Lipantil Micro 67 capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Fenofibrate micronised

Saatavilla:

Dowelhurst Ltd

ATC-koodi:

C10AB05

INN (Kansainvälinen yleisnimi):

Fenofibrate micronised

Annos:

67mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02120000

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 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.
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
information)
•
While taking other medicines, you have had a

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lipantil
®
Micro 67 mg, capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 67 mg 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
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
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 three capsules of
Lipantil
Micro 67mg.
The dose can be titrated up to 267mg daily administered as 4 capsules
of Lipantil
Micro 67mg, if required. This maximum dose is not recommended in
addition to a
statin.
_ _
_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 stan