LIPIDIL fenofibrate 145 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

fenofibrate, Quantity: 145 mg

Inapatikana kutoka:

Viatris Pty Ltd

INN (Jina la Kimataifa):

Fenofibrate

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: colloidal anhydrous silica; sodium lauryl sulfate; crospovidone; hypromellose; magnesium stearate; lactose monohydrate; docusate sodium; microcrystalline cellulose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

10 tablets, 30 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

LIPIDIL is indicated as an adjunct to diet in the treatment of: hypercholesterolaemia; types II, III, IV and V dislipidaemia; dyslipidaemia associated with type 2 diabetes. Lipidil is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Lipidil does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

Bidhaa muhtasari:

Visual Identification: White, oval film-coated tablet, engraved with "145" on one side and the Fournier logo on reverse.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2006-06-02

Taarifa za kipeperushi

LIPIDIL
®
_fenofibrate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LIPIDIL.
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 or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will 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 LIPIDIL IS USED
FOR
LIPIDIL is used to help regulate
cholesterol and triglycerides which
are fat-like substances in the blood.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body does not balance
the amount of cholesterol it needs
with the amount of cholesterol eaten,
then your cholesterol becomes too
high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
When you have high levels of
cholesterol it may 'stick' to the inside
of your blood vessels instead of
being carried to the parts of the body
where it is needed.
Over time, this can form hard areas
(called plaque) on the walls of your
blood vessels, making it more
difficult for the blood to flow. This
blocking of your blood vessels can
lead to heart disease (such as heart
attack and angina), and stroke.
Cholesterol is carried through the
body by different proteins, LDL and
HDL. LDL cholesterol is the 'bad'
cholesterol that can block your blood
vessels. HDL cholesterol is the 'good'
cholesterol that is thought to remove
the 'bad' cholesterol from the blood
vessels.
In most patients, LIPIDIL reduces
the bad cholesterol and can actually
raise the good cholesterol.
Patients with type 2 diabetes may
have some level of diabetic
retinopathy, a complication of
diabetes that may lead to vision loss
or impairment. LIPIDIL has been
shown to slow the progression of
diabetic retinopathy in

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION
LIPIDIL
®
_fenofibrate tablet _
1
NAME OF THE MEDICINE
Fenofibrate
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 48 mg or 145 mg of fenofibrate as the active
ingredient.
Excipients with known effect: Sugars (as lactose) and soya bean
products.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
48 mg tablets: Yellow, oval, film-coated tablets engraved with
“FI” on one side.
145 mg tablets: White, oval, film-coated tablets engraved “145” on
one side and “Fournier logo” on the
reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LIPIDIL is indicated as an adjunct to diet in the treatment of:
•
hypercholesterolaemia;
•
types II, III, IV and V dyslipidaemia;
•
dyslipidaemia associated with type 2 diabetes.
LIPIDIL is indicated for the reduction in the progression of diabetic
retinopathy in patients with type 2 diabetes
and existing diabetic retinopathy. LIPIDIL does not replace the
appropriate control of blood pressure, blood
glucose and blood lipids in reducing the progression of diabetic
retinopathy.
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS (DYSLIPIDAEMIA AND DIABETIC RETINOPATHY)
LIPIDIL is presented as a 145 mg tablet and a 48 mg tablet. The usual
dose of fenofibrate is 1 x 145 mg tablet.
Although 3 x 48 mg tablets are equivalent to 1 x 145 mg tablet, the 48
mg tablets are only recommended when
a decreased dosage is required (see Section 4.2 DOSE AND METHOD OF
ADMINISTRATION - Renal
Impairment).
Patients should never be administered any combination of the 48 mg
tablet and the 145 mg tablet of
fenofibrate. There is no indication for use of fenofibrate dosages
above 145 mg per day. LIPIDIL 145 mg and
48 mg tablets should be swallowed whole with a glass of water. LIPIDIL
145 mg and 48 mg may be given at
any time of the day, with or without food, but it is recommended that
they be taken at the same time each day.
Dietary measures instituted before therapy should be continued.
ELDERLY
In elderl