Pravafenix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

fenofibrate, Pravastatin

Available from:

Laboratoires SMB S.A.

ATC code:

C10BA03

INN (International Name):

fenofibrate, pravastatin

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Dyslipidemias

Therapeutic indications:

Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.

Product summary:

Revision: 8

Authorization status:

Authorised

Authorization date:

2011-04-14

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVAFENIX 40 MG/160 MG HARD CAPSULES
pravastatin sodium/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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pravafenix is and what it is used for
2.
What you need to know before you take Pravafenix
3.
How to take Pravafenix
4.
Possible side effects
5.
How to store Pravafenix
6.
Contents of the pack and other information
1.
WHAT PRAVAFENIX IS AND WHAT IT IS USED FOR
Pravafenix contains two active substances: pravastatin and
fenofibrate. Both are cholesterol/lipid
modifying medicines.
PRAVAFENIX IS USED IN ADDITION TO LOW FAT DIET IN ADULTS
-
To lower the level of your ‘bad’ cholesterol (LDL cholesterol). It
does this by lowering the level
of total cholesterol, and fatty substances called triglycerides in the
blood.
-
To raise the level of your ‘good’ cholesterol (HDL cholesterol).
WHAT SHOULD I KNOW ABOUT CHOLESTEROL AND TRIGLYCERIDES?
Cholesterol is one of several fats found in your blood. Your total
cholesterol is made up mainly of
LDL and HDL cholesterol.
LDL cholesterol is often called ‘bad’ cholesterol because it can
build up in the walls of your arteries
and form plaque. Over time, this plaque build-up can lead to a
clogging of your arteries. This clogging
can slow or block blood flow to vital organs such as the heart and
brain. When the blood flow is
blocked, the result can be a heart attack or stroke.
HDL cholesterol is often called ‘good’ cholesterol because it
helps keep the ‘bad’ cholesterol

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pravafenix 40 mg/160 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each hard capsule contains 40 mg pravastatin sodium and 160 mg
fenofibrate.
Excipient(s) with known effect:
Each hard capsule contains 19 mg of lactose monohydrate and 33.3 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Hard capsule, with light green body and olive cap, containing a waxy
white beige mass and a tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pravafenix is indicated as an adjunct to diet and other
non-pharmacological treatment (e.g. exercise,
weight reduction) for the treatment of mixed hyperlipidaemia in adult
patients at high cardiovascular
risk to reduce triglycerides and increase HDL-C when LDL-C levels are
adequately controlled while
on a treatment with pravastatin 40 mg monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravafenix, secondary causes of combined
dyslipidaemia should be excluded and
patients should be placed on a standard cholesterol and
triglycerides-lowering diet which should be
continued during treatment.
Posology
The recommended dose is one capsule per day. Dietary restrictions
instituted before therapy should be
continued.
Response to therapy should be monitored by determination of serum
lipid values. Rapid reduction of
serum lipid levels usually follows Pravafenix treatment, but treatment
should be discontinued if an
adequate response has not been achieved within three months.
_Special populations _
_Elderly patients_
_(≥ 65 years old) _
Treatment initiation with Pravafenix should be decided after renal
function has been evaluated (see
section 4.4 Renal and urinary disorders). Limited safety data on
Pravafenix is available in patients >75
years of age and care should be exercised.
_ _
_Renal impairment _
Pravafenix is contraindicated in patients with moderate to severe
renal impairment (defined as a
creatinine clearance < 6