Lipantil Micro 200 mg capsules, hard

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:

200 milligram(s)

Pharmaceutical form:

Capsule, hard

Administration route:

Oral use

Units in package:

Blister packs of 30

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Recipharm Fontaine

Therapeutic group:

Serum Lipid Reducing Agents/Cholesterol and Triglyceride 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
 MICRO 200MG CAPSULES, HARD
Fenofibrate
PILLIPM200/2
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.
WHAT IS IN THIS LEAFLET:
1. What Lipantil Micro is and what it is used for
2. What you need to know before you take Lipantil Micro
3. How to take Lipantil Micro
4. Possible side effects
5. How to store Lipantil Micro
6. Contents of the pack and other information
1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR
Lipantil Micro 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 Micro 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 Micro can be used in addition to other medicines (called
‘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 MICRO
DO NOT TAKE LIPANTIL MICRO 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)
•
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 have pancreatitis (an inflamed pancreas which causes

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2018
CRN008QDP
Page 1 of 3
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: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from Spain:_
Ochre hard gelatin capsule.
4 CLINICAL PARTICULARS
As per PA2010/015/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/015/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Excipients:
Lactose monohydrate
Magnesium stearate
Pregelatinised maize starch
Sodium laurilsulfate
Crospovidone.
Capsule shell:
Gelatin
Titanium dioxide (E 171)
Red iron oxide (E 172)
Yellow iron oxide (E172)
Health Products Regulatory Authority
06 November 2018
CRN008QDP
Page 2 of 3
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 package of the product on the market in the country of
origin.
Health Products Regulatory Authority
06 November 2018
CRN008QDP
Page 3 of 3
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture.
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack size: 30 capsules in blister (PVC/aluminium) contained in a
repackaged outer
cardboard box.
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
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex
UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/036/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17
th
April 2015
10 DATE OF REVISION OF THE TEXT
November 2018