Rosuvastatin 10mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Rosuvastatin calcium

Beszerezhető a:

Viatris UK Healthcare 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: 5016695005232

Betegtájékoztató

*
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

Termékjellemzők

OBJECT 1
ROSUVASTATIN 10MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 31-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Rosuvastatin 10 mg film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect
Lactose:
Each 10 mg film-coated tablet contains 24.9 mg lactose.
Sunset yellow:
Each 10 mg film-coated tablet contains 0.009 mg Sunset yellow.
Allura Red:
Each 10 mg film-coated tablet contains 0.010 mg Allura red.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
10 mg: a pink, round, biconvex, film-coated tablet of 5.55 mm
diameter, debossed with 'M' on one side
and 'RS1' 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.
Adults, adolescents and children aged 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.
Rosuvastatin may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLES