Rosuvas F 5 Mg Tablet (15 Tab)

ROSUVAS F 5 MG TABLET

Name:

• Brand Name: ROSUVAS F 5 MG TABLET (15 TAB) by SUN PHARMACEUTICAL IND.LTD.
• Common Name: Rosuvas F 5mg Tablet

Composition: ROSUVAS F 5 MG TABLET contains a combination of two active ingredients:

• Rosuvastatin: 5 mg
• Fenofibrate: 160 mg

Uses: This medication is primarily used to manage abnormal lipid/cholesterol levels in the blood. It is prescribed for:

• Hyperlipidemia (high blood lipid levels)
• High cholesterol levels (hypercholesterolemia)
• Increased levels of triglycerides (hypertriglyceridemia)
• Mixed dyslipidemia, a condition involving elevated LDL cholesterol and triglyceride levels.
• By reducing lipid levels, it helps to manage the risk of cardiovascular events such as heart attack, stroke, and atherosclerosis.

Dosage and Administration:

• ROSUVAS F 5 MG TABLET is for oral administration.
• Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
• It can be taken with or without food, but it is generally recommended to take it at the same time each day for consistent effect.
• The typical dosage is once daily, as directed by your doctor.
• Adults: Initial dose is usually 5 or 10 mg once daily, which may be increased at 4-weekly intervals to 20 mg daily as per the medical condition. The maximum dose is 40 mg once daily.
• Children (above 10 years): Initial dose is 5 mg once daily, which may be adjusted at intervals of at least 4 weeks. The maximum dose is 20 mg once daily.

Side Effects:

• Common Side Effects: Headache, dizziness, stomach pain/abdominal pain, constipation, nausea, diarrhea, flatulence, muscle pain, weakness, increased blood sugar levels, skin redness and itching, joint pain, elevated creatine kinase levels.
• Serious Side Effects (Seek immediate medical attention if experienced):
  • Severe allergic skin reactions (rash, itching, skin redness with blisters or peeling of the skin, swelling in the mouth).
  • Unexplained severe muscle pain or weakness, especially if accompanied by fever, weakness, or reddish-brown urine (indicative of rhabdomyolysis).
  • Lupus-like disease syndrome characterized by rash, muscle pain, joint disorders, pain, and swelling.
  • Severe stomach pain due to inflammation of the pancreas.
  • Signs of liver damage such as fever, rash, loss of appetite, nausea, vomiting, fatigue, stomach pain, dark urine, or yellowing of the skin or eyes.

Precautions:

• Contraindications:
  • Pregnancy and breastfeeding are contraindicated due to potential harm to the fetus or nursing infant. Women of childbearing potential must use suitable contraceptive methods.
  • Allergy to Rosuvastatin, Fenofibrate, or any other components of the tablet.
  • Severe liver disease, increased liver enzymes, or severe kidney diseases.
  • Repeated or unexplained muscle aches or pains.
  • Concurrent therapy with ciclosporin (increases risk of kidney damage).
  • Gallbladder disease or inflammation of the pancreas.
• Warnings and General Precautions:
  • Caution is advised in patients with mild to moderate liver or kidney impairment, diabetes (as it may increase blood sugar levels), pre-existing gallbladder disease, muscle problems, a family history of muscle disorders, thyroid disorders, or lung-related disorders.
  • 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. Interactions can occur with blood thinners (e.g., warfarin), ciclosporin, other cholesterol-lowering medicines (e.g., gemfibrozil), fusidic acid, antacids, certain antiviral medicines (e.g., ritonavir), and estrogen-containing oral contraceptives.
  • Regular monitoring of liver functions, kidney functions, blood sugar levels, muscle functions, and blood cholesterol levels is essential during treatment.
  • The safety and effectiveness of ROSUVAS F 5 MG TABLET in children have not been established, and it is generally not recommended for use in children.

Storage:

• Store at room temperature, ideally between 10°C to 25°C or below 30°C.
• Keep the medicine in a dry place, protected from moisture and direct sunlight.
• Always maintain the tablets in their original packaging.
• Keep out of sight and reach of children and pets.

