TYLEX 30/500 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CODEINE PHOSPHATE HEMIHYDRATE PARACETAMOL
Available from:
LTT Pharma Limited
INN (International Name):
CODEINE PHOSPHATE HEMIHYDRATE PARACETAMOL
Dosage:
30/500 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-03-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tylex 30 mg / 500 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
Excipients: sodium metabisulphite (E223), soya lecithin
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from the UK:_
Hard gelatin capsule with white body and red cap, both with “C30” printed in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: The capsules are given orally. The usual dose is one or two capsules every four hours as required. The total
daily dose should not exceed 240 mg of codeine phosphate hemihydrate (i.e. not more than four doses per 24 hours
should be taken).
Elderly: A reduced dose may be required.
Children: Use in children under 12 years of age is not recommended.
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be
kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is
dose related. Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong
analgesia and are associated with an appreciably increased incidence of undesirable side effects.
4.3 CONTRAINDICATIONS
Tylex Capsules should not be administered to patients who have previously exhibited hypersensitivity to either
paracetamol or codeine, or to any of its excipients. Tylex contains soya lecithin. If you are allergic to peanut or soya, do
not use this medicinal product.
Tylex Capsules are not recommended for children under the age of 12 y
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