Cholib 145mg20mg Film-Coated Tablet

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

FENOFIBRATE; SIMVASTATIN

Tilgjengelig fra:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

FENOFIBRATE; SIMVASTATIN

Enheter i pakken:

30tablet Tablets

Produsert av:

Fournier Laboratories Ireland Limited

Informasjon til brukeren

_Consumer Medication Information Leaflet (RiMUP)_
_ _
_ _
CHOLIB 145MG/20MG FILM COATED
TABLET
Fenofibrate 145mg/ Simvastatin 20mg
1
WHAT IS IN THIS LEAFLET
1. What CHOLIB is used for
2. How CHOLIB works
3. Before you use CHOLIB
4. How to use CHOLIB
5. While you are using CHOLIB
6. Side effects
7. Storage and Disposal of
CHOLIB
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial number
1.WHAT CHOLIB 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).
2. HOW CHOLIB WORKS
Cholib is used in adults at high
risk of problems like heart attack
and stroke who have high blood
levels of 2 types of fats
(triglycerides and LDL
cholesterol). It is given to lower
triglycerides and increase the
good cholesterol (HDL
cholesterol) in patients whose bad
cholesterol (LDL cholesterol) is
already controlled with
simvastatin alone in a dose of 20
mg.
3. BEFORE YOU USE CHOLIB
-
_When you must not use it _
DO NOT TAKE CHOLIB:
-
If you are allergic to
fenofibrate or simvastatin or
any of the other ingredients
of Cholib (listed in section
8).
-
If you are allergic to peanut,
arachis oil, soya lecithin or
related substances.
-
If while taking other
medicines, you have had an
allergic reaction or skin
damage from sunlight or UV
light (these medicines
include other fibrates and an
anti-inflammatory medicine
called “ketoprofen”).
-
If you have liver or
gallbladder problems.
-
If you have pancreatitis
(inflamed pancreas which
causes abdominal pain),
which is not caused by high
levels of fats in the blood.
-
If you have moderate or
severe kidney problems.
-
If you have a history of
muscle problems during
treatment to lower the level
of

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
Cholib 145 mg/20 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cholib 145 mg/20 mg 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, 19.3 x 9.3 mm film-coated tablet with
bevelled edges and the inscription
145/20 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cholib 145 mg/20 mg film-coated tablet 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
145 mg/20 mg film-coated tablet
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 m2 where Cholib
145 mg/20 mg film-coated tablet
is contraindicated (see section 4.3).
_Patients with