Properties
- Form
- tableti saghech i
- Dosage mg
- 20
- Pack
- 28
What is it?
International Name: rosuvastatin Indication ROLIPEX is a medicine belonging to the statin group. It improves lipid (fat) levels in the blood. The most common blood lipid is cholesterol. There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-Ch) and "good" cholesterol (HDL-Ch). ROLIPEX reduces "bad" cholesterol levels and increases "good" cholesterol levels in the blood. If you have been prescribed ROLIPEX, it means your cholesterol level is high and you are at risk of stroke or myocardial infarction. If statins have been recommended for you, changing your diet and exercise alone was no longer sufficient. ROLIPEX helps your body to prevent the production of "bad" cholesterol and to reduce its content in the blood. Why is it important to continue treatment with ROLIPEX? You should continue taking ROLIPEX even when your cholesterol level approaches the desired level. ROLIPEX protects you from your cholesterol level rising again. You should stop taking ROLIPEX if you are pregnant. Continue your cholesterol-lowering diet and exercise in parallel with ROLIPEX treatment. Most people think that high cholesterol levels do not harm them until they feel the relevant symptoms. However, if this condition is not treated properly, lipids accumulate on the walls of blood vessels, causing them to narrow. Sometimes narrowed blood vessels can cause myocardial infarction. Myocardial infarction and stroke occur when the heart or brain no longer receives blood supply. You can reduce the risk of myocardial infarction or stroke by improving your cholesterol level. Contraindications What you should know before starting ROLIPEX ROLIPEX is not recommended if: you are hypersensitive to rosuvastatin or the excipients of the preparation you are pregnant or breastfeeding; if you become pregnant during ROLIPEX treatment, stop taking ROLIPEX immediately and consult your doctor you are pregnant or breastfeeding; if you become pregnant during ROLIPEX treatment, stop taking ROLIPEX immediately and consult your doctor. Women should avoid pregnancy through contraceptive methods during ROLIPEX treatment you have liver disease you have severe kidney disease you suffer from recurrent and unexplained muscle pain you are being treated with cyclosporine (e.g., after organ transplantation). Please consult your doctor if any of the above cases apply to you. Do not use 40 mg ROLIPEX (the highest dose) in the following cases: if you have moderate kidney failure (consult your doctor in case of doubt) if you have thyroid dysfunction if you suffer from recurrent and unexplained muscle pain (you have a personal or family history of muscle diseases, you have had problems with cholesterol-lowering medications in the past) if you regularly consume large amounts of alcohol if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian) if you are taking fibrates, which lower blood fat levels. Please consult your doctor if any of the above cases apply to you or if you think any of them apply. Use ROLIPEX with caution in the following cases: if you have kidney problems if you have liver problems if you suffer from recurrent and unexplained muscle pain, have a personal or family history of muscle diseases, have had problems with cholesterol-lowering medications in the past. Seek medical attention immediately if you have a fever and experience unexplained muscle pain. if you regularly consume large amounts of alcohol if you have thyroid dysfunction if you are taking fibrates, which lower blood fat levels if the patient is a child: ROLIPEX is not indicated in children. if you are over 70 years of age: your doctor will decide on the appropriate starting dose of ROLIPEX for your age. if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor will decide on the appropriate starting dose of ROLIPEX for you. If any of the above apply to you or if you think any of them apply, consult your doctor or pharmacist before taking ROLIPEX. Use of ROLIPEX with food and drink ROLIPEX can be taken on an empty stomach or after meals. Pregnancy Consult your doctor or pharmacist before using the medication. Do not use ROLIPEX if you are pregnant. Women should avoid possible pregnancy through appropriate contraceptive methods during ROLIPEX treatment. If you notice that you are pregnant during treatment, consult your doctor or pharmacist immediately for advice. Lactation Consult your doctor or pharmacist before using the medication. Do not use ROLIPEX during breastfeeding. Driving ROLIPEX does not impair the ability to drive a car or other vehicle; however, drowsiness is sometimes reported during ROLIPEX treatment. If you experience drowsiness, consult your doctor before driving a car or other vehicle. Important information about some excipients of ROLIPEX If you have intolerance to some sugars, consult your doctor before taking the medication. Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any medicine, including over-the-counter medicines. Inform your doctor if you are taking any of the following medicines: cyclosporine (e.g., after organ transplantation), warfarin (or other anticoagulants), fibrates (gemfibrozil, fenofibrate, etc.) or other cholesterol-lowering agents (ezetimibe, etc.), anti-dyspeptic agents (for high stomach acidity), erythromycin (antibiotic), contraceptive pills, hormone replacement therapy or lopinavir/ritonavir (for HIV infection). The effects of these medicines may be altered by ROLIPEX and vice versa, they may affect the effects of ROLIPEX. Please inform your doctor or pharmacist if you are currently taking any medicines or have recently been treated with other prescription or over-the-counter medicines. Dosage and administration Always take ROLIPEX as recommended by your doctor. Check with your doctor or pharmacist if you are unsure about the correct use and dosage/frequency of administration of the preparation: Starting dose: Treatment with ROLIPEX should be started with 5 mg if you have not taken statins before; and if you have taken another statin before, treatment may be started with 10 mg. The selection of the starting dose depends on: your cholesterol level the risks of myocardial infarction and stroke your condition, which may cause drug side effects. Your doctor will choose the dose of ROLIPEX that is best for you. Your doctor may recommend taking the lowest dose, i.e., 5 mg, in the following cases: if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian) if you are over 70 years of age if you have moderate kidney failure if you have muscle pain (myopathy) Dose increase and maximum daily dose: Your doctor may decide to increase the dose to achieve the most suitable dose for you. If you started treatment with 5 mg, your doctor may increase the dose to 10 mg, then to 20 mg, and if necessary, double the dose to 40 mg. A 4-week interval is made after each dose increase. Method of administration: Swallow the whole tablet with water. Take ROLIPEX once a day. You can take ROLIPEX at any time of the day. Pay attention to taking the medication at the same time every day. Regular cholesterol monitoring Regular visits to the doctor are very important to monitor cholesterol levels. This way you will ensure that you achieve and maintain your desired cholesterol level. Different age groups: Pediatrics: ROLIPEX is not recommended for children. Geriatrics: If you are 70 years of age or older, your doctor may recommend a starting dose of 5 mg rosuvastatin. No other dose adjustment is necessary in this age group. Special conditions: Kidney failure: No dose adjustment is necessary in patients with mild and moderate kidney failure. The recommended starting dose in patients with moderate kidney failure is 5 mg. The daily dose should not exceed 10 mg. 40 mg cannot be prescribed in patients with moderate kidney failure. ROLIPEX is not prescribed in patients with severe kidney failure. Liver damage: ROLIPEX should not be used in patients with active liver disease. Overdose Consult your doctor or pharmacist for advice in case of ROLIPEX overdose. If you forget to take ROLIPEX: Skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose. Effects that may occur when ROLIPEX treatment is stopped If you wish to stop taking ROLIPEX, consult your doctor for advice. Your cholesterol level may rise again when ROLIPEX treatment is stopped. Side effects It is important for you to know what side effects may occur when using ROLIPEX. Such side effects are usually mild and pass quickly. If any of the following occur, stop taking ROLIPEX and contact your doctor immediately or seek emergency medical attention: Difficulty breathing: with or without swelling of the face, lips, tongue and throat, swelling of the face, lips, tongue and/or throat with dysphagia Exanthema with severe itching Stop taking ROLIPEX immediately if you experience unusual muscle pain; rarely, these effects can lead to life-threatening muscle damage called rhabdomyolysis. This serious side effect is very rare. Very rare side effects (may occur in less than 1/10,000 cases) Jaundice (yellowing of the skin and eyes) Hepatitis (inflammation of the liver) Hematuria Nerve damage in the limbs (numbness) Amnesia Arthralgia Consult your doctor if you experience any of the above. Rare side effects (may occur in 1/1,000 - 1/10,000 cases) Allergic reactions: swelling of the face, lips, tongue and/or throat, difficulty breathing and swallowing, severe itching with rash. If you think you are having an allergic reaction, stop taking ROLIPEX immediately and consult your doctor. Muscle damage: If you experience unusual muscle pain that lasts longer than expected, stop taking ROLIPEX as a precaution and consult your doctor. Severe abdominal pain (pancreatitis) Increased liver enzymes in the blood. Consult your doctor if you experience any of the above. Serious side effects are rare. Uncommon side effects (may occur in 1/100 - 1/1,000 cases) Rash, itching and skin reactions, increased protein in the urine. Generally, this condition is transient and returns to normal even before stopping ROLIPEX (characteristic only for 5 mg, 10 mg and 20 mg ROLIPEX). Consult your doctor if you experience any of the above. Frequent side effects (may occur in 1/10 - 1/100 cases) Consult your doctor if you experience: Headache Abdominal pain Constipation Malaise Muscle pain Weakness Drowsiness Increased protein in the urine. Generally, this condition is transient and returns to normal even before stopping ROLIPEX (usually characteristic only for 40 mg ROLIPEX). These are mild side effects of ROLIPEX. If you experience a side effect not described in the patient information leaflet, contact your doctor or pharmacist. Storage conditions and expiry dates Store ROLIPEX in its original packaging, out of reach of children. Store ROLIPEX at room temperature, up to 25°C. Expiry date: 24 months Do not use ROLIPEX after the expiry date indicated on the packaging. Do not use ROLIPEX if you notice that the product or its packaging is damaged. Dispensing category: Pharmaceutical product group II (can be used with a doctor's prescription)
