Rozavel F Tablet (15 Tab)

ROZAVEL F TABLET is a combination medication manufactured by SUN PHARMA LABORATORIES LTD., primarily used for managing high cholesterol and triglyceride levels.

Name

• Common Name: ROZAVEL F TABLET
• Brand Name: ROZAVEL F TABLET (by SUN PHARMA LABORATORIES LTD.)

Composition

ROZAVEL F TABLET contains two active ingredients:

• Rosuvastatin: 10mg
• Fenofibrate: 160mg

Uses

This medicine is prescribed to manage various lipid disorders, including:

• High blood lipid levels (hyperlipidemia), particularly high LDL ("bad cholesterol") and triglycerides.
• Increasing HDL ("good cholesterol") levels.
• Reducing the risk of cardiovascular events like heart attack, stroke, and atherosclerosis (hardening of the arteries), especially when diet and lifestyle changes alone are insufficient.

Dosage and Administration

• Typically, one tablet is taken once daily, with or without food.
• It is important to take the tablet at the same time each day.
• Swallow the tablet whole with water; do not chew, crush, or break it.
• Always follow the dosage and duration advised by your doctor.

Side Effects

Common side effects may include:

• Headache, muscle pain, abdominal pain, nausea, constipation, weakness, and daytime drowsiness.
• Increased blood sugar levels and abnormal liver function tests are also possible.

Serious side effects requiring immediate medical attention include:

• Severe allergic reactions (skin rash, itching, swelling).
• Unexplained muscle pain or weakness, especially if accompanied by fever or reddish-brown urine (rhabdomyolysis).
• Signs of liver damage (fever, fatigue, dark urine, yellow skin or eyes).

Precautions

• ROZAVEL F TABLET is contraindicated during pregnancy and breastfeeding.
• Avoid excessive alcohol consumption as it may increase the risk of liver problems.
• Inform your doctor about any history of liver or kidney disease (contraindicated in severe cases), gall bladder disease, diabetes, thyroid disorders, high blood pressure, or muscle disorders.
• Regular monitoring of lipid levels, liver, kidney, and muscle functions is recommended during treatment.
• This medicine may interact with certain antibiotics (e.g., fusidic acid), immunosuppressants, and anticoagulants.

Storage

• Store in a cool, dry place, protected from direct sunlight and moisture.
• Keep the medicine out of the sight and reach of children.
• Maintain storage temperatures below 30°C.

What is ROZAVEL F TABLET used for?

ROZAVEL F TABLET is a combination medication primarily used to manage high blood lipid levels, including elevated cholesterol and triglycerides (hyperlipidemia and hypertriglyceridemia). It is prescribed when lifestyle changes like a low-fat diet alone have not been sufficient. By reducing these lipid levels, it helps lower the risk of cardiovascular events such as heart attack, stroke, and atherosclerosis (plaque buildup in arteries).

How does ROZAVEL F TABLET work?

ROZAVEL F TABLET contains two active ingredients: Fenofibrate and Rosuvastatin.

• Rosuvastatin belongs to a class of drugs called statins. It works mainly in the liver by inhibiting an enzyme (HMG-CoA reductase) responsible for cholesterol production, thereby reducing the amount of "bad" cholesterol (LDL) and total cholesterol. It also helps increase levels of "good" cholesterol (HDL).
• Fenofibrate is a fibric acid derivative. It helps lower triglyceride levels by enhancing the natural processes that eliminate cholesterol and fats from the body (lipolysis) and by activating a receptor called PPAR-alpha. It also helps increase HDL cholesterol. Together, these ingredients effectively reduce harmful cholesterol and triglycerides and raise good cholesterol, improving the overall lipid profile.

What is the usual dosage of ROZAVEL F TABLET?

The usual dose of ROZAVEL F TABLET is one tablet per day, or as directed by your doctor. It's important to take it at the same time each day, and it can be taken with or without food. The exact dosage may vary based on your lipid levels and response to the medicine, so always follow your doctor's instructions. Do not chew, crush, or break the tablet; swallow it whole with a glass of water.

What are the possible side effects of ROZAVEL F TABLET?

Common side effects of ROZAVEL F TABLET may include:

• Headache
• Muscle pain or weakness
• Abdominal pain or stomach discomfort
• Nausea or vomiting
• Constipation
• Diarrhea, flatulence, or excessive gas
• Joint pain
• Elevated creatine kinase and abnormal liver function tests
• Increased blood sugar levels

Some rare but serious side effects that require immediate medical attention include severe allergic reactions (rash, swelling, difficulty breathing), unexplained severe muscle pain or weakness with fever or reddish-brown urine (rhabdomyolysis), or severe stomach pain due to pancreas inflammation.

Is ROZAVEL F TABLET safe during pregnancy or breastfeeding?

No, ROZAVEL F TABLET is generally considered unsafe for use during pregnancy. It is contraindicated as it may cause serious harm to the developing fetus. Women of childbearing potential should use a suitable contraceptive method while undergoing therapy with this medication. Similarly, it is not recommended for use during breastfeeding due to the potential for undesirable effects on the newborn.

Can it be taken with other medications?

ROZAVEL F TABLET can interact with several other medications. It is important to inform your doctor about all medicines, supplements, and herbal products you are taking to prevent potential interactions. Some specific interactions include:

• Antibiotics (e.g., fusidic acid, erythromycin)
• Immunosuppressants (e.g., cyclosporine)
• Anticoagulants (e.g., warfarin, acenocoumarol) due to an increased risk of bleeding.
• Other lipid-lowering drugs (e.g., gemfibrozil) which may increase the risk of muscle-related side effects.
• Antacids containing aluminum hydroxide and magnesium hydroxide may decrease the absorption of ROZAVEL F TABLET, so they should be taken at separate times.

What precautions should be taken?

Several precautions should be observed while taking ROZAVEL F TABLET:

• Liver and Kidney Disease: It is not recommended for patients with severe liver or kidney problems. Inform your doctor if you have any liver or kidney issues, as dose adjustments or alternative treatments may be necessary.
• Alcohol Consumption: Avoid consuming large amounts of alcohol as it may increase the risk of liver problems.
• Diabetes: Patients with diabetes should monitor their blood sugar levels carefully, as this medicine can potentially increase them.
• Muscle Problems: Inform your doctor if you have a history of muscle disorders or experience unexplained muscle pain or weakness, particularly if accompanied by fever, as it may cause myopathy or rhabdomyolysis.
• Gallbladder Disease: It is not recommended for use if you have gallbladder problems due to the increased risk of gallstones.
• Your doctor will regularly monitor your liver and kidney functions, blood sugar levels, muscle functions, and cholesterol levels during treatment.

What happens if a dose is missed?

If you forget to take a dose of ROZAVEL F TABLET, take it as soon as you remember. However, if it's 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 missed one. It is important not to stop taking the medicine without consulting your doctor, even if you feel better, as this could lead to an increase in your lipid levels again.

How should it be stored?

ROZAVEL F TABLET should be stored at room temperature, ideally below 30°C. Keep the tablets in a tightly closed container to protect them from light and moisture. Always keep this medicine out of the sight and reach of children.