Lipantil Supra 145mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fenofibrate

Available from:

Primecrown 2010 Limited

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 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 as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: 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:

2015-04-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPANTIL
 SUPRA 145MG FILM-COATED TABLETS
Fenofibrate
PILLIPS145/2
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 proble

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: soybean lecithin, lactose monohydrate
and sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
_Product imported from 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 laurilsulfate
Docusate sodium
Magnesium stearate
_COATING:_
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Soybean lecithin
Xanthan gum
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf –life expiry date of this product shall be the date shown
on the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack size:
30 tablets in blister (PVC/aluminium) repackaged in an overlabelled
outer cardboard box.