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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
05-12-2017

Viambatanisho vya kazi:

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Inapatikana kutoka:

Procter & Gamble (Health & Beauty Care) Limited

ATC kanuni:

N02BE51

INN (Jina la Kimataifa):

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Kipimo:

1000/12.2 Milligram

Dawa fomu:

Powder for Oral Solution

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Analgesics and antipyretics

Idhini hali ya:

Authorised

Idhini ya tarehe:

2011-12-16

Tabia za bidhaa

                                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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