Rosufit F 10/160 Mg Tablet (15 Tab)

ROSUFIT F 10/160 MG TABLET

ROSUFIT F 10/160 MG TABLET is a prescription medicine manufactured by Ajanta Pharma Limited, primarily used to manage abnormal lipid (fat) levels in the blood.

Composition

Each tablet contains:

• Rosuvastatin (10 mg): An HMG-CoA reductase inhibitor (statin) that works by slowing down cholesterol production in the liver, reducing the buildup of "bad" cholesterol (LDL) on artery walls, and increasing "good" cholesterol (HDL).
• Fenofibrate (160 mg): A fibric acid derivative that primarily lowers triglyceride levels in the blood by activating a receptor called peroxisome proliferator-activated receptor α (PPARα), which stimulates the breakdown and elimination of triglyceride-rich particles.

Uses

ROSUFIT F 10/160 MG TABLET is prescribed for the following conditions:

• Treatment of high cholesterol levels (hypercholesterolemia).
• Management of high triglyceride levels (hypertriglyceridemia).
• Treatment of mixed dyslipidemia (abnormal levels of various lipids, including high bad cholesterol and triglycerides, and low good cholesterol).
• To reduce the risk of serious cardiovascular complications such as heart attack and stroke.

Dosage and Administration

This medication should be taken as advised by your doctor. Typically, it is taken once daily, with or without food, but consistency in timing is important for optimal results. The tablet should be swallowed whole with a glass of water; it should not be crushed, chewed, or broken. Your doctor may start with a lower dose and adjust it based on your lipid levels and overall health. Regular monitoring of cholesterol and triglyceride levels is essential.

Side Effects

Common side effects may include:

• Headache
• Abdominal pain/Stomach discomfort
• Nausea
• Constipation
• Diarrhea
• Muscle pain, tenderness, or weakness
• Increased liver enzymes
• Dizziness

Serious side effects, though less common, can include liver damage, muscle breakdown (rhabdomyolysis), and severe allergic reactions. Consult your doctor if any side effects persist or worsen.

Precautions

• Allergies: Do not take this medicine if you are allergic to Fenofibrate, Rosuvastatin, or any of its components.
• Pregnancy and Breastfeeding: It is not recommended during pregnancy or breastfeeding due to potential risks to the fetus or infant.
• Liver and Kidney Disease: Contraindicated in severe liver disease and severe renal impairment. Caution is advised for moderate impairment or a history of liver problems.
• Alcohol Consumption: Limit alcohol intake as it may intensify side effects and potentially harm your liver.
• Muscle Disorders: Use with caution if you have a history of muscle disorders or experience unexplained muscle pain, tenderness, or weakness.
• Diabetes: May alter blood sugar levels; monitoring is advised for diabetic patients.
• Gallbladder Disease: Not recommended for individuals with gallbladder disease or a history of gallstones due to increased risk of stone formation.
• Drug Interactions: Inform your doctor about all other medicines, supplements, or herbal products you are taking, especially blood thinners (like warfarin), ciclosporin, and other lipid-lowering agents (like gemfibrozil), as interactions can occur.

Storage

Store the medicine in a cool and dry place, away from direct sunlight and moisture. Keep it out of sight and reach of children. The recommended storage temperature is below 30°C.

What is ROSUFIT F 10/160 MG TABLET used for?

ROSUFIT F 10/160 MG TABLET is primarily used to treat high cholesterol and triglyceride levels in the blood, a condition known as hyperlipidemia or mixed dyslipidemia. By lowering "bad" cholesterol (LDL) and triglycerides and increasing "good" cholesterol (HDL), it helps reduce the risk of serious cardiovascular events such as heart attack and stroke, and can also slow the progression of atherosclerosis (hardening of the arteries).

How does ROSUFIT F 10/160 MG TABLET work?

This medicine combines two active ingredients: Rosuvastatin and Fenofibrate. Rosuvastatin, a statin, works by blocking an enzyme in the liver (HMG-CoA reductase) that is essential for cholesterol production, thereby reducing the amount of "bad" cholesterol (LDL) and total cholesterol. Fenofibrate, a fibrate, activates a protein called PPARα, which helps to break down triglycerides and increase the levels of "good" cholesterol (HDL). This dual action provides a comprehensive approach to managing lipid disorders.

What is the usual dosage for ROSUFIT F 10/160 MG TABLET?

ROSUFIT F 10/160 MG TABLET is typically taken once daily, usually in the evening. It can be taken with or without food, but consistency in timing is important for optimal results. The tablet should be swallowed whole with a glass of water and not crushed, chewed, or broken. Your doctor will determine the appropriate dosage and duration of treatment based on your medical condition, response to treatment, and other medications you may be taking.

What are the possible side effects of ROSUFIT F 10/160 MG TABLET?

Common side effects may include headache, nausea, vomiting, stomach pain, abdominal pain, constipation, diarrhea, gas, muscle pain, muscle weakness, dizziness, and fatigue. More serious, though rare, side effects can include liver damage, muscle breakdown (rhabdomyolysis), and an increase in blood sugar levels. If you experience persistent or severe side effects, especially unexplained muscle pain, tenderness, or weakness, or signs of liver problems (like dark urine, yellow skin/eyes, or severe stomach pain), contact your doctor immediately.

Is ROSUFIT F 10/160 MG TABLET safe during pregnancy or breastfeeding?

No, ROSUFIT F 10/160 MG TABLET is not recommended and is considered unsafe for use during pregnancy as it may 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 it is not known if its components pass into breast milk and could affect the nursing infant. Consult your doctor for safer alternatives if you are pregnant, planning a pregnancy, or breastfeeding.

Can ROSUFIT F 10/160 MG TABLET be taken with other medications?

ROSUFIT F 10/160 MG TABLET can interact with several other medications. It may increase the risk of bleeding when taken with blood thinners like warfarin. Concomitant use with medicines that reduce immune system activity (like ciclosporin) may lead to kidney damage. Taking it with other cholesterol-lowering medicines (such as gemfibrozil, other fibrates, or certain statins) can increase the risk of muscle damage. Estrogen-containing oral contraceptives may interfere with fenofibrate's effectiveness. If you are taking bile acid sequestrants (e.g., cholestyramine, colestipol), you should take them at least 4-5 hours before or 1 hour after Rosufit F. Always inform your doctor about all prescription, over-the-counter, and herbal medications you are taking to prevent potential drug interactions.

What precautions should be taken while taking ROSUFIT F 10/160 MG TABLET?

Before starting this medication, inform your doctor if you have any existing liver or kidney problems, diabetes, a thyroid disorder, gallbladder disease, or a history of unexplained muscle aches or pains, or a family history of muscle disorders. Regular monitoring of liver function, kidney function, and blood sugar levels may be recommended during treatment. It is advisable to avoid or limit alcohol consumption, as it can increase the risk of liver problems. Also, avoid consuming large amounts of grapefruit or grapefruit juice, as it can increase the levels of rosuvastatin in your blood. This medicine is not recommended for children under 18 years of age and should be used with caution in elderly patients.

What happens if a dose of ROSUFIT F 10/160 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 dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should ROSUFIT F 10/160 MG TABLET be stored?

ROSUFIT F 10/160 MG TABLET should be stored in a cool and dry place, protected from direct sunlight and moisture. Keep it out of sight and reach of children. The ideal storage temperature is typically below 30°C.