LIPANTIL SUPRA
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
03-05-2024
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Virkt innihaldsefni:
FENOFIBRATE
Fáanlegur frá:
Abbott Healthcare Products Ltd
Skammtar:
215 Milligram
Lyfjaform:
Film Coated Tablet
Leyfisdagur:
2007-03-02
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 215 mg, film-coated tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 215.0 mg fenofibrate.
Excipients: each tablet contains:
-
134.4 mg of lactose monohydrate
-
2.28 mg of Sunset yellow lake (E110)
-
5.31 mg of Allura red AC lake (E129)
-
0.6 mg of Soybean lecithin
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Orange-red, oblong, film-coated tablet engraved “215” on one side and “Fournier logo” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Supra 215mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight
reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
Adults: The recommended initial dose is 160 mg daily administered as one Lipantil Supra 160 mg tablet.
The dose can be titrated up to 215 mg daily administered as one Lipantil Supra 215 mg tablet.
Patients currently taking one Lipantil Micro 267mg capsule can be changed to one Lipantil Supra 215 mg tablet
without further dose adjustment.
Lipantil Supra 215 mg should always be taken with food, because it is less well absorbed from an empty stomach.
Dietary measures instituted before therapy should be continued.
Elderly patients: In elderly patients without renal impairment, the normal adult dose is recommended
Patients with renal impairment: Dosage reduction is required in patients with renal impairment. The use of dosage
forms containing a lower dose of active ingredient (67 mg micronised fenofibrate capsules o
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