Cholib 145mg40mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SIMVASTATIN; FENOFIBRATE

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

SIMVASTATIN; FENOFIBRATE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Fournier Laboratories Ireland Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CHOLIB 145MG/40MG FILM-COATED
TABLET
Fenofibrate (145mg), Simvastatin (40mg)
Page no. 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 it
6. Side effects
7. Storage and disposal of Cholib
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT CHOLIB
IS USED FOR
Cholib contains fenofibrate and
simvastatin 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 40 mg.
HOW CHOLIB WORKS
Cholib 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)
BEFORE YOU USE CHOLIB
_- When you must not use it_
Do not take Cholib if:
•
If you are allergic to
fenofibrate or simvastatin or
any of the other ingredients
•
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
Do not take Cholib if any of the
above applies to you. Check with
your doctor or pharmacist if you are
not sure.
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking Cholib if:
•
you have an under

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Cholib 145 mg/40 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cholib 145 mg/40 mg film-coated tablet contains 145 mg of fenofibrate
and 40 mg of simvastatin.
Excipient(s) with known effect:
One film-coated tablet contains 194.7mg of lactose (as monohydrate),
145 mg of sucrose, 0.8 mg of
lecithin (derived from soya bean (E322)).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, brick-red coloured, 19.3 x 9.3 mm film-coated tablet
with bevelled edges and the inscription
145/40 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cholib 145 mg/40 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/40 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/40 mg film-coated tablet
is contraindicated (see section 4.3).
_Patients with renal impairment _
Cholib 145 mg/4