NOUMED ATORVASTATIN atorvastatin (as calcium trihydrate) 10 mg tablets blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

atorvastatin calcium trihydrate, Quantity: 10.845 mg (Equivalent: atorvastatin, Qty 10 mg)

থেকে পাওয়া:

AVALLON PHARMACEUTICALS PTY LTD

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: magnesium stearate; calcium carbonate; lactose monohydrate; croscarmellose sodium; hyprolose; microcrystalline cellulose; polysorbate 80; Euphorbia antisyphilitica; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

6, 30

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

As an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,Indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

পণ্য সারাংশ:

Visual Identification: White to off-white, elliptical, film-coated tablets debossed with "AS10" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2019-11-05

তথ্য লিফলেট

NOUMED ATORVASTATIN
1
NOUMED
ATORVASTATIN
_atorvastatin calcium trihydrate 10/20/40/80 mg Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
ATORVASTATIN.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may
contain important information about
the medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NOUMED
ATORVASTATIN against the
benefits it is expected to 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 THIS MEDICINE IS
USED FOR
NOUMED ATORVASTATIN is
used to lower high cholesterol levels
in your blood.
NOUMED ATORVASTATIN also
helps reduce the risk of having a
heart attack or stroke in people who
have high blood pressure and
coronary heart disease (CHD) or who
have multiple risk factors for CHD,
including diabetes, a history of
stroke, or small blood vessel disease.
Cholesterol is a type of blood fat
needed by the body for many things,
such as building cell lining, making
bile acids (which help to digest food)
and some hormones. However, too
much cholesterol can be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you have too much
cholesterol in your diet, then its level
may become 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 'bad'
cholesterol in your blood, it may
begin to 'stick' to the inside of your
blood vessels instead of being carried
to the parts of the body where it is
n

পণ্য বৈশিষ্ট্য

Product Information – Australia
Noumed Atorvastatin PI
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – NOUMED
ATORVASTATIN (ATORVASTATIN (AS CALCIUM TRIHYDRATE))
1 NAME OF THE MEDICINE
Atorvastatin calcium trihydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Atorvastatin 10 mg tablet contain atorvastatin calcium
equivalent to 10 mg atorvastatin
Noumed Atorvastatin 20 mg tablet contain atorvastatin calcium
equivalent to 20 mg atorvastatin
Noumed Atorvastatin 40 mg tablet contain atorvastatin calcium
equivalent to 40 mg atorvastatin
Noumed Atorvastatin 80 mg tablet contain atorvastatin calcium
equivalent to 80 mg atorvastatin
Excipients with known effects: lactose monohydrate (the 10 mg, 20 mg,
40 mg and 80 mg contains lactose
monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Noumed Atorvastatin 10 mg tablets are white to off-white, elliptical,
film-coated tablets debossed ‘AS10’ on one
side and plain on the other side.
Noumed Atorvastatin 20 mg tablets are white to off-white, elliptical,
film-coated tablets debossed ‘AS20’ on one
side and plain on the other side.
Noumed Atorvastatin 40 mg tablets are white to off-white, elliptical,
film-coated tablets debossed ‘AS40’ on one
side and plain on the other side.
Noumed Atorvastatin 80 mg tablets are white to off-white, elliptical,
film-coated tablets debossed ‘AS80’ on one
side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noumed Atorvastatin is indicated as an adjunct to diet for the
treatment of patients with hypercholesterolaemia.
Prior to initiating therapy with atorvastatin, secondary causes of
hypercholesterolaemia (e.g. poorly controlled
diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive liver disease, other drug
therapy, and alcoholism) should be identified and treated.
Noumed Atorvastatin is indicated in hypertensive patients with
multiple risk factors for coronary heart disease
(CHD) which may include diabetes, h