Rosuvastatin Teva Pharma 20 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin

Available from:

Teva B.V.

ATC code:

C10AA; C10AA07

INN (International Name):

Rosuvastatin

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; rosuvastatin

Authorization status:

Marketed

Authorization date:

2015-11-06

Patient Information leaflet

Rosuvastatin, DK/H/2293/001-004/DC, 19.10.23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN TEVA PHARMA 5 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA PHARMA 10 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA PHARMA 20 MG FILM-COATED TABLETS
ROSUVASTATIN TEVA PHARMA 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 Pharma Teva Pharma is and what it is used
for
2. What you need to know before you take Rosuvastatin Teva Pharma Teva
Pharma
3. How to take Rosuvastatin Teva Pharma film-coated tablets
4. Possible side effects
5. How to store Rosuvastatin Teva Pharma film-coated tablets
6. Contents of the pack and other information
1.
WHAT ROSUVASTATIN TEVA PHARMA FILM-COATED TABLETS IS AND WHAT IT IS
USED FOR
Rosuvastatin Teva Pharma film-coated tablets belongs to a group of
medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN TEVA PHARMA FILM-COATED TABLETS
BECAUSE:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
Rosuvastatin Teva Pharma film-coated tablets 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 Teva Pharma film-coated tablets.
Or
•
You have other factors that increase your risk of having a hear

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2024
CRN00DPZY
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Teva Pharma 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 20 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect:
Each 20 mg film-coated tablet contains 190 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Rosuvastatin 20 mg film-coated tablets: round, biconvex, pink tablet,
debossed with '20' on one side and with a score line on
the other side, diameter: 9 mm.
The tablets can be divided into equal halves.
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 5, 10, 20, 40 mg film-coated tablets _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 ora