Ezetrol 10mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Ezetimibe

可用日期:

Organon Pharma (UK) Ltd

ATC代码:

C10AX09

INN（国际名称）:

Ezetimibe

剂量:

10mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 02120000; GTIN: 5013945197785

资料单张

[Organon] Proprietary
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETROL® 10 MG TABLETS
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 EZETROL is and what it is used for
2.
What you need to know before you take EZETROL
3.
How to take EZETROL
4.
Possible side effects
5.
How to store EZETROL
6.
Contents of the pack and other information
1. WHAT EZETROL IS AND WHAT IT IS USED FOR
EZETROL is a medicine to lower increased levels of cholesterol.
EZETROL lowers levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and
fatty substances called triglycerides in the blood. In addition,
EZETROL raises levels
of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of EZETROL, works by reducing the
cholesterol
absorbed in your digestive tract.
EZETROL adds to the cholesterol lowering effect of statins, a group of
medicines that
reduce the cholesterol your body makes by itself.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total
cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls
of
your
arteries
forming
plaque.
Eventually
this
plaque
build-up
can
lead
to
a
narrowing of the arteries. This narrowing can slow or block blood flow
to vital organs
such as the heart and brain. This blocking of blood flow can result in
a heart attack or
stroke.
HDL cholesterol is often called “good” cholesterol because it
helps keep the bad
cho

产品特点

OBJECT 1
EZETROL 10MG TABLETS
Summary of Product Characteristics Updated 30-Aug-2022 | Organon
Pharma (UK) Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Ezetrol® 10 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect:
Each tablet contains 55 mg of lactose monohydrate.
Ezetrol contains less than 1 mmol (23 mg) sodium per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to off-white, capsule-shaped tablets, approximately 2.60 mm
thick, debossed with “414” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Primary Hypercholesterolaemia
Ezetrol co-administered with an HMG-CoA reductase inhibitor (statin)
is indicated as adjunctive therapy to
diet for use in patients with primary (heterozygous familial and
non-familial) hypercholesterolaemia who are
not appropriately controlled with a statin alone.
Ezetrol monotherapy is indicat