Rosuvastatin Pinewood 20 mg Film-coated Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Rosuvastatin

Dostępny od:

Pinewood Laboratories Ltd

Kod ATC:

C10AA; C10AA07

INN (International Nazwa):

Rosuvastatin

Dawkowanie:

20 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

HMG CoA reductase inhibitors; rosuvastatin

Status autoryzacji:

Marketed

Data autoryzacji:

2017-07-28

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN PINEWOOD 5 MG FILM-COATED TABLETS
ROSUVASTATIN PINEWOOD 10 MG FILM-COATED TABLETS
ROSUVASTATIN PINEWOOD 20 MG FILM-COATED TABLETS
ROSUVASTATIN PINEWOOD 40 MG FILM-COATED TABLETS
Rosuvastatin
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 Rosuvastatin Pinewood is and what it is used for
2.
What you need to know before you take Rosuvastatin Pinewood
3.
How to take Rosuvastatin Pinewood
4.
Possible side effects
5.
How to store Rosuvastatin Pinewood
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN PINEWOOD IS AND WHAT IT IS USED FOR
Rosuvastatin Pinewood belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN PINEWOOD BECAUSE:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
ROSUVASTATIN PINEWOOD
is used in adults, adolescents and children 6 years or older to treat
high cholesterol.
You have been advised to take a statin, because changing your diet and
doing more exercise were not
enough to correct your cholesterol levels. You should continue with
your cholesterol-lowering diet and
exercise while you are taking Rosuvastatin Pinewood.
Or
•
You have other factors that increase your risk of having a heart
attack, stroke or related health
problems.
Heart attack, stroke and other problems can be caused by a disease
called atherosclerosis.
Atherosclerosis is due to build up of fatty deposits in your arteries.
WHY IS IT IMPORTANT TO KEEP TAKING ROSUVASTAT

Charakterystyka produktu

Health Products Regulatory Authority
20 November 2023
CRN00DJ5F
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Pinewood 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: Lactose monohydrate.
Each film-coated tablet contains 193.57 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘20’
on one side, with diameter 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia (type IIa including heterozygous
familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as
an adjunct to diet when response to diet and other
non-pharmacological treatments (e.g. exercise, weight reduction) is
inadequate.
Adults, adolescents and children aged 6 years or older with homozygous
familial hypercholesterolaemia as an adjunct to diet
and other lipid lowering treatments (e.g. LDL apheresis) or if such
treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are
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
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that should continue during
treatment. The dose should be individualised according to the goal of
therapy and patient response, using current consensus
guidelines.
Rosuvastatin Pinewood may be given at any time of day, with or without
food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 mg or 10 mg orally once daily in both
statin naïve or patients switched from another HMG
CoA reductase inhibi