ROSUVAS F 5 MG TABLET is a combination medication containing Rosuvastatin (5 mg) and Fenofibrate (160 mg). It is primarily used to manage high levels of cholesterol and triglycerides in the blood. This medication helps reduce the risk of cardiovascular diseases such as heart attack and stroke.

What is ROSUVAS F 5 MG TABLET used for?

ROSUVAS F 5 MG TABLET is used to treat hyperlipidemia (high lipid levels), hypercholesterolemia (high cholesterol), hypertriglyceridemia (high triglycerides), and mixed dyslipidemia (abnormal levels of various lipids). It helps lower "bad" cholesterol (LDL) and triglycerides while increasing "good" cholesterol (HDL), thus reducing the risk of heart disease and stroke.

How does ROSUVAS F 5 MG TABLET work?

ROSUVAS F 5 MG TABLET contains two active ingredients: Rosuvastatin and Fenofibrate. Rosuvastatin is a statin that works by inhibiting HMG-CoA reductase, an enzyme in the liver responsible for cholesterol production, which lowers LDL cholesterol. Fenofibrate is a fibric acid derivative that reduces triglyceride levels by decreasing their production and enhancing their clearance, and can also increase HDL cholesterol. Together, they improve the overall lipid profile.

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

The dosage of ROSUVAS F 5 MG TABLET should be as prescribed by your doctor. It depends on your medical condition and how you respond to the treatment. It can generally be taken with or without food, but it is often recommended to take it at the same time each day to help remember the dose.

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

Common side effects may include headache, muscle pain (myalgia), nausea, abdominal pain, constipation, flatulence, and joint pain. More serious, but rare, side effects can include liver damage or severe muscle injury (rhabdomyolysis). Inform your doctor if you experience persistent or worsening side effects, particularly unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever.

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

ROSUVAS F 5 MG TABLET is generally not recommended during pregnancy as it may cause harm to the developing fetus. Women of childbearing potential should use effective contraception while taking this medicine. For breastfeeding mothers, it is generally advised against due to potential risks to the infant, although some studies suggest low exposure via breast milk. Your doctor will help decide the best course of action.

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

ROSUVAS F 5 MG TABLET can interact with several medications. It's crucial to inform your doctor about all medicines, including over-the-counter drugs, supplements, and herbal products you are taking. Notable interactions include:

• Immunosuppressants (e.g., Cyclosporine): Increased risk of kidney damage.
• Blood thinners (e.g., Warfarin, Clopidogrel): Increased risk of bleeding.
• Other cholesterol-lowering medications (e.g., Gemfibrozil, Niacin, Ezetimibe): May increase the risk of muscle problems.
• Anti-viral agents (e.g., Ritonavir, Atazanavir, Paxlovid): Can increase rosuvastatin levels and side effects.
• Antacids (e.g., Aluminium hydroxide): May interfere with absorption.
• Fusidic acid (an antibiotic): Not usually safe to take together due to muscle issues.

What precautions should be taken while on ROSUVAS F 5 MG TABLET?

Before taking ROSUVAS F 5 MG TABLET, inform your doctor if you have liver or kidney problems, a history of gallbladder disease (including gallstones), diabetes, thyroid problems, or muscle disorders. Avoid or limit alcohol consumption as it can increase the risk of liver problems. Regular monitoring of liver function and lipid levels is recommended.

What happens if a dose of ROSUVAS F 5 MG TABLET is missed?

If you miss a dose of ROSUVAS F 5 MG TABLET, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed one and continue your regular dosing schedule. Do not double the dose to make up for the forgotten one.

How should ROSUVAS F 5 MG TABLET be stored?

Store ROSUVAS F 5 MG TABLET at room temperature, ideally below 30°C, in a cool, dry place. Keep the medication in a tightly closed container and out of the sight and reach of children and pets. Do not use the medicine after its expiry date.