Rosuvastatin 10mg film-coated tablets What Rosuvastatin is used for: Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. Rosuvastatin can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. It works by helping to block your body’s production of ‘bad’ cholesterol. Do not take Rosuvastatin: If you have ever had an allergic reaction to Rosuvastatin, or to any of its ingredients. If you are pregnant or breastfeeding. 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. If you take a drug called ciclosporin (used, for example, after organ transplants). In addition, do not take Rosuvastatin 40 mg (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. If you regularly drink large amounts of alcohol. If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). If you take other medicines called fibrates to lower your cholesterol. Warnings & Precautions: 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. 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. If you take medicines used to treat the HIV infection. If you are taking or have taken in the last 7 days a medicine called fusidic acid orally or by injection. The combination of fusidic acid and Rosuvastatin can lead to serious muscle problems (rhabdomyolysis). If you are over 70. If you have severe respiratory failure. If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Possible Side Effects: These include headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness, diabetes, 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 tablets. Other medicines and Rosuvastatin: Tell your doctor if you are taking any of the following medicines: ciclosporin (used for example, after organ transplants), warfarin or clopidogrel (or any other drug used for thinning the blood), fibrates 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) an oral contraceptive (the pill), regorafenib, darolutamide (used to treat cancer), hormone replacement therapy, any of the following drugs used to treat viral infections, including HIV or hepatitis C infection. How to take Rosuvastatin: Usual doses in adults: If you are taking Rosuvastatin for high cholesterol: Starting dose Your treatment with Rosuvastatin must start with the 5 mg or the 10 mg 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. Your doctor may decide to give you the lowest dose (5 mg) if you are of Asian origin, if you are over 70 years of age, if you have moderate kidney problems, if you are at risk of muscle aches and pains. 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 5 mg dose, your doctor may decide to double this to 10 mg, then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment. The maximum daily dose of Rosuvastatin is 40 mg. If you are taking Rosuvastatin to reduce your risk of having a heart attack, stroke or related health problems: The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above. Use in children and adolescents aged 6-17 years The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg 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 10 or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day. Rosuvastatin 40 mg tablet should not be used by children. How to store Rosuvastatin: Keep this medicine out of the sight and reach of children. Blisters: Store below 30°C. Store in the original package in order to protect from moisture. Containers: Store below 30°C. Keep the bottle tightly closed in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the box/blisters/label. A valid prescription should be available upon delivery

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