Crevas 5 mg Film-Coated Tablets

CREVAS contains 5 mg, 10 mg , 15 mg, 20 mg, 30 mg or 40 mg of rosuvastatin, as rosuvastatin calcium, per film coated tablet and belongs to the pharmacotherapeutic group called HMG - CoA reductase inhibitors. CREVAS 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. CREVAS 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. CREVAS, in addition to diet, lowers “bad” cholesterol (LDL) and increases “good” cholesterol (HDL) in the blood.

CREVAS 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. CREVAS 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 CREVAS or alternative therapy. Specialist supervision is recommended when the 40 mg dose is initiated. CREVAS 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 CREVAS:

• if you are hypersensitive (allergic) to rosuvastatin or any of the other ingredients of CREVAS (see 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 CREVAS)
• 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 repeated or unexplained muscle aches or pains.

Patients with the following predisposing conditions for a muscle disease called myopathy must not take CREVAS 40 (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 CREVAS

Tell your doctor or healthcare professional before taking CREVAS:

• 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
• 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 medicine and CREVAS
• 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 CREVAS can lead to serious muscle problems (rhabdomyolysis), please see Other medicine and CREVAS.

CREVAS 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 CREVAS.

Serious skin reactions including Stevens - Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with CREVAS treatment. Stop taking CREVAS and seek medical attention immediately if you notice any of the following symptoms: reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes preceded by fever and flu-like symptoms, widespread rash, high body temperature and enlarged lymph nodes.

Should you develop a serious reaction such as SJS or DRESS during CREVAS therapy, treatment must not be restarted at any time.

In a small number of people, CREVAS 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 CREVAS, and if needed thereafter.

CREVAS may cause myasthenia gravis and ocular myasthenia, which are conditions that cause muscle weakness, impaired speech, difficulty swallowing and drooping of one or both eyelids or double vision. Tell your doctor if you experience any of these symptoms while taking CREVAS.

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 CREVAS. While you are on CREVAS 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. CREVAS should be used with care in patients with Type 2 diabetes and in patients at risk.

Children and adolescents

The same special warnings and special precautions for use in adults also apply to children and adolescents.

Do not share medicines prescribed for you with any other person. Always take CREVAS 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 CREVAS 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 CREVAS - therapy. The majority of patients are controlled at the 10 mg dose. However, if necessary, your doctor will adjust your dose 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 Your doctor will prescribe a suitable dosage if you are elderly, if you have a kidney or liver disorder. Your doctor will tell you how long your treatment with CREVAS 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 CREVAS is started. Do not stop treatment early. If you have the impression that the effect of CREVAS is too strong or too weak, tell your doctor or pharmacist.

If you take more CREVAS 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 CREVAS: If you forget to take CREVAS, take a dose as soon as you remember, then continue to take CREVAS at the usual times. Do not take a double dose to make up for the forgotten individual doses.

If you stop taking CREVAS: Talk to your doctor if you want to stop taking CREVAS. Your cholesterol levels might increase again if you stop taking this medicine.

CREVAS can have side effects. Not all side effects reported for CREVAS are included in this leaflet. Should your general health worsen or if you experience untoward effects while taking CREVAS, please consult your healthcare provider for advice. If any of the following happens, stop taking CREVAS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CREVAS. 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:

• severe itching of the skin (with raised lumps), blistering of the skin, mouth and eyes (Steven - Johnson syndrome)
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• jaundice (yellowing of the skin and eyes)
• lupus - like disease syndrome (including rash, joint disorders and effects on blood cells)
• 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
• o edema (swelling under the skin)
• muscle rupture, inflammation of the muscle
• joint pain
• traces of blood in your urine
• breast enlargement in men (gynaecomastia).

Side effects with unknown frequency:

• depression
• sleep disturbances including insomnia and nightmares
• diarrhoea
• an increase in the amount of protein in the urine
• numbness and tingling in hands or feet (peripheral neuropathy)
• muscle weakness, impaired speech, difficulty swallowing and drooping of one or both eyelids or double vision (myasthenia gravis and ocular myasthenia)
• cough, shortness of breath, difficulty breathing.

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of CREVAS. You can also send an email directly to the company, [email protected] to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 30 °C in a cool, dry place. Protect from light. Keep the tablets in the outer carton until required for use. 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).