Lipantil Supra 145 mg film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fenofibrate

Available from:

PCO Manufacturing Ltd.

ATC code:

C10AB; C10AB05

INN (International Name):

Fenofibrate

Dosage:

145 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Blister strips in a pack of 30 tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Recipharm Fontaine

Therapeutic group:

Serum Lipid Reducing Agents / Cholesterol and Triglycerides Reducers / Fibrates.

Therapeutic area:

Fibrates; fenofibrate

Therapeutic indications:

It is indicated for: 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:

2015-05-29

Patient Information leaflet

_ _
_ _
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
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

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2022
CRN00CRNC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 145 mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 145.0 mg fenofibrate (nanoparticles).
Excipients with known effect: each tablet contains:
- Lactose monohydrate
- Sucrose
- Soybean lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
_Product imported from France and Spain;_
White, oblong, film-coated tablets engraved “145” on one side and
“Fournier logo” on the other side.
4 CLINICAL PARTICULARS
As per PA2010/015/003
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/015/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Sucrose
Lactose monohydrate
Silicified microcrystalline cellulose
Crospovidone
Hypromellose
Sodium lauril sulfate
Docusate sodium
Magnesium stearate
Coating Opadry also contains:
polyvinyl alcohol
titanium dioxide (E 171)
talc
soybean lecithin
xanthan gum
Health Products Regulatory Authority
03 February 2022
CRN00CRNC
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer carton of the product as marketed
in the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C. Store in the original package in order to protect
from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips in a pack of 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/409/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: May 2015
Last updated: November 2016
10 DATE OF REVISION OF THE TEXT
February 2022