LIPOTHIN 200MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENOFIBRATE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

FENOFIBRATE

Unit dalam pakej:

300 Capsule Capsules; 30Capsule Capsules

Dikeluarkan oleh:

T.O. CHEMICALS (1979) LTD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LIPOTHIN 200MG CAPSULE
Fenofibrate (200mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Lipothin is used for
2.
How Lipothin works
3.
Before you use Lipothin
4.
How to use Lipothin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lipothin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LIPOTHIN IS USED FOR
Lipothin is used as adjunctive therapy to
diet to lower blood cholesterol level.
HOW LIPOTHIN_ _WORKS
Fenofibrate belongs to a group of
medicines, commonly known as fibrates.
It works by reducing the number of
triglycerides and bad cholesterol made in
the body and increases the good
cholesterol.
BEFORE YOU USE LIPOTHIN_ _
_- _
_When you must not use it _
•
have allergy to fenofibrate, its
related compound or other
ingredients in this preparation.
•
have severe kidney disease
•
have liver disease
•
have gallbladder disease
•
had light sensitivity during
treatment with fibrates / ketoprofen
_- _
_Before you start to use it _
Tell your doctor if you have:
•
allergies to any other medicines,
foods, preservatives, or dyes
•
liver problems
•
kidney problems
•
experienced low red and white
blood cells count when taking
similar medicine.
•
gallstone formation or pancreas
inflammation when taking similar
medicine.
•
muscle pain when taking other
cholesterol lowering medicine.
Elderly patient should be cautious in
using this medicine as kidney functions
may be compromised in this age group.
Do regular check up to ascertain this.
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking any other medicines, including
any that you get without a prescription.
These medicines may be affected by
Lipothin or may affect how well it
works. You may need different amount
of your medicines, or you may need to
take different medicines.
Your doctor and pharmacist have more
information on medicines to be careful
with or avoid while taking these
medicines:
-
blood thinning medicine such

Ciri produk

PLEASE READ CAREFULLY
LIPOTHIN 200MG CAPSULES
CONTENT
Each capsule contains 200mg micronised fenofibrate.
DESCRIPTION
White powder filled in orange-orange capsule no. 1
INDICATIONS
LIPOTHIN 200 is indicated as an adjunctive therapy to diet for
treatment of endogenous hypertriglyceridemia isolated (type IV),
hypercholesterolemia
(type
IIa)
or
combined
hypertriglyceridemia (type IIb and III).
RECOMMENDED DOSAGE
Patients should be placed on an appropriate lipid-lowering diet
before receiving LIPOTHIN 200, and should continue this diet
during treatment. The recommended dosage is one LIPOTHIN
200 capsule daily with the main meal.
METHOD OF ADMINISTRATION
For oral administration.
The recommended dose is one capsule taken daily during the
evening
meal.
Since
it
less
well
absorbed
from
an
empty
stomach, LIPOTHIN 200 should always be taken with food.
CONTRAINDICATIONS
• Hypersensitivity to the active substance or to any of the
excipients
•
Hepatic
insufficiency
(including
biliary
cirrhosis
and
unexplained persistent liver function abnormality).
• Known gallbladder disease.
• Severe renal insufficiency (estimated glomerular filtration rate <
30 mL/min/1.73m
2
)
• Chronic or acute pancreatitis with the exception of acute
pancreatitis due to severe hypertriglyceridemia.
• Known photoallergy or phototoxic reaction during treatment
with fibrates or ketoprofen
PRECAUTIONS / WARNING
•
Secondary causes of hyperlipidaemia
Secondary causes of hyperlipidaemia, such as uncontrolled
type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemia, obstructive liver disease, pharmacological
treatment, alcoholism, should be adequately treated before
fenofibrate
therapy
is
initiated.
Secondary
cause
of
hypercholesterolemia
related
to
pharmacological
treatment
can be seen with diuretics
•
Renal impairment
In renal dysfunction the dose of fenofibrate may need to be
reduced, depending on the rate of creatinine clearance.
LIPOTHIN 200 capsules are contraindicated in severe renal
impairment.
Fenofibrate 200 capsul