LIPANTIL SUPRA 145 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FENOFIBRATE

Available from:

BGP Products Ltd

ATC code:

C10AB05

INN (International Name):

FENOFIBRATE

Dosage:

145 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

oral use

Units in package:

Packs of 10 or 14 tablets; Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Serum Lipid Reducing Agents / Cholesterol and Triglycerides Reducers / Fibrates

Therapeutic area:

Fibrates

Therapeutic indications:

It 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.

Authorization status:

Authorised

Authorization date:

2015-03-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lipantil Supra 145 mg Film-coated tablet
Fenofibrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Lipantil Supra is and what it is used for
2.
What you need to know before you take Lipantil Supra
3.
How to take Lipantil Supra
4.
Possible side effects
5.
How to store Lipantil Supra
6.
Contents of the pack and other information
1.
WHAT LIPANTIL SUPRA IS AND WHAT IT IS USED FOR
Lipantil Supra belongs to a group of medicines, commonly known as
‘fibrates’. These medicines are used to
lower the level of fats (lipids) in the blood. For example the fats
known as triglycerides.
Lipantil Supra is used alongside a low fat diet and other non-medical
treatments such as exercise and weight
loss, to lower levels of fats in the blood.
Lipantil Supra can be used in addition to other medicines (statins) in
some circumstances when levels of fats
in the blood are not controlled with a statin alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIPANTIL SUPRA
DO NOT TAKE LIPANTIL SUPRA IF:
-
you are allergic to fenofibrate or any of the other ingredients of
this medicine (listed in Section
6,Contents of the pack and other other information)
-
you are allergic to peanuts, arachis oil, soya lecithin or related
products
-
while taking other medicines (such as other fibrates or an
anti-inflammatory medicine called
‘ketoprofen’),
-
you have had an allergic reaction or skin damage from sunlight or UV
light
-
you have severe liver, kidney or gallbladder problems
-
you hav

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 145mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 145.0 mg fenofibrate (nanoparticles).
Excipients with known effect: each tablet contains:
-
132.00 mg of Lactose monohydrate
-
145.00 mg of Sucrose
-
0.50 mg of Soybean lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets engraved “145” on one side and
“Fournier logo” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Supra 145mg 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
Dietary measures initiated before therapy should be continued.
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 one tablet containing 145 mg fenofibrate taken
once daily. Patients currently taking one 200
mg capsule or one 160 mg tablet can be changed to one 145 mg
fenofibrate tablet without further dose adjustment.
Special populations
Elderly patients (
65 years old)
No dose adjustment is necessary. The usual dose is recommended, except
for decreased renal function with estimated
glomerular filtration rate < 60 mL/min/1.73 (see Patients with renal
impairment).
Patients with renal impairment
Fenofibrate should not be used if severe renal impairment, defined as
eGFR <30 mL/min per 1.73 m2, is present.
If eGFR