Rozavel F 20 Mg Tablet (10 Tab)

ROZAVEL F 20 MG TABLET is a combination medication designed for the comprehensive management of elevated cholesterol and triglyceride levels. Manufactured by Sun Pharmaceutical Industries Ltd., it combines two potent lipid-lowering agents to reduce the risk of cardiovascular diseases such as heart attacks and strokes.

Name

• Brand Name: ROZAVEL F 20 MG TABLET
• Common Name: Rosuvastatin and Fenofibrate tablets

Composition

Each tablet contains:

• Rosuvastatin: 20 mg
• Fenofibrate: 160 mg

Uses

ROZAVEL F 20 MG TABLET is prescribed for:

• Management of hyperlipidemia (high lipid levels)
• Treatment of mixed dyslipidemia (low good cholesterol and high bad cholesterol and triglycerides)
• Reducing hypercholesterolemia (high cholesterol)
• Lowering hypertriglyceridemia (high levels of triglycerides)
• Prevention of heart attacks and strokes in individuals at risk by reducing LDL ("bad" cholesterol) and increasing HDL ("good" cholesterol).

Dosage and Administration

• Typically taken orally once daily, with or without food.
• Swallow the tablet whole with a glass of water; do not crush, break, or chew it.
• It is recommended to take the medicine at the same time each day to maintain consistent levels and avoid missing a dose.
• The dosage and duration will be determined by a healthcare professional based on the individual's lipid levels and response to treatment.

Side Effects

Common Side Effects:

• Nausea
• Headache
• Abdominal pain or stomach pain
• Muscle pain, tenderness, or weakness
• Constipation
• Joint pain
• Flatulence or excessive gas
• Daytime drowsiness
• Abnormal liver function tests
• Elevated creatine kinase levels

Serious Side Effects:

• Myopathy and Rhabdomyolysis (severe muscle damage leading to kidney failure)
• Liver damage (rare, signs include fever, rash, loss of appetite, dark urine, yellow skin or eyes)
• Increase in blood glucose levels, particularly in diabetic patients.

Precautions

• Allergies: Do not take if allergic to Rosuvastatin, Fenofibrate, or any other components of the tablet.
• Liver Disease: Contraindicated for severe liver disease or active liver disease, and should be used with caution in patients with liver problems. Regular monitoring of liver function tests is recommended.
• Kidney Disease: Use with caution in patients with kidney problems, as it may worsen the condition. Monitoring of kidney function is recommended due to increased risk of elevated serum creatinine levels.
• Gallbladder Disease: Not recommended for use if you have gallbladder problems due to the increased risk of gallbladder stones.
• Pregnancy and Breastfeeding: Highly unsafe during pregnancy and probably unsafe during breastfeeding. Consult a doctor.
• Alcohol Consumption: Limit alcohol intake as it can increase triglyceride levels and potentially harm the liver.
• Drug Interactions: Inform your doctor about all other medicines, including supplements and herbal products, to prevent potential interactions.
  • Cyclosporine: May enhance toxic effects.
  • Oral Anticoagulants (e.g., Warfarin): May increase bleeding risk.
  • Bile Acid Sequestrants (e.g., Cholestyramine): May decrease rosuvastatin absorption.
  • Other Lipid-Lowering Agents (e.g., Gemfibrozil, Niacin): May heighten the risk of muscle damage.
• Diabetes: May slightly elevate blood glucose levels; diabetic patients should monitor sugar levels closely.
• Muscle Symptoms: Notify your doctor if you experience muscle pain, tenderness, or weakness, especially if accompanied by fever.

Storage

• Store in a cool and dry place away from direct sunlight.
• Keep out of sight and reach of children.
• Non-cold chain storage, typically below 30°C (or between 10°C to 25°C).

Here are the most frequently asked questions about ROZAVEL F 20 MG TABLET:

What is ROZAVEL F 20 MG TABLET used for?

ROZAVEL F 20 MG TABLET is primarily used to manage high cholesterol levels (hypercholesterolemia) and elevated triglyceride levels (hypertriglyceridemia) in the blood. This medication helps reduce the risk of heart attacks and strokes in individuals at risk by improving overall cardiovascular health, especially when diet and exercise alone have not been sufficient.

How does ROZAVEL F 20 MG TABLET work?

This medicine contains two active ingredients: Rosuvastatin (20mg) and Fenofibrate (160mg). Rosuvastatin, a statin, works by inhibiting an enzyme in the liver that is essential for cholesterol production, thereby lowering "bad" cholesterol (LDL) and total cholesterol. Fenofibrate, a fibrate, works by activating a protein that helps break down triglycerides and increase "good" cholesterol (HDL) levels. Together, they offer a comprehensive approach to managing lipid disorders.

What is the usual dosage for ROZAVEL F 20 MG TABLET?

The usual dosage is one tablet once daily. Your doctor will determine the appropriate dose and duration based on your individual health factors and response to the medicine. It can be taken with or without food, but it is recommended to take it at the same time each day for optimal effect. The tablet should be swallowed whole with a glass of water and not crushed or chewed.

What are the possible side effects of ROZAVEL F 20 MG TABLET?

Common side effects can include headache, muscle pain, constipation, joint pain, nausea, stomach pain, flatulence, and abnormal liver function tests. More serious, though rare, side effects may include severe muscle damage (rhabdomyolysis) or liver damage. If you experience persistent or severe symptoms, especially muscle pain or weakness accompanied by fever, or signs of liver problems like yellowing of the skin or eyes, contact your doctor immediately.

Is ROZAVEL F 20 MG TABLET safe during pregnancy or breastfeeding?

No, ROZAVEL F 20 MG TABLET is considered highly unsafe during pregnancy and is not recommended. Women of childbearing potential should use appropriate contraceptive measures while taking this medicine. It is also advised not to use this medication while breastfeeding due to the possibility of adverse effects on the baby, as components may pass into breast milk.

Can ROZAVEL F 20 MG TABLET be taken with other medications?

ROZAVEL F 20 MG TABLET can interact with several medications. For instance, it may increase the risk of bleeding if taken with oral anticoagulants like warfarin. Concomitant use with other lipid-lowering agents such as gemfibrozil or niacin may increase the risk of muscle damage. Cyclosporine and certain antacids (like aluminum hydroxide) can also interact with this medicine. It is crucial to inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential interactions.

What precautions should be taken while using ROZAVEL F 20 MG TABLET?

Inform your doctor if you have kidney or liver problems, pre-existing gallbladder disease, diabetes, or a history of muscle pain. This medicine is not recommended for individuals with severe liver disease, active liver disease, gallbladder disease, or inflammation of the pancreas. Diabetic patients should monitor their blood glucose levels closely as the medication might slightly elevate them. It is also advisable to limit or avoid alcohol consumption, as it can increase triglyceride levels and potentially harm your liver. Do not discontinue the medicine without consulting your doctor, even if your cholesterol levels improve.

What happens if a dose of ROZAVEL F 20 MG 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 one and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten one.

How should ROZAVEL F 20 MG TABLET be stored?

Store ROZAVEL F 20 MG TABLET at room temperature, ideally between 20°C and 25°C, or below 30°C. Keep the medicine protected from light and moisture to maintain its effectiveness. Always ensure it is kept out of reach of children and used before its expiry date.