LIPANTIL MICRO 200 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
FENOFIBRATE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
FENOFIBRATE
Dosage:
200 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 200mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200mg fenofibrate.
Excipients with known effect: Each capsule contains 101 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Orange hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Micro 200mg 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.
- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL
cholesterol are not adequately controlled.
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:
Adults
The recommended dose is 200mg daily administered as one capsule Lipantil Micro 200mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/08/2013_
_CRN 2135975_
_page number: 1_
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 (creatine clearance < 60mL/min). Therefore
Lipantil
Micro
200mg should not be used in patients with renal impairment.
Hepatic impairment:
Lipantil Micro 200mg is no
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