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ROSUVASTATIN 5 MG FILM COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM

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1656
29.09.15[20]

Crestor® 5mg Film-Coated Tablets
Rosuvastatin 5mg Film-Coated Tablets
(rosuvastatin calcium)
PATIENT INFORMATION 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.
This medicine is available using any one of the above names but will be
referred to as Crestor throughout this leaflet.
Crestor Tablets are also available in other strengths.
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.
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).
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 usual start dose is 5 mg. 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 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.

The following is a translation of the days of the week on the blister strip:
LUN – Monday
MAR – Tuesday
MER – Wednesday
JEU – Thursday
VEN – Friday
SAM – Saturday
DIM – Sunday
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
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
- 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
- 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: 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
- As with all medicines, keep your tablets in a safe place where children
cannot see or reach them. Your tablets could harm them.
- Do not store your tablets above 30°C. Store in the original package.
- 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 container. Take any
tablets that are out of date back to your pharmacist.
- If your tablets show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Crestor contains
The active ingredient in Crestor is rosuvastatin calcium.
Each Crestor film-coated tablet contains 5mg rosuvastatin (as the
rosuvastatin calcium).
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 yellow iron oxide (E172).
Crestor is available as round, yellow coloured, film coated tablets
intagliated with ‘ZD4522’ and ‘5’ on one side and plain on the reverse.
Crestor comes in a calendar blister strip pack containing 28 or 84 tablets in
strips of 14 tablets and blister strip pack containing 30 or 90 tablets.
Manufacturer and Product Licence holder
Manufactured by AstraZeneca Reims, Chemin de Vrilly, BP 1050, 51689
Reims Cedex 2, France. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/1656

Leaflet revision and issue date (Ref) 29.09.15[20]
Crestor is a trademark of IPR Pharmaceuticals, Inc.
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.

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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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