Lipantil Micro 267 capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fenofibrate micronised

Available from:

Stephar (U.K.) Ltd

ATC code:

C10AB05

INN (International Name):

Fenofibrate micronised

Dosage:

267mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000

Patient Information leaflet

LIPANTIL
® MICRO 267 MG CAPSULES
(fenofibrate)
PATIENT INFORMATION LEAFLET
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 symptoms are the same as
yours.
- If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor, or pharmacist or
nurse.
Your medicine is known by the above name but will be referred to as
Lipantil
Micro throughout the following 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.
Lipantil Micro can often also increase the amount of a ‘good’ type
of
cholesterol, called HDL or high density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment
with Lipantil
Micro.
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
infor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lipantil® Micro 267 mg, capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 267 mg fenofibrate.
Excipients with known effect: each capsule contains:
-134.9 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Orange/ivory, hard gelatin capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lipantil® Micro 267 mg 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dietary measures initiated before therapy should be continued.
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 of
Lipantil Micro
200mg.
The dose can be titrated up to 267 mg daily administered as one
capsule of Lipantil
Micro 267mg.
_ _
_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 m
2
, is present. If eGFR is between 30 and 59 mL/min per 1.73 m
2
,
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
m
2
, fenofibrate should be discontinued.
_Hepatic impairment: _
Lipantil Micro 267mg is not recommended for use in pat