LIPANTIL MICRO 267 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
FENOFIBRATE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
FENOFIBRATE
Dosage:
267 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-04-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 267 mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 267 mg fenofibrate.
Excipients with known effect: Each capsule contains 134.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard (capsules)
Orange/ivory hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Micro 267mg 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
Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been
achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered.
_Posology:_
The recommended dose is 200 mg daily administered as one capsule Lipantil Micro 200 mg.
The dose can be titrated up to 267 mg daily administered as one capsule Lipantil Micro 267 mg
Special populations
Geriatric population:
In elderly patients, without renal impairment, the usual adult dose is recommended.
Renal impairment:
Dosage reduction is required in patients with renal impairment (creatinine clearance<60mL/min). Therefore, Lipantil
Micro 267mg should not be used in patients with renal impairment.
Hepatic impairment:
Lipantil Micro 267 mg is not recommended for use in patients with hepatic impairment due to the lack of data.
Paediatric population:
The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been esta
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