Rozulip Plus capsules 10mg/10mg №10×3

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Rozulip Plus caps 10mg/10mg in bl. in pack. No. 10×3
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Capsules Appearance: Capsules Rozulip® Plus 10 mg/10 mg: Hard gelatin capsules without marking, self-closing, with a yellow base and a yellow cap. Each capsule contains two tablets. Rosulip® Plus 20 mg/10 mg capsules: Unmarked, self-closing hard gelatin capsules with yellow base and light brown cap. Each capsule contains two tablets. Capsules Rosulip® Plus 40 mg/10 mg: Unmarked, self-closing hard gelatin capsules with yellow base and brown cap. Each capsule contains two tablets. The main active ingredient is rosuvastatin and ezetimibe. Release form: 10 capsules in a blister pack made of a combined “cold” film (OPA/aluminum foil/PVC)/aluminum foil. 3 blisters are packed in a cardboard box along with instructions for use for patients. Dosage 10mg/10mg in bl. in pack. No. 10×3 Special instructionsRozulip® Plus contains two active ingredients in one capsule. The first active ingredient is rosuvastatin. It belongs to the so-called statins. The second active ingredient is ezetimibe. Rosulip® Plus is a medicine used to lower the levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fats (triglycerides) in the blood. In addition, the drug increases the levels of “good” cholesterol (HDL cholesterol). The drug leads to a decrease in blood cholesterol levels, acting in two directions: reducing the absorption of cholesterol in the digestive tract and reducing the formation of cholesterol in the body. For most people, high cholesterol does not affect their well-being and does not cause any symptoms. But if left untreated, patients with elevated cholesterol levels, there is a deposition of fat in the walls of blood vessels, which leads to vasoconstriction. Sometimes these narrowed blood vessels can become blocked, and blood stops flowing to one or another part of the heart or brain: this leads, respectively, to a heart attack or stroke. Lowering cholesterol levels can reduce the risk of heart attack, stroke, and similar health problems. Rosulip® Plus is used in patients whose cholesterol levels cannot be reduced with diet alone. You should continue to follow a cholesterol-lowering diet while taking this medicine. Your doctor may prescribe Rosulip® Plus if treatment with rosuvastatin alone does not provide sufficient cholesterol control, or if you are already taking rosuvastatin and ezetimibe at the same doses. Rosulip® Plus does not help to reduce weight. Indications for useRozulip® Plus is a medicine used to lower the levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fats (triglycerides) in the blood. In addition, the drug increases the levels of “good” cholesterol (HDL cholesterol). The drug leads to a decrease in blood cholesterol levels, acting in two directions: reducing the absorption of cholesterol in the digestive tract and reducing the formation of cholesterol in the body. Dosage and Administration Always take this medicine exactly as directed by your doctor or pharmacist. If you are not sure if you are taking it correctly, ask your doctor or pharmacist. While taking Rozulip® Plus, you should continue to follow a low cholesterol diet and sufficient physical activity. The recommended dose for adults is one capsule daily. Take Rozulip® Plus once a day. You can take this medicine at any time of the day, with or without food. Each capsule should be taken with a glass of water. Take this medicine at the same time every day. Rosulip® Plus is not suitable for the initial treatment of high cholesterol. Combined treatment should be started only after the selection of suitable dosages of rosuvastatin or both components of the drug. The maximum daily dose of rosuvastatin is 40 mg. It is used only in patients with high cholesterol levels and at high risk of heart attack or stroke, when cholesterol reduction with a dose of 20 mg is insufficient. Regular cholesterol checks It is important to see your doctor regularly to check your cholesterol levels and make sure you have reached and are maintaining your desired cholesterol levels. If you take more than you should Contact your doctor or go to the emergency room at the nearest hospital as you may need medical attention. If you forget to take Don’t worry, don’t take the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a missed dose. If you stop taking it Tell your doctor that you want to stop taking Rosulip® Plus. After you stop taking Rosulip® Plus, your cholesterol levels may rise again. If you have any questions about the use of this medicine, ask your doctor or pharmacist. Use during pregnancy and lactation Do not take Rosulip® Plus if you are pregnant, expect or plan to become pregnant. If you become pregnant while taking Rozulip® Plus, stop taking the drug immediately and tell your doctor. During treatment with