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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Recommended doses in adults If you are taking Rosuvastatin for high cholesterol: Starting dose Your treatment with Rosuvastatin 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 or 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 Rosuvastatin 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 to reduce your risk of having a heart attack, stroke or related health problems: The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6–17 years: The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day and your doctor may gradually increase your dose to find the right amount of Rosuvastatin for you. The maximum daily dose of Rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated.

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.

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 neutralize acid in your stomach), erythromycin (an antibiotic), fusidic acid (an antibiotic), an oral contraceptive (the pill), regorafenib (used to treat cancer), any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination: ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. The effects of these medicines could be changed by Rosuvastatin or they could change the effects of Rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin. Taking Rosuvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis)

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.

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 (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 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 (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 5 mg, 10 mg and 20 mg)

Rare possible side effects (may affect up to 1 in 1000 people): 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, Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells), Muscle rupture, A severe stomach pain (inflamed pancreas), Increase in liver enzymes in the blood., Decrease of platelets in the blood (thrombocytopenia)

Very rare possible side effects (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 (gynaecomastia)

Side effects of not known 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin:

• If you have problems with your kidneys or Liver or thyroid gland.
• 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.
• If you regularly drink large amounts of alcohol.
• 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, or If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and Rosuvastatin can lead to serious muscle problems (rhabdomyolysis), please see Other medicines and Rosuvastatin.
• 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.

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 tablet is not suitable for use in children and adolescents below 18 years of age

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.