Fenofibrate Lupin fenofibrate 145 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

fenofibrate, Quantity: 145 mg

Beschikbaar vanaf:

Cipla Australia Pty Ltd

farmaceutische vorm:

Tablet, film coated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

10 tablets, 30 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Fenofibrate is indicated as an adjunct to diet in the treatment of:,- hypercholesterolaemia;,- types II, III, IV and V dyslipidaemia;,- dyslipidaemia assocated with type 2 diabetes.

Product samenvatting:

Visual Identification: White to off white coloured, oval biconvex film coated tablet debossed with Cipla on one side and code 458 on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Registered

Autorisatie datum:

2018-04-30

Bijsluiter

Fenofibrate Lupin CMI v1.1
1
FENOFIBRATE LUPIN
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 LUPIN?
Fenofibrate Lupin contains the active ingredient fenofibrate.
Fenofibrate Lupin 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 Lupin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FENOFIBRATE LUPIN?
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 Lupin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fenofibrate Lupin 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 LUPIN?
•
The initial recommended dose is 145 mg daily, taken as 1 x 145 mg or 3
x 48 mg tablets. 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
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FENOFIBRATE LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Fenofibrate Lupin.
•
Have your blood fats checked when requested by your doctor to make
sure Fenofibrate Lupin is
working.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage without
checking with your doctor.
DRIVING OR USING
MACHINES
•
Fenofibrate Lupin may cause dizziness in some people. Be careful
driving or operating machinery until
you know how Fenofibrate Lupin affects you.
DRINKING
A

Productkenmerken

AUSTRALIAN PRODUCT INFORMATION – FENOFIBRATE LUPIN
(FENOFIBRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Fenofibrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 48 mg tablet contains 48 mg of fenofibrate.
Each 145 mg tablet contains 145 mg of fenofibrate
List of excipients with known effect: sugars (as lactose and sucrose)
and soya bean products.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Fenofibrate Lupin 48 mg are yellow-coloured, oval-shaped, biconvex,
film-coated tablets debossed with
‘Cipla’ on one side and ‘459’ on the other side.
Fenofibrate Lupin 145 mg are white to off-white, oval-shaped,
biconvex, film-coated tablets debossed
with ‘Cipla’ on one side and ‘458’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenofibrate Lupin 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 Lupin is presented as a 145 mg and 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
Lupin 145 mg and 48 mg tablets should be swallowed whole with a glass
of water. Fenofibrate Lupin
Fenofibrate Lupin v1.2
Page 2 of 17
(fenofibrate) film-coated tablets
145 mg and 48 mg tablets 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 no