Rosulip® Plus, women should use contraceptives. Do not take Rosulip® Plus if you are breastfeeding as it is not known if this drug passes into breast milk. Precautions Talk to your doctor or pharmacist before taking Rosulip® Plus if: You have kidney disease. You have liver disease. You have experienced recurring or unexplained muscle pain, muscle disease (for yourself and in your family), or muscle problems while taking other cholesterol-lowering medications. Tell your doctor or pharmacist immediately if you develop unexplained muscle pain, especially if accompanied by fever. Also tell your doctor or pharmacist if you develop persistent muscle weakness. You are a person of East Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian): your doctor should select the dose of Rosulip® Plus that is right for you. You are taking medicines to treat HIV infection, such as lopinavir/ritonavir and/or atazanavir (see section “Other medicines and Rosulip® Plus”). You have severe respiratory failure. You are taking fibrates (other cholesterol-lowering medicines) (see section “Other medicines and Rosulip® Plus”). You regularly consume alcohol in large quantities. You have an impaired thyroid function (hypothyroidism). You are over 70 years of age (the doctor must choose the dose of Rosulip® Plus that is appropriate for your age). You are taking antibiotics containing fusidic acid (see section “Other medicines and Rosulip® Plus”). If any of the above apply to you (or you are not sure about the opposite): Do not take Rosulip® Plus capsules 40 mg/10 mg (highest dose), and talk to your doctor or pharmacist before taking Rosulip® Plus . In a small number of patients, statins may affect liver function. These changes are detected by a simple measurement of the levels of liver enzymes in the blood. Therefore, the doctor will prescribe you to regularly conduct this study (assessment of biochemical indicators of liver function) during therapy with Rosulip® Plus. It is important to visit a doctor for laboratory tests prescribed by him. If you have or are at risk of developing diabetes, your doctor will watch you closely while you take this medicine. You are likely to be at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Children and adolescents It is not recommended to use Rozulip® Plus in children and adolescents (under 18 years of age). Interactions with other drugs Tell your doctor or pharmacist about all medicines you are taking, have recently taken or may take. Tell your doctor if you are taking any of the following medicines: Cyclosporine (Used, for example, after an organ transplant to prevent rejection of the transplanted organ. Simultaneous use enhances the effect of rosuvastatin.). Do not take Rosulip® Plus if you are taking ciclosporin. Blood thinners such as warfarin, acenocoumarol or fluindione (when taken with Rosulip® Plus increase their effect on blood clotting and the risk of bleeding), as well as clopidogrel. Other drugs, fibrates (gemfibrozil, etc.), used to lower cholesterol levels and also to correct blood triglyceride levels. The action of rosuvastatin is enhanced when taken together with fibrates. Do not take Rosulip® Plus 40 mg/10 mg capsules if you are taking fibrates. Cholestyramine (cholesterol-lowering medicine) – it affects the mechanism of action of ezetimibe. Antivirals used in HIV infection (so-called HIV protease inhibitors, such as lopinavir/ritonavir and/or atazanavir). See “Warnings and Precautions” section. Anti-acid agents containing aluminum and magnesium (These are used to neutralize stomach acid; they also reduce the level of rosuvastatin). This effect may be reduced if these medicines are taken no earlier than 2 hours after taking rosuvastatin. Erythromycin (antibiotic): this combination leads to a decrease in the effect of rosuvastatin. Fusidic acid (antibiotic – see “Warnings and Precautions”). Oral contraceptives: there is an increase in the absorption of sex hormones from contraceptive tablets. Hormone replacement therapy (increases the levels of hormones in the blood). If you are visiting a hospital or receiving treatment for another condition, tell the medical staff that you are taking Rosulip® Plus. Rosulip® Plus and alcohol Do not take Rosulip® Plus 40 mg/10 mg capsules (highest dose) if you regularly drink large amounts of alcohol. Contraindications Do not take Rosulip® Plus if you are: allergic to rosuvastatin, ezetimibe or any of the other ingredients listed in the “Contents of the pack and other information” section; Have liver disease There is a severe impairment of kidney function; Recurring or unexplained muscle pain (myopathy) if you are taking a medicine called cyclosporine (for example, after an organ transplant); If you are pregnant or breastfeeding. If you become pregnant while taking Rosulip® Plus, stop taking this drug immediately and contact your doctor. Women should avoid becoming pregnant while taking Rozulip® Plus