Cholecomb calcium 20 mg/10 mg harde capsules

Land: Holland

Sprog: hollandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv bestanddel:

EZETIMIB ; ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE

Tilgængelig fra:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

ATC-kode:

C10BA06

INN (International Name):

EZETIMIB ; ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN

Lægemiddelform:

Capsule, hard

Sammensætning:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Rosuvastatin and ezetimibe

Produkt oversigt:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisation dato:

2018-04-25

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECOMB CALCIUM 10 MG/10 MG HARDE CAPSULES
CHOLECOMB CALCIUM 20 MG/10 MG HARDE CAPSULES
rosuvastatin and ezetimibe
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 Cholecomb calcium is and what it is used for
2.
What you need to know before you take Cholecomb calcium
3.
How to take Cholecomb calcium
4.
Possible side effects
5.
How to store Cholecomb calcium
6.
Contents of the pack and other information
1.
WHAT CHOLECOMB CALCIUM IS AND WHAT IT IS USED FOR
Cholecomb calcium contains two different active substances in one
capsule. One of the active substances
is rosuvastatin, belonging to the group of so-called statins, the
other active substance is ezetimibe.
Cholecomb calcium is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol) and fatty substances called triglycerides in your blood.
In addition, it also raises levels of
“good” cholesterol (HDL cholesterol). This medicine works to
reduce your cholesterol in two ways: it
reduces the cholesterol absorbed in your digestive tract, as well as
the cholesterol your body makes by
itself.
_ _
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to the heart
or brain leading to a heart atta

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cholecomb calcium 10 mg/10 mg harde capsules
Cholecomb calcium 20 mg/10 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cholecomb calcium 10 mg/10 mg hard capsules
Each capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium)
and 10 mg of ezetimibe.
Cholecomb calcium 20 mg/10 mg hard capsules
Each capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium)
and 10 mg of ezetimibe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Cholecomb calcium 10
mg/10
mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard
gelatin capsule with yellow coloured cap and yellow coloured body
filled with two tablets. The length of
the capsule is about 21.7
mm (±
0.3
mm).
Cholecomb calcium 20
mg/10
mg hard capsules: Unmarked self-closing Coni Snap type, size 0, hard
gelatin capsule with caramel coloured cap and yellow coloured body
filled with two tablets. The length of
the capsule is about 21.7
mm (±
0.3
mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cholecomb calcium is indicated as adjunct to diet for treatment of
primary hypercholesterolemia as
substitution therapy in adult patients adequately controlled with the
individual substances given
concurrently at the same dose level as in the fixed dose combination,
but as separate products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cholecomb calcium is indicated in adult patients whose
hypercholesterolemia is adequately controlled
with separately administered monocomponent preparations of the same
doses as the recommended
combination.
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with Cholecomb calcium.
The recommended daily dose is one capsule of the given strength with
or without food.
2
Cholecomb calcium are not suitable for initial therapy. Treatment
initiation or dose adjustment if
necessary, should only be done with the monocomponents and after
sett