NEWVAST PLUS tab 20mg+10mg #30

• High levels of cholesterol in the blood (primary hypercholesterolemia).

The medicine lowers cholesterol levels in the blood through a dual mechanism: it reduces the absorption of cholesterol in the digestive tract and decreases the production of cholesterol in the body. Nyuvaste Plus is used in patients whose cholesterol levels cannot be controlled by diet alone. During treatment with this medicine, you should continue following a cholesterol-lowering diet.

• Heart disease. Newvast Plus reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

• Your doctor may prescribe Newvast Plus if you are already taking rosuvastatin and ezetimibe at the same doses.
  ​Newvast Plus does not help with weight loss.

Do not take Newvast Plus if:
• You are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine;
• You have liver disease;
• You have severe kidney impairment;
• You have repeated or unexplained muscle pain (myopathy);
• You are taking cyclosporine (e.g., after an organ transplant);
• You are pregnant or breastfeeding; if you become pregnant while taking Nyuvaste Plus, stop taking it immediately and contact your doctor. Use appropriate contraception while taking Nyuvaste Plus;
• You have previously developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking Newvast Plus or similar medicines.

In addition, do not take rosuvastatin 40 mg (maximum dose) if:
• You have moderate kidney impairment (if unsure, consult your doctor);
• You have thyroid dysfunction (hypothyroidism);
• You regularly consume large amounts of alcohol;
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• You are taking fibrates to lower cholesterol (see “Other medicines and Nyuvaste Plus”).
If any of the above applies to you (or if you are unsure), consult your doctor.

Special warnings and precautions:
Talk to your doctor or pharmacist before taking NewvastPlus if:
• You have kidney problems.
• You have liver problems.
• You have repeated or unexplained muscle pain, a personal or family history of muscle problems, or have previously had muscle problems when taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, especially if accompanied by weakness or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will choose the appropriate dose of Nyuvaste Plus for you.
• You are taking medicines for infections, including HIV infection or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir; see “Other medicines and Nyuvaste Plus”.
• You have severe respiratory problems;
• You are taking fibrates to lower cholesterol. See “Other medicines and Nyuvaste Plus”.
• You regularly consume large amounts of alcohol;
• You have thyroid dysfunction (hypothyroidism);
• You are over 70 years old (your doctor should choose the appropriate dose of Nyuvaste 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 together with Nyuvaste Plus may cause serious muscle problems (rhabdomyolysis).
• You have or have ever had myasthenia (a disease characterized by muscle weakness, in some cases including the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may worsen the condition. In some cases, statins may also cause myasthenia.

In some cases, statins may cause liver problems. This can be detected by a simple blood test checking for increased liver enzymes. For this reason, your doctor will regularly perform blood tests (liver function tests) during treatment with Newvast Plus.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Newvast Plus.

If you have diabetes or are at risk of developing diabetes, your doctor will monitor you closely during treatment with 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:Use of  NewvastPlus is not recommended in children and adolescents under 18 years of age.

Other medicines and Newvast Plus:
Tell your doctor if you are taking any of the following medicines:
• Cyclosporine (used, for example, after organ transplantation. Concomitant use increases the effect of rosuvastatin). Do not take Newvast Plus if you are taking cyclosporine.
• Blood thinners such as warfarin, acenocoumarol or fluindione (their effect on blood clotting and risk of bleeding may increase when taken with Newvaste Plus), ticagrelor or clopidogrel.
• Other cholesterol-lowering medicines, fibrates (gemfibrozil and others), also used to correct triglyceride levels in the blood. Concomitant use increases the effect of rosuvastatin.
• Cholestyramine (a cholesterol-lowering medicine), as it affects the way ezetimibe works.
• Antacids containing aluminum and magnesium (used to neutralize stomach acid; they reduce rosuvastatin plasma levels). This effect may be reduced if these medicines are taken 2 hours after rosuvastatin.
• Erythromycin (an 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 this medicine. Your doctor will tell you when it is safe to restart Nyuvaste Plus. Taking Newvast Plus together with fusidic acid may rarely cause muscle weakness or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
• Oral contraceptives (the level of sex hormones absorbed from the pill increases).
• Hormone replacement therapy (increases hormone levels in the blood).
• Regorafenib (used to treat cancer).
• 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 medical staff that you are taking Newvast Plus.

Newvast Plus with alcohol:Do not take Newvast Plus 40 mg/10 mg (maximum dose) if you regularly consume large amounts of alcohol.

