Rozustat F Tablet (10 Tab)

ROZUSTAT F TABLET

ROZUSTAT F TABLET is a combination medication manufactured by MACLEODS PHARMACEUTICALS LTD., primarily used to manage abnormal lipid (fat) levels in the blood.

Composition

ROZUSTAT F TABLET typically contains two active ingredients:

• Rosuvastatin (10 mg): A statin that works by inhibiting an enzyme crucial for cholesterol production in the liver, thereby reducing "bad" cholesterol (LDL) and total cholesterol.
• Fenofibrate (67 mg): A fibric acid derivative that primarily lowers triglyceride levels and increases "good" cholesterol (HDL) by enhancing the natural breakdown of fats.

Uses

ROZUSTAT F TABLET is prescribed for the management of:

• High blood cholesterol and triglyceride levels.
• Mixed dyslipidemia, a condition with an imbalance of lipids in the bloodstream.
• Hypercholesterolemia (high cholesterol levels) and hypertriglyceridemia (high triglyceride levels).
• Reducing the risk of heart disease, heart attacks, and strokes by improving overall lipid profiles.
• Slowing the progression of atherosclerosis (hardening of the arteries).

Dosage and Administration

• ROZUSTAT F TABLET should be taken once daily, as directed by a doctor.
• It can be taken with or without food, but some sources suggest taking it after meals to avoid stomach upset.
• The tablet should be swallowed whole with water and not crushed, chewed, or split.
• Do not alter the prescribed dosage or discontinue the medicine without consulting your doctor.

Side Effects

Common side effects of ROZUSTAT F TABLET may include:

• Headache
• Nausea and vomiting
• Abdominal pain
• Muscle pain (myalgia) or weakness
• Constipation or diarrhea
• Weakness or asthenia

Serious side effects, though rare, can include liver damage, muscle breakdown (rhabdomyolysis), and kidney problems. Seek immediate medical attention if you experience severe allergic reactions, unexplained muscle pain or weakness (especially with fever or dark urine), or signs of liver damage (e.g., yellow skin or eyes, dark urine, persistent nausea, stomach pain).

Precautions

• Allergy: Do not take if allergic to Rosuvastatin, Fenofibrate, or any components of the tablet.
• Pregnancy and Breastfeeding: Contraindicated during pregnancy and breastfeeding, as it may cause harm to the fetus or infant.
• Liver Disease: Not recommended for individuals with active liver disease or unexplained elevated liver enzymes.
• Kidney Disease: Use with caution in kidney problems; contraindicated in severe renal impairment due to potential toxicity.
• Alcohol: Avoid or limit alcohol consumption during treatment as it may increase the risk of liver damage and side effects.
• Drug Interactions: Inform your doctor about all other medications, supplements, or herbal products you are taking. Interactions can occur with blood thinners (e.g., warfarin), bile acid sequestrants, other lipid-lowering agents (e.g., gemfibrozil), ciclosporin, oral contraceptives, and fusidic acid.
• Other Conditions: Use with caution in patients with diabetes, hypothyroidism, or a personal/family history of muscle disorders. Regular monitoring of lipid levels and liver function is often advised.
• Children: Not recommended for use in children below 18 years of age.

Storage

Store ROZUSTAT F TABLET in a cool, dry place, ideally below 30°C. Protect from direct sunlight and keep out of reach of children. Ensure the medicine is used before its expiry date.

ROZUSTAT F TABLET (10 TAB) by MACLEODS PHARMACEUTICALS LTD. is a combination medication containing Rosuvastatin and Fenofibrate, primarily used to manage high cholesterol and triglyceride levels in the blood. This medicine helps reduce the risk of heart disease, heart attack, and stroke.

What is ROZUSTAT F TABLET used for?

ROZUSTAT F TABLET is used to lower elevated levels of "bad" cholesterol (LDL) and triglycerides (fats) in the blood and to increase "good" cholesterol (HDL). It is often prescribed when lifestyle modifications like diet and exercise alone are insufficient to control lipid levels. This medication helps prevent serious cardiovascular complications such as heart attacks and strokes.

How does ROZUSTAT F TABLET work?

ROZUSTAT F TABLET combines two active ingredients: Rosuvastatin and Fenofibrate. Rosuvastatin, a statin, works by inhibiting an enzyme called HMG-CoA reductase in the liver, which is crucial for cholesterol production. This reduces the amount of LDL cholesterol the liver produces and increases the removal of LDL cholesterol from the blood. Fenofibrate, a fibrate, activates a protein called PPARα, leading to an increase in the breakdown of triglycerides and an increase in the production of HDL cholesterol. Together, these actions provide a comprehensive approach to managing lipid levels.

What is the usual dosage of ROZUSTAT F TABLET?

Typically, ROZUSTAT F TABLET is taken orally once daily, with or without food, as directed by your doctor. Consistency in timing is recommended to maintain stable blood levels of the drugs. Your doctor may start with a lower dose and adjust it based on your response and cholesterol levels. It is important to swallow the tablet whole and not to crush or chew it.

What are the possible side effects of ROZUSTAT F TABLET?

Common side effects may include muscle pain, headache, nausea, abdominal pain, weakness, constipation, and diarrhea. Less common or more serious side effects can include severe muscle damage (rhabdomyolysis), liver problems, kidney problems, and allergic reactions. If side effects persist, worsen, or if you experience unusual muscle pain, tenderness, or weakness, especially with fever, or signs of liver damage (like dark urine, yellow skin or eyes), promptly inform your doctor.

Is ROZUSTAT F TABLET safe during pregnancy or breastfeeding?

ROZUSTAT F TABLET is generally not recommended and is considered highly unsafe during pregnancy and probably unsafe during breastfeeding. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor for alternative treatments.

Can ROZUSTAT F TABLET be taken with other medications?

ROZUSTAT F TABLET can interact with certain medications. It is crucial to inform your doctor about all medications, supplements, and herbal products you are taking. Interactions can occur with blood thinners (e.g., warfarin), other cholesterol-lowering drugs (e.g., gemfibrozil, niacin), immunosuppressants (e.g., cyclosporine), certain antibiotics (e.g., fusidic acid), bile acid sequestrants (e.g., cholestyramine), and some antiviral agents. Taking it with bile acid sequestrants requires specific timing (1 hour before or 4-6 hours after).

What precautions should be taken with ROZUSTAT F TABLET?

Before starting ROZUSTAT F TABLET, inform your doctor about any pre-existing medical conditions, especially liver or kidney disease, gallbladder problems, muscle disorders, diabetes, or hypothyroidism. Regular monitoring of liver function and lipid levels is usually required during treatment. Avoid consuming large amounts of grapefruit or grapefruit juice, as it can increase the levels of rosuvastatin in your blood and potentially increase the risk of side effects. Limit or avoid alcohol consumption as it may increase the risk of liver damage.

What happens if a dose of ROZUSTAT F TABLET is missed?

If you miss a dose of ROZUSTAT F TABLET, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for the missed dose without consulting your doctor.

How should ROZUSTAT F TABLET be stored?

ROZUSTAT F TABLET should be stored in a cool, dry place where the temperature stays below 30°C. Keep it away from direct sunlight and moisture, and out of reach of children. Ensure the medicine is used before its expiry date.