Rozat F 5 Mg Tablet (10 Tab)

ROZAT F 5 MG TABLET

Name

Brand Name: ROZAT F 5 MG TABLET Common Name: Rosuvastatin (5 mg) + Fenofibrate (160 mg)

Composition

ROZAT F 5 MG TABLET contains two active ingredients:

• Rosuvastatin: 5 mg
• Fenofibrate: 160 mg

Rosuvastatin is a statin that works by inhibiting an enzyme crucial for cholesterol production in the liver, thereby reducing "bad" cholesterol (LDL) and triglycerides, and increasing "good" cholesterol (HDL). Fenofibrate, a fibric acid derivative, primarily lowers triglyceride levels and also helps raise HDL cholesterol.

Uses

ROZAT F 5 MG TABLET is prescribed for the management of:

• High blood cholesterol and triglyceride levels (hyperlipidemia, hypercholesterolemia, hypertriglyceridemia)
• Mixed dyslipidemia (abnormal levels of lipids in the blood, including high LDL, high triglycerides, and low HDL)
• Reducing the risk of cardiovascular events such as heart attack and stroke.
• Slowing the progression of atherosclerosis.

It is typically used when lifestyle changes like diet and exercise alone are insufficient.

Dosage and Administration

• The typical dosage for adults is one tablet once daily, with or without food.
• It should be taken regularly at the same time each day.
• Do not chew, crush, or break the tablet.
• The dosage may vary based on individual lipid levels and response to the medicine, as determined by a doctor.
• Do not stop taking the medicine without consulting your doctor.

Side Effects

Common side effects include:

• Headache
• Muscle pain, tenderness, or weakness (myalgia)
• Nausea, vomiting, stomach pain, or upset stomach
• Constipation or diarrhea
• Joint pain
• Abnormal liver function tests or elevated liver enzymes
• Dizziness
• Increased blood sugar levels

Serious but rare side effects can include:

• Rhabdomyolysis (severe muscle damage)
• Liver damage (yellow skin or eyes, dark urine)
• Severe allergic reactions (rash, itching, swelling)
• Inflammation of the pancreas (severe stomach pain)

Precautions

• Allergies: Avoid if allergic to rosuvastatin, fenofibrate, or any other ingredients.
• Liver Disease: Not recommended for those with severe liver disease or pre-existing liver conditions. Use with caution in mild to moderate liver impairment. Regular monitoring of liver function is advised.
• Kidney Disease: Not recommended for severe kidney problems due to increased risk of side effects like rhabdomyolysis.
• Gallbladder Disease: Not recommended for those with gallbladder conditions such as gallstones.
• Pregnancy and Breastfeeding: Contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception.
• Alcohol: Avoid excessive alcohol consumption as it may increase the risk of liver damage.
• Muscle Disorders: Use with caution if you have a history of muscle disorders or experience unexplained muscle pain or weakness; consult your doctor immediately.
• Diabetes: Use with caution in diabetic patients as it may affect blood sugar control. Regular monitoring is advised.
• Drug Interactions: Inform your doctor about all other medications, including supplements and herbal products, especially anticoagulants (e.g., Warfarin), ciclosporin, and other lipid-lowering medicines (e.g., gemfibrozil).
• Children: Not recommended for use in children under 18 years of age due to a lack of safety and efficacy data.
• Elderly Patients: Use with caution; dose modification or replacement may be required based on medical conditions. Regular monitoring of liver and kidney function is advised.

Storage

• Store at room temperature below 25°C or 30°C.
• Keep the medication in its original packaging, protected from light and moisture.
• Always keep this medicine out of reach of children.
• Do not use after the expiry date.

ROZAT F 5 MG TABLET is a combination medication containing Rosuvastatin (5 mg) and Fenofibrate (160 mg). It is primarily used to manage high cholesterol and triglyceride levels in the blood.

What is ROZAT F 5 MG TABLET used for?

ROZAT F 5 MG TABLET is used to manage high cholesterol (hypercholesterolemia) and high triglyceride levels (hypertriglyceridemia), as well as mixed dyslipidemia. By reducing these harmful fatty substances, it helps to decrease the risk of cardiovascular events such as heart attack and stroke.

How does ROZAT F 5 MG TABLET work?

ROZAT F 5 MG TABLET works through its two active ingredients. Rosuvastatin, a statin, inhibits an enzyme (HMG-CoA reductase) in the liver that is crucial for cholesterol production, thereby lowering "bad" LDL cholesterol and increasing "good" HDL cholesterol. Fenofibrate, a fibrate, activates a specific enzyme that reduces the production and increases the breakdown of triglycerides in the liver, also slightly increasing HDL cholesterol levels.

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

ROZAT F 5 MG TABLET is typically administered orally, once daily, with or without food. The exact dosage and duration of treatment are determined by your doctor based on your lipid levels and response to the medication. It's crucial to follow your physician's prescribed dosage and schedule strictly.

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

Common side effects may include headache, muscle pain or spasms, indigestion, flatulence, nausea, constipation, and abdominal pain. More serious but less common side effects can include liver problems (yellowing of skin/eyes, dark urine, abdominal pain), kidney problems, and muscle damage (rhabdomyolysis) which may present as unexplained muscle pain or weakness, especially with fever or reddish-brown urine. Contact your doctor immediately if you experience severe or persistent side effects.

Is it safe during pregnancy or breastfeeding?

ROZAT F 5 MG TABLET is contraindicated during pregnancy and is considered highly unsafe. It is also not recommended for breastfeeding women, as it may pass into breast milk and harm the infant. Women of childbearing potential should use suitable contraception during treatment. Always consult your doctor if you are pregnant, planning to conceive, or breastfeeding.

Can it be taken with other medications?

ROZAT F 5 MG TABLET can interact with certain medications. It may increase the risk of bleeding when taken with anticoagulants like Warfarin. Other cholesterol-lowering drugs (e.g., other statins, gemfibrozil) may increase the risk of muscle disorders. Cyclosporine, certain antacids, and some antifungals or antibiotics can also interact. Always inform your doctor about all medications, supplements, and herbal products you are taking to avoid potential interactions.

What precautions should be taken?

Precautions for ROZAT F 5 MG TABLET include avoiding its use if you have severe kidney disease, active liver disease, or gallbladder conditions like gallstones. Caution is advised for patients with mild to moderate liver impairment, kidney disease, diabetes, or a history of muscle disorders. Alcohol consumption should be limited or avoided as it can increase the risk of liver damage. Regular monitoring of lipid levels, liver function, kidney function, and blood sugar levels is recommended during treatment. Avoid consuming large amounts of grapefruit juice.

What happens if a dose is missed?

If you forget to take your dose of ROZAT 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 the missed one.

How should it be stored?

ROZAT F 5 MG TABLET should be stored at room temperature below 25°C or below 30°C, in its original packaging, protected from light and moisture. Keep this medicine out of reach of children. Ensure to use it before the expiry date.