ROSUVASTATIN TEVA 5 Milligram Film Coated Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

Teva Pharma B.V.

Kod ATC:

C10AA07

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Dos:

5 Milligram

Borang farmaseutikal:

Film Coated Tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

HMG CoA reductase inhibitors

Status kebenaran:

Authorised

Tarikh kebenaran:

2010-04-16

Risalah maklumat

Rosuvastatin, HU/H/0218/001-004, 22.12.2016
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN TEVA 5 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA 10 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA 20 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Rosuvastatin Teva
3.
How to take Rosuvastatin Teva
4.
Possible side effects
5.
How to store Rosuvastatin Teva
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN TEVA IS AND WHAT IT IS USED FOR
Rosuvastatin Teva belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN TEVA BECAUSE:

You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
Rosuvastatin Teva 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
taking 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 Teva.
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 ROSUVASTATIN

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Teva 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatin Teva 5 mg: Each film-coated tablet contains 5 mg
rosuvastatin (as rosuvastatin calcium).
Excipients with known effect
Rosuvastatin Teva 5 mg: Lactose anhydrous (54.97 mg/tablet) and sunset
yellow FCF (0.022 mg/tablet).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orange, round, standard convex film-coated tablets, debossed with "N"
on one side and with "5" on the other side of
the tablet.
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.
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 Teva may be given at any time of day, with or without
food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 or 10 mg orally once daily in both
statin naïve or patients switched from another
HMG CoA reductase inhibitor. The choice of start dose should take into
account the individual patient's cholesterol
level and future