PARACODOL 500/8 %v/v Capsule

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:

Capsule

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Withdrawn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 Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
Hard gelatin capsules with an opaque, white cap and body with ‘Paracodol’ printed in red along the cap and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic in the relief of mild to moderate pain as is 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 to 2 capsules, which can be repeated every 4 to 6 hours or as directed by a physician. The
maximum 24 hour dose is 8 capsules.
Not recommended for children under 12 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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 psychological dependence
(addiction) and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped.
Each capsule contains:
Paracetamol
500
mg
Codeine Phosphate
8
mg
IRISH MEDICINES BOARD
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_Date Printed 04/07/2006_
_CRN 2025100_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Paracetamol should be given with care to patients taking oth