Lipantil Micro 200 mg hard capsules

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

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Fibrates; fenofibrate

Authorization date:

2022-02-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPANTIL
® MICRO 200 MG
HARD CAPSULES
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.
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
abdominal pain),

Summary of Product characteristics

Health Products Regulatory Authority
21 February 2022
CRN00CS5R
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 200 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg fenofibrate.
Excipient(s) with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
_Product imported from Poland:_
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 (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture. Do
not store above 25°C.
Health Products Regulatory Authority
21 February 2022
CRN00CS5R
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips in a pack of 30 capsules.
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
PPA0465/471/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
February 2022
10 DATE OF REVISION OF THE TEXT