IPOLIPID CAPSULES 300MG

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

GEMFIBROZIL

Commercializzato da:

KOMEDIC SDN BHD

INN (Nome Internazionale):

GEMFIBROZIL

Confezione:

500 Capsules

Prodotto da:

MEDOCHEMIE LTD

Foglio illustrativo

_Consumer Medication Information Leaflet (RiMUP) _
IPOLIPID CAPSULE
Gemfibrozil (300mg)
1
WHAT IS IN THIS LEAFLET
1.
What IPOLIPID is used for
2.
How it works
3.
Before you use IPOLIPID
4.
How to use IPOLIPID
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of IPOLIPID
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
11.
Serial no.
WHAT IPOLIPID IS USED FOR
IPOLIPID
is
used
to
treat
hyperlipidaemia (having too much fat in
the blood) and to prevent heart disease in
people in hyperlipidaemia.
IPOLIPID helps reduce cholesterol and
triglycerides (fatty acids) in the blood.
High levels if these types of fat in the
blood are associated with an increased
risk
of
atherosclerosis
(hardening
of
blood vessels/arteries).
IPOLIPID is also used to lower the risk
of stroke, heart attack, or other heart
complications
in
people
with
high
cholesterol and triglycerides who have
not
responded
to
dietary
and
other
measures.
HOW IPOLIPID WORKS
IPOLIPID contains the active substance
gemfibrozil which 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.
BEFORE YOU USE IPOLIPID
_- When you must not use it _
Do not take IPOLIPID:
-
if you are allergic to gemfibrozil or
any of the other ingredients of this
medicine
-
if you have liver disease
-
if you have severe kidney disease
-
if you have a history of gall stones,
bile and gall bladder disease (biliary
tract disease)
-
if in the past you have had
photoallergy or a phototoxicity
reaction (allergic reaction triggered
by exposure to sunlight) during
treatment with fibrates
_- Before you start to use it _
Talk to your doctor or pharmacist before
taking IPOLIPID especially if you have
any of the following conditions:
-
high
risk
of
muscle
breakdown
(rhabdomyolysis):
risk
factors
include
kidney
impairment;
under-
active
thyroid;
over
70
years;
excessive
use
of
alcohol;
previous
history
of
muscular
pain
and
w

Scheda tecnica

IPOLIPID
1. NAME OF THE MEDICINAL PRODUCT
Ipolipid 300mg Capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg of gemfibrozil.
3. PHARMACEUTICAL FORM
Capsule, hard
Description
Ipolipid 300mg: maroon white hard gelatine capsule, size 0 printed
‘IPOLIPID’
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gemfibrozil is used in conjunction with dietary modification in the
treatment of type IIa, type III and type V
hyperlipoproteinemia. It is also indicated for the primary prevention
of ischaemic heart disease in hyperlipidaemic
patients who have not responded to dietary and other measures; in the
USA this use is restricted to type IIb
patients who also have low HDL cholesterol concentrations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Usual adult dose:
Orally 4 capsules (1.2g) a day in two divided dose thirty minutes
before the morning and evening meals.
Usual paediatric dose:
Dose has not been established.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Hepatic impairment
•
Severe renal impairment
•
History of/or pre-existing gall bladder or biliary tract disease,
including gallstones
•
Concomitant use of repaglinide, dasabuvir, selexipag (see section
4.5), simvastatin, or rosuvastatin at 40 mg
•
Patients with previous history of photo allergy or phototoxic reaction
during treatment with fibrates
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Muscle disorders (myopathy/rhabdomyolysis)
There have been reports of myositis, myopathy and markedly elevated
creatine phosphokinase associated with
gemfibrozil. Rhabdomyolysis has also been reported rarely.
Muscle damage must be considered in any patient presenting with
diffuse myalgia, muscle tenderness and/or
marked increase in muscle CPK levels (>5x ULN); under these conditions
treatment must be discontinued.
Concomitant HMG CoA reductase inhibitors
The concomitant administration of gemfibrozil with simvastatin, as