Newvast Plus 20/10mg 30 tablets

Form

tableti

Pack

30

NEWVAST PLUS 20mg+10mg film-coated tablets Rosuvastatin and Ezetimibe Read the package leaflet carefully before you start taking this medicine because it contains important information for you. Keep the leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not give it to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, or if you notice any side effects not listed in this leaflet, tell your doctor. See section 4. Contents: 1) What NEWVAST PLUS is and what it is used for 2) What you need to know before taking NEWVAST PLUS 3) How to take NEWVAST PLUS 4) Possible side effects 5) How to store NEWVAST PLUS 6) What NEWVAST PLUS contains and other information 1. What NEWVAST PLUS is and what it is used for NEWVAST PLUS contains two different active substances in one film-coated tablet. One active substance is rosuvastatin calcium, which belongs to a group of medicines called statins. The other active substance is ezetimibe. NEWVAST PLUS is used to lower levels of total cholesterol, "bad" cholesterol (LDL-C), and fatty substances called triglycerides in your blood. It also increases the level of "good" cholesterol (HDL-C). The medicine lowers cholesterol levels in the blood through a dual action: it reduces the absorption of cholesterol in the digestive tract and reduces the production of cholesterol in the body. In most cases, high cholesterol levels do not affect patients' general condition as they do not show symptoms. However, if high cholesterol levels are not treated, it will lead to the accumulation of fats in the walls of blood vessels, resulting in narrowing of the blood vessels. Sometimes, these narrowed blood vessels can become blocked, and blood will no longer be supplied to parts of the heart or brain, leading to a heart attack or stroke. Lowering cholesterol levels can reduce the risk of heart attack, stroke, or related health problems. NEWVAST PLUS is used in patients whose cholesterol levels cannot be controlled by diet alone. While taking this medicine, you should continue to follow a cholesterol-lowering diet. Your doctor may prescribe NEWVAST PLUS if you are already taking rosuvastatin and ezetimibe at the same doses. NEWVAST PLUS is prescribed for patients with heart disease. NEWVAST PLUS reduces the risk of heart attack, stroke, the need for surgery to increase blood flow to the heart, or hospitalization due to chest pain. NEWVAST PLUS is used if you have: - High cholesterol levels in your blood (primary hypercholesterolemia). - Heart disease. NEWVAST PLUS does not help with weight loss. See also: NEWVAST PLUS - Newvast Plus 5/10mg 30 tablets 2. What you need to know before taking NEWVAST PLUS Do not take NEWVAST PLUS if: · You are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6); · You have liver disease; · You have severe kidney impairment; · You have recurrent or unexplained muscle pain (myopathy); · You are taking ciclosporin (e.g., after organ transplantation); · You are pregnant or breastfeeding. If you become pregnant while taking NEWVAST PLUS, stop taking it immediately and consult your doctor. Use adequate contraception to avoid pregnancy while taking NEWVAST PLUS; · You have developed severe skin rash or peeling, blistering and/or sores in the mouth following treatment with NEWVAST PLUS or other similar medicines in the past. Also, do not take rosuvastatin 40 mg (maximum dose) if: · You have moderate to severe kidney impairment (consult your doctor if unsure); · You have thyroid dysfunction (hypothyroidism); · You regularly consume large amounts of alcohol; · You are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian); · You are taking fibrates to lower cholesterol (see "Other medicines and NEWVAST PLUS"); Consult your doctor for advice if any of the above apply to you (if unsure). Special warnings and precautions Before taking NEWVAST PLUS, consult your doctor or pharmacist if: · You have kidney problems. · You have liver problems. · You experience recurrent or unexplained muscle pain, have a personal or family history of muscle problems, or have had muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately about any unexplained muscle pain, especially with weakness and fever. Also, tell your doctor or pharmacist about persistent muscle weakness. · You are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor will choose the appropriate dose of NEWVAST PLUS for you. · You are taking medicines to treat infections, including HIV or hepatitis C, e.g., lopinavir/ritonavir and/or atazanavir or simeprevir, see "Other medicines and NEWVAST PLUS". · You have acute respiratory problems; · You are taking fibrates to lower cholesterol. See "Other medicines and NEWVAST PLUS". · You regularly consume large amounts of alcohol; · You have thyroid dysfunction (hypothyroidism); · You are over 70 years of age (your doctor should choose the appropriate dose of NEWVAST PLUS for you); · You are taking or have taken within the last 7 days a medicine called fusidic acid (for bacterial infection) orally or by injection. Taking fusidic acid and NEWVAST PLUS together can cause serious muscle problems (rhabdomyolysis). · You have or have ever had myasthenia gravis (a disease characterized by muscle weakness, sometimes including the muscles that control breathing) or ocular myasthenia gravis (a condition that causes weakness of the eye muscles), as statins can worsen these conditions. In some cases, statins can also cause myasthenia gravis (see section 4). If any of the above conditions apply to you (or if you are unsure): Talk to your doctor or pharmacist before taking NEWVAST PLUS. In some cases, statins can cause liver problems. This can be detected by a simple blood test to check for elevated liver enzymes. For this purpose, your doctor will perform periodic blood tests (liver function tests) during