Rosuvastatin 5 mg Film-Coated Tablets

ROSUVASTATIN SMART 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. ROSUVASTATIN SMART 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. ROSUVASTATIN SMART 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. ROSUVASTATIN SMART, in addition to diet, lowers “bad” cholesterol (LDL) and increases “good” cholesterol (HDL) in the blood. ROSUVASTATIN SMART 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. ROSUVASTATIN 40 mg SMART 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 ROSUVASTATIN SMART or alternative therapy. Specialist supervision is recommended when the 40 mg dose is initiated. ROSUVASTATIN SMART 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 ROSUVASTATIN SMART:

• if you are hypersensitive (allergic) to rosuvastatin or any of the other ingredients of ROSUVASTATIN SMART (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 transplant) (see Other medicines and ROSUVASTATIN SMART)
• 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).

Patients with the following predisposing conditions for a muscle disease called myopathy must not take ROSUVASTATIN 40 mg SMART (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 ROSUVASTATIN SMART: Tell your doctor or health care provider before taking ROSUVASTATIN SMART:

• if you have problems with your kidneys
• if you have unexplained muscle aches or pains, muscle weakness, cramps and especially if you feel unwell or have a fever, tell your doctor immediately
• if your thyroid gland is not working properly (hypothyroidism)
• if you have a personal or family history of hereditary muscular disorders
• if you have a previous history of muscle problems when using cholesterol lowering medicines
• if you regularly consume large amounts of alcohol
• if you are above 70 years of age
• if you are taking fibrates (cholesterol lowering medicine) please see Other medicines and ROSUVASTATIN SMART
• 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 SMART can lead to serious muscle problems (rhabdomyolysis), please see Other medicines and ROSUVASTATIN SMART.

ROSUVASTATIN SMART may cause interstitial lung disease, especially with long-term treatment. Tell your doctor if you experience difficulty breathing, develop a non-productive cough and/or deterioration in general health (e.g. fatigue, weight loss and fever) while taking ROSUVASTATIN SMART. In a small number of people, ROSUVASTATIN SMART can affect the liver. This is identified by a 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 treatment starts with ROSUVASTATIN SMART, and if needed thereafter. In patients whose high cholesterol is caused by another disease, such as thyroid or kidney problems, the underlying disease should be treated prior to initiating therapy with ROSUVASTATIN SMART. While you are on ROSUVASTATIN SMART, 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. ROSUVASTATIN SMART should be used with care in patients with Type 2 diabetes and patients at risk.

Do not share medicines prescribed for you with any other person. Always take ROSUVASTATIN SMART 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 ROSUVASTATIN SMART is 5 - 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 ROSUVASTATIN SMART-therapy. The majority of patients are controlled at the 10 mg dose. However, if necessary, dose adjustment can be made at 2 – 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 - 17 years of age

In children and adolescents with genetically inherited high cholesterol, the usual dose range is 5 - 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 ROSUVASTATIN SMART 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 ROSUVASTATIN 5 mg SMART, doses above 10 mg should be carefully considered. Race A 5 mg starting dose of ROSUVASTATIN SMART should be considered for Asian patients. Your doctor will tell you how long your treatment with ROSUVASTATIN SMART 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 ROSUVASTATIN SMART is started. Do not stop treatment early. If you have the impression that the effect of ROSUVASTATIN SMART is too strong or too weak, tell your doctor or pharmacist.

If you take more ROSUVASTATIN SMART than you should In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take ROSUVASTATIN SMART Do not take a double dose to make up for the forgotten individual doses.

ROSUVASTATIN SMART can have side effects. Not all side effects reported for ROSUVASTATIN SMART are included in this leaflet. Should your general health worsen or if you experience untoward effects while taking ROSUVASTATIN SMART, please consult your health care provider for advice. If any of the following happens, stop taking ROSUVASTATIN SMART 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 ROSUVASTATIN SMART. 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:

• 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. Tell your doctor if you notice any of the following:

Frequent side effects

• Increased glucose levels, diabetes
• Headache, dizziness
• Constipation, nausea, stomach pain
• Muscle pain
• Feeling weak, or a lack of energy

Less frequent side effects

• Abnormal bleeding or bruising
• Memory loss
• Numbness, tingling, loss of sensation in the arms and legs, burning feeling in the hands or feet (polyneuropathy)
• Rash, itching or other skin reactions
• Oedema (swelling under the skin)
• Cough, shortness of breath, difficulty breathing
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells)
• Muscle rupture
• Joint pain
• Traces of blood in your urine
• Breast enlargement in men (gynaecomastia).

Side effects with unknown frequency

• Depression
• Diarrhoea
• An increase in the amount of protein in the urine
• Numbness and tingling in hands or feet (peripheral neuropathy).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ROSUVASTATIN SMART.

Store all medicines out of reach of children. Store at or below 30 °C, in the original packaging. Keep blisters in the carton until required for use. Do not store in a bathroom. Do not use ROSUVASTATIN SMART after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).