Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for oral solution, Lemon flavourParacetamol 1000mg, Phenylephrine HCl 12.2mgPowder for oral solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Phenylephrine hydrochloride; Paracetamol

Saatavilla:

WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH

ATC-koodi:

N02BE; N02BE51

INN (Kansainvälinen yleisnimi):

Phenylephrine hydrochloride; Paracetamol

Annos:

1000/12.2 milligram(s)

Lääkemuoto:

Powder for oral solution

Prescription tyyppi:

Product not subject to medical prescription

Terapeuttinen alue:

Anilides; paracetamol, combinations excl. psycholeptics

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2011-12-16

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for
oral solution, Lemon
flavour
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 or
nurse has 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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4
-
You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
WHAT IS IN THIS LEAFLET
:
1.
What Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder
for oral solution,
Lemon flavour is and what it is used for
2.
What you need to know before you take Paracetamol 1000mg,
Phenylephrine hydrochloride
12.2mg, Powder for oral solution, Lemon flavour
3.
How to take Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg,
Powder for oral
solution, Lemon flavour
4.
Possible side effects
5.
How to store Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg,
Powder for oral
solution, Lemon flavour
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL 1000MG, PHENYLEPHRINE HYDROCHLORIDE 12.2MG, POWDER
FOR ORAL
SOLUTION, LEMON FLAVOUR IS AND WHAT IT IS USED FOR
Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for
oral solution, Lemon
flavour is for relief of symptoms of colds and flu, such as headaches,
aches and pains, sore
throat, nasal congestion and lowering of temperature. It contains two
active ingredients;
•
Paracetamol is a well known pain killer (analgesic) and can also
reduce fever
(antipyretic).
•
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in
the passages of the
nose and so relieves a blocked nose.
You should only use this medicine if you have a combination of cold
and flu symptoms such as
p

Valmisteyhteenveto

Health Products Regulatory Authority
22 September 2022
CRN00CXZG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for
oral solution, Lemon flavourParacetamol 1000mg,
Phenylephrine HCl 12.2mgPowder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains:
1000mg Paracetamol
12.2mg Phenylephrine hydrochloride (equivalent to 10mg phenylephrine
base)
Excipients with known effect:
Sucrose 1936mg
Aspartame 25mg
Sodium 117.5 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution, sachet
Yellow powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief of symptoms of colds and influenza, including the relief of
headaches, aches and pains, sore throat, nasal congestion
and lowering of temperature.
Paracetamol 1000mg, Phenylephrine HCl 12.2mg, Powder for oral
solution, Lemon flavour, is indicated in adults and
adolescents aged 16 and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Dissolve the contents of one sachet in a standard mug of hot, but not
boiling, water (approx. 250ml). Allow to cool to a
drinkable temperature.
Posology
Adults: One sachet
May be repeated every 4-6 hours as required
Adolescents aged 16 years of age and over: One sachet
May be repeated every 6 hours as required
Maximum of 4 doses (4 sachets) in 24 hours
_Elderly:_
No special dosage modifications are required.
_ _
_Patients with renal and/or hepatic impairment:_
Do not give to patients with severe hepatic or moderate to severe
renal impairment (see section 4.3).
_Paediatric population_:
Paracetamol 1000mg, Phenylephrine HCl 12.2mg, Powder for oral
solution, Lemon flavour is contraindicated in children under
16 years of age.
Health Products Regulatory Authority
22 September 2022
CRN00CXZG
Page 2 of 6
4.3 CONTRAINDICATIONS
Hypersensitivity to active ingredients paracetamol, phenylephrine or
any of the excipients listed in section 6.1;
Severe ischaemic heart d