Rosuvastatin 10mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Rosuvastatin calcium

Dostupno od:

Sandoz Ltd

ATC koda:

C10AA07

INN (International ime):

Rosuvastatin calcium

Doziranje:

10mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 02120000; GTIN: 5050650146028

Uputa o lijeku

*
IF YOU REGULARLY DRINK LARGE AMOUNTS OF ALCOHOL.
*
IF YOUR THYROID GLAND is not working properly.
*
IF YOU TAKE OTHER MEDICINES CALLED FIBRATES to lower your cholesterol.
Please read this leaflet carefully, even if you have taken other
medicines for
high cholesterol before.
*
IF YOU TAKE MEDICINES USED TO TREAT THE HIV INFECTION e.g. ritonavir
with
lopinavir and/or atazanavir, please see “OTHER MEDICINES AND
CRESTOR”
*
IF YOU ARE TAKING OR HAVE TAKEN IN THE LAST 7 DAYS A MEDICINE CALLED
FUSIDIC ACID (a medicine for bacterial infection), orally or by
injection. The
combination of fusidic acid and Crestor can lead to serious muscle
problems (rhabdomyolysis), please see “OTHER MEDICINES AND
CRESTOR”
*
IF YOU ARE OVER 70 (as your doctor needs to choose the right start
dose of
Crestor to suit you)
*
IF YOU HAVE SEVERE RESPIRATORY FAILURE.
*
IF YOU ARE OF ASIAN ORIGIN – that is Japanese, Chinese, Filipino,
Vietnamese, Korean and Indian. Your doctor needs to choose the right
start dose of Crestor to suit you.
If any of the above applies to you (or if you are not sure):
*
DO NOT TAKE CRESTOR 40 MG (THE HIGHEST DOSE) AND CHECK WITH YOUR
DOCTOR OR PHARMACIST BEFORE YOU ACTUALLY START TAKING ANY DOSE OF
CRESTOR.
In a small number of people, statins can affect the liver. This is
identified by
a simple test which looks for increased levels of liver enzymes in the
blood. For this reason, your doctor will usually carry out this blood
test (liver
function test) before and during treatment with Crestor.
While you are on this medicine your doctor will monitor you closely if
you
have diabetes or are at risk of developing diabetes. You are likely to
be at risk of developing diabetes if you have high levels of sugars
and fats in
your blood, are overweight and have high blood pressure.
CHILDREN AND ADOLESCENTS
*
IF THE PATIENT IS UNDER 6 YEARS OLD: Crestor should not be given to
children younger than 6 years.
*
IF THE PATIENT IS BELOW 18 YEARS OF AGE: The Crestor 40 mg tablet is
not
suitable for use in children and adolesc

Svojstava lijeka

OBJECT 1
ROSUVASTATIN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Jan-2018 | Sandoz
Limited
1. Name of the medicinal product
Rosuvastatin 10 mg film-coated tablets
2. Qualitative and quantitative composition
Rosuvastatin 10 mg film-coated tablets
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: 53 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Rosuvastatin 10 mg film-coated tablets
Brown, round, film-coated tablets, with a diameter of 6 mm, with
“RSV 10”debossed on one 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.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are
estimated to have a high risk for a first
cardiovascular event (see section 5.1), as an adjunct to correction of
other risk factors.
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 i