Cresagen 5 mg Film-Coated Tablets

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

Do not take CRESAGEN:

• If you are hypersensitive (allergic) to rosuvastatin calcium or any of the other ingredients of CRESAGEN (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 Medicines and CRESAGEN)
• 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 myopathy or any disease of the muscle.
• Children as safety and efficacy have not been demonstrated.

Warnings and precautions

Special care should be taken with CRESAGEN:

• If you if you consume excessive quantities of alcohol and/or have a history of liver disease.
• if you have muscle pain/disease
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• if you are over 70 years of age.
• if you have an underactive thyroid gland
• if you take protease inhibitors (used in the treatment of HIV infections).
• Serious liver problems may occur. You should therefore notify your medical practitioner right away if you have the following symptoms: unusual fatigue or weakness; loss of appetite; stomach pain; dark-coloured urine; or yellowing of the skin or the whites of the eyes. Your doctor will carry out a liver function test before treatment starts and if needed thereafter.
• You may experience increase in blood sugar levels.
• if you are taking fibrates (cholesterol lowering medicine) please see Other medicine and CRESAGEN
• 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 CRESAGEN can lead to serious muscle problems (rhabdomyolysis), please see Other medicine and CRESAGEN
• if you are taking other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors (such as lopinavir/ritonavir – medicines used to treat HIV infection) and macrolide antibiotics (see Other medicine and CRESAGEN).
• CRESAGEN 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 CRESAGEN.
• In a small number of people, CRESAGEN 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 CRESAGEN, 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 CRESAGEN.
• While you are on CRESAGEN 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. CRESAGEN should be used with care in patients with Type 2 diabetes and in patients at risk. Please consult your doctor if these statements were applicable to you any time in the past.

Do not share medicines prescribed for you with any other person. Always take CRESAGEN exactly as your doctor or pharmacist has told you. 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 CRESAGEN 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 CRESAGEN-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. The usual dose is 5 mg once daily. 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 CRESAGEN 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 CRESAGEN 5 mg, doses above 10 mg should be carefully considered. Race: A 5 mg starting dose of CRESAGEN should be considered for Asian patients. Your doctor will tell you how long your treatment with CRESAGEN 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 CRESAGEN is started. Do not stop treatment early. If you have the impression that the effect of CRESAGEN is too strong or too weak, tell your doctor or pharmacist. If you take more CRESAGEN than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take use CRESAGEN Do not take a double dose to make up for forgotten individual doses.

CRESAGEN can have side effects. Not all side effects reported for CRESAGEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CRESAGEN, please consult your health care provider for advice. If any of the following happens, stop taking / using CRESAGEN 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 ng of the skin (with raised lumps).
• Blistering of the skin, mouth and eyes (Steven-Johnson syndrome).
• Yellowing of the skin and eyes, also called jaundice. These are all very serious side effects. If you have them, you may have had a serious reaction to CRESAGEN. 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:

• If you have any unusual aches or pains in your muscles which go on for longer than you might expect, especially if you develop a fever or feel unwell. These have 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).
• Severe stomach pain due to inflamed pancreas (pancreatitis)
• 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 Headache
• Dizziness
• Stomach pain
• Constipation
• Feeling sick (nausea)
• Muscle pain
• Feeling weak (asthenia)
• Increased blood glucose levels, diabetes

Less frequent

• Abnormal bleeding or bruising
• Rash, itching or other skin reactions
• Memory loss or impairment, forgetfulness and confusion
• Numbness, tingling, loss of sensation in the arms and legs, burning feeling in the hands or feet (polyneuropathy)
• 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
• A severe stomach pain (inflamed pancreas)
• Jaundice (yellowing of the skin and eyes)
• Hepatitis (an inflamed liver)
• Increased liver enzymes in the blood
• Joint pain
• Traces of blood in your urine
• Breast enlargement in men (gynaecomastia).

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 or, 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: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CRESAGEN.

Store all medicines out of reach of children.

• Store at or below 30 °C
• Store in the original package/ container
• Protect from light / moisture
• Do not store in a bathroom
• Do not use after the expiry date stated on the carton
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).