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PROVISACOR 5MG FILM COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM / ROSUVASTATIN CALCIUM / 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
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 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 it is 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 are taking or have taken in the last 7 days a medicine
called fusidic acid (a medicine for bacterial infection), orally or by
injection. The combination of fusidic acid and Crestor can lead to
serious muscle problems (rhabdomyolysis), please see Other
medicines and Crestor.
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.
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.
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 below and 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 effect of Crestor.
If you need to take oral fusidic acid to treat a bacterial infection you
will need to temporarily stop using this medicine. Your doctor will
tell you when it is safe to restart Crestor. Taking Crestor with fusidic
acid may rarely lead to muscle weakness, tenderness or pain
(rhabdomyolysis). See more information regarding rhabdomyolysis
in Section 4.
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.

Increasing the dose and maximum daily dose
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).
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 5 mg dose, your doctor may decide to double this to 10
mg, then 20 mg and then 40 mg if necessary. If you started on 10 mg,
your doctor may decide to double this to 20 mg and then 40 mg if
necessary. There will be a gap of four weeks between every dose
adjustment.
The maximum daily dose of Crestor is 40 mg. 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 20 mg.
If you are taking Crestor to reduce your risk of having a heart attack,
stroke or related health problems:
The recommended dose is 20 mg 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 dose range in children and adolescents aged 6 to 17 years is 5 to 20
mg once daily. The usual start dose is 5 mg per day, and your doctor may
gradually increase your dose to find the right amount of Crestor for you.
The maximum daily dose of Crestor is 10 or 20 mg for children aged
6 to 17 years depending on your underlying condition being treated. Take
your dose once a day. Crestor 40 mg 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.
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.
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



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
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)
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 30ºC. Store in the original package to protect
from moisture.
 If your doctor tells you to stop taking your tablets, take any tablets
you have left back to your pharmacist. Do not take your tablets after
the expiry date on the package. Take any tablets that are out of date
back to your pharmacist. If your tablets become discoloured, or show
any other signs of deterioration, take them to your pharmacist for
safe disposal.
 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.
 If you notice signs of your medicine deteriorating, consult your
pharmacist.
6.

Contents of the pack and other information

What Crestor contains
 Each film-coated tablet contains 5mg of the active ingredient,
rosuvastatin (as rosuvastatin calcium).
 The other ingredients are: lactose monohydrate, microcrystalline
cellulose, calcium phosphate, crospovidone, magnesium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171), and yellow
iron oxide (E172).
What Crestor looks like and contents of the pack
Crestor 5mg film-coated tablets are yellow, round and marked with
ZD4522 and 5 on one side and plain on the reverse.
Crestor comes in blister packs containing 28 tablets.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Manufacturer:

It is important that you are aware of what these side effects may be. They
are usually mild and disappear after a short time.

AstraZeneca UK Ltd, Silk Road
Buisness Park, Macclesfield,
Cheshire, SK102NA,
United Kingdom.

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
 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 40 mg)
 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.
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 5 mg, 10 mg and 20 mg).
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

Corden Pharma GmbH,
Otto-Hahn-Strasse, 68723
Plankstadt, Germany.

AstraZeneca GmbH, Tinsdaler
AstraZeneca Reims, Parc
Weg 183, 22880, Wedel, Germany. Industriel Pompelle, Chemin de
Vrilly, Box 1050, Reims Cedex 2,
France.
AstraZeneca AB, S-151085,
Sodertalje, Sweden

AndersonBrecon (UK) Ltd, 2-7
Wye Valley Buisness Park,
Brecon Road, Hay-on-Wye,
Hereford, HR3 5PG,
United Kingdom.

Procured from within the EU.
Parallel Import Product Licence holder: G Pharma Ltd, Salford M50 2PU.
POM

PL 16369/1213
Leaflet Revision Date: 05/04/2017
‘CRESTOR’ is a registered trademark of the AstraZeneca group of
companies.
H.E.A.R.T UK - The Cholesterol Charity - provides information and
advice for patients through a membership magazine, health and diet fact
sheets and a helpline manned by nurses and dieticians.
To become a member of H.E.A.R.T UK or for further information contact:
H.E.A.R.T UK
7 North Road
Maidenhead
Berkshire
SL6 1PE
Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0161 877 8999 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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