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PROVISACOR 5MG FILM COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CRESTOR® 5MG FILM-COATED TABLETS
PROVISACOR 5MG FILM-COATED TABLETS
(rosuvastatin calcium)
This product is available as either of the above but will be referred
to as Crestor throughout the remainder of this leaflet.
This product is also available in multiple strengths and all strengths
will be referred to throughout this leaflet.
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 Crestor is and what it is used for
2. What you need to know before you take Crestor
3. How to take Crestor
4. Possible side effects
5. How to store Crestor
6. Contents of the pack and other information
1. WHAT CRESTOR IS AND WHAT IT IS USED FOR
Crestor belongs to a group of medicines called statins.
You have been prescribed Crestor because:
· You have a high cholesterol level. This means you are at risk from a
heart attack or stroke. Crestor 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 Crestor.
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 Crestor?
CRESTOR is used to correct the levels of fatty substances in the blood
called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood – ‘bad’
cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).
· Crestor can reduce the ‘bad’ cholesterol and increase the ‘good’
cholesterol.
· It works by helping to block your body’s production of ‘bad’
cholesterol. It also improves your body’s ability to remove it from your
blood.
For most people, high cholesterol does not affect the way they feel
because it does not produce any symptoms. However, if it is left
untreated, fatty deposits can build up in the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to the heart or brain leading to a heart attack or a
stroke. By lowering your cholesterol levels, you can reduce your risk of
having a heart attack, a stroke or related health problems.
You need to keep taking Crestor, even if it has got your cholesterol to
the right level, because it prevents your cholesterol levels from
creeping up again and causing build up of fatty deposits. However, you
should stop if your doctor tells you to do so, or you have become
pregnant.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CRESTOR
Do not take Crestor:
· If you have ever had an allergic reaction to Crestor, or to any of its
ingredients.
· If you are pregnant or breast-feeding. If you become pregnant while
taking Crestor stop taking it immediately and tell your doctor.
Women should avoid becoming pregnant while taking Crestor by
using suitable contraception.
· If you have liver disease.
· If you have severe kidney problems.
· If you have repeated or unexplained muscle aches or pains.
· If you take a drug called ciclosporin (used, for example, after organ
transplants)
If any of the above applies to you (or you are in doubt), please go back
and see your doctor.
In addition, do not take Crestor 40 mg (the highest dose):
· If you have moderate kidney problems (if in doubt, please ask your
doctor).
· If your thyroid gland is not working properly.
· If you have had any repeated or unexplained muscle aches or
pains, a personal or family history of muscle problems, or a previous
history of muscle problems when taking other cholesterol-lowering
medicines.
· If you regularly drink large amounts of alcohol.
· If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese,
Korean and Indian).
· If you take other medicines called fibrates to lower your
cholesterol.
If any of the above applies to you (or you are in doubt), please go back
and see your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Crestor.
· If you have problems with your kidneys.

·
·

·
·
·
·
·

If you have problems with your liver.
If you have had repeated or unexplained muscle aches or pains,
a personal or family history of muscle problems, or a previous history
of muscle problems when taking other cholesterol-lowering
medicines. Tell your doctor immediately if you have unexplained
muscle aches or pains especially if you feel unwell or have a fever.
Also tell your doctor or pharmacist if you have a muscle weakness
that is constant.
If you regularly drink large amounts of alcohol.
If your thyroid gland is not working properly.
If you take other medicines called fibrates to lower your
cholesterol. Please read this leaflet carefully, even if you have taken
other medicines for high cholesterol before.
If you take medicines used to treat the HIV infection e.g. ritonavir
with lopinavir and/or atazanavir, please see Other medicines and
Crestor.
If you take antibiotics containing fusidic acid, please see Other
medicines and Crestor.

Children and adolescents
· If the patient is under 6 years old: Crestor should not be given to
children younger than 6 years.
· If the patient is below 18 years of age: The Crestor 40 mg tablet is
not suitable for use in children and adolescents below 18 years of
age.
· If you are over 70 (as your doctor needs to choose the right start
dose of Crestor to suit you)
· If you have severe respiratory failure.
· If you are of Asian origin – that is Japanese, Chinese, Filipino,
Vietnamese, Korean and Indian. Your doctor needs to choose the
right start dose of Crestor to suit you.
If any of the above applies to you (or if you are not sure):
· Do not take Crestor 40 mg (the highest dose) and check with
your doctor or pharmacist before you actually start taking any
dose of Crestor.
In a small number of people, statins can affect the liver. This is identified
by a simple test which looks for increased levels of liver enzymes in the
blood. For this reason, your doctor will usually carry out this blood test
(liver function test) before and during treatment with Crestor.
While you are on this medicine your doctor will monitor you closely if you
have diabetes or are at risk of developing diabetes. You are likely to be at
risk of developing diabetes if you have high levels of sugars and fats in
your blood, are overweight and have high blood pressure.
Other medicines and Crestor
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines
Tell your doctor if you are taking any of the following: ciclosporin (used for
example, after organ transplants), warfarin or clopidogrel (or any other
drug used for thinning the blood), fibrates (such as gemfibrozil,
fenofibrate) or any other medicine used to lower cholesterol (such as
ezetimibe), indigestion remedies (used to neutralise acid in your
stomach), erythromycin (an antibiotic), fusidic acid (an antibiotic – please
see Warnings and precautions), an oral contraceptive (the pill), hormone
replacement therapy or anti-viral medications such as ritonavir with
lopinavir and/or atazanavir or simeprevir (used to treat infections,
including HIV or hepatitis C infection – please see Warnings and
precautions). The effects of these medicines could be changed by
Crestor or they could change the effects of Crestor.
Pregnancy and breast-feeding
Do not take Crestor if you are pregnant or breast-feeding. If you
become pregnant while taking Crestor stop taking it immediately and
tell your doctor. Women should avoid becoming pregnant while taking
Crestor by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and operate machinery while using Crestor –
it will not affect their ability. However, some people feel dizzy during
treatment with Crestor. If you feel dizzy, consult your doctor before
attempting to drive or use machines.
Crestor contains lactose.
If you have been told by your doctor that you have an intolerance to some
sugars (lactose or milk sugar), contact your doctor before taking Crestor.
For a full list of ingredients please see Contents of the pack and other
information.
3. HOW TO TAKE CRESTOR
Always take this medicine as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Please find below a translation of the days of the week printed on the
blister.
LUN
MON

MAR
TUE

MER
WED

GIO
THUR

VEN
FRI

SAB
SAT

DOM
SUN

Usual doses in adults
If you are taking CRESTOR for high cholesterol:
Starting dose
Your treatment with CRESTOR must start with the 5 mg or the 10 mg
dose, even if you have taken a higher dose of a different statin before.
The choice of your start dose will depend upon:
· Your cholesterol level.
· The level of risk you have of experiencing a heart attack or stroke.
· Whether you have a factor that may make you more sensitive to
possible side effects.
Please check with your doctor or pharmacist which start dose of
CRESTOR will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
· You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese,
Korean and Indian).
· You are over 70 years of age.
· You have moderate kidney problems.
· You are at risk of muscle aches and pains (myopathy).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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