Cholestagel
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
25-05-2021
Produktets egenskaber
(SPC)
25-05-2021
Offentlige vurderingsrapport
(PAR)
17-05-2010
Aktiv bestanddel:
colesevelam (as hydrochloride)
Tilgængelig fra:
CHEPLAPHARM Arzneimittel GmbH
ATC-kode:
C10AC04
INN (International Name):
colesevelam
Terapeutisk gruppe:
Lipid modifying agents
Terapeutisk område:
Hypercholesterolemia
Terapeutiske indikationer:
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
Produkt oversigt:
Revision: 23
Autorisation status:
Authorised
Autorisation dato:
2004-03-09
Indlægsseddel
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHOLESTAGEL 625 MG FILM-COATED TABLETS
Colesevelam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Cholestagel is and what it is used for
2.
What you need to know before you take Cholestagel
3.
How to take Cholestagel
4.
Possible side effects
5.
How to store Cholestagel
6.
Contents of the pack and other information
1.
WHAT CHOLESTAGEL IS AND WHAT IT IS USED FOR
Cholestagel contains the active substance colesevelam (as
hydrochloride). Taking Cholestagel helps to
lower the level of cholesterol in your blood. Your doctor should only
give you Cholestagel if a diet
low in fat and cholesterol did not work well enough on its own.
Cholestagel works in your intestinal system by binding bile acids
produced by your liver and carrying
the bile acids out of your body with your faeces. This prevents your
body from recycling the bile acids
from your intestines in the usual way. Without the recycling process,
your liver has to make additional
bile acids. Your liver uses cholesterol from your blood to do this,
which lowers the level of cholesterol
in your blood.
Cholestagel is prescribed to treat a condition known as primary
hypercholesterolaemia (when
cholesterol in the blood is elevated) in adults.
-
Cholestagel may be prescribed on its own in addition to a diet low in
fat and cholesterol when
treatment with a statin (a class of cholesterol-lowering medicines
that work in the liver) is
inappropriate or not well tolerated.
-
Cholestagel may be u
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cholestagel 625 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 625 mg colesevelam (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Off-white, capsule-shaped film-coated tablets imprinted with
“C625” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cholestagel co-administered with a
3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase
inhibitor (statin) is indicated as adjunctive therapy to diet to
provide an additive reduction in
low-density lipoprotein cholesterol (LDL-C) levels in adult patients
with primary
hypercholesterolaemia who are not adequately controlled with a statin
alone.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet
for reduction of elevated
total-cholesterol and LDL-C in adult patients with primary
hypercholesterolaemia, in whom a statin is
considered inappropriate or is not well-tolerated.
Cholestagel can also be used in combination with ezetimibe, with or
without a statin, in adult patients
with primary hypercholesterolaemia, including patients with familial
hypercholesterolaemia (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Combination therapy _
The recommended dose of Cholestagel for combination with a statin with
or without ezetimibe is 4 to
6 tablets per day. The maximum recommended dose is 6 tablets per day
taken as 3 tablets twice per
day with meals or 6 tablets taken once per day with a meal. Clinical
trials have shown that Cholestagel
and statins can be co-administered or dosed apart, and that
Cholestagel and ezetimibe can be co-
administered or dosed apart.
_ _
_Monotherapy _
The recommended starting dose of Cholestagel is 6 tablets per day
taken as 3 tablets twice per day
with meals or 6 tablets once per day with a meal. The maximum
recommended dose is 7 tablets per
day.
During therapy, the cholesterol-lowering diet shoul
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