Luvinsta XL 80mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Fluvastatin sodium

から入手可能:

Actavis UK Ltd

ATCコード:

C10AA04

INN（国際名）:

Fluvastatin sodium

投薬量:

80mg

医薬品形態:

Modified-release tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02120000; GTIN: 5012617017796

情報リーフレット

_Continued over page_
_Continued top of next column_
AAAI5873
T00075-01 Malta Zejtun 190x380 PIL
Fluvastatin 80mg PIL (Blister Packaging) UK
item no: AAAI5873
print proof no: 1
origination date: 10.2.15
originated by: MB
revision date:
revised by:
dimensions: 190x380 mm
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: N/A
supplier: Malta Zejtun
technically app. date*: N/A
min pt size: 9
TECHNICAL APPROVAL
* Please note the technical approval is provided by the supplier and
is valid on the date indicated.
Any technical changes made by the supplier after approval are not the
responsibility of the Artwork Studio.
[e-mail]
LUVINSTA XL 80MG
PROLONGED-RELEASE TABLETS
Fluvastatin
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, please 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 LUVINSTA XL IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LUVINSTA XL
3 HOW TO TAKE LUVINSTA XL
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE LUVINSTA XL
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT LUVINSTA XL IS AND WHAT IT IS USED FOR
Luvinsta XL contains the active fluvastatin (as fluvastatin
sodium) which belongs to a group of medicines known as
statins, which are lipid-lowering medicines: they lower the
fat (lipids) in your blood. They are used in patients whose
conditions cannot be controlled by diet and exercise alone.
• Luvinsta XL is a medicine used to TREAT RAISED LEVELS OF
FATS IN THE BLOOD IN ADULTS, in particular total cholesterol
and so called “b

製品の特徴

OBJECT 1
LUVINSTA XL 80 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 17-Mar-2016 | Accord-UK Ltd
1. Name of the medicinal product
Luvinsta XL 80 mg Prolonged-Release Tablets
Fluvastatin
2. Qualitative and quantitative composition
One prolonged-release tablet of Luvinsta contains 84.48mg fluvastatin
sodium equivalent to 80 mg
fluvastatin free acid.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Yellow, round, biconvex tablet.
4. Clinical particulars
4.1 Therapeutic indications
Dyslipidaemia
Treatment of adults with primary hypercholesterolaemia or mixed
dyslipidaemia, as an adjunct to diet,
when response to diet and other non-pharmacological treatments (e.g.
exercise, weight reduction) is
inadequate.
Secondary prevention in coronary heart disease
Secondary prevention of major adverse cardiac events in adults with
coronary heart disease after
percutaneous coronary interventions (see section 5.1).
4.2 Posology and method of administration
Adults
Dyslipidaemia
Prior to initiating treatment with Luvinsta, patients should be placed
on a standard cholesterol-lowering
diet, which should be continued during treatment..
Starting and maintenance doses should be individualized according to
the baseline LDL-C levels and the
treatment goal to be accomplished.
The recommended dosing range is 20 to 80 mg/day. For patients
requiring LDL-C reduction to a goal of
< 25% a starting dose of 20 mg of fluvastatin may be used,
administered in the evening. For patients
requiring LDL-C reduction to a goal of ≥25%, the recommended
starting dose is 40 mg of fluvastatin in
the evening. The dose may be uptitrated to 80 mg daily, administered
as a single dose (one Luvinsta
prolonged-release tablet) at any time of the day or as 40 mg of
fluvastatin given twice daily (in the
morning and in the evening).
Luvinsta is only available as 80 mg prolonged-release tablets. For
doses of 20 mg and 40 mg, other
fluvastatin medicinal products must be used.
The maximum lipid-lowerin