Rozavel F 5 Mg Tablet (15 Tab)

Here is a detailed product description for ROZAVEL F 5 MG TABLET:

Name: ROZAVEL F 5 MG TABLET (Brand Name)

Composition:

• Rosuvastatin: 5 mg
• Fenofibrate: 160 mg

Uses: ROZAVEL F 5 MG TABLET is a combination medicine primarily prescribed for the management of abnormal lipid/cholesterol levels in the blood. It is used for:

• Hyperlipidemia (high lipid levels)
• Hypercholesterolemia (high cholesterol)
• Hypertriglyceridemia (high levels of triglycerides)
• Mixed dyslipidemia (low good cholesterol and high bad cholesterol and triglycerides)
• Reducing the risk of cardiovascular events such as heart attack, stroke, and coronary revascularization procedures in patients with multiple cardiovascular risk factors. It works by lowering levels of "bad" cholesterol (LDL) and triglycerides, while also helping to increase "good" cholesterol (HDL) levels.

Dosage and Administration:

• Swallow the tablet whole with a glass of water. Do not crush or chew it.
• It can be taken with or without food.
• Try to take it at the same time each day for consistency.
• The dosage and duration of therapy will be determined by your doctor based on your lipid levels and response to the medicine.
• Do not stop taking this medicine without consulting your doctor.

Side Effects: Common side effects may include:

• Headache
• Nausea
• Abdominal pain
• Muscle pain (myalgia) or weakness
• Constipation
• Flatulence (excessive gas)
• Abnormal liver function tests
• Increased blood sugar levels

Precautions:

• Contraindications: Do not take if you are allergic to Rosuvastatin, Fenofibrate, or any of its components. It is contraindicated in severe liver disease, severe kidney disease, pre-existing gall bladder disease, pregnancy, and breastfeeding.
• Warnings: Use with caution in patients with diabetes or hypothyroidism as it may increase the risk of muscle problems. Inform your doctor if you experience muscle pain, tenderness, or weakness, especially if accompanied by fever.
• Alcohol: Avoid consuming alcohol as it may increase the risk of liver damage.
• Drug Interactions: Inform your doctor about all other medicines, supplements, or herbal products you are taking. It may interact with anticoagulants (e.g., Warfarin), cyclosporine, other statins (e.g., gemfibrozil), antacids, fusidic acid, and antiviral medicines like ritonavir.
• Elderly Patients: Use with caution in elderly patients, as they may be at a greater risk of muscle and liver/kidney problems.

Storage:

• Store in a cool and dry place, away from direct sunlight.
• Keep out of sight and reach of children.
• Store at room temperature (between 10ºC to 30ºC).

Here are some frequently asked questions about ROZAVEL F 5 MG TABLET, along with concise answers:

What is ROZAVEL F 5 MG TABLET used for?

ROZAVEL F 5 MG TABLET is primarily used to manage hyperlipidemia, a condition characterized by high levels of fats like cholesterol and triglycerides in the blood. It helps reduce high levels of "bad" cholesterol (LDL) and triglycerides while increasing "good" cholesterol (HDL). Additionally, it is prescribed to reduce the risk of cardiovascular events such as heart attacks, strokes, and the need for coronary revascularization procedures in patients with multiple risk factors.

How does ROZAVEL F 5 MG TABLET work?

This medicine is a combination of two active ingredients: Fenofibrate (160 mg) and Rosuvastatin (5 mg). Fenofibrate works by activating a specific receptor (PPAR-α) in the body, which leads to the breakdown of triglyceride-rich particles and reduces triglyceride production in the liver. It also slightly increases HDL cholesterol. Rosuvastatin, a statin, works by blocking HMG-CoA reductase, an enzyme essential for cholesterol formation in the liver. This action reduces the production of LDL cholesterol and increases its uptake and breakdown by liver cells.

What is the usual dosage for ROZAVEL F 5 MG TABLET?

The usual dosage is one tablet once daily, with or without food. It is advisable to take it at the same time each day to help with remembering. Your doctor will determine the appropriate dose based on your lipid levels and response to the medication.

What are the possible side effects of ROZAVEL F 5 MG TABLET?

Common side effects include headache, muscle pain (myalgia), abdominal pain, back pain, nausea, and abnormal liver function tests. If these side effects persist or worsen, you should consult your doctor. Serious side effects, though rare, can include severe muscle problems (myopathy/rhabdomyolysis) and liver damage.

Is ROZAVEL F 5 MG TABLET safe during pregnancy or breastfeeding?

No, ROZAVEL F 5 MG TABLET is contraindicated during pregnancy as it could potentially harm the unborn baby. Women of childbearing potential should use appropriate contraceptive measures while taking this medication. It is also not recommended for use during breastfeeding, as both fenofibrate and rosuvastatin can pass into breast milk.

Can ROZAVEL F 5 MG TABLET be taken with other medications?

ROZAVEL F 5 MG TABLET can interact with several medications. Concomitant use with anticoagulants like warfarin can increase the risk of bleeding. Other lipid-lowering agents, such as gemfibrozil and niacin, may increase the risk of muscle problems when taken with this medicine. Medicines like ciclosporin may lead to kidney damage, and antacids can reduce the absorption of rosuvastatin. It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, herbal remedies, and supplements.

What precautions should be taken with ROZAVEL F 5 MG TABLET?

Caution is advised for patients with liver disease, kidney disease (contraindicated in severe cases), hypothyroidism, and diabetes. Heavy alcohol users should also exercise caution due to an increased risk of liver damage. Regular monitoring of liver and kidney function, blood sugar levels, and muscle functions may be advised by your doctor. Avoid consuming grapefruit and grapefruit juice, as they can increase rosuvastatin levels.

What happens if a dose is missed?

If you forget to take a dose of ROZAVEL F 5 MG TABLET, 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 ROZAVEL F 5 MG TABLET be stored?

ROZAVEL F 5 MG TABLET should be stored at room temperature, typically below 25°C to 30°C. Keep the medication in its original packaging, protected from light and moisture, and always out of the reach of children.