TRENTAL 400 MG MODIFIED-RELEASE, COATED TABLETS.
Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Ciri produk
(SPC)
03-05-2024
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Bahan aktif:
PENTOXIFYLLINE
Boleh didapati daripada:
Sanofi-Aventis Ireland Limited
Dos:
400 Milligram
Borang farmaseutikal:
Modified-release Tablets
Tarikh kebenaran:
1977-03-07
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trental 400 mg Modified-Release, Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of pentoxifylline.
Excipients: Sucrose 141.88 mg.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release, coated tablet.
Oblong, pink tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
USES: Trental 400 is indicated in the management of peripheral vascular disease.
Trental has been shown to increase cerebral blood flow but this may not necessarily be accompanied by an
improvement in clinical signs and symptoms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended initial dose is 1 tablet (400mg) three times daily; two tablets daily may prove sufficient in some
patients, particularly for maintenance therapy.
_Elderly_: No special dosage requirements.
Children: No experience is available concerning the use of pentoxifylline in children. Consequently Trental 400mg is
not currently recommended for use in children.
Special Cases:
In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approx. 30%
to 50% may be necessary – guided by individual tolerance, see section 4.4
A dose reduction-guided by individual tolerance- is necessary in patients with severely impaired liver function, see
section 4.4.
Treatment must be started at low-dose levels in hypotensive patients or patients whose circulation is unstable as well as
in patients, who would be at particular risk from a reduction in blood pressure (e.g. patients with severe coronary heart
disease or relevant stenoses of blood vessels supplying the brain); in such cases, the dose must only be increased
gradually, see section 4.4.
4.3 CONTRAINDICATIONS
Trental 400 is
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