and use suitable contraception for this purpose. In addition, do not take Rosulip® Plus 40 mg/10 mg capsules (highest dose) if: You have moderate renal impairment. You have an impaired thyroid function (hypothyroidism). You have experienced recurring or unexplained muscle pain, muscle disease (for yourself and in your family), or muscle problems while taking other cholesterol-lowering medications. You regularly consume alcohol in large quantities. You are of East Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). You are taking fibrates (another type of cholesterol-lowering medicine, see Other Medicines and Rosulip® Plus). If any of the above applies to you (or if you are unsure), tell your doctor. Active ingredients: rosuvastatin and ezetimibe. Rosulip® Plus 10 mg/10 mg: each capsule contains 10 mg rosuvastatin zinc) and 10 mg ezetimibe. Rosulip® Plus 20 mg/10 mg: each capsule contains 20 mg rosuvastatin zinc) and 10 mg ezetimibe. Rosulip® Plus 40 mg/10 mg: each capsule contains 40 mg of rosuvastatin zinc) and 10 mg of ezetimibe. Excipients: Rosulip® Plus 10 mg / 10 mg: microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, povidone, croscarmellose sodium, mannitol, sodium lauryl sulfate, low-substituted hydroxypropyl cellulose, yellow iron oxide (E172), titanium dioxide (E171 ), gelatin. Rosulip® Plus 20 mg / 10 mg and 40 mg / 10 mg: microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, povidone, croscarmellose sodium, mannitol, sodium lauryl sulfate, low-substituted hydroxypropyl cellulose, iron oxide red (E172), iron yellow oxide (E172), titanium dioxide (E171), gelatin. Side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. It is important that you know what side effects may occur. Stop taking Rosulip® Plus and seek medical attention immediately if you notice any of the following symptoms: Rare side effects (may affect up to 1 in 1,000 patients or less): pharynx – this can lead to difficulty breathing and swallowing. Unusual muscle pain that lasts longer than usual. Rarely, a life-threatening muscle injury called rhabdomyolysis can develop, leading to general weakness, fever, and impaired kidney function. Not known (frequency cannot be estimated from available data): Ulcers or blisters on the skin, mouth, eyes, and vulva – this may be a manifestation of Stevens-Johnson syndrome (a life-threatening allergic reaction that manifests itself on the skin and mucous membranes shells). Common side effects (may affect up to 1 in 10 patients or less) headache; constipation; bad feeling; muscle pain; feeling of weakness; dizziness; an increase in the protein content in the urine is possible – this deviation usually normalizes without the need to cancel rosuvastatin (only when taking 40 mg of rosuvastatin); Diabetes: You are more likely to have diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will watch you while you continue taking this medicine; abdominal pain; diarrhea; flatulence (increased amount of gas in the intestines); feeling tired; increase in some laboratory parameters of liver function (transaminases). Uncommon side effects (may affect up to 1 in 100 patients or less) skin rash, blisters and itching; it is possible to increase the protein content in the urine – this deviation usually normalizes without the need to cancel rosuvastatin (only when taking 10 and 20 mg of rosuvastatin); increase in some laboratory parameters of muscle tissue (CPK); cough; indigestion; heartburn; joint pain; muscle spasms; pain in the neck; loss of appetite; chest pain; hot flashes; high blood pressure; tingling sensation; dry mouth; inflammation of the stomach; backache; muscle weakness; pain in the arms and legs; swelling, especially of the hands and feet. Rare side effects (may affect up to 1 in 1,000 patients or less) inflammation of the pancreas: causes severe abdominal pain that radiates to the back; decrease in the number of platelets. Very rare side effects (may affect up to 1 in 10,000 people or less) jaundice (yellowing of the skin and eyes); inflammation of the liver (hepatitis); traces of blood in the urine; nerve damage in the arms and legs (numbness and other symptoms); memory loss; male breast enlargement (gynecomastia). Not known (frequency cannot be determined from the available data) dyspnoea; swelling; sleep disturbances, including insomnia and nightmares; sexual dysfunction; depression; respiratory problems, including persistent cough and/or shortness of breath and fever; tendon injuries; persistent muscle weakness; formation of stones in the biliary tract or inflammation of the gallbladder (may manifest as abdominal pain, nausea and vomiting). Reporting side effects If you experience any side effects, including those not mentioned in this leaflet, please contact your doctor or pharmacist. Storage conditions Store at a temperature not exceeding 30 ° C, out of the reach of children! Buy Rosulip Plus capsules 10mg / 10mg No. 10×3