Lipantil Micro 67 mg hard capsules.

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Fenofibrate

Saatavilla:

Mylan IRE Healthcare Limited

ATC-koodi:

C10AB; C10AB05

INN (Kansainvälinen yleisnimi):

Fenofibrate

Annos:

67 milligram(s)

Lääkemuoto:

Capsule, hard

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Fibrates; fenofibrate

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1998-07-13

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPANTIL® MICRO 67MG 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 67 mg is and what it is used for
2. What you need to know before you take Lipantil® Micro 67 mg
3. How to take Lipantil® Micro 67 mg
4. Possible side effects
5. How to store Lipantil® Micro 67 mg
6. Contents of the pack and other information
1. WHAT LIPANTIL® MICRO 67 MG IS AND WHAT IT IS USED FOR
Lipantil® Micro 67 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’.
Lipantil® Micro 67 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.
Lipantil® Micro 67 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 LIPANTIL® MICRO 67 MG
DO NOT TAKE LIPANTIL® MICRO 67 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 liver, kidney or gallbladder problems
•
y

Valmisteyhteenveto

Health Products Regulatory Authority
23 November 2020
CRN00C1PM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Micro 67 mg hard capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 67mg fenofibrate.
Excipients with known effect: Each capsule contains 33.8 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule).
Yellow hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipantil Micro 67mg 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 three capsules
Lipantil Micro67 mg.
The dose can be titrated up to 267 mg daily administered as 4 capsules
Lipantil Micro67 mg if required.
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 pe