PARACODOL 500/8 %v/v Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL CODEINE PHOSPHATE

Available from:

Bayer PLC

INN (International Name):

PARACETAMOL CODEINE PHOSPHATE

Dosage:

500/8 %v/v

Pharmaceutical form:

Tablets

Authorization status:

Withdrawn

Authorization date:

2007-09-04

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracodol Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablets.
White, effervescent tablets with bevelled edges and flat faces.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic in the relief of mild to moderate pain as associated with rheumatism, neuralgia, musculoskeletal
disorders, headache, migraine, toothache, sore throat, period pains, discomfort associated with influenza, feverishness
and feverish colds.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration.
Recommended dosage
Adults:
The usual dose is 1 - 2 tablets, which may be repeated every four to six hours or as directed by the physician. The
maximum 24 hour dose is 8 tablets.
Children:
Children 6 - 12 years: ½ - 1 tablet with a maximum of 4 tablets in any 24 hour period.
If symptoms persist for more than 3 days a doctor should be consulted.
Children under 6 years: Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The tablet base contains 420 mg of sodium. This should be kept in mind if long term treatment is contemplated in
patients on a low salt diet.
Each tablet contains:
Paracetamol
500 mg
Codeine phosphate
8 mg
IRISH MEDICINES BOARD
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_Date Printed 06/07/2006_
_CRN 2025134_
_page number: 1_
Paracetamol should only be used with caution in patients with liver dysfunction.
Prolonged use except under medical supervision can be harmful. If symptoms persist, the physician should be
consulted.
Prolonged regular use, except under medical supervision, may lead to physical and psycho