Lescol XL 80 mg Prolonged-release tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Fluvastatin sodium

Dostupné z:

LTT Pharma Limited

ATC kód:

C10AA; C10AA04

INN (Medzinárodný Name):

Fluvastatin sodium

Dávkovanie:

80 milligram(s)

Forma lieku:

Prolonged-release tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

HMG CoA reductase inhibitors; fluvastatin

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2010-11-12

Príbalový leták

LESCOL 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:
What Lescol XL is and what it is used for
What you need to know before you take Lescol XL
How to take Lescol XL
Possible side effects
How to store Lescol XL
Contents of the pack and other information
WHAT LESCOL XL IS AND WHAT IT IS USED FOR
Lescol 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.
*
Lescol 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 Lescol 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.
If you have any questions about how Lescol XL works or why this
medicine
has been prescribed for you, ask your doctor.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LESCOL XL
Follow all your doctor’s instructions carefully, even if they differ
from the
general information contained in this leaf

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lescol XL 80 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
One prolonged release tablet of Lescol contains 84.24 mg fluvastatin
sodium equivalent of 80 mg Fluvastatin free acid.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet
_Product imported from the Czech Republic_
Yellow round, slightly biconvex film-coated tablet with bevelled
edges, approx. 10mm in diameter, debossed with
“LE” on one side/”NVR” on the other.
4 CLINICAL PARTICULARS
As per PA0013/053/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/053/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core
Cellulose microcrystalline
Hypromellose
Hydroxypropyl cellulose
Potassium hydrogen carbonate
Povidone
Magnesium stearate
Coating
Hypromellose
Macrogol 8000
Iron oxide yellow (E172)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_4_
_/_
_1_
_2_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_5_
_7_
_4_
_5_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original package to protect
from light and moisture.
6.