PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE 1000/12.2 Milligram Powder for Oral Solution

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Disponível em:

Procter & Gamble (Health & Beauty Care) Limited

Código ATC:

N02BE51

DCI (Denominação Comum Internacional):

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Dosagem:

1000/12.2 Milligram

Forma farmacêutica:

Powder for Oral Solution

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Analgesics and antipyretics

Status de autorização:

Authorised

Data de autorização:

2011-12-16

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for
oral solution, Lemon flavour
Paracetamol 1000mg, Phenylephrine HCl 12.2mg
Powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains:
1000mg Paracetamol
12.2mg Phenylephrine hydrochloride (equivalent to 10mg phenylephrine
base)
Excipients
Sucrose 1936mg
Aspartame 25mg
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.
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
_Paediatric population_
Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for
oral solution, Lemon flavour is indicated in
adults and adolescents aged 16 and over.
Elderly:
No special dosage modifications are required.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol, phenylephrine or any of the
excipients
Severe ischaemic heart disease
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