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ROSUVASTATIN 5MG FILM COATED TABLETS

Active substance(s): ROSUVASTATIN / ROSUVASTATIN CALCIUM / ROSUVASTATIN ZINC

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Transcript
CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Crestor 5mg tabs

ARTWORKER:
DATE OF PROOF

CODE:

6464/2371E

MANUFACTURER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/04/14

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 04/04/14

Í2§´yd
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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
Keep out of the sight and reach of children.
Do not use after the expiry date, which is stated on the carton, label or blister strip after EXP. The expiry
date refers to the last day of the month.
The tablets should not be thrown in the bin or put down the drain. If they are out of date, or no longer suitable
for you, return them to your pharmacist for safe disposal.
Crestor should not be stored above 30°C.
Keep in the original packaging.
If your tablets become discoloured or show any signs of deterioration, consult your doctor or pharmacist who
will tell you what to do.

6. Contents of the pack and other information
What Crestor contains:
The active substance in Crestor 5mg film-coated tablets is Rosuvastatin calcium equivalent to 5mg
Rosuvastatin.
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:
The tablets are yellow, round and marked ‘ZD4522’ and ‘5’ on one side and plain on the reverse.
Crestor 5mg film-coated tablets are available as blister packs of 30 tablets and calendar blister packs of 28
tablets.
POM

PL No: 6464/2371

This product is manufactured by AstraZeneca Reims, Chemin de Vrilly, BP 1050, 51689 Reims, Cedex 2,
France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 04.04.2014
CRESTOR is a registered 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.

CRESTOR® 5mg Film-Coated Tablets
(Rosuvastatin calcium)
Patient Information Leaflet

This product is known by the above name but will be referred to throughout this leaflet as Crestor. Other
strengths (10mg, 20mg & 40mg) are also available.
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.
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 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.

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.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

&2v2[ª
‘¢>§ƒ(

[v>ƒÌ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Crestor 5mg tabs

ARTWORKER:
DATE OF PROOF

CODE:

6464/2371E

MANUFACTURER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/04/14

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 04/04/14

Í2§´yd
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

Pg 2

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.
Children and adolescents

If the patient is under 10 years old:
Crestor should not be given to children younger than 10 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.
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 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), an oral contraceptive (the pill), hormone replacement therapy or
ritonavir with lopinavir and/or atazanavir (used to treat the HIV 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.
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).

Pg 3

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.
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 overleaf.
Use in children and adolescents aged 10–17 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 20mg. 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.
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 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.
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).
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
Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

&2v2[ª
‘¢>§ƒ(

[v>ƒÌ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Rosuvastatin 5mg tabs

ARTWORKER:

CODE:

6464/2371E

DATE OF PROOF

MANUFACTURER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/04/14

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 04/04/14

Í2§´yd
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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 Rosuvastatin
Keep out of the sight and reach of children.
Do not use after the expiry date, which is stated on the carton, label or blister strip after EXP. The expiry
date refers to the last day of the month.
The tablets should not be thrown in the bin or put down the drain. If they are out of date, or no longer
suitable for you, return them to your pharmacist for safe disposal.
Rosuvastatin should not be stored above 30°C.
Keep in the original packaging.
If your tablets become discoloured or show any signs of deterioration, consult your doctor or pharmacist who
will tell you what to do.

6. Contents of the pack and other information
What Rosuvastatin contains:
The active substance in Rosuvastatin 5mg film-coated tablets is Rosuvastatin calcium equivalent to 5mg
Rosuvastatin.
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 Rosuvastatin looks like and contents of the pack:
The tablets are yellow, round and marked ‘ZD4522’ and ‘5’ on one side and plain on the reverse.
Rosuvastatin 5mg film-coated tablets are available as blister packs of 30 tablets and calendar blister packs
of 28 tablets.
POM

PL No: 6464/2371

This product is manufactured by AstraZeneca Reims, Chemin de Vrilly, BP 1050, 51689 Reims, Cedex 2,
France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 04.04.2014
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.

