Rosuvastatin Zentiva 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin calcium

Available from:

Zentiva k.s.

ATC code:

C10AA07

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

rosuvastatin

Authorization date:

2022-06-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN ZENTIVA 5 MG FILM-COATED TABLETS
ROSUVASTATIN ZENTIVA 10 MG FILM-COATED TABLETS
ROSUVASTATIN ZENTIVA 20 MG FILM-COATED TABLETS
ROSUVASTATIN ZENTIVA 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 Zentiva is and what it is used for
2. What you need to know before you take Rosuvastatin Zentiva
3. How to take Rosuvastatin Zentiva
4. Possible side effects
5. How to store Rosuvastatin Zentiva
6. Contents of the pack and other information
1. WHAT ROSUVASTATIN ZENTIVA IS AND WHAT IT IS USED FOR
The name of your medicine is Rosuvastatin Zentiva 5 mg, 10 mg, 20 mg
or 40 mg film-coated Tablets
(referred to as Rosuvastatin Zentiva throughout this leaflet).
Rosuvastatin Zentiva belongs to a group
of medicines called statins.
You have been prescribed Rosuvastatin Zentiva because:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
Rosuvastatin Zentiva 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 Zentiva.
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

Summary of Product characteristics

Health Products Regulatory Authority
01 September 2023
CRN00DHXJ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Zentiva 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10.4 mg rosuvastatin calcium,
equivalent to 10 mg rosuvastatin.
Excipient with known effect
Each film-coated tablet contains 57 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light pink, film-coated, oval, biconvex tablet with score line on one
side with length approx. 9 mm and width approx. 5 mm.
The tablet can be divided into equal doses.
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.
Posology
_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 inhib