Atorvastatin Clonmel 10 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Atorvastatin

Dostupno od:

Clonmel Healthcare Ltd

ATC koda:

C10AA; C10AA05

INN (International ime):

Atorvastatin

Doziranje:

10 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

HMG CoA reductase inhibitors; atorvastatin

Status autorizacije:

Marketed

Datum autorizacije:

2016-03-11

Uputa o lijeku

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN CLONMEL 10 MG FILM-COATED TABLETS
ATORVASTATIN CLONMEL 20 MG FILM-COATED TABLETS
ATORVASTATIN CLONMEL 40 MG FILM-COATED TABLETS
ATORVASTATIN CLONMEL 80 MG FILM-COATED TABLETS
atorvastatin
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Atorvastatin Clonmel is and what it is used for
2.
What you need to know before you take Atorvastatin Clonmel
3.
How to take Atorvastatin Clonmel
4.
Possible side effects
5.
How to store Atorvastatin Clonmel
6.
Contents of the pack and other information
1. WHAT ATORVASTATIN CLONMEL IS AND WHAT IT IS USED FOR
Atorvastatin Clonmel belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin Clonmel is used to lower lipids known as cholesterol and
triglycerides in the blood when a
low fat diet and life style changes on their own have failed. If you
are at an increased risk of heart
disease, Atorvastatin Clonmel can also be used to reduce such risk
even if your cholesterol levels are
normal. You should maintain a standard cholesterol lowering diet
during treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN CLONMEL
DO NOT TAKE ATORVASTATIN CLONMEL
•
if you are allergic to atorvastatin or any of the other ingredients of
this medicine (listed in section 6)
•
if you have or have ever had a disease which affects the liver
•
if you have had any unexplained abnormal blood tests for liver
function
•
if you are a woman able to have c

Svojstava lijeka

Health Products Regulatory Authority
24 November 2023
CRN00DV3G
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Clonmel 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 39 mg lactose monohydrate.
Each film-coated tablet contains 20 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 78 mg lactose monohydrate.
Each film-coated tablet contains 40 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 156 mg lactose monohydrate.
Each film-coated tablet contains 80 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each film-coated tablet contains 312 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, biconvex film-coated tablets, diameter: 6
mm.
The _SCORE LINE_ is _NOT INTENDED_ for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Clonmel is indicated as an adjunct to diet for reduction
of elevated total cholesterol (total-C), LDL-cholesterol
(LDL-C), apolipoprotein B, and triglycerides in adults, adolescents
and children aged 10 years or older with primary
hypercholesterolaemia including familial hypercholesterolaemia
(heterozygous variant) or combined (mixed) hyperlipidaemia
(Corresponding to Types Ila and Ilb of the Fredrickson classification)
when response to diet and other non-pharmacological
measures is inadequate.
Atorvastatin Clonmel is also indicated to reduce total-C and LDL-C in
adults with homozygous familial hypercholesterolaemia
as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis)
or if such treatments are unavailable.
Prevention of cardiovascular disease
Pre