Atorvastatin Pinewood 10 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Atorvastatin calcium trihydrate

Disponibil de la:

Pinewood Laboratories Ltd

Codul ATC:

C10AA05

INN (nume internaţional):

Atorvastatin calcium trihydrate

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

atorvastatin

Statutul autorizaţiei:

Marketed

Data de autorizare:

2022-09-16

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN PINEWOOD 10 MG FILM-COATED TABLETS
ATORVASTATIN PINEWOOD 20 MG FILM-COATED TABLETS
ATORVASTATIN PINEWOOD 40 MG FILM-COATED TABLETS
ATORVASTATIN PINEWOOD 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 Pinewood is and what it is used for
2.
What you need to know before you take Atorvastatin Pinewood
3.
How to take Atorvastatin Pinewood
4.
Possible side effects
5.
How to store Atorvastatin Pinewood
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN PINEWOOD IS AND WHAT IT IS USED FOR
Atorvastatin Pinewood belongs to a group of medicines known as
statins, which are lipid (fat)
regulating medicines.
Atorvastatin Pinewood 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 Pinewood 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 PINEWOOD
DO NOT TAKE
ATORVASTATIN PINEWOOD
-
IF YOU USE THE COMBINATION OF GLECAPREVIR/PIBRENTASVIR IN THE
TREATMENT OF HEPATITIS C
-
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 a

Caracteristicilor produsului

Health Products Regulatory Authority
27 March 2024
CRN00F657
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Pinewood 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 film-coated tablet contains 48.23 mg lactose monohydrate. For the
full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets with bisection line on one
side and debossed 10 on other side.
Diameter 7mm ± 0.2mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Pinewood 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 Pinewood 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
Pinewood and should continue on this diet during treatment with
Atorvastatin Pinewood.
The dose should be indivi