Lipocomb 40 mg/10 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin zinc; Ezetimibe

Available from:

EGIS Pharmaceuticals PLC

ATC code:

C10BA06

INN (International Name):

Rosuvastatin zinc; Ezetimibe

Dosage:

40 /10 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

rosuvastatin and ezetimibe

Authorization status:

Marketed

Authorization date:

2014-08-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIPOCOMB 40 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 having a heart attack, a stroke or re

Summary of Product characteristics

Health Products Regulatory Authority
22 January 2024
CRN00F2F2
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipocomb 40 mg/10 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 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.
Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule
with red coloured cap and yellow coloured body filled with
three 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; two pieces 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 substitution treatment in adult patients with
coronary heart disease (CHD) and a history of acute
coronary syndrome (ACS), who are adequately controlled with the
individual substances administered simultaneously at the
same dose level as in the fixed combination medicinal products, but as
separate products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lipocomb is indicated in adult patients 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 Lipocomb.
The recommended daily dose is one capsuleof the given strength