Package leaflet: Information for the patient Rosuvastatin 5 mg film-coated tablets Rosuvastatin 10 mg film-coated tablets Rosuvastatin 20 mg film-coated tablets Rosuvastatin 40 mg film-coated tablets

Rosuvastatin

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 Rosuvastatin

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 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 it is 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 are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6)

•    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 are taking a drug called ciclosporin (used, for example, after organ transplants).

If any of the above applies to you (or you are in doubt), do not take these tablets and go back and see your doctor.

In addition, do not take Rosuvastatin, (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 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.

•    if you take antibiotics containing fusidic acid, please see Other medicines and Rosuvastatin

Children and adolescents

•    If the patient is under 6 years old: Rosuvastatin should not be given to children younger than 6 years.

•    If the patient is below 18 years of age: The Rosuvastatin 40 mg film-coated 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 40 mg (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 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 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 effect of Rosuvastatin.

Pregnancy, 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 exactly as your doctor or pharmacist 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 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 Rosuvastatin 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 Rosuvastatin 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 Rosuvastatinis 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 rosuvastatin 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 rosuvastatin for you. The maximum daily dose of rosuvastatin 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. Rosuvastatin 40 mg tablet should not be used by children.

Taking your tablets

Swallow each tablet whole with a drink of water.

Take Rosuvastatinonce 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.

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.

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 possible 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.

[Reporting system to be completed nationally]

5. How to store Rosuvastatin

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 Rosuvastatinand 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 tablets (only Rosuvastatin 40 mg film-coated tablets)

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 (may affect between 1 in 100 and 1 in 1000 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 tablets (only Rosuvastatin 5 mg,

10 mg and 20 mg).

Rare possible side effects (these may affect between 1 in 1000 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

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the box/blisters/label after EXP The expiry date refers to the last day of the month.

•    Use within 30 days of opening the bottle. Once the pack has been opened write the date of opening on the space provided on the package label and also write the date by when the product should be used.

•    Blisters: Store in the original package in order to protect from light.

•    Bottle: Store in the original package in order to protect from light. Use within 30 days of opening.

•    If your tablets come in a plastic container, keep the lid tightly closed.

•    Keep your tablets in the container you received them in.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will

help protect the environment.

6. Contents of the pack and other information

What Rosuvastatin contains

The active substance is rosuvastatin. Rosuvastatin contains rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone, sodium hydrogen carbonate, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171) and red iron oxide (E172).

What Rosuvastatin looks like and contents of the pack

Rosuvastatin comes in blister packs containing 14, 15,

28, 30, 42, 56, 60, 84, 90, and 98 tablets and plastic containers with 30, 50, 90 and 100 tablets (Not all packs are available in every country).

The tablets packed in plastic containers include a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.

Rosuvastatin comes in four tablet strengths:

Rosuvastatin 5 mg film-coated tablets are pink coloured film-coated circular tablets debossed with “G” on one side and “C” on the other side of the tablet.

Rosuvastatin 10 mg film-coated tablets are pink coloured film-coated, circular tablets debossed with “G” on one side and “D” on the other side of the tablet.

Rosuvastatin 20 mg film-coated tablets are pink coloured film-coated, circular tablets debossed with “G” on one side and “O” on the other side of the tablet.

Rosuvastatin 40 mg film-coated tablets are pink coloured film-coated, oval shaped tablets debossed with “G 264” on one side and “40” on the other side of the tablet. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue Kenton, Middlesex HA3 0BU United Kingdom

Manufacturer

Glenmark Pharmaceuticals s.r.o Fibichova 143, 566 17 Vysoke Myto,

Czech Republic or

Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,

Croxley Green, Hertfordshire WD18 8YA United Kingdom

This leaflet was last revised in 02/2015.