Lipocomb 20 mg/10 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN, EZETIMIBE

Available from:

Egis Pharmaceuticals PLC Kereszturi Ut 30-38 1106 Budapest, Hungary

ATC code:

C10BA06

INN (International Name):

ROSUVASTATIN 20 mg EZETIMIBE 10 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ROSUVASTATIN 20 mg EZETIMIBE 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-12-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIPOCOMB 10 MG/10 MG HARD CAPSULES
LIPOCOMB 20 MG/10 MG HARD 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 Lipocomb is and what it is used for
2.
What you need to know before you take Lipocomb
3.
How to take Lipocomb
4.
Possible side effects
5.
How to store Lipocomb
6.
Contents of the pack and other information
1.
WHAT LIPOCOMB IS AND WHAT IT IS USED FOR
Lipocomb 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.
Lipocomb 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 attack or a stroke. By lowering your
cholesterol levels, you can reduce your risk
of ha

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lipocomb 10 mg/10 mg hard capsules
Lipocomb 20 mg/10 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lipocomb 10 mg/10 mg hard capsules
Each capsule contains 10 mg of rosuvastatin (as rosuvastatin zinc) and
10 mg of ezetimibe.
_ _
Lipocomb 20 mg/10 mg hard capsules
Each capsule contains 20 mg of rosuvastatin (as rosuvastatin zinc) and
10 mg of ezetimibe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Lipocomb 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:
one piece of white or almost
white round, flat and bevel-edged
_Ezetimibe 10 mg tablet_
with a stylized E sign on one side of the tablet
and 612 code on the other side; one piece of white or almost white
round
_Rosuvastatin 10 mg tablet_
with
mark on one side of the tablet and no mark on the other side. The
length of the capsule is about
21.7 mm (± 0.5 mm).
Lipocomb 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: one piece of white or almost
white round, flat and bevel-edged
_Ezetimibe 10 mg tablet _
with a stylized E sign on one side of the tablet
and 612 code on the other side; one piece of white or almost white
round
_Rosuvastatin 20 mg _
tablet with
mark on one side of the tablet and no mark on the other side.The
length of the capsule is about
21.7 mm (± 0.5 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Primary hypercholesterolemia: _
Lipocomb 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.
_Prevention of cardiovascular events:_
Lipocomb is indicated as substit