ROSUVASTATIN MOMAJA 10 Milligram Film Coated Tablet

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

ROSUVASTATIN (AS CALCIUM)

थमां उपलब्ध:

Momaja s.r.o

ए.टी.सी कोड:

C10AA07

INN (इंटरनेशनल नाम):

ROSUVASTATIN (AS CALCIUM)

डोज़:

10 Milligram

फार्मास्यूटिकल फॉर्म:

Film Coated Tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

HMG CoA reductase inhibitors

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2016-03-11

सूचना पत्रक

PACKAGE LEAET: INFORMATION FOR THE USER
ROSUVASTATIN MOMAJA 5 MG LM-COATED TABLETS
ROSUVASTATIN MOMAJA 10 MG LM-COATED TABLETS
ROSUVASTATIN MOMAJA 20 MG LM-COATED TABLETS
ROSUVASTATIN MOMAJA 40 MG LM-COATED TABLETS
Rosuvastatin
READ ALL OF THIS LEAET CAREFULLY BEFORE YOU START TAKING 
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
-  Keep this leaet. 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 leaet. See section 4.
WHAT IS IN THIS LEAET
1)
 What Rosuvastatin Momaja is and what it is used for
2)
 What you need to know before you take Rosuvastatin 
Momaja
3)
 How to take Rosuvastatin Momaja
4)
 Possible side effects
5)
 How to store Rosuvastatin Momaja
6)
 Contents of the pack and other information
1.
 WHAT ROSUVASTATIN MOMAJA IS AND WHAT IT 
IS USED FOR
Rosuvastatin Momaja belongs to a group of medicines 
called statins.
You have been prescribed Rosuvastatin Momaja because:
-  You have a high cholesterol level. This means you are 
at risk from a heart attack or stroke. Rosuvastatin 
Momaja 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 Momaja.
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 de

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Momaja 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipient(s) with known effect:
Each film-coated tablet contains 79.9 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex, coated tablets of approximately 7.1 mm in
diameter, debossed with ‘10’ on one side and ‘B’
on other side.
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 Momaja 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 cardiovascular risk as