treatment with NEWVAST PLUS. Serious skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with NEWVAST PLUS treatment. If you develop any of the symptoms mentioned in section 4, stop taking NEWVAST PLUS immediately and consult your doctor. If you have diabetes or are at risk of developing diabetes, you will need medical supervision while being treated with this medicine. If you have high blood sugar and fat levels, are overweight, and have high blood pressure, you are at risk of developing diabetes. Children and adolescents The use of NEWVAST PLUS is not recommended in children and adolescents under 18 years of age. Other medicines and NEWVAST PLUS Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Tell your doctor if you are taking any of the following medicines: · Ciclosporin (used, for example, after organ transplantation. Concomitant use enhances the effect of rosuvastatin). Do not take NEWVAST PLUS if you are taking ciclosporin. · Blood thinners such as warfarin, acenocoumarol, or fluindione (taking with NEWVAST PLUS increases their effect on blood clotting and the risk of bleeding), ticagrelor or clopidogrel. · Other medicines, fibrates (gemfibrozil, etc.), used to lower cholesterol levels, as well as to correct triglyceride levels in the blood. Concomitant use enhances the effect of rosuvastatin. · Cholestyramine (cholesterol-lowering medicine), as it affects the mechanism of action of ezetimibe. · Antacids containing aluminum and magnesium (used to neutralize stomach acid; they reduce the plasma levels of rosuvastatin). This effect may 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. If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking NEWVAST PLUS. Your doctor will tell you when it is safe to start taking NEWVAST PLUS again. Taking NEWVAST PLUS with fusidic acid may rarely cause muscle weakness or pain (rhabdomyolysis). More information about rhabdomyolysis is given in section 4. · Oral contraceptives (pills); the levels of sex hormones absorbed from the pill increase. · Hormone replacement therapy (increases hormone levels in the blood). · Regorafenib (anti-cancer medicine). · Antiviral medicines used to treat HIV or hepatitis C infections, alone or in combination (see "Special warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking NEWVAST PLUS. Taking NEWVAST PLUS with alcohol Do not take NEWVAST PLUS 40mg/10mg (maximum dose) if you regularly consume large amounts of alcohol. Pregnancy and breastfeeding Do not take NEWVAST PLUS if you are pregnant, suspect you are pregnant, or plan to become pregnant. If you become pregnant while taking NEWVAST PLUS, stop taking it immediately and consult your doctor. Women should use contraceptive methods while taking NEWVAST PLUS. Do not take NEWVAST PLUS if you are breastfeeding, as it is unknown whether this medicine passes into breast milk. Driving and using machines NEWVAST PLUS is not expected to affect your ability to drive or operate machinery. However, dizziness has been reported in some cases when taking NEWVAST PLUS. If you experience dizziness, consult your doctor before driving or operating machinery. NEWVAST PLUS contains lactose NEWVAST PLUS tablets contain sugar, lactose. If you have an intolerance to some sugars, consult your doctor before starting NEWVAST PLUS. NEWVAST PLUS contains sodium The preparation contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially "sodium-free". 3. How to take NEWVAST PLUS Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. While taking NEWVAST PLUS, you should continue to follow a low-cholesterol diet and get enough physical activity. The recommended dose for adults is one tablet per day. Take NEWVAST PLUS once a day. You can take it at any time of the day, with or without food. Swallow the tablet whole with water. Take it every day at the same time. NEWVAST PLUS is not recommended for initial treatment. Treatment should be initiated or, if necessary, the dose adjusted by taking the active substances separately, and once the appropriate doses have been selected, you can switch to the corresponding dose of NEWVAST PLUS. The maximum daily dose of rosuvastatin is 40 mg. It is intended only for patients with high cholesterol levels who are at high risk of heart attack or stroke, and when cholesterol lowering is insufficient with a dose of 20 mg. When NEWVAST PLUS is prescribed together with other cholesterol-lowering medicines containing cholestyramine or any medicine containing bile acid sequestrants, take NEWVAST PLUS at least 2 hours before or 4 hours after taking such medicines. Regular monitoring of cholesterol levels is recommended to ensure that your cholesterol levels return to the appropriate level. Overdose Immediately contact your doctor or the nearest hospital, as you may require medical assistance. Missed dose Do not worry, do not take a missed dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose. Stopping NEWVAST PLUS Inform your doctor if you decide to stop taking NEWVAST PLUS. Stopping NEWVAST PLUS may cause your cholesterol levels to rise again. For more information on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. It is important to be aware of the types of side effects that can occur. Stop taking NEWVAST PLUS and seek immediate medical help if you develop the following allergic reactions: · Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat; · Swelling of the face, lips, tongue and/or throat, which makes swallowing difficult; · Severe itching of the skin (hives). · Widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals. This severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). · Rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome (DHS)). Also, stop taking NEWVAST PLUS immediately and consult your doctor if: · You experience unusual muscle pain that lasts longer than expected. Muscle-related symptoms are more