Novastat Tg 5 Tab

NOVASTAT TG 5 TAB by LUPIN LIMITED

Name

• Brand Name: Novastat-TG 5 Tablet
• Manufacturer: Lupin Limited

Composition Novastat-TG 5 Tablet is a combination medicine containing:

• Rosuvastatin (5 mg)
• Fenofibrate (160 mg)

Uses Novastat-TG 5 Tablet is primarily used to manage and lower high levels of lipids, including cholesterol and triglycerides, in the blood. This helps to reduce the risk of heart disease, heart attack, and stroke. It is prescribed for:

• Primary hypercholesterolemia
• Mixed dyslipidemia
• Hypercholesterolemia
• Hypertriglyceridemia This medicine is often prescribed when lifestyle changes like a low-fat diet and exercise alone have not been sufficient.

Dosage and Administration The tablet is typically taken orally, once daily, as directed by a healthcare provider. It can be taken with or without food. The tablet should be swallowed whole and not chewed or crushed. Consistency in taking the medication at the same time each day is recommended. It is crucial not to discontinue the medicine without consulting a doctor, as this may lead to an increase in lipid levels. Regular monitoring of cholesterol and triglyceride levels through blood tests is essential.

Side Effects Common side effects may include:

• Headache
• Muscle pain, tenderness, or weakness
• Stomach pain, nausea, vomiting, indigestion, or diarrhea
• Constipation
• Joint pain
• Abnormal liver function tests
• Fatigue or weakness

Serious, though rare, side effects can include liver damage and muscle injury (rhabdomyolysis). Patients should report any persistent or severe side effects to their doctor immediately.

Precautions

• Allergies: Do not take if allergic to Rosuvastatin, Fenofibrate, or any other ingredients.
• Liver Disease: Not recommended for use in severe pre-existing liver conditions or increased liver enzymes, as it may worsen the condition and cause liver damage.
• Kidney Disease: Contraindicated in severe kidney problems due to the risk of accumulation and potential complications like rhabdomyolysis.
• Gallbladder Disease: Not recommended for use if there are existing gallbladder conditions like gallstones.
• Pregnancy and Breastfeeding: Highly unsafe and contraindicated during pregnancy (pregnancy category X). It is also probably unsafe and not recommended during breastfeeding. Women of childbearing potential should use appropriate contraceptive measures.
• Alcohol Consumption: Avoid consuming alcohol, as it may increase triglyceride levels and potentially cause liver damage.
• Drug Interactions: Use with caution when taken with blood thinners (e.g., warfarin) due to an increased risk of bleeding. Concomitant use with immunosuppressants (e.g., ciclosporin) may lead to kidney damage.
• Other Conditions: Use with caution if you have diabetes or hypothyroidism.
• Pediatric Use: Not recommended for use in children below 18 years of age.

Storage Store Novastat-TG 5 Tablet at room temperature, below 30°C. Keep the medication in its original packaging, protected from light and moisture. Always keep this medicine out of reach of children.

What is Novastat TG 5 Tablet used for?

Novastat TG 5 Tablet is a combination medication primarily used to lower high levels of "bad" cholesterol (Low-Density Lipoprotein or LDL) and fats (triglycerides) in the blood, while also helping to increase "good" cholesterol (High-Density Lipoprotein or HDL). It is prescribed when diet and exercise alone are not sufficient. This medicine helps to reduce the risk of cardiovascular events such as heart attack and stroke.

How does Novastat TG 5 Tablet work?

Novastat TG 5 Tablet contains two active ingredients: Rosuvastatin and Fenofibrate. Rosuvastatin belongs to a class of drugs called statins, which work by inhibiting an enzyme (HMG-CoA reductase) in the liver that is crucial for cholesterol production, thereby lowering cholesterol levels. Fenofibrate is a fibric acid derivative that works by decreasing the production of triglycerides in the liver and enhancing their breakdown, leading to reduced triglyceride levels and a slight increase in HDL cholesterol.

What is the usual dosage for Novastat TG 5 Tablet?

The typical dosage of Novastat TG 5 Tablet is usually one tablet taken once daily, with or without food. It is recommended to take the medicine at the same time each day to maintain consistency. Your doctor will determine the appropriate dose and duration of treatment based on your lipid levels and how you respond to the medication.

What are the possible side effects of Novastat TG 5 Tablet?

Common side effects may include stomach pain, diarrhea, nausea, dizziness, gas, vomiting, headache, muscle pain, tiredness, indigestion, flatulence, muscle spasms, runny nose, sneezing, sore throat, constipation, and joint pain. In rare cases, more serious side effects such as liver damage (symptoms like fever, rash, loss of appetite, fatigue, stomach pain, dark urine, yellow skin or eyes, or abnormal liver enzymes) or severe muscle injury (including rhabdomyolysis) can occur. It's important to contact your doctor if you experience persistent or severe side effects.

Is Novastat TG 5 Tablet safe during pregnancy or breastfeeding?

Novastat TG 5 Tablet should not be used during pregnancy as it is considered highly unsafe and can harm the unborn baby. Women of childbearing potential should use effective contraceptive measures while taking this medication. It is also not recommended for use during breastfeeding, as it is unknown if the components of this medicine pass into breast milk and could affect the baby's health.

Can Novastat TG 5 Tablet be taken with other medications?

Novastat TG 5 Tablet can interact with several other medications, potentially leading to increased side effects or reduced effectiveness. Important interactions include:

• Blood thinners (e.g., warfarin): Increased risk of bleeding.
• Immunosuppressants (e.g., ciclosporin): May lead to kidney damage.
• Other cholesterol-lowering medicines (e.g., gemfibrozil, other statins, fibrates): Increased risk of muscle disorders.
• Certain antibiotics (e.g., fusidic acid): Increased risk of muscle disorders.
• Antacids (containing aluminum and magnesium): May reduce the absorption and effectiveness of rosuvastatin.
• Antiviral medicines (e.g., ritonavir): May delay the elimination of rosuvastatin from the body.
• Estrogen-containing oral contraceptives: May interfere with the action of fenofibrate.
• Colchicine: Increased risk of muscle damage.
• Bile acid sequestrants (e.g., cholestyramine): Can reduce the absorption of the medicine. Always inform your doctor about all prescription, over-the-counter, herbal, and supplement medications you are taking to prevent potential interactions.

What precautions should be taken while using Novastat TG 5 Tablet?

• Alcohol: Avoid consuming alcohol, as it can increase the risk of liver damage.
• Liver and Kidney Conditions: This medicine is not recommended for individuals with severe liver or kidney disease, or gallbladder disease. Use with caution in patients with mild to moderate liver or kidney impairment, diabetes, or hypothyroidism. Regular liver function tests are often recommended.
• Muscle Pain: Inform your doctor immediately if you experience unexplained muscle aches, tenderness, or weakness, especially if accompanied by fever.
• Driving: Dizziness may occur, so avoid driving or operating machinery if you feel dizzy.
• Children: Novastat TG 5 Tablet is not recommended for use in children under 18 years of age.
• Lifestyle: Continue to follow a healthy lifestyle, including a low-fat diet and regular exercise, as advised by your doctor.

What happens if a dose of Novastat TG 5 Tablet is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Novastat TG 5 Tablet be stored?

Store Novastat TG 5 Tablet at room temperature, typically below 25°C to 30°C. Keep the medicine in its original packaging, protected from light and moisture. Always ensure it is kept out of reach of children. Check the expiry date on the packaging and do not use the medicine after this date.