Cholib
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
06-03-2024
Summary of Product characteristics
(SPC)
06-03-2024
Public Assessment Report
(PAR)
18-09-2013
Active ingredient:
fenofibrate, simvastatin
Available from:
Viatris Healthcare Limited
ATC code:
C10BA04
INN (International Name):
fenofibrate, simvastatin
Therapeutic group:
Lipid modifying agents
Therapeutic area:
Dyslipidemias
Therapeutic indications:
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
Product summary:
Revision: 16
Authorization status:
Authorised
Authorization date:
2013-08-26
Patient Information leaflet
54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHOLIB 145 MG/20 MG FILM-COATED TABLETS
fenofibrate/simvastatin
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. 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 Cholib is and what it is used for
2.
What you need to know before you take Cholib
3.
How to take Cholib
4.
Possible side effects
5.
How to store Cholib
6.
Contents of the pack and other information
1.
WHAT CHOLIB IS AND WHAT IT IS USED FOR
Cholib contains two different active substances: fenofibrate (belongs
to the group called ‘fibrates’)
and simvastatin (belongs to the group called ‘statins’). They are
both used to lower levels of total
cholesterol, “bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the blood.
In addition, they both raise levels of “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.
HDL cholesterol is often called ‘good’ cholesterol because it
helps keep the ‘bad’ cholesterol from
building up in the arteries and because it protects against heart
disease.
Triglycerides are another fat in your blood. They may raise your risk
of having heart problems.
In most people, there are no signs of cholesterol or
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cholib 145 mg/20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 145 mg of fenofibrate and 20 mg of
simvastatin.
Excipient(s) with known effect:
One film-coated tablet contains 160.1 mg of lactose (as monohydrate),
145 mg of sucrose, 0.7 mg
of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset
yellow FCF (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, tan coloured, film-coated tablet, with bevelled edges
and 145/20 on one side. The
diameter dimensions are 19.3 x 9.3 mm approximately and the tablet
weight is about 734 mg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cholib is indicated as adjunctive therapy to diet and exercise in high
cardiovascular risk adult patients
with mixed dyslipidaemia to reduce triglycerides and increase HDL-C
levels when LDL-C levels are
adequately controlled with the corresponding dose of simvastatin
monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Secondary causes of hyperlipidaemia, such as uncontrolled type 2
diabetes mellitus, hypothyroidism,
nephrotic syndrome, dysproteinemia, obstructive liver disease,
pharmacological treatment (like oral
oestrogens), alcoholism should be adequately treated, before Cholib
therapy is considered 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 tablet per day. Grapefruit juice should be
avoided (see section 4.5).
Response to therapy should be monitored by determination of serum
lipid values (total cholesterol
(TC), LDL-C, triglycerides (TG)).
_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 m
2
where Cholib is
contraindicated (see section 4.3).
_Patients w
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