Rosuvastatin 10mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Rosuvastatin calcium

Beszerezhető a:

Milpharm Ltd

ATC-kód:

C10AA07

INN (nemzetközi neve):

Rosuvastatin calcium

Adagolás:

10mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02120000; GTIN: 8901175028689

Betegtájékoztató

READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR
YOU.
•
Keep this leaflet. You may
need to read it again
•
If you have any further
questions, ask your doctor
or pharmacist
•
This medicine has been
prescribed for you only.
Do not pass it on to
others. It may harm them,
even if their signs of
illness are the same as
yours
•
If you get any side effects,
talk to your doctor or
pharmacist. This includes
any possible side effects
not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Rosuvastatin is and
what it is used for
2.
What you need to know
before you take
Rosuvastatin
3.
How to take Rosuvastatin
4.
Possible side effects
5.
How to store Rosuvastatin
6.
Contents of the pack and
other information
Rosuvastatin belongs to a
group of medicines called
statins.
YOU HAVE BEEN PRESCRIBED
ROSUVASTATIN BECAUSE:
•
You have a HIGH
CHOLESTEROL LEVEL. This
means you are AT RISK
FROM A HEART ATTACK OR
STROKE. Rosuvastatin is
used in adults,
adolescents and children
6 years or older to treat
high cholesterol.
You have been advised to
take a statin, because
changing your diet and taking
more exercise were not
enough to correct your
cholesterol levels. You should
continue with your
cholesterol-lowering diet and
exercise while you are taking
Rosuvastatin.
WHY IS IT IMPORTANT TO KEEP
TAKING ROSUVASTATIN?
Rosuvastatin is used to
correct the levels of fatty
substances in the blood
called lipids, the most
common of which is
cholesterol.
There are different types of
cholesterol found in the blood
– 'bad' cholesterol (LDL-C)
and 'good' cholesterol (HDL-
C).
•
Rosuvastatin can reduce
the 'bad' cholesterol and
increase the 'good'
cholesterol.
•
It works by helping to
block your body's
production of 'bad'
cholesterol. It also
improves your body's
ability to remove it from
your blood.
For most people, high
cholesterol does not affect the
way they feel because it does
not produce any symptoms.
However, if it is left untreated,
fatty depo

Termékjellemzők

OBJECT 1
ROSUVASTATIN 10MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Jan-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Rosuvastatin 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg of Rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: Each 10 mg tablet contains 45.878 mg
lactose monohydrate, 0.015 mg
allura red AC and 0.013 mg Sunset yellow FCF.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink coloured, round shaped [diameter 5.8 mm], biconvex film-coated
tablets, debossed with 'J' on one
side and '54' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia (type IIa
including heterozygous familial hypercholesterolaemia) or mixed
dyslipidaemia (type IIb) as an adjunct
to diet when response to diet and other non-pharmacological treatments
(e.g. exercise, weight reduction)
is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and
other lipid lowering treatments
(e.g. LDL apheresis) or if such treatments are not appropriate.
4.2 Posology and method of administration
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that
should continue during treatment. The dose should be individualised
according to the goal of therapy and
patient response, using current consensus guidelines.
Rosuvastatin may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 or 10 mg orally once daily in both
statin naïve or patients switched from
another HMG CoA reductase inhibitor. The choice of start dose should
take into account the individual
patient's cholesterol level and future cardiovascular risk as well as
the potential risk for adverse reactions
(see below). A dose adjustment to the next