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PROVISACOR 10MG TABLETS

Active substance(s): ROSUVASTATIN

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Crestor 10mg Tablets/Provisacor 10mg Tablets
(rosuvastatin calcium)

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.



Patient Information Leaflet
This medicine is available using any of the above names but
will be referred to as Crestor throughout this leaflet. Please
note this leaflet contains information about other strengths of
the medicine; Crestor 5mg, 20mg and 40mg tablets. This leaflet
has been written to help you get the best effect from your
medicine.

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.

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 cholesterollowering 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.

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
40mg 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 40mg (the highest dose) and
check with your doctor or pharmacist before you
actually start taking any dose of Crestor.

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.

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.

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.

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 40mg (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.

Product: Crestor 10mg Tablets PLPI: 17211/0979 Dimensions: 210 x 400mm Colours: Black Item Code: CRE2010I/K Proof:2

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.

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.
Usual doses in adults
If you are taking Crestor for high cholesterol:

Starting dose
Your treatment with Crestor must start with the 5mg or the
10mg 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.






Uncommon possible side effects (these may affect
between 1 in 100 and 1 in 1,000 patients):

Rash, itching or other skin reactions

An increase in the amount of protein in the urine - this
usually returns to normal on its own without having to
stop taking your Crestor tablets (only Crestor 5mg,
10mg and 20mg).

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 (5mg) 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).

Rare possible side effects (these may affect between 1 in
1,000 and 1 in 10,000 patients):

Severe allergic reaction – signs include swelling of the
face, lips, tongue and/or throat, difficulty in swallowing
and breathing, a severe itching of the skin (with raised
lumps). If you think you are having an allergic
reaction, then stop taking Crestor and seek medical
help immediately

Muscle damage in adults – as a precaution, stop
taking Crestor and talk to your doctor immediately
if you have any unusual aches or pains in your
muscles which go on for longer than expected

A severe stomach pain (inflamed pancreas)

Increase in liver enzymes in the blood

Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is so that
you are taking the amount of Crestor that is right for you. If you
started with a 5mg dose, your doctor may decide to double this
to 10mg, then 20mg and then 40mg if necessary. If you started
on 10mg, your doctor may decide to double this to 20mg and
then 40mg if necessary. There will be a gap of four weeks
between every dose adjustment.
The maximum daily dose of Crestor is 40mg. It is only for
patients with high cholesterol levels and a high risk of heart
attacks or stroke whose cholesterol levels are not lowered
enough with 20mg.

Very rare possible side effects (these may affect less than
1 in 10,000 patients):

Jaundice (yellowing of the skin and eyes)

Hepatitis (an inflamed liver)

Traces of blood in your urine

Damage to the nerves of your legs and arms (such
as numbness)

Joint pain

Memory loss

Breast enlargement in men (gynaecomastia)

If you are taking Crestor to reduce your risk of having
a heart attack, stroke or related health problems:
The recommended dose is 20mg daily. However, your doctor
may decide to use a lower dose if you have any of the factors
mentioned above.
Use in children and adolescents aged 6-17 years
The usual start dose is 5mg. Your doctor may increase your
dose to find the right amount of Crestor for you. The maximum
daily dose of Crestor is 10 mg for children aged 6 to 9 years
and 20 mg for children aged 10 to 17 years. Take your dose
once a day. Crestor 40mg tablet should not be used by
children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Crestor once daily. You can take it at any time of the
day with or without food. Try to take your tablet at the same
time every day to help you to remember it.

If you take more Crestor than you should
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another
condition, tell the medical staff that you’re taking Crestor.
If you forget to take Crestor
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Crestor
Talk to your doctor if you want to stop taking Crestor. Your
cholesterol levels might increase again if you stop taking
Crestor.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
It is important that you are aware of what these side effects
may be. They are usually mild and disappear after a short time.
Stop taking Crestor and seek medical help immediately if
you have any of the following allergic reactions:

Difficulty in breathing, with or without swelling of the
face, lips, tongue and/or throat

Swelling of the face, lips, tongue and/or throat,
which may cause difficulty in swallowing

Severe itching of the skin (with raised lumps).
Also, stop taking Crestor and talk to your doctor
immediately if you have any unusual aches or pains in your
muscles which go on for longer than you might expect. Muscle
symptoms are more common in children and adolescents than
in adults. As with other statins, a very small number of people
have experienced unpleasant muscle effects and rarely these
have gone on to become a potentially life threatening muscle
damage known as rhabdomyolysis.
Common possible side effects (these may affect between 1
in 10 and 1 in 100 patients):

Headache

Stomach pain

Constipation

Feeling sick

Muscle pain

Feeling weak

Product: Crestor 10mg Tablets PLPI: 17211/0979 Dimensions: 210 x 400mm Colours: Black Item Code: CRE2010I/K Proof:2

Regular cholesterol checks
It is important to go back to your doctor for regular cholesterol
checks, to make sure your cholesterol has reached and is
staying at the correct level.
Your doctor may decide to increase your dose so that you are
taking the amount of Crestor that is right for you.

Dizziness
An increase in the amount of protein in the urine – this
usually returns to normal on its own without having to
stop taking your Crestor tablets (only Crestor 40mg)
Diabetes. This is more likely if you have high levels of
sugars and fats in your blood, are overweight and
have high blood pressure. Your doctor will monitor you
while you are taking this medicine.

Side effects of unknown frequency may include:

Diarrhoea (loose stools)

Stevens-Johnson syndrome (serious blistering
condition of the skin, mouth, eyes and genitals)

Cough

Shortness of breath

Oedema (swelling)

Sleep disturbances, including insomnia and
nightmares

Sexual difficulties

Depression

Breathing problems, including persistent cough and/or
shortness of breath or fever

Tendon injury

Muscle weakness that is constant
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5) HOW TO STORE CRESTOR

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Do not use after the expiry date stated on the carton
and blister. The expiry date refers to the last day of the
month.

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Crestor contains:
The active substance in Crestor is rosuvastatin calcium.
Crestor film-coated tablets have 10mg rosuvastatin in them.
The tablets also contain a number of inactive ingredients which
are used to form them. These are: lactose monohydrate,
microcrystalline cellulose, calcium phosphate, crospovidone,
magnesium stearate, hypromellose, glycerol triacetate, titanium
dioxide (E171) and red iron oxide (E172).
What Crestor looks like and contents of the pack
Crestor 10mg film-coated tablets are pink, round and marked
with ‘ZD4522’ and ‘10’ on one side and plain on the reverse.
Crestor 10mg Tablets come in a blister pack containing 28
tablets in two strips of 14 tablets.
Manufacturer
This product is manufactured by AstraZeneca UK Ltd.,
Macclesfield, Cheshire, UK and procured from within the EU by
the Product Licence Holder Polyfarma Ltd and repackaged by
Kent Pharmaceuticals Ltd both at Repton Road, Measham,
DE12 7DT, UK.
POM

Crestor 10mg Tablets/
Provisacor 10mg Tablets

PL No. 17211/0979

Crestor® is a Registered Trademark of the AstraZeneca group
of companies.
Leaflet revision and issue date: 13.10.2015.

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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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