Dorisin XL 80mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Fluvastatin sodium

Beszerezhető a:

Aspire Pharma Ltd

ATC-kód:

C10AA04

INN (nemzetközi neve):

Fluvastatin sodium

Adagolás:

80mg

Gyógyszerészeti forma:

Modified-release tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02120000; GTIN: 5060209730066

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORISIN 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, 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 Dorisin XL is and what it is used for
2. Before you take Dorisin XL
3. How to take Dorisin XL
4. Possible side effects
5. How to store Dorisin XL
6. Contents of the pack and other information
1. WHAT DORISIN XL IS AND WHAT IT IS USED FOR
Dorisin XL contains the active substance 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.
• Dorisin XL is a medicine used to TREAT RAISED LEVELS
OF FATS IN THE BLOOD IN ADULTS, in particular total
cholesterol and so called “bad” or LDL cholesterol,
which is associated with an increased risk of heart
disease and stroke.
• in adult patients with high blood levels of cholesterol.
•
in adult patients with high blood levels of both
cholesterol and triglycerides (another sort of blood
lipid).
• Your doctor can also prescribe Dorisin XL to prevent
further serious cardiac events (e.g. heart attack) in
patients who have already had a heart catheterisation,
with an intervention in the heart vessel.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DORISIN XL
DO NOT TAKE DORISIN XL
• If you are allergic to fluvastatin or any of the other
ingredients of this medicine (listed in section 6).
• If you currently have liver problems or i

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dorisin XL 80mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet of Dorisin XL contains 84.2mg
fluvastatin sodium
equivalent to 80mg fluvastatin free acid.
Excipient with known effect
Each prolonged-release tablet contains 0.19 mmol (4.47 mg) sodium.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Prolonged release tablet.
Dorisin XL tablets are dark yellow, round, biconvex tablets. 10.1mm ±
0.1mm
in diameter and 3.7mm ± 0.2mm in thickness.
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
Posology
_ _
_Adults _
Dyslipidaemia
Prior to initiating treatment with fluvastatin, patients should be
placed on a standard
cholesterollowering 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 fluvastatin may
be used in the
evening. For patients requiring LDL-C reduction to a goal of
≥
25%, the
recommended starting dose is 40 mg Fluvastatin in the evening. The
dose may be
uptitrated to 80 mg daily, administered as a single dose (one Dorisin
XL tablet) at any
time of the day or as one 40 mg dose of Fluvastatin given twice daily
(one dose in the
morning and one dose in the evening).
The maximum lipid-lowering effect with a given dose is achieved within
4 weeks.