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Package leaflet: information for the user

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 or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Rosuvastatin tablet is and what it is used for

2.    What you need to know before you take Rosuvastatin tablets

3.    How to take Rosuvastatin tablets

4.    Possible side effects

5.    How to store Rosuvastatin tablets

6.    Contents of the pack and other information

1. What Rosuvastatin tablet is and what it is used for

Rosuvastatin tablets belong to a group of medicines called statins.

You have been prescribed Rosuvastatin tablets because:

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

Rosuvastatin tablets 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 tablets.

Or

•    You have other factors that increase your risk of having a heart attack, stroke or related health problems.

Why is it important to keep taking Rosuvastatin

tablets?

•    Rosuvastatin tablets 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 tablets 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 tablets, 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 tablets

Do not take Rosuvastatin tablets

•    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 tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin tablets 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 see your doctor.

In addition, do not take Rosuvastatin tablets (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 see your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Rosuvastatin tablets

•    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. Additional test and medicines may be needed to diagnose and treat this.

•    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 fight the HIV infection e.g. combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir, please see Other medicines and Rosuvastatin tablets.

•    If you are taking antibiotics containing fusidic acid, please see Other medicines and Rosuvastatin tablets.

Children and adolescents

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

•    if the patient is below 18 years of age: The Rosuvastatin tablets 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 Rosuvastatin tablets 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 tablets to suit you.

If any of the above applies to you (or if you are not sure):

•    Do not take Rosuvastatin tablets 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin tablets.

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 tablets.

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 tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including 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).

•    Fusidic acid (an antibiotic - please see Warnings and precautions).

•    an oral contraceptive (the pill).

•    hormone replacement therapy.

•    Anti-viral medications such as ritonavir with atazanavir, lopinavir, and/or tipranavir 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 Rosuvastatin tablets or they could change the effects of Rosuvastatin tablets.

Pregnancy and breast-feeding

Do not take Rosuvastatin tablets if you are pregnant or breast feeding. If you become pregnant while taking Rosuvastatin tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin tablets by using suitable contraception.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Most people can drive a car and operate machinery while using Rosuvastatin tablets it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin tablets contains lactose, sunset yellow and allura red

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Rosuvastatin tablets 40 mg also contain sunset yellow and allura red, which may cause allergic reactions.

3. How to take Rosuvastatin tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses in adults is

If you are taking Rosuvastatin tablets for high

cholesterol:

Starting dose

Your treatment with Rosuvastatin tablets 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 tablets 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 tablets 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 Rosuvastatin tablets 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 Rosuvastatin tablets 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 tablets for you. The maximum daily dose of Rosuvastatin tablets 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 tablets 40 mg tablet should not be used by children. Taking your tablets

Swallow each tablet whole with a drink of water. Take Rosuvastatin tablets 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 tablets that is right for you.

If you take more Rosuvastatin tablets 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 tablets.

If you forget to take Rosuvastatin tablets

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 tablets

Talk to your doctor if you want to stop taking Rosuvastatin tablets. Your cholesterol levels might increase again if you stop taking Rosuvastatin tablets.

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 tablets 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. Rare (may affect up to 1 in 1,000 people)

•    Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing. Rare (may affect up to 1 in 1,o0o people)

•    Severe itching of the skin (with raised lumps). Rare (may affect up to 1 in 1,000 people)

•    Also, stop taking Rosuvastatin tablets 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. Rare (may affect up to 1 in 1,000 people)

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.

Rosuvastatin tablets may cause the following possible side effects:

Common (may affect up to 1 in 10 people)

•    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 tablets 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 (may affect up to 1 in 100 people)

•    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 tablets 5 mg, 10 mg and 20 mg).

Rare (may affect up to 1 in 1,000 people)

•    A severe stomach pain (inflamed pancreas).

•    Increase in liver enzymes in the blood.

Very rare (may affect up to 1 in 10,000 people)

•    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 (Gynecomastia).

Not known (frequency cannot be estimated from the available data)

•    Diarrhoea (loose stools).

•    Steven-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.

•    Tendoninjury.

•    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 United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

6. Contents of the pack and other information

What Rosuvastatin tablets contains

The active substance is rosuvastatin calcium.

Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).

Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium).

