Properties
What is it?
1. What is Zetor Plus and what is it used for Zetor Plus contains two different active substances in one capsule. The first active substance is rosuvastatin, which belongs to the so-called statins. The second active substance is ezetimibe. Zetor Plus is a preparation used to lower total cholesterol, "bad" cholesterol (LDL), and fats (triglycerides) in the blood. In addition, the preparation increases the level of "good" cholesterol (HDL). The preparation lowers blood cholesterol levels through a dual action: it reduces cholesterol absorption in the digestive tract and reduces cholesterol production in the body. In most cases, high cholesterol levels do not affect health and do not cause any symptoms. However, if high cholesterol levels are not treated, it will lead to the accumulation of fats in the walls of blood vessels and, as a result, narrowing of the blood vessels. Sometimes, these narrowed blood vessels can become blocked, and blood will no longer be supplied to a part of the heart or brain: consequently, this will lead to a heart attack or stroke. Lowering cholesterol levels can reduce the risk of heart attack, stroke, and similar health problems. Zetor Plus is used in patients whose cholesterol levels cannot be lowered by diet alone. During the use of this preparation, the diet aimed at lowering cholesterol should be continued. Your doctor may prescribe Zetor Plus if cholesterol levels are not adequately controlled with rosuvastatin alone or if you are already taking rosuvastatin and ezetimibe at the same doses. Zetor Plus does not help with weight loss. 2. What you need to know before taking Zetor Plus Warnings and precautions Do not take Zetor Plus if: • you are allergic to rosuvastatin, ezetimibe, or any other component of the preparation; • you have liver disease; • you have severe kidney dysfunction; • you have recurrent or unexplained muscle pain (myopathy); • if you are taking cyclosporine (e.g., after organ transplantation); • you are pregnant or breastfeeding. If pregnancy occurs during treatment with this preparation, stop taking it immediately and consult your doctor. Women should avoid becoming pregnant while using Zetor Plus and use appropriate contraception for this purpose; additionally, do not take Zetor Plus 40mg/10mg tablets (the highest dose) if: • you have moderate kidney dysfunction; • you have impaired thyroid function (hypothyroidism); • you have recurrent or unexplained muscle pain, muscle disease (personally or in your family) or have had problems with muscles when taking other cholesterol-lowering drugs; • you regularly consume large amounts of alcohol; • you are of East Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian); • you are taking fibrates to lower cholesterol (see section "Interactions with other medicines"). If you are unsure whether any of the above conditions apply to you, consult your doctor before taking the preparation. Take care when taking Zetor Plus if: • you have kidney disease; • you have liver disease; • you have recurrent or unexplained muscle pain, muscle disease (personally or in your family) or have had problems with muscles when taking other cholesterol-lowering drugs. Be sure to tell your doctor if unexplained muscle pain develops, especially if you feel unwell or have a fever. Also, tell them or your pharmacist if persistent muscle pain develops; • you are of East Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian): your doctor should choose the appropriate dose of Zetor Plus for you; • you are taking medication for HIV infection, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (see section "Interactions with other medicines"); • you have severe respiratory failure; • you are taking fibrates (other cholesterol-lowering drugs) (see Interactions with other medicines); • you are undergoing surgery. You may need to temporarily stop taking the preparation; • you regularly consume large amounts of alcohol; • you have impaired thyroid function (hypothyroidism); • you are over 70 years of age (your doctor should choose a dose appropriate for your age); • you are taking or have taken antibiotics containing fusidic acid within the last 7 days, orally or by injection. Combined use of fusidic acid and Zetor Plus may cause serious muscle damage (rhabdomyolysis); • you are taking regorafenib (used to treat cancer). If any of the above applies to you (or if you are unsure), do not take Zetor Plus tablets and consult your doctor or pharmacist before taking them. In some patients, statins can affect liver function. These changes are detected by a simple measurement of liver enzyme levels in the blood, so your doctor will schedule regular tests during Zetor Plus therapy (assessment of biochemical indicators of liver function). It is important to visit your doctor to undergo the laboratory tests prescribed by them. If you have diabetes or a risk of developing it, your doctor will closely monitor your condition while taking this preparation. You are likely at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Children and adolescents: The use of Zetor Plus in children and adolescents under 18 years of age is not recommended. Interactions with other medicines Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or may take. It is important to inform your doctor if you are taking the following medicines: • Cyclosporine (used, for example, after organ transplantation to prevent rejection of the transplanted organ. Concurrent use enhances the effect of rosuvastatin). Do not take Zetor Plus if you are taking cyclosporine. • Blood thinners, such as warfarin, acenocoumarol, or fluindione (taking with Zetor Plus increases their effect on blood clotting and the risk of bleeding), as well as clopidogrel. • Other medicines, fibrates (gemfibrozil, etc.), used to lower cholesterol, as well as to correct triglyceride levels in the blood. The effect of rosuvastatin is enhanced when taken with fibrates. Do not take Zetor Plus 40mg/10mg tablets if you are taking fibrates. • Cholestyramine (cholesterol-lowering drug) – affects the mechanism of action of ezetimibe. • Regorafenib (used to treat cancer). • Antiviral agents (HIV protease inhibitors) used to treat HIV infection (e.g., lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir) - see section 2 Warnings and precautions. • Antacids containing aluminum and magnesium (used to neutralize stomach acid; they also reduce rosuvastatin levels). This effect can be reduced if these medicines are taken more than 2 hours after taking rosuvastatin. • Erythromycin (antibiotic): this combination reduces the effect of rosuvastatin. • Fusidic acid (antibiotic) – see section 2 Warnings and precautions. • Oral contraceptives (increased absorption of sex hormones from the contraceptive). • Hormone replacement therapy (increases hormone levels in the blood). If you are admitted to the hospital or receive treatment for another condition, inform your doctor that you are taking Zetor Plus. Zetor Plus and alcohol Do not take Zetor Plus 40mg/10mg tablets if you regularly consume large amounts of alcohol. Pregnancy and breastfeeding Pregnancy Before taking the preparation, consult your doctor or pharmacist. Do not use Zetor Plus if you are pregnant, suspect you are pregnant, or wish to become pregnant. If pregnancy occurs during treatment with Zetor Plus, stop taking the preparation immediately and inform your doctor. Women should use contraceptive methods during treatment with this preparation. Breastfeeding Before taking the preparation, consult your doctor or pharmacist. Do not take Zetor Plus if you are breastfeeding, as it is not known whether this preparation passes into breast milk. Ability to drive and operate machinery It is not expected that taking Zetor Plus will negatively affect your ability to drive or operate machinery; however, it should be noted that some people may experience dizziness when using Zetor Plus. If dizziness occurs, consult your doctor before driving or operating machinery. Important information about some excipients in Zetor Plus Zetor Plus contains lactose. If you have an intolerance to some types of sugar, consult your doctor before taking the preparation. 3. How to take Zetor Plus Dosage and frequency of administration Take Zetor Plus exactly as prescribed by your doctor. If you are unsure whether you are taking the preparation correctly, consult your doctor. The recommended dose of Zetor Plus for adults is 1 tablet per day. Take the preparation orally, at the same time each day, with or without food. Swallow the tablet whole with a sufficient amount of water. While taking Zetor Plus, you should continue a low-cholesterol diet and engage in sufficient physical activity. Zetor Plus is not intended for the initial treatment of high cholesterol levels. Combination therapy with Zetor Plus should only be initiated after appropriate doses of rosuvastatin or both components of the preparation have been selected. The maximum daily dose of rosuvastatin is 40 mg. It is used only in patients with high cholesterol levels and a high risk of heart attack or stroke, when cholesterol lowering is insufficient at a dose of 20 mg. If your doctor prescribes another cholesterol-lowering medication along with Zetor Plus, such as cholestyramine or a bile acid sequestrant, Zetor Plus should be taken 2 hours before or 4 hours after taking these medications. Regular monitoring of cholesterol levels