Rosave F 20

ROSAVE F 20 Tablet

ROSAVE F 20 Tablet is a prescription medication manufactured by Alembic Pharmaceuticals Ltd..

Composition Each tablet of ROSAVE F 20 contains two active ingredients:

• Fenofibrate (160 mg)
• Rosuvastatin (20 mg)

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

Uses ROSAVE F 20 is primarily used to manage abnormal lipid/cholesterol levels in the blood and reduce the risk of cardiovascular diseases. It is prescribed for:

• High cholesterol (Hyperlipidemia/Hypercholesterolemia)
• High triglycerides (Hypertriglyceridemia)
• Mixed dyslipidemia (low good cholesterol and high bad cholesterol and triglycerides)
• Prevention of serious heart conditions, heart attack, and stroke in high-risk patients.

Dosage and Administration ROSAVE F 20 Tablet is taken orally, usually once daily, with or without food. The tablet should be swallowed whole with a glass of water and not crushed or chewed. It is recommended to take it at the same time each day to maintain consistent medication levels. The dosage and duration of treatment are determined by a doctor based on individual lipid levels and response to the medicine.

Side Effects Common side effects may include:

• Headache
• Stomach pain or indigestion/abdominal pain
• Muscle pain or weakness
• Nausea or vomiting
• Diarrhoea or constipation
• Back pain
• Fatigue/dizziness

Serious side effects, though rare, can include severe muscle pain, tenderness, or weakness, and signs of liver problems (e.g., yellowing of the skin or eyes, dark urine).

Precautions

• Pregnancy and Breastfeeding: ROSAVE F 20 is contraindicated during pregnancy due to the risk of fetal harm and is considered unsafe during breastfeeding as it may pass into breast milk.
• Liver and Kidney Conditions: Caution is advised in patients with mild to moderate liver impairment or kidney disease. It is contraindicated in severe kidney impairment and active or severe liver disease.
• Alcohol Consumption: Alcohol consumption should be avoided or limited as it can increase the risk of liver damage.
• Drug Interactions: Inform your doctor about all other medications, including supplements, to prevent potential interactions with drugs like anticoagulants (e.g., warfarin), cyclosporine, bile acid sequestrants, other fibric acid derivatives (e.g., gemfibrozil), niacin, and HIV protease inhibitors.
• Muscle Problems: The medicine may increase the risk of muscle problems. Patients should report any unexplained muscle pain, tenderness, or weakness.
• Driving: The medicine generally does not affect the ability to drive, but if dizziness occurs, driving should be avoided.
• Regular monitoring of lipid levels and liver enzymes is important during treatment.

Storage Store ROSAVE F 20 Tablet in its original packaging at room temperature, ideally between 20°C to 25°C, protected from light and moisture. Keep out of reach of children.

Here are some frequently asked questions about ROSAVE F 20, manufactured by ALEMBIC PHARMACEUTICALS LTD:

What is ROSAVE F 20 used for?

ROSAVE F 20 is a combination medicine primarily used to lower high levels of total cholesterol and triglycerides in the blood. It is prescribed for conditions such as hyperlipidemia (high lipid levels), mixed dyslipidemia (low "good" cholesterol and high "bad" cholesterol and triglycerides), hypercholesterolemia (high cholesterol), and hypertriglyceridemia (high triglyceride levels). By managing these lipid levels, it helps reduce the risk of heart disease, heart attacks, and strokes.

How does ROSAVE F 20 work?

ROSAVE F 20 contains two active ingredients: Rosuvastatin (20mg) and Fenofibrate (160mg). Rosuvastatin is a statin that works by blocking an enzyme (HMG-CoA reductase) in the liver, which is essential for cholesterol production. This reduces the levels of "bad" cholesterol (LDL) and increases the removal of LDL from the blood. Fenofibrate is a fibric acid derivative that primarily works by lowering triglyceride levels in the blood and can also help increase "good" cholesterol (HDL). Together, they improve the overall lipid profile.

What is the usual dosage for ROSAVE F 20?

The typical dosage for ROSAVE F 20 is one tablet once daily. It can be taken with or without food, but it is often advised to take it at the same time each day to help with adherence. The tablet should be swallowed whole with a glass of water and not crushed, broken, or chewed. Your doctor will determine the exact dose and duration of treatment based on your lipid levels and response to the medication.

What are the possible side effects of ROSAVE F 20?

Common side effects may include nausea, headache, abdominal pain or stomach pain, muscle pain or weakness, constipation, diarrhea, joint pain, and abnormal liver function tests. While most of these are usually mild and temporary, more serious but rare side effects can include severe muscle pain or weakness (which might indicate a serious condition called rhabdomyolysis) and liver damage. If you experience persistent or severe side effects, or symptoms like yellowing of the skin or eyes, dark urine, or unusual bleeding, consult your doctor immediately.

Is ROSAVE F 20 safe during pregnancy or breastfeeding?

No, ROSAVE F 20 is considered highly unsafe during pregnancy and is not recommended. Rosuvastatin, one of its components, is a pregnancy category X medicine, meaning it can cause harm to the developing fetus. Similarly, it is not recommended for use during breastfeeding because the medicine may pass into breast milk and could potentially affect the baby's health. Women who are pregnant, planning to become pregnant, or breastfeeding should consult their doctor for alternative treatment options.

Can ROSAVE F 20 be taken with other medications?

ROSAVE F 20 can interact with several other medications. Taking it with blood thinners like warfarin can increase the risk of bleeding. Concomitant use with other lipid-lowering medicines such as gemfibrozil or niacin, or with fusidic acid, may increase the risk of muscle problems. Cyclosporine, an immune system suppressant, may increase the risk of kidney damage. Antacids containing aluminum or magnesium hydroxide can decrease the absorption of rosuvastatin, potentially reducing its effectiveness. HIV protease inhibitors (e.g., ritonavir) can also affect how rosuvastatin is processed in the body. Oral contraceptives may interfere with the action of fenofibrate. Always inform your doctor about all medicines, supplements, and herbal products you are taking to prevent potential interactions.

What precautions should be taken while on ROSAVE F 20?

Inform your doctor if you have any pre-existing medical conditions, including liver or kidney problems, active liver disease, pre-existing gall bladder disease, diabetes, thyroid disorders, or a history of muscle pain or weakness, or lung disorders. Alcohol consumption should be avoided or limited, as it can increase the risk of liver damage. Regular monitoring of liver enzymes and lipid levels is often recommended during treatment. ROSAVE F 20 should be used with caution in elderly patients due to a potentially increased risk of muscle problems. Do not discontinue the medication without consulting your doctor, even if your cholesterol levels improve.

What happens if a dose of ROSAVE F 20 is missed?

If you miss a dose of ROSAVE F 20, 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. Maintaining a consistent schedule is important for the medication's effectiveness.

How should ROSAVE F 20 be stored?

ROSAVE F 20 should be stored in a cool and dry place, away from direct sunlight and moisture. The ideal storage temperature is typically between 20°C to 25°C. Keep the medicine in its original packaging to protect it from light and moisture. Always ensure it is kept out of sight and reach of children and pets.