Atorvastatin Bluefish 10 mg Film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Atorvastatin calcium trihydrate

Tersedia dari:

Bluefish Pharmaceuticals AB

Kode ATC:

C10AA05

INN (Nama Internasional):

Atorvastatin calcium trihydrate

Dosis:

10 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

atorvastatin

Status otorisasi:

Marketed

Tanggal Otorisasi:

2018-11-30

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN BLUEFISH 10 MG FILM-COATED TABLETS
ATORVASTATIN BLUEFISH 20 MG FILM-COATED TABLETS
ATORVASTATIN BLUEFISH 30 MG FILM-COATED TABLETS
ATORVASTATIN BLUEFISH 40 MG FILM-COATED TABLETS
ATORVASTATIN BLUEFISH 60 MG FILM-COATED TABLETS
ATORVASTATIN BLUEFISH 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 BLUEFISH
is and what it is used for
2.
What you need to know before you take
ATORVASTATIN BLUEFISH
3.
How to take
ATORVASTATIN BLUEFISH
4.
Possible side effects
5.
How to store
ATORVASTATIN BLUEFISH
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN BLUEFISH IS AND WHAT IT IS USED FOR
ATORVASTATIN BLUEFISH
belongs to a group of medicines known as statins, which are lipid
(fat) regulating
medicines.
ATORVASTATIN BLUEFISH
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 BLUEFISH
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 BLUEFISH
DO NOT TAKE ATORVASTATIN BLUEFISH
−
if you are hypersensitive (allergic) to
ATORVASTATIN
or to any similar medicines used to lower blood
lipids or to any of the other ingredients of this medicine listed in
section 6

Karakteristik produk

Health Products Regulatory Authority
21 June 2023
CRN00DHV6
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Bluefish 10 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Atorvastatin Bluefish 10 mg film-coated tablets: Each film-coated
tablet contains 10 mg atorvastatin (as atorvastatin calcium
trihydrate).
Excipient(s) with known effect:
Each Atorvastatin Bluefish 10 mg film-coated tablet contains 53.80 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Atorvastatin Bluefish 10 mg film-coated tablets: white oblong,
film-coated tablets, embossed 10 on one side and 'ATV' on the
other side and length: 8.3 mm; width: 4.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
ATORVASTATIN BLUEFISH 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 non-pharmacological
measures is inadequate.
ATORVASTATIN BLUEFISH 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 BLUEFISH and should
continue on this diet during treatment with ATORVASTATIN BLUEFISH.
The dose