Rosuvastatin 10mg/5ml Oral Solution

• 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.

The name of your medicine is Rosuvastatin 10mg/5ml Oral Solution but it will be referred to as ‘Rosuvastatin’ throughout 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

• 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 doing 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.

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.

• If you have ever had an allergic reaction 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 take a drug combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection of the liver called hepatitis C).
• 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 speak to your doctor.

In addition, do not take Rosuvastatin 40 mg (20ml) (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 (e.g. 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 speak to your doctor.

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 have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Rosuvastatin or other related Medicines. (e.g. atorvastatin, simvastatin, fluvastatin, pravastatin, and lovastatin).
• 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 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.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Rosuvastatin treatment. Stop using Rosuvastatin and seek medical attention immediately if you notice any of the symptoms described in section 4.

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.

• 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 dose is not suitable for use in children and adolescents below 18 years of age.

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 below and Warnings and precautions),
• an oral contraceptive (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• hormone replacement therapy,
• any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines could be changed by Rosuvastatin or they could change the effect 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). See more information regarding rhabdomyolysis in Section 4.

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.

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.

Ethanol (E 1510): This medicine contains 500mg of alcohol (ethanol 96%) in each 5ml which is equivalent to 100mg/ml. The amount in each ml of this medicine is equivalent to 2.6ml of beer or 1.04ml of wine.

The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

If you are taking Rosuvastatin for high cholesterol:

Starting dose

Your treatment with Rosuvastatin must start with the 5mg (2.5ml) or the 10mg (5ml) 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 levels.
• 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 starting dose of Rosuvastatin will best suit you.

Your doctor may decide to give you the lowest dose 5mg (2.5ml) if:

• You are of Asian origin (e.g. 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 5mg (2.5ml) dose, your doctor may decide to double this to 10mg (5ml), then 20mg (10ml) and then 40mg (20ml) if necessary. If you started on 10mg (5ml), your doctor may decide to double this to 20mg (10ml) and then 40mg (20ml) if necessary. There will be a gap of four weeks between every dose adjustment.

The maximum daily dose of Rosuvastatin is 40mg (20ml). 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 (10ml).

The recommended dose is 20mg (10ml) daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

The dose range in children and adolescents aged 6 to 17 years is 5mg (2.5ml) to 20mg (10ml) once daily. The usual start dose is 5mg (2.5ml) 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 10mg (5ml) or 20mg (10ml) for children aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day.

• This medicine must be taken orally.
• Take Rosuvastatin once daily. You can take it at any time of the day with or without food.
• Try to take your dose at the same time every day to help you to remember it.
• Use the measuring syringe provided in the pack to deliver the required dose.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic cap. Wash the syringe with water (figure 8).

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.

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 and take your bottle with you to the hospital.

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.

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 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.
• If you experience muscle rupture.
• If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

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 (only at 40mg dose).
• 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.

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.
• Bleeding or bruising more easily than normal due to low level of blood platelets.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

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 and breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• Diarrhoea (loose stools), 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 and muscle weakness that is constant.

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is rosuvastatin (as rosuvastatin calcium).

Each 5ml of oral solution contains 10mg rosuvastatin (as rosuvastatin calcium).

The other ingredients are poloxamers, macrogols, sucralose, disodium edetate, ethanol (96%), meglumine and purified water.

Rosuvastatin is clear, colourless solution supplied in amber glass bottles fitted with a tamper evident, child resistant white plastic (polyethylene/polypropylene) cap with EPE liner. The pack also contains 10ml oral syringe with 0.5 ml intermediate graduations and a syringe adaptor.

Rosuvastatin is supplied in a bottle containing 150ml oral solution.