Lipantil Micro 200mg capsules, hard.

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:

200mg

Pharmaceutical form:

Capsule, hard.

Administration route:

oral use

Units in package:

Pack sizes: 28, 30, 90 and 100 capsules

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Famar L’Aigle

Therapeutic group:

Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/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

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 or nurse.
•  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 or nurse. 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: Further information)
•  while taking other medicines, you have had 
an allergic reaction or skin damage from 
sunlight or UV light (these medicines include�

Summary of Product characteristics

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: Each capsule contains 101 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Ochre hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Micro 200mg 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
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 200mg daily administered as one capsule Lipantil Micro 200mg
Special populations
Geriatric population:
In elderly patients without renal impairment, the usual adult dose is recommended.
Renal impairment:
Dosage reduction is required in patients with renal impairment (creatine clearance < 60mL/min). Therefore
Lipantil
Micro
200mg should not be used in patients with renal impairment.
Hepatic impairment:
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/06/2015_
_CRN 2162454_
_page number: 1_
Lipantil Micro