)
WHAT SOLPA COLD & FLU MULTI-RELIEF CAPSULES IS AND WHAT IT IS USED FOR
Solpa Cold & Flu Multi-Relief Capsules 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
which is a decongestant to reduce swelling in the passages of the
nose to help you breathe more easily.
These capsules 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.
This medicine can be used by adults, the elderly and adolescents aged
16 years and
over.
You must talk to a doctor if symptoms persist for more than 3 days,
get worse or other

Productkenmerken

Health Products Regulatory Authority
08 November 2022
CRN00CTX1
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa Cold & Flu Multi-Relief Capsules Paracetamol 500mg,Guaifenesin
100mg,Phenylephrine hydrochloride 6.1mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
MG/CAPSULE
Paracetamol
500
Guaifenesin
100
Phenylephrine hydrochloride
6.1 (corresponding to 5mg phenylephrine base)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Dark blue/dark green hard gelatin capsules 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.
Solpa Cold & Flu Multi-Relief Capsules is indicated in adults, the
elderly and adolescents aged 16 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and adolescents aged 16 years and over:
Two capsules every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.
No more than 8 capsules should be taking in any 24 hour period.
Solpa Cold & Flu Multi-Relief Capsules should not be used in adults,
the elderly and adolescents aged 16 years and over, who
weigh less than 50 kg
Paediatric population:
Do not give to children and adolescents under 16 years of age.
_Elderly patients_
Elderly patients, especially those who are frail or immobile, may
require a reduced dose or frequency of dosing.
_Renal impairment_
Health Products Regulatory Authority
08 November 2022
CRN00CTX1
Page 2 of 10
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 hou