Lipocomb 10 mg/10 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Rosuvastatin

Available from:

PCO Manufacturing Ltd.

ATC code:

C10BA06

INN (International Name):

Ezetimibe; Rosuvastatin

Dosage:

10 mg/10 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

rosuvastatin and ezetimibe

Authorization date:

2021-03-05

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIPOCOMB
® 10 MG/10 MG HARD CAPSULES
LIPOCOMB
® 20 MG/10 MG HARD CAPSULES
rosuvastatin/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

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2024
CRN00F1HP
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipocomb 10 mg/10 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg rosuvastatin (as zinc) and 10 mg of
ezetimibe.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
_Product imported from Poland_
Unmarked self-closing Coni Snap type, hard gelatin capsule with yellow
coloured cap and yellow coloured body.
4 CLINICAL PARTICULARS
As per PA1470/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1470/004/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Silicified microcrystalline cellulose (microcrystalline cellulose
(E460) and Colloidal anhydrous silica (E551))
Colloidal anhydrous silica (E551)
Magnesium stearate (E572)
Povidone (E 1201)
Croscarmellose sodium (E468)
Microcrystalline cellulose (E460)
Mannitol (E421)
Sodium laurilsulfate (E514)
Low-substituted hydroxypropyl cellulose (E463)
Capsule shell:
Cap and body:
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatine
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product as marketed in
the country of origin.
Health Products Regulatory Authority
17 January 2024
CRN00F1HP
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30 °C. Store in the original package in order to protect
from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack of 30 hard capsules in cold-formed foil blister (OPA/Al/PVC//Al)
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/460/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 5
th
March 2021
10 DATE OF REVISION OF THE TEXT
January 2024