Rosuvastatin 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rosuvastatin calcium

Available from:

Zentiva Pharma UK Ltd

ATC code:

C10AA07

INN (International Name):

Rosuvastatin calcium

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5000283659747

Patient Information leaflet

*
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

Summary of Product characteristics

OBJECT 1
ROSUVASTATIN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Jan-2018 | Zentiva
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 10.4 mg of rosuvastatin calcium,
which is equal to 10 mg of rosuvastatin.
Excipient with known effect: lactose monohydrate.
Rosuvastatin 10 mg film-coated tablets contain 60 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Rosuvastatin 10 mg film-coated tablets: light pink, film-coated, oval,
biconvex tablets with halving score
with length approx. 8.8 mm and width approx. 4.5 mm. The tablet can be
divided into equal doses.
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.
Adults, adolescents and children over 6 years or older with 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.
Posology
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 mg o