Cadaff XL 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluvastatin sodium

Available from:

Torrent Pharma (UK) Ltd

ATC code:

C10AA04

INN (International Name):

Fluvastatin sodium

Dosage:

80mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5060183631953

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CADAFF XL 80 MG 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.
WHAT IS IN THIS LEAFLET
1.
What Cadaff XL is and what it is used for
2.
What you need to know before you take Cadaff XL
3.
How to take Cadaff XL
4.
Possible side effects
5.
How to store Cadaff XL
6.
Contents of the pack and other information
1.
WHAT CADAFF XL IS AND WHAT IT IS USED FOR
Cadaff XL contains the active 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.
•
Cadaff 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.
o
in adult patients with high blood levels of cholesterol
o
in adult patients with high blood levels of both cholesterol and
triglycerides (another sort
of blood lipid)
•
Your doctor can also prescribe Cadaff XL to prevent further serious
cardiac events (e.g. heart
attack) in patients after they already went through a heart
catheterisation, with an intervention in
the heart vessel.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CADAFF XL
Follow all instructions given to you by your doctor carefully. They
may differ from the information
contained in this leaflet.
Read the following explanations before you take Cadaff XL.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cadaff XL 80 mg prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cadaff XL 80 mg prolonged-release tablet contains 84.48 mg
fluvastatin
sodium equivalent to 80 mg fluvastatin.
Excipients:
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet
Yellow, round, biconvex tablet embossed with “F” on one side.
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
cholesterol-lowering
diet,
which
should
be
continued
during
treatment.
Starting and maintenance doses should be individualised 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 may be used
as
one capsule in the evening. For patients requiring LDL-C reduction to
a goal
of
≥
25%, the recommended starting dose is 40 mg as one capsule in the
evening. The dose may be uptitrated to 80 mg daily, administered as a
single
dose (one Cadaff XL tablet) at any time of the day or as one 40 mg
capsule
given twice daily (one in the morning and one in the evening).
The maximum lipid-lowering effect with a given dose is achieved within
4
weeks. Dose adjustments should be made at intervals of 4 weeks or
more.
Secondary prevention in coronary heart disease
In
patients
with
coronary
heart
disease
after
percuta