LIPAZIL gemfibrozil 600mg tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

gemfibrozil, Quantity: 600 mg

Tilgængelig fra:

Medis Pharma Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: hyprolose; colloidal anhydrous silica; pregelatinised maize starch; calcium stearate; microcrystalline cellulose; polysorbate 80; titanium dioxide; hypromellose; indigo carmine; macrogol 4000

Indgivelsesvej:

Oral

Enheder i pakken:

60 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Gemfibrozil is indicated as an adjunct to diet and other therapeutic measures for the following: * Severe hypertriglyceridaemia (Types IV and V) in persons who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. * Dyslipidaemia associated with diabetes. * Reduction of risk of coronary heart disease in patients with Type IIa and IIb hypercholesterolaemia. * Because of potential toxicity such as malignancy, gall bladder disease, abdominal pain leading to appendicectomy and other abdominal surgeries, an increased incidence in noncoronary mortality, and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug clofibrate, the potential benefits of gemfibrozil in treating Type IIa patients with elevations of LDL choleserol only is not likely to outweigh the risks. In a subgroup analysis of patients in the Helsinki Heart Study with above median HDL cholesterol values at baseline (greater than 1.2mmol/L), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups. NOTE: Gemfibrozil is indicated when exercise, weight loss and specific dietary or other non-drug measures such as limiting alcohol intake have failed. Other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. Periodic determinations of serum lipids should be obtained during treatment with gemfibrozil. The drug should be withdrawn or additionals therapy instituted if the lipid response is deemed inadequate after three months.

Produkt oversigt:

Visual Identification: White, film coated, biconvex, capsule-shaped tablets engraved with 600 and a breakline on one face and plain on the other face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1998-04-03

Indlægsseddel

LIPAZIL
TM
GEMFIBROZIL 600 MG TABLETS
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME OF THE COMMON
QUESTIONS ABOUT LIPAZIL TABLETS. It does not
contain all the available information. It does
not take the place of talking to your doctor or
pharmacist.
ALL MEDICINES HAVE RISKS AND BENEFITS.
Your doctor has weighed the risks of you
taking Lipazil tablets_ _against the benefits the
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You
may need to read it again.
WHAT LIPAZIL TABLETS ARE USED FOR
Lipazil tablets contain gemfibrozil.
Gemfibrozil is used TO TREAT ABNORMAL LEVELS
OF CHOLESTEROL AND TRIGLYCERIDE.
The exact way that gemfibrozil works is
unclear, however, it is thought to reduce the
amount of triglyceride made in the body.
Gemfibrozil belongs to a class of medicines
called fibrates.
Gemfibrozil does not reduce the cholesterol
that enters your body through food.
Therefore, when you are taking Lipazil
tablets, you also need to follow a low fat diet
and other measures such as exercise and
weight control.
Lipazil is only available with a doctor’s
prescription.
Your doctor will have explained why you are
being treated with Lipazil. FOLLOW ALL
DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR
CAREFULLY. THEY MAY DIFFER FROM THE
INFORMATION CONTAINED IN THIS LEAFLET.
Your doctor may have prescribed Lipazil for
another reason. ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY LIPAZIL HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE LIPAZIL TABLETS
_WHEN YOU MUST NOT TAKE LIPAZIL: _
Do not take Lipazil if:

You have ever had an allergic reaction to:

Lipazil or any other medicine
containing gemfibrozil_ _(e.g. Lopid™,
Jezil
TM
, Ausgem
TM
).

Any other medicines containing fibrate
derivates such as fenofibrate.

Any of the ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic reaction
may include: skin rash, itching, difficulty
breathing.

You

Produktets egenskaber

Page 1 of 7
111013 Lipazil PI v4
LIPAZIL
_PRODUCT INFORMATION _
NAME OF THE MEDICINE
LIPAZIL (gemfibrozil) 600 mg tablets
_Chemical Structure: _
CAS no. 25812-30-0 MW 250.3
DESCRIPTION
Gemfibrozil is a nonhalogenated phenoxypentanoic acid. Its chemical
name is 5-(2,5-dimethylphenoxy)-2,2-
dimethylpentanoic acid. It is a white, waxy powder which is stable
under ordinary conditions. The melting point is
58 to 61
o
C. It is practically insoluble in water & acid, sparingly soluble in
alkali, & freely soluble in methanol.
The
other
ingredients
are:
starch-pregelatinised
maize,
silica-colloidal
anhydrous,
hydroxypropylcellulose,
polysorbate 80, cellulose microcrystalline, and calcium stearate in
the tablet core while the coating contains
opadry
white Y-1R-7000B (consisting: hypromellose, Macrogol 4000, indigo
carmine aluminium lake CI 73015 & titanium
dioxide.
ACTIONS
PHARMACOLOGY:
Gemfibrozil
is
a
lipid
regulating
agent
which
decreases
serum
triglycerides
and
total
cholesterol, and increases high density lipoprotein cholesterol (HDL
cholesterol). The lipid lowering changes
occur primarily in the very low density lipoprotein (VLDL) fraction
rich in triglycerides and to a lesser extent in the
low density lipoprotein (LDL) fraction rich in cholesterol.
Gemfibrozil treatment of patients with elevated
triglycerides due to type IV hyperlipoproteinaemia may cause a rise in
LDL cholesterol. However, gemfibrozil
increases the HDL cholesterol subfractions HDL
2
& HDL
3
, as well as apolipoproteins A1 & A11.
The mechanism of action of gemfibrozil has not been definitely
established. In humans, gemfibrozil inhibits
peripheral lipolysis & decreases the hepatic extraction of free fatty
acids, thus reducing hepatic triglyceride
production. Gemfibrozil also inhibits synthesis and increases
clearance of apolipoprotein B, which is a carrier of
VLDL, leading to a decrease in VLDL production.
Gemfibrozil is a lipid regulating agent which decreases serum
triglycerides and VLDL cholesterol, and increases
HDL cholesterol. While modest decre