Solpa Cold & Flu Multi-Relief Max Powder for Oral Solution Paracetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine hydrochloride 12.2 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Available from:

Chefaro Ireland DAC

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosage:

1000 mg/200 mg/12.2 milligram(s)

Pharmaceutical form:

Powder for oral solution

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

2009-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA COLD & FLU MULTI-RELIEF MAX POWDER FOR ORAL SOLUTION,
PARACETAMOL 1000 MG,
GUAIFENESIN 200 MG,
PHENYLEPHRINE
HYDROCHLORIDE
12.2 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 Solpa Cold & Flu Multi-Relief Max Powder is and what it is
used for
2. What you need to know before you take Solpa Cold & Flu Multi-Relief
Max
Powder
3. How to take Solpa Cold & Flu Multi-Relief Max Powder
4. Possible side effects
5. How to store Solpa Cold & Flu Multi-Relief Max Powder
6. Contents of the pack and other information
1) WHAT IS
SOLPA COLD & FLU MULTI-RELIEF MAX POWDER AND WHAT IS IT USED FOR?
Solpa Cold & Flu Multi-Relief Max Powder 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 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.
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 tha

Summary of Product characteristics

Health Products Regulatory Authority
08 November 2022
CRN00CTWY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa Cold & Flu Multi-Relief Max Powder for Oral Solution Paracetamol
1000 mg, Guaifenesin 200 mg, Phenylephrine
hydrochloride 12.2 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT MG/SACHET
Paracetamol 1000
Guaifenesin 200
Phenylephrine hydrochloride 12.2 (corresponding to 10 mg phenylephrine
base)
Excipients with known effects
Each sachet contains:
Sucrose 2000mg
Aspartame (E951) 30mg
Sodium 117mg
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.
Solpa Cold & Flu Multi-Relief Max Powder for Oral Solution 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:
One sachet every 4 to 6 hours when necessary to a maximum of 4 doses
in 24 hours.
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_
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 th