The other ingredients are:

Core tablet Lactose, anhydrous Cellulose, microcrystalline (E460) Magnesium oxide Magnesium stearate (E470b) Crospovidone (E1202)

Film coating For 5 mg -

Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, iron oxide yellow (E172).

For 10 mg and 20 mg -

Opadry II 39K540032 pink containing: Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, Iron oxide red (E172), Quinoline yellow aluminum lake (E104), Brilliant blue FCF aluminum lake (E133).

For 40 mg -

Opadry II 39K540012 pink containing: Hypromellose (E464), Triacetin (E1518), Titanium dioxide (E171), Lactose monohydrate, Sunset yellow FCF aluminum lake (E110), Allura red AC aluminum lake (E129) and Brilliant blue FCF aluminum lake (E133).

What Rosuvastatin tablets look like and contents of the pack

This medicine is presented as 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets.

5 mg: Yellow, round, approximately 7.0 mm in diameter, biconvex, film-coated tablet, debossed “5” on one side and “R” on other side.

10 mg: Pink, round, approximately 7.0 mm in diameter, biconvex, film-coated tablet, debossed “10” on one side and “R” on other side.

20 mg: Pink, round, approximately 9.0 mm in diameter, biconvex, film-coated tablet, debossed “20” on one side and “R” on other side.

40 mg: Pink, oval, approximately 11.5 mm in length and 6.9 mm in width, biconvex, film-coated tablet, debossed “40” on one side and “R” on other side.

Tablets are packed in Alu-Alu blister pack & HDPE bottle pack (white opaque HDPE bottle with white opaque PP closure and white opaque desiccant canister with blue printing).

Pack sizes:

5mg:    Blister pack: 7, 28, 30, 60, 84, 90 or 98

tablets in blister. HDPE bottle: 30 or 500 tablets

10mg:    Blister pack: 7, 28, 30, 60, 84, 90, 98 or

100 tablets in blister. HDPE bottle: 30 or 500 tablets

20mg:    Blister pack: 7, 28, 30, 60, 84, 90, 98 or

100 tablets in blister. HdPE bottle: 30 or 500 tablets

40mg:    Blister pack: 7, 28, 30, 60, 90, 98 or 100

tablets in blister. HDPE bottle: 500 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare Limited,

Sage house, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF, United Kingdom

Manufacturers

Accord Healthcare Limited,

Sage house, 319 Pinner road,

North Harrow, Middlesex HA1 4HF, United Kingdom

Wessling Hungary Kft.,

Foti ut 56., Budapest 1047,

Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of Name of the medicinal product Member States

Austria    Rosuvastatin Accord    5/10/20/

40 mg Filmtabletten

Bulgaria    Rosuvastatin AKopg 5/10/20/40 Mr

^MHMMpaHM Ta6neTKM

Cyprus    Rosuvastatin Accord    5/10/20/

40 mg EniKaAuppsva p£ ArmTO upsvio 5iawa

Denmark    Rosuvastatin Accord    5/10/20/

40 mg filmovertrukne tabletter Estonia    Rosuvastatin Accord

Finland    Rosuvastatin Accord    5/10/20/

40 mg tabletti, kalvopaallysteinen France    ROSUVASTATIN ACCORD

5/10/20 mg comprime pellicule Ireland    Rosuvastatin 5/10/20/40    mg

Film-coated Tablets

Italy    Rosuvastatina Accord

Lithuania    Rosuvastatin Accord 5/10/20/

40 mg plevele dengtos tabletes Latvia    Rosuvastatin Accord 5/10/20/

40 mg apvalkotas tabletes Malta    Rosuvastatin 5/10/20/40 mg

Film-coated Tablets

The Netherlands Rosuvastatine Accord 5/10/20/ 40 mg filmomhulde tabletten Norway    Rosuvastatin Accord

Sweden    Rosuvastatin Accord 5/10/20/

40 mg filmdragerad tablet United Kingdom Rosuvastatin 5/10/20/40    mg

Film-coated Tablets

This leaflet was last approved in 07/2015.

5. How to store Rosuvastatin tablets

•    This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture and light.

•    HDPE bottle pack should be used within 3 months after first opening.

•    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 label or blister or carton after EXP. The expiry date refers to the last day of that month.

•    Do not use this medicine if you notice the pack that is damaged or shows signs of tampering.

•    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.