Pregnancy and breastfeeding:
Do not take NewvastPlus if you are pregnant, think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking Newvast Plus, stop taking it immediately and contact your doctor. Women should use contraception while taking Newvast Plus.
Do not take Newvast Plus if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines:
Newvast Plus is not expected to affect your ability to drive or use machines. However, some people may experience dizziness while taking Newvast Plus. If you feel dizzy, consult your doctor before driving or operating machines.

Contains:

- Lactose

- Sugar, lactose. If you have intolerance to some sugars, consult your doctor before starting Newvast Plus.

- Less than 1 mmol (23 mg) sodium per tablet, that is to say essentially “sodium-free”.

​

How to take Newvast Plus?
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

• While taking Newvast Plus, you should continue a cholesterol-lowering diet and adequate physical activity.

• The recommended dose for adults is one tablet daily.

• Take Newvast Plus once a day.

• You may take it at any time of the day, with or without food. Swallow the tablet whole with water.

• Take it at the same time each day.

• Newvast Plus is not recommended for initial treatment. Treatment should be started, or dose adjustment made if necessary, with the individual active substances separately, and after determining the appropriate doses, you may 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 whose cholesterol levels are not sufficiently lowered with the 20 mg dose.
  When prescribing Nyuvaste Plus together with another cholesterol-lowering medicine containing cholestyramine, or any bile acid sequestrant, take Newvast Plus at least 2 hours before or 4 hours after such medicines.

Regular cholesterol checks:It is important to have regular cholesterol checks to ensure that your cholesterol has reached and remains at the appropriate level.

Overdose:Contact your doctor or the nearest hospital immediately, as you may need medical attention.
Missed dose:Do not take a double dose to make up for a forgotten dose.
Stopping Newvast Plus:Inform your doctor if you wish to stop taking Newvast Plus. Your cholesterol levels may rise again if you stop taking it.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects:
Stop taking NewvastPlus and seek immediate medical help if you develop any of 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 may cause difficulty swallowing;
• Severe itching of the skin (with raised lumps).
• A widespread rash with blisters and peeling skin, particularly 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 contact your doctor if:
• You have unusual muscle pain that lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, and rarely these have developed into a potentially life-threatening muscle damage known as rhabdomyolysis.
• You have muscle rupture.
• You have a lupus-like illness (including rash, joint disorders and effects on blood cells).

Common side effects
• Headache
• Constipation
• Nausea
• Muscle pain
• Feeling weak
• Dizziness
• Diabetes. This is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you.
• Abdominal pain
• Diarrhea
• Flatulence (gas)
• Fatigue
• Increased levels of certain liver laboratory tests (transaminases)
• Increased protein in urine – this usually returns to normal on its own and it is not necessary to stop taking Newvast Plus tablets (only with 40 mg/10 mg Newvast Plus).

Uncommon side effects
• Rash, itching, hives
• Increased protein in urine – this usually returns to normal on its own and it is not necessary to stop rosuvastatin (only with 5 mg+10 mg, 10 mg+10 mg and 20 mg+10 mg Newvast Plus).
• Increased levels of certain muscle laboratory tests (CK)
• Cough
• Dyspepsia
• Heartburn
• Joint pain
• Muscle spasms
• Neck pain
• Decreased appetite
• Pain
• Chest pain
• Flushing
• Increased blood pressure
• Tingling sensation
• Dry mouth
• Inflammation of the stomach lining
• Back pain
• Muscle weakness
• Pain in arms and legs
• Swelling, especially of the hands and feet.

Rare side effects
• Inflammation of the pancreas, causing severe abdominal pain that may spread to the back, reduced number of platelets in the blood.
• Lupus-like syndrome
• Muscle rupture

Very rare side effects
• Jaundice (yellowing of the skin and eyes), hepatitis (inflammation of the liver), traces of blood in urine, nerve disorders of the arms and legs (e.g., numbness), memory loss, breast enlargement 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 injury, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting).
• Myasthenia gravis (a disease characterized by muscle weakness, in some cases including the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).
Tell your doctor if you experience weakness in your arms or legs that worsens after activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Storage conditions:

• Store in the original package to protect from moisture and light.

• No special temperature storage conditions are required.

• Keep out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month.

• Do not throw medicines away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Dispensing conditions:Pharmaceutical product group II, dispensed with prescription form No. 3.

Manufacturer:
Rontis Hellas Medical and Pharmaceutical Products S.A.
Greece, 41500, Larissa, Larissa Industrial Area, Postal Code 3012

Marketing authorization holder:
LLC “New Pharma”
Georgia, Tbilisi, 0154, 18 I. Evdoshvili Street