LIPANTIL MICRO 200 Milligram 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:

200 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Fibrates

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
•
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
lightyou have
severe liver, kidney or gallbladder problems
•
you have pancreatitis (an inflamed pancreas which causes abdominal
pain), which i

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 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.
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