PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK 10 mg+10 mg ezetimibe 10 mg tablet and rosuvastatin (as calcium) 10 mg tablet blister composite pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

rosuvastatin calcium, Quantity: 10.4 mg (Equivalent: rosuvastatin, Qty 10 mg)

Boleh didapati daripada:

Pharmacor Pty Ltd

Borang farmaseutikal:

Tablet

Komposisi:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; light magnesium oxide; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red

Laluan pentadbiran:

Oral

Unit dalam pakej:

60 tablets - 3 x 10 day calendar packs containing 30 x ezetimibe10 mg tablets and 30 x rosuvastatin (as calcium) 10 mg tablets, 20 tablets - 1 x 10 day calendar pack containing 10 x ezetimibe 10 mg tablets and 10 x rosuvastatin (as calcium) 10 mg tablets (starter pack)

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Primary HypercholesterolaemiaPHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:,? not appropriately controlled with rosuvastatin or ezetimibe alone; or,? already treated with rosuvastatin and ezetimibe,Homozygous Familial Hypercholesterolaemia (HoFH),PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Ringkasan produk:

Visual Identification: Pink coloured, circular, biconvex, film coated tablets debossed with R on one side and 10 on the other side.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

2023-02-06

Risalah maklumat

PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK
Ver 01
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK?
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR EZETIMIBE ROSUVASTATIN
COMPOSITE PACK?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
4.
HOW DO I USE PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK?
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR EZETIMIBE ROSUVASTATIN
COMPOSITE PACK?
6.
ARE THERE ANY SIDE EFFECTS?
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK contains the active
ingredient ezetimibe and rosuvastatin
calcium. PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE helps to lower
cholesterol levels. It is used in people whose
cholesterol levels are too high and when diet alone cannot lower these
levels adequately.
For more information, see Section 1. Why am I using PHARMACOR
EZETIMIBE ROSUVASTATIN COMPOSITE PACK? in the full
CMI.
Do not use if you have ever had an allergic reaction to PHARMACOR
EZETIMIBE ROSUVASTATIN COMPOSITE PACK 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
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE
PACK? in the full CMI.
Some medicines may interfere with PHARMACOR EZETIMIBE ROSUVASTATIN
COMPOSITE PACK 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.
Your doctor will tell you how much to take. This may depend on your
age, your condition and whether or not you are taking any
other medicines.
More instructions can be found in Section 4. How do I use PHARMACOR
EZETIMIBE ROSUVASTATIN COMPOSITE PACK? in the
full CMI.
THINGS YOU SHOULD
DO

Take PHARMACOR EZETIMIBE ROS

Ciri produk

PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK
Ver: 01 1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR EZETIMIBE
ROSUVASTATIN COMPOSITE PACK
(EZETIMIBE, ROSUVASTATIN) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
Rosuvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR EZETIMIBE
Each tablet of PHARMACOR EZETIMIBE for oral administration contains 10
mg ezetimibe.
List of excipients with known effect:
Contains sugar (as lactose).
CRESTABS
Each film-coated tablet of CRESTABS contains 10 mg, 20 mg or 40 mg
rosuvastatin (as calcium).
Excipients with known effect:
Contains sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PHARMACOR
EZETIMIBE
CRESTABS
PHARMACOR
EZETIMIBE
ROSUVASTATIN
COMPOSITE PACK
10 mg + 10 mg
PHARMACOR
EZETIMIBE
is
White
to
off
white
capsule shaped, flat
faced, beveled edge
tablets,
debossed
with
A25
on
one
side
and
plain
on
other side.
CRESTABS
10
mg
are
pink
color,
circular,
biconvex,
film
coated
tablets
debossed with “R” on one side and “10”
on the other side.
PHARMACOR
EZETIMIBE
ROSUVASTATIN
COMPOSITE PACK
10 mg + 20 mg
CRESTABS
20
mg
are
pink
color,
circular,
biconvex,
film
coated
tablets
debossed with “R” on one side and “20”
on the other side.
PHARMACOR
EZETIMIBE
ROSUVASTATIN
COMPOSITE PACK
10 mg + 40 mg
CRESTABS 40 mg are
pink
color,
oval
shape,
biconvex,
film
coated
tablets
debossed with “R” on one side
and “40” on the other side.
PHARMACOR EZETIMIBE ROSUVASTATIN COMPOSITE PACK
Ver: 01 2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA
PHARMACOR
EZETIMIBE
ROSUVASTATIN
COMPOSITE
PACK
is
indicated
as
adjunctive therapy to diet in patients with primary (heterozygous
familial and non-familial)
hypercholesterolaemia where use of a combination product is
appropriate in those patients:

not appropriately controlled with rosuvastatin or ezetimibe alone; or

already treated with rosuvastatin and ezetimibe
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)
PHARMACOR
EZETIMIBE
ROSUVAS