Lipantil Micro 200 mg hard capsules

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Fenofibrate

זמין מ:

Mylan IRE Healthcare Limited

קוד ATC:

C10AB; C10AB05

INN (שם בינלאומי):

Fenofibrate

כמות:

200 milligram(s)

טופס פרצבטיות:

Capsule, hard

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Fibrates; fenofibrate

מצב אישור:

Marketed

תאריך אישור:

1998-07-13

עלון מידע

Mylan
fenofibrate, hard capsules, 200 mg
1.3.1 Package Leaflet
IE/H/0120/002
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
200 MG CAPSULES, HARD
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 200 mg is and what it is used for
2. What you need to know before you take 200 mg
3. How to take 200 mg
4. Possible side effects
5. How to store 200 mg
6. Contents of the pack and other information
1. WHAT 200 MG IS AND WHAT IT IS USED FOR
200 mg 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’.
200 mg 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.
200 mg 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 200 MG
DO NOT TAKE 200 MG 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 live

מאפייני מוצר

Health Products Regulatory Authority
23 November 2020
CRN00C1PM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 200 mg hard capsules
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
Hard capsule (capsule).
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 200 mg daily administered as one capsule
Lipantil Micro 200 mg.
Special populations
_Elderly patients (≥ 65 years old) _
No dose adjustment is necessary. The usual dose is recommended, except
for decreased renal function with estimated
glomerular filtration rate < 60 mL/min/1.73 (see Patients with renal
impairment).
_Patients with renal impairment _
Fenofibrate should not be used if severe renal impairment, defined as
eGFR <30 mL/min per 1.73 m2, is present.
If eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of
fenofibrate should not exceed 100 mg standard or 67 mg
micronized once daily.
If, during follow-up, the eGFR decreases persistently to <30 mL/min
per 1.73 m2, fenofibrate should be discontinued.
_Hepatic impairment:_
L