is important Regular visits to the doctor are important to monitor cholesterol levels and confirm that the desired cholesterol level is achieved and maintained. If you take more Zetor Plus than you should If you take more Zetor Plus than prescribed, seek immediate medical attention or go to the nearest emergency medical center, as you may require medical assistance. If you miss a dose of Zetor Plus Do not take a missed dose. Take your next scheduled dose at the usual scheduled time. Do not take a double dose to compensate for a missed dose. If you stop taking Zetor Plus Tell your doctor if you wish to stop taking Zetor Plus. After stopping this preparation, your cholesterol levels may rise again. If you have any questions about the use of the preparation, consult your doctor or pharmacist. 4. Possible side effects Like all medicines, Zetor Plus can cause side effects in people sensitive to its components. If any of the following side effects occur, stop taking Zetor Plus and seek immediate medical attention or go to the nearest emergency medical center. Rare side effect - may occur in 1 in 1000 patients or less: • Unusual muscle pain that lasts longer than usual. Rarely, life-threatening muscle damage – rhabdomyolysis – may occur: this causes general weakness, fever, and kidney dysfunction. • Allergic reactions, such as swelling of the face, tongue, and/or throat – this can make breathing and swallowing difficult. Unknown frequency (cannot be determined from available data): Ulcers and rash on the skin, in the mouth, eyes, and external genitalia – this may be a sign of Stevens-Johnson syndrome (a life-threatening allergic reaction characterized by severe skin and mucous membrane damage). Other known side effects Common side effects (may occur in 1 in 10 patients or less) • Headache • Constipation • Nausea • Muscle pain • Feeling of weakness • Dizziness • Diabetes: The probability of diabetes is higher if you have elevated blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you; however, you should continue taking this preparation. • Abdominal pain • Diarrhea • Flatulence (increased amount of gas in the intestines) • Feeling of fatigue • Increase in some laboratory indicators of liver function (transaminases) • Increased protein in the urine may be observed – this deviation usually normalizes without the need to discontinue rosuvastatin (only when taking 40 mg rosuvastatin) Uncommon side effects (may occur in 1 in 100 patients or less) • Rash, itching of the skin, blistering rash on the skin • Increase in some laboratory indicators characteristic of muscle tissue • Cough • Indigestion • Heartburn • Joint pain • Neck pain • Muscle spasms • Decreased appetite • Pain • Chest pain • Feeling of blood rushing • Increased blood pressure • Tingling sensation • Dry mouth • Burning sensation in the stomach • Back pain • Muscle weakness • Limb pain • Swelling, especially of the ankles and wrists • Increased protein in the urine may be observed – this deviation usually normalizes without the need to discontinue rosuvastatin (only when taking 10 and 20 mg rosuvastatin) Rare side effects (may occur in 1 in 1000 patients or less) • Pancreatitis: causes severe abdominal pain that radiates to the back • Decrease in platelet count, which can lead to bruising, bleeding • Lupus-like syndrome (rash, joint pain, changes in blood cells) • Muscle rupture Very rare side effects (may occur in 1 in 10,000 patients or less) • Jaundice (yellowing of the skin and eyes) • Liver inflammation (hepatitis) • Trace amounts of blood in the urine • Numbness and other neurological symptoms in the hands and feet • Memory loss • Enlargement of the mammary glands in men (gynecomastia) Unknown frequency (cannot be determined from available data) • Shortness of breath • Swelling • Sleep disturbances, including insomnia and nightmares • Sexual dysfunction • Depression • Respiratory disorders, including persistent cough and/or shortness of breath and fever • Tendon damage • Persistent muscle weakness • Red, raised rash on the skin with lesions (erythema multiforme) • Muscle stiffness • Formation of gallstones or inflammation of the gallbladder (may manifest as abdominal pain, nausea, and vomiting) 5. Storage conditions of Zetor Plus The preparation does not require special storage conditions. Store in the original packaging, in a dry place protected from light. Keep out of reach of children! Dispensing method: Pharmaceutical product group II, dispensed with prescription form #3. Expiration date: 3 years Use considering the expiration date: Do not use Zetor Plus after the expiration date indicated on the box. Do not use Zetor Plus if you notice that the preparation or its packaging is damaged.