Atorvastatin 10 mg Film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Atorvastatin

Disponibil de la:

Accord Healthcare Ireland Ltd.

Codul ATC:

C10AA; C10AA05

INN (nume internaţional):

Atorvastatin

Dozare:

10 milligram(s)

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

HMG CoA reductase inhibitors; atorvastatin

Statutul autorizaţiei:

Marketed

Data de autorizare:

2017-07-28

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN 10 MG FILM-COATED TABLETS
ATORVASTATIN 20 MG FILM-COATED TABLETS
ATORVASTATIN 40 MG FILM-COATED TABLETS
ATORVASTATIN 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 tablets are and what they are used for
2.
What you need to know before you take Atorvastatin tablets
3.
How to take Atorvastatin tablets
4.
Possible side effects
5.
How to store Atorvastatin tablets
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Atorvastatin tablets belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin tablets are 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 tablets 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 TABLETS
DO NOT TAKE ATORVASTATIN TABLETS:
•
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 children and not using

Caracteristicilor produsului

Health Products Regulatory Authority
16 June 2023
CRN00DJVJ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 10 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Atorvastatin 10 mg film-coated tablet contains 23.38 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round shaped, biconvex, film coated tablets with
approx. 5.6 mm diameter, debossed with “FUI” on one side
and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin 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 IIa and IIb of the Fredrickson classification)
when response to diet and other nonpharmacological
measures is inadequate.
Atorvastatin 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
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first cardiovascular event (see section
5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving Atorvastatin and should continue on
this diet during treatment with Atorvastatin.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient response.
The usual starting