CRESTABS rosuvastatin (as calcium) 10 mg film-coated tablet bottle pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

rosuvastatin calcium, Quantity: 10.4 mg

Dostupno od:

Pharmacor Pty Ltd

Farmaceutski oblik:

Tablet, film coated

Sastav:

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

Administracija rute:

Oral

Jedinice u paketu:

90, 30

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

CRESTABS should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events CRESTABS is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). CRESTABS is indicated to: ? Reduce the risk of nonfatal myocardial infarction ? Reduce the risk of nonfatal stroke ? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia CRESTABS is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with CRESTABS, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Proizvod sažetak:

Visual Identification: Pink color, circular, biconvex, film coated tablets debossed with R on one side and 10 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2022-05-23

Uputa o lijeku

CRESTABS
1
CRESTABS
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 CRESTABS?
CRESTABS film-coated tablets contains the active ingredient
Rosuvastatin calcium. CRESTABS is used to lower high cholesterol
levels.
For more information, see Section 1. Why am I using CRESTABS?
i
n the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CRESTABS?
Do not use if you have ever had an allergic reaction to CRESTABS 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
CRESTABS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CRESTABS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? i
n the full CMI.
4.
HOW DO I USE CRESTABS?
•
The dose of CRESTABS is related to body weight for all patients. Your
doctor will calculate the dose you need and tell you
how many tablets to take each day.
•
Take CRESTABS once a day, every day, at about the same time each day
with some water.
More instructions can be found in Section 4. How do I use CRESTABS? i
n the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CRESTABS?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CRESTABS.
•
Keep all of your doctor's appointments so that your progress can be
checked. Your doctor will do
regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to
make sure the medicine is
working and to prevent unwanted side effects. Your doctor will also
use these tests to decide when
you should stop taking CRESTABS.
THINGS YOU SHOULD
NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•
Do not use it to treat any ot

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION
CRESTABS (ROSUVASTATIN CALCIUM)
1.
NAME OF THE MEDICINE
Rosuvastatin calcium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of CRESTABS contains 10 mg, 20 mg and 40 mg of
rosuvastatin (as
calcium).
Excipient with known effect: Sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients
3. PHARMACEUTICAL FORM
CRESTABS 10 mg are pink color, circular, biconvex, film coated tablets
debossed with “R” on one
side and “10” on the other side.
CRESTABS 20 mg are pink color, circular, biconvex, film coated tablets
debossed with “R” on one
side and “20” on the other side.
CRESTABS 40 mg are pink color, oval shape, biconvex, film coated
tablets debossed with “R” on
one side and “40” on the other side
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
CRESTABS should be used as an adjunct to diet when the response to
diet and exercise is inadequate.
Prevention of cardiovascular events CRESTABS is indicated for
prevention of major cardiovascular
events in men ≥50 years old and women ≥60 years old with no
clinically evident cardiovascular
disease but with at least two conventional risk factors for
cardiovascular disease (hypertension, low
HDL-C, smoking, or a family history of premature coronary heart
disease). CRESTABS is indicated
to:
• Reduce the risk of nonfatal myocardial infarction
• Reduce the risk of nonfatal stroke
• Reduce the risk of coronary artery revascularisation procedures.
IN PATIENTS WITH HYPERCHOLESTEROLAEMIA
CRESTABS
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
Prior to initiating therapy with CRESTABS, secondary causes of
hypercholesterolaemia (e.g. poorly
controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive liver
disease, other drug therapy, alcoholism) should be identified and
treated.
4.2.
DOSE AND METHOD OF ADMINISTRATION
CRESTABS TABLETS ARE AVAILABLE ONLY IN A 10 MG, 20 MG AND 40 MG
STRENGT