common in children and adolescents than in adults. Similar to therapy with other statins, adverse effects on the musculoskeletal system are rare, and these rare adverse effects can be life-threatening and progress to rhabdomyolysis (muscle tissue damage). · You have muscle rupture. · You develop a lupus-like illness (including rash, joint problems, and effects on blood cells). The frequency of side effects is defined as follows: - Very common (may affect more than 1 in 10 people) - Common (may affect up to 1 in 10 people) - Uncommon (may affect up to 1 in 100 people) - Rare (may affect up to 1 in 1,000 people) - Very rare (may affect up to 1 in 10,000 people, including isolated cases). Common side effects · Headache · Constipation · Nausea · Muscle pain · Feeling of weakness · Dizziness · Diabetes. This is expected if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Medical supervision is required. · Abdominal pain · Diarrhea · Flatulence (accumulation of gas in the gastrointestinal tract); · Feeling of fatigue · Increase in some laboratory indicators of liver function (transaminases) · Increase in protein in the urine - usually, protein concentration in the urine normalizes on its own and it is not necessary to stop taking NEWVAST PLUS tablets (only with NEWVAST PLUS 40 mg/10 mg). Uncommon side effects · Rash, itching, hives · Increase in protein in the urine - usually, protein concentration in the urine normalizes on its own and it is not necessary to stop taking rosuvastatin (only with NEWVAST PLUS 5 mg+10 mg, 10 mg+10 mg, and 20 mg+10 mg). · Increase in some laboratory indicators of muscle tissue (CK) · Cough · Indigestion · Heartburn · Joint pain · Muscle spasms · Neck pain · Decreased appetite · Pain · Chest pain · Hot flashes · Increased blood pressure · Tingling sensation · Dry mouth · Inflammation of the gastric mucosa · Back pain · Muscle weakness · Pain in arms and legs · Swelling, especially of the hands and feet. Rare side effects · Pancreatitis, causing severe abdominal pain that radiates to the back, decreased platelet count in the blood. · Lupus-like syndrome · Muscle rupture Very rare side effects · Jaundice (yellowing of the skin and whites of the eyes), hepatitis (inflammation of the liver), traces of blood in the urine, impaired function of nerves in the upper and lower limbs (e.g., numbness), memory loss, enlargement of the mammary glands in men (gynecomastia). Side effects of unknown frequency: · Shortness of breath, swelling, sleep disturbances, including insomnia and nightmares, sexual dysfunction, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon damage, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting). · Myasthenia gravis (a disease characterized by muscle weakness, sometimes including the muscles that control breathing). · Ocular myasthenia gravis (a condition that causes weakness of the eye muscles). Tell your doctor if you develop weakness in your arms and legs that worsens after physical activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath. Reporting of side effects If you notice any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. You can report side effects directly through the national reporting system indicated in Annex V. By reporting side effects, you will help provide more information about the safety of this medicine. 5. How to store NEWVAST PLUS Store in the original packaging to protect from moisture and light. This medicinal product does not require any special storage temperature conditions. Keep out of reach of children. Do not use this medicine after the expiry date printed on the carton and bottle. The expiry date refers to the last day of that month. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. What NEWVAST PLUS contains and other information NEWVAST PLUS contains: The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe. NEWVAST PLUS 5mg+10mg: Each tablet contains 5.20 mg of rosuvastatin calcium (equivalent to 5 mg of rosuvastatin) and 10 mg of ezetimibe. NEWVAST PLUS 10mg+10mg: Each tablet contains 10.40 mg of rosuvastatin calcium (equivalent to 10 mg of rosuvastatin) and 10 mg of ezetimibe. NEWVAST PLUS 20mg+10mg: Each tablet contains 20.80 mg of rosuvastatin calcium (equivalent to 20 mg of rosuvastatin) and 10 mg of ezetimibe. NEWVAST PLUS 40mg+10mg: Each tablet contains 41.60 mg of rosuvastatin calcium (equivalent to 40 mg of rosuvastatin) and 10 mg of ezetimibe. Other ingredients Tablet core (for all strengths): microcrystalline cellulose (E460), colloidal anhydrous silica (E551), magnesium stearate (E572), povidone (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), lactose monohydrate, hypromellose (E464), coating: Opadry Yellow (5mg/10mg): hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), talc (E553b), red iron oxide (E171), Opadry Beige (10mg/10mg): hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), talc (E553b), Vivacoat Yellow (20mg/10mg): hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), talc (E553b), Opadry White (40mg/10mg): lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol (E1521). Appearance and contents of the pack NEWVAST PLUS 5mg+10mg film-coated tablets: Light yellow, round, biconvex, film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 5" on one side. NEWVAST PLUS 10mg+10mg film-coated tablets: Beige, round, biconvex, film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 4" on one side. NEWVAST PLUS 20mg+10mg film-coated tablets: Yellow, round, biconvex, film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 3" on one side. NEWVAST PLUS 40mg+10mg film-coated tablets: White, round, biconvex, film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 2" on one side. The pack contains 30 film-coated tablets. Not all pack sizes may be marketed. Dispensing category: Pharmaceutical product group II, dispensed with prescription form №3