Lorstat

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Atorvastatin calcium trihydrate 10.844mg equivalent to Atorvastatin 10 mg;  

Предлага се от:

Viatris Limited

INN (Международно Name):

Atorvastatin calcium trihydrate 10.844 mg (equivalent to Atorvastatin 10 mg)

дозиране:

10 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Atorvastatin calcium trihydrate 10.844mg equivalent to Atorvastatin 10 mg   Excipient: Arginine Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose Magnesium stearate Microcrystalline cellulose Opadry white 85F18378 Opadry White OY-B-28920 AMB Sodium carbonate

Вид предписание :

Prescription

Произведено от:

Mylan Laboratories Limited

Терапевтични показания:

Lorstat is indicated as an adjunct to diet to reduce elevated total-C, LDL-C and TG levels in patients with primary hypercholesterolaemia or mixed dyslipidaemia where the primary abnormality is either elevated cholesterol or triglycerides when response to diet and other non-pharmacological measures is inadequate. Lorstat is also indicated to reduce total-C and LDL-C in patients with heterozygous and homozygous familial hypercholesterolaemia.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, PVC/ Aclar and aluminium - 10 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, OPA/ Al/ PVC - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/ Aclar and aluminium - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, OPA/ Al/ PVC - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, White opaque high density HDPE - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, White opaque high density HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Дата Оторизация:

2014-10-28

Листовка

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LORSTAT
®
_ATORVASTATIN TABLETS 10 MG, 20 MG, 40 MG & 80 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Lorstat.
This leaflet answers some common
questions about Lorstat.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lorstat
against the benefits they expect it
will 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 LORSTAT IS
TAKEN FOR
Lorstat is used to treat lower high
cholesterol levels.
Lorstat is also used in people who
have high blood pressure and
coronary heart disease (CHD) or
who are at risk of CHD (for
example, if they have diabetes, a
history of stroke, or small blood
vessel disease). In these people,
Lorstat is used to reduce the risk of
having a heart attack or stroke.
_HOW LORSTAT WORKS_
Lorstat contains the active
ingredient _atorvastatin calcium._ It
belongs to a group of medicines
called HMG-CoA reductase
inhibitors (also known as “statins”)
It works by reducing the amount of
cholesterol made by the liver. More_ _
specifically, Lorstat reduces the
amount of LDL (bad cholesterol)
and raises the amount of HDL
(good cholesterol). Lorstat also
helps to protect you from a heart
attack or stroke.
_WHAT IS CHOLESTEROL_
Everyone has cholesterol and
triglycerides in their blood. They
are types of blood fat needed by the
body for many things, such as
building cell walls, making bile acids
(which help to digest food) and
some hormones. However, too
much cholesterol and triglycerides
can be a problem.
Cholesterol is present in many
foods and is also made in your body
by the liver. If your body does not
balance the amount of cholesterol it
needs with the amount of
cholesterol eaten, then your
cholesterol becomes too high.
High cholestero

Данни за продукта

Page 1 of 21
NEW ZEALAND DATA SHEET
LORSTAT
®
1. PRODUCT NAME
Lorstat, 10 mg, 20 mg, 40 mg & 80 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lorstat tablet contains 10 mg, 20 mg, 40 mg or 80 mg of
atorvastatin (as calcium trihydrate).
Excipient with known effect: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lorstat 10 mg: White, oval, biconvex, film coated tablet, plain on one
side and debossed “10” on the
other side.
Lorstat 20 mg: White, oval, biconvex, film coated tablet, with
breakline on one side and debossed
“20” on the other side.
Lorstat 40 mg: White, oval, biconvex, film coated tablet, with
breakline on one side and debossed
“40” on the other side.
Lorstat 80 mg: White, oval, biconvex, film coated tablet, with
breakline on one side and debossed
“80” on the other side.
The 20 mg, 40 mg and 80 mg tablets can be divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Lorstat is indicated as an adjunct to diet to reduce elevated total
cholesterol (total-C), low density
lipoprotein
cholesterol
(LDL-C)
and
triglycerides
(TG)
levels
in
patients
with
primary
hypercholesterolaemia or mixed dyslipidaemia where the primary
abnormality is either elevated
cholesterol or triglycerides when response to diet and other
non-pharmacological measures is
inadequate.
Lorstat is also indicated to reduce total-C and LDL-C in patients with
heterozygous and homozygous
familial hypercholesterolaemia.
Lorstat is indicated to increase plasma high density lipoprotein
cholesterol (HDL-C) and decrease
the LDL-C/HDL-C and total-C/HDL-C ratios.
Page 2 of 21
Lorstat is indicated as an adjunct to diet for the treatment of
patients with elevated serum triglyceride
levels (hypertriglyceridaemia), and for the treatment of patients with
dysbetalipoproteinaemia who
do not respond adequately to diet.
Lorstat is indicated for the reduction of cardiac ischaemic events in
patients with asymptomatic or
mildly to moderately