Crestor 5mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Rosuvastatin calcium

Dostopno od:

CST Pharma Ltd

Koda artikla:

C10AA07

INN (mednarodno ime):

Rosuvastatin calcium

Odmerek:

5mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02120000; GTIN: 5055946803937

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CRESTOR® 5 MG FILM-COATED TABLETS
(rosuvastatin calcium)
Your medicine is called Crestor 5mg Film-coated Tablets but will
be referred to as Crestor Tablets throughout this leaflet.
Your medicine is also available in strengths of 10mg, 20mg &
40mg.
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 Crestor is and what it is used for
2)
What you need to know before you take Crestor
3)
How to take Crestor
4)
Possible side effects
5)
How to store Crestor
6)
Contents of the pack and other information
1)
WHAT CRESTOR IS AND WHAT IT IS USED FOR
Crestor belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED CRESTOR BECAUSE:
•
You have a high cholesterol level. This means you are at risk
from a heart attack or stroke. Crestor 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 doing more exercise were not enough to correct
your cholesterol levels. You should continue with your
cholesterol-lowering diet and exercise while you are taking
Crestor.
Or
•
You have other factors that increase your risk of having a
heart attack, stroke or related health problems.
Heart attack, stroke and other problems can be caused by a
disease called atherosclerosis. Atherosclerosis is due to build-up
of fatty deposits in your arteries.
WHY IT IS IMPORTANT TO KEEP TAKING CRESTOR
Crestor is used to correct the levels of fatty substances in the
bloo

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Crestor 5mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium). Each tablet
contains 94.88 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, yellow coloured tablets, intagliated with 'ZD4522' and '5' on
one side
and plain on the reverse.
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.
Crestor 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 (se