Vusor Film-Coated Tablets

VUSOR OD contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin, as rosuvastatin calcium, per film-coated tablet and belongs to the pharmacotherapeutic group called HMG-CoA reductase inhibitors. VUSOR OD is used to reduce the risk of incidents that may cause damage to the heart muscle in patients at risk of developing heart disease as a result of build-up of fats in and on the blood vessels of the heart. VUSOR OD is used, together with diet, to lower high levels of fats in the blood, which are called lipids, usually when changes to diet and exercise have failed to do this. VUSOR OD, in addition to diet, lowers bad cholesterol (LDL) and increases good cholesterol (HDL) in the blood. VUSOR OD is also used to reduce total cholesterol and bad cholesterol (LDL) in adult patients with very high cholesterol and a family history of high cholesterol, either alone or together with diet and other lipid lowering treatments. VUSOR 40 OD should only be considered in patients with severe high cholesterol and high cardiovascular risk who do not achieve their treatment goal on 20 mg of VUSOR OD or alternative therapy. Specialist supervision is recommended when the 40 mg dose is initiated. VUSOR OD can be used in children and adolescents (10 to 17 years of age) to reduce the total cholesterol, bad cholesterol (LDL) and lipids in patients with genetically inherited high cholesterol called heterozygous familial hypercholesterolaemia (HeFH).

Do not take VUSOR OD:

• if you are hypersensitive (allergic) to rosuvastatin or any of the other ingredients of VUSOR OD (listed in section 6)
• if you currently have a liver disease
• if you have severe kidney problems
• if you take a medicine called ciclosporin (used, for example, after organ transplants) (see Other medicine and VUSOR OD)
• if you are pregnant or breastfeeding or if you are a woman of childbearing potential not using appropriate contraceptive measures (see Pregnancy, breastfeeding and fertility)
• if you have a muscle disease called myopathy. Patients with the following predisposing conditions for a muscle disease called myopathy must not take VUSOR 40 OD (the highest dose). The following conditions may increase the risk of muscle disorders:
• if you have moderate kidney problems (if in doubt, please ask your doctor)
• if you have a condition called hypothyroidism (underactive thyroid)
• 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 taking other medicines called fibrates (for high cholesterol)
• if you are of Asian descent.

Warnings and precautions:

Take special care with VUSOR OD: Tell your doctor or healthcare professional before taking VUSOR OD:

• if you suffer from a condition called myasthenia gravis or ocular myasthenia with symptoms of a weakness and rapid fatigue of voluntary muscles or muscles that move the eyes and eyelids
• if you have problems with your kidneys
• if you have unexplained muscle aches and pains, muscle weakness, cramps and especially if you feel unwell or have a fever, tell your doctor immediately

Do not share medicines prescribed for you with any other person. Always take VUSOR OD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Before starting treatment, your doctor should place you on a standard cholesterol-lowering diet that should continue during treatment. The dosage range for VUSOR OD is 5 to 40 mg orally once a day. The recommended start dose is 5 mg once a day. Your dosage will be individualised according to your cholesterol levels, your risk factors and your response to VUSOR OD-therapy. The majority of patients are controlled at the 10 mg dose. However, if necessary, dose adjustment can be made at 2 to 4 week intervals. A 5 mg starting dose is recommended for patients of Asian ancestry and for patients requiring a smaller reduction in ‘bad’ cholesterol (LDL-C) to achieve treatment target. For patients with severely high cholesterol (including genetically inherited high cholesterol), a start dose of 20 mg may be considered. For patients with genetically inherited high cholesterol, a start dose of 20 mg once a day is recommended. Children and adolescents 10 to 17 years of age: In children and adolescents with genetically inherited high cholesterol, the usual dose range is 5 to 20 mg orally once daily. Special populations: Use in the elderly: The usual dose range applies. Dosage in patients with renal insufficiency: The starting dose applies in patients with mild to moderate renal impairment. For patients with severe renal impairment the dose of VUSOR OD should not exceed 10 mg once daily. Dosage in patients with hepatic insufficiency: The usual starting dose applies in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should start therapy with VUSOR 5 OD, doses above 10 mg should be carefully considered. Race: A 5 mg starting dose of VUSOR OD should be considered for Asian patients. Your doctor will tell you how long your treatment with VUSOR OD will last. It may take weeks or months of treatment for you to see any improvement in your symptoms and your symptoms might even worsen when VUSOR OD is started. Do not stop treatment early. If you have the impression that the effect of VUSOR OD is too strong or too weak, tell your doctor or pharmacist. If you take more VUSOR OD than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take VUSOR OD: Do not take a double dose to make up for the forgotten individual doses.

VUSOR OD can have side effects. Not all side effects reported for VUSOR OD are included in this leaflet. Should your general health worsen or if you experience untoward effects while taking VUSOR OD, please consult your healthcare provider for advice.

If any of the following happens, stop taking VUSOR OD and tell your doctor immediately or go to the casualty department at your nearest hospital:

• difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing, severe itching of the skin (with raised lumps)
• blistering of the skin, mouth and eyes (Steven-Johnson syndrome)
• jaundice (yellowing of the skin and eyes).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VUSOR OD. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• symptoms of myasthenia gravis and ocular myasthenia which include weakness in the arm and leg muscles, double vision, drooping eyelids, trouble focusing and difficulties with speech and chewing
• any unusual aches and pains in your muscles which go on for longer than you might expect, especially if you develop a fever or feel unwell. Unpleasant muscle effects may become a potentially life-threatening muscle damage known as rhabdomyolysis. Muscle symptoms are more frequent in children and adolescents than in adults
• tendon disorders sometimes complicated by rupture
• serious muscle damage presenting as unexplained muscle aches and pains, feeling unwell and a fever (immune-mediated necrotising myopathy)
• a severe stomach pain (inflamed pancreas)
• increase in liver enzymes in the blood
• hepatitis (an inflamed liver).

These are all serious side effects. You may need urgent medical attention.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 30 °C. Store in the original container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).