INTRODUCTION ABOUT ROZAVEL F 5 TABLET

ROZAVEL F 5 TABLET is used to manage hyperlipidemia in addition to proper diet, exercise, and lifestyle changes. It is a combination of Rosuvastatin and Fenofibrate which belongs to the group of medicines called Anti-lipidemic agents. It helps to reduce the levels of bad cholesterol (VLDL and LDL) and triglycerides in the body by modulating the actions of certain enzymes that are involved in lipid metabolism. By reducing lipid levels in the blood, ROZAVEL F 5 TABLET can also be used to manage the risk of heart attack, stroke, atherosclerosis and other circulatory disorders.

Along with the management, follow the diet, exercise and lifestyle changes instructed by your doctor to achieve better results. Avoid drinking large amount of alcohol while taking ROZAVEL F 5 TABLET. If you are diabetic, work on the blood sugar levels and keep them under control. Before taking ROZAVEL F 5 TABLET inform your doctor if you have any liver or kidney problems. You must also inform your doctor if you have thyroid problems, diabetes, high blood pressure or a family history of muscle disorders. ROZAVEL F 5 TABLET is not recommended for use in patients with severe liver or kidney problems. It is also not suitable for use in patients with severe repetitive unexplained muscle pain or in patients who had recently taken an antibiotic called Fusidic acid to manage bacterial infections.

Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with ROZAVEL F 5 TABLET. During management with the medicine, your doctor will periodically monitor liver functions, kidney functions, blood sugar levels, muscle functions and blood cholesterol levels to avoid the risk of unwanted side effects. The most common side effects are headache, constipation, bloating, muscle pain and liver problems. You must also inform your doctor if you experience severe unexplained muscle pain or weakness with fever, weakness or reddish-brown urine after taking the medicine.

USES OF ROZAVEL F 5 TABLET

It is used to manage:

• hyperlipidemia (high blood lipid levels)
• heart attack, stroke or atherosclerosis

HOW ROZAVEL F 5 TABLET WORKS

ROZAVEL F 5 TABLET is a combination of Fenofibrate and Rosuvastatin which helps to reduces the levels of bad cholesterol (VLDL and LDL) and triglycerides in the body by modulating the actions of certain enzymes that are involved in lipid metabolism (such as HMG-CoA reductase and lipoprotein lipase). Additionally, it can also reduce the amount of cholesterol absorbed in the body. By lowering the blood lipid levels, it helps to manage fat deposition within the blood vessels and reduces the chances of heart attack, stroke, atherosclerosis or other circulatory problems.

DIRECTIONS FOR USE

• Take the medicine as directed by the physician
• It is taken preferably after meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine
• Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition
• Do not stop taking ROZAVEL F 5 TABLET without consulting the doctor

SIDE EFFECTS OF ROZAVEL F 5 TABLET

Common side effects of ROZAVEL F 5 TABLET:

• headache
• dizziness
• stomach pain, constipation, nausea, diarrhea, flatulence
• muscle pain
• weakness
• increased blood sugar levels
• skin redness and itching

Stop taking ROZAVEL F 5 TABLET and consult your doctor immediately if you experience any of the following side effects:

• severe allergic skin reactions (skin rash, itching, skin redness with blisters or peeling of the