Rosuvastatin 5mg Film-Coated Tablets
(Rosuvastatin calcium)
Patient Information Leaflet

This product is known by the above name, but will be referred to throughout this leaflet as Rosuvastatin.
Other strengths (10mg, 20mg & 40mg) are also available.
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 Rosuvastatin is and what it is used for
2. What you need to know before you take Rosuvastatin
3. How to take Rosuvastatin
4. Possible side effects
5. How to store Rosuvastatin
6. Contents of the pack and other information

1. What Rosuvastatin is and what it is used for
Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because:

You have a high cholesterol level. This means you are at risk from a heart attack or stroke.
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.
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 Rosuvastatin?
Rosuvastatin 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).

Rosuvastatin 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 Rosuvastatin, 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 Rosuvastatin
Do not take Rosuvastatin:

If you have ever had an allergic reaction to Rosuvastatin, or to any of its ingredients.

If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin stop
taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking
Rosuvastatin 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 Rosuvastatin 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.

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.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

&2v2[ª
‘¢>§ƒ(

[v>ƒÌ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Rosuvastatin 5mg tabs

ARTWORKER:

CODE:

6464/2371E

DATE OF PROOF

MANUFACTURER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/04/14

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 04/04/14

Í2§´yd
Leaflet Flat Size = 296 x 317

TVT CHECKED

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ARIAL BOLD FONT SIZE 10
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UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

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Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin.
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 Rosuvastatin.
Children and adolescents

If the patient is under 10 years old:
Rosuvastatin should not be given to children younger than 10 years.

If the patient is below 18 years of age:
The Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin to suit you.
If any of the above applies to you (or if you are not sure):

Do not take Rosuvastatin 40mg (the highest dose) and check with your doctor or pharmacist
before you actually start taking any dose of Rosuvastatin.
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 Rosuvastatin.
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 Rosuvastatin
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 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), an oral contraceptive (the pill), hormone replacement therapy or
ritonavir with lopinavir and/or atazanavir (used to treat the HIV infection – please see Warnings and
precautions). The effects of these medicines could be changed by Rosuvastatin or they could change the
effects of Rosuvastatin.
Pregnancy and breast-feeding
Do not take Rosuvastatin if you are pregnant or breast-feeding. If you become pregnant while taking
Rosuvastatin stop
taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin
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 Rosuvastatin – it will not affect their ability.
However, some people feel dizzy during treatment with Rosuvastatin. If you feel dizzy, consult your doctor
before attempting to drive or use machines.
Rosuvastatin 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 Rosuvastatin.
For a full list of ingredients please see Contents of the pack and other information.

3. How to take Rosuvastatin
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 Rosuvastatin for high cholesterol:
Starting dose
Your treatment with Rosuvastatin 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.
Please check with your doctor or pharmacist which start dose of Rosuvastatin 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).

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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 Rosuvastatin 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 Rosuvastatin 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.
If you are taking Rosuvastatin 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 overleaf.
Use in children and adolescents aged 10–17 years
The usual start dose is 5mg. Your doctor may increase your dose to find the right amount of Rosuvastatin for
you.
The maximum daily dose of Rosuvastatin is 20mg. Take your dose once a day. Rosuvastatin 40mg tablet
should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin 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 Rosuvastatin that is right
for you.
If you take more Rosuvastatin 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
Rosuvastatin.
If you forget to take Rosuvastatin
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 Rosuvastatin
Talk to your doctor if you want to stop taking Rosuvastatin. Your cholesterol levels might increase again if you
stop taking Rosuvastatin.
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 Rosuvastatin 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 Rosuvastatin 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 Rosuvastatin tablets (only Rosuvastatin 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.
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 Rosuvastatin tablets (only Rosuvastatin 5mg, 10mg and 20mg).
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 Rosuvastatin and seek medical help
immediately

Muscle damage in adults – as a precaution, stop taking Rosuvastatin 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

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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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