FENOFIBRATE VIATRIS fenofibrate 48 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fenofibrate, Quantity: 48 mg

Available from:

Viatris Pty Ltd

INN (International Name):

Fenofibrate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; lactose monohydrate; sucrose; hypromellose; docusate sodium; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; sunset yellow FCF aluminium lake; purified talc; xanthan gum; polyvinyl alcohol; quinoline yellow aluminium lake; lecithin; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fenofibrate Viatris 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.

Product summary:

Visual Identification: Yellow, oval film-coated tablet, engraved with "FI" on one side.; 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

Authorization status:

Licence status A

Authorization date:

2016-04-01

Patient Information leaflet

FENOFIBRATE VIATRIS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FENOFIBRATE VIATRIS?
FENOFIBRATE VIATRIS contains the active ingredient fenofibrate.
FENOFIBRATE VIATRIS is used to help regulate cholesterol
and triglycerides which are fat-like substances in the blood.
For more information, see Section 1. Why am I using FENOFIBRATE
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FENOFIBRATE VIATRIS?
Do not use if you have ever had an allergic reaction to fenofibrate or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
FENOFIBRATE VIATRIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FENOFIBRATE VIATRIS and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE FENOFIBRATE VIATRIS?
•
The initial recommended dose is 145 mg daily, taken as 1 x 145 mg
tablet, your doctor may prescribe a lower dose if you have
kidney problems.
More instructions can be found in Section 4. How do I use FENOFIBRATE
VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FENOFIBRATE VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, surgery, dentist or pharmacist you visit that you
are using this medicine.
•
Tell you doctor if you have these medical conditions: kidney problems,
muscular aching, tenderness or
weakness not caused by exercise.
•
Tell your doctor if you become pregnant.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take this medicine if you have an allergy to any fibrates (such
as gemfibrozil) and ketoprofen.
•
Do not take this medicine if yo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FENOFIBRATE VIATRIS
_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: Soya bean products, sulfites and sugars
as lactose.
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
FENOFIBRATE VIATRIS 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS (DYSLIPIDAEMIA)
FENOFIBRATE VIATRIS 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. FENOFIBRATE
VIATRIS 145 mg and 48 mg tablets should be swallowed whole with a
glass of water. FENOFIBRATE
VIATRIS 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 elderly patients without renal impairment, the normal adult dose is
recommended.
RENAL IMPAIRMENT
FENOFIBRATE VIATRIS Dosage reduction is required in patients with
renal impairment.
In moderate renal dysfunction (eGFR between 30 and 60ml/min/1.73m
2
or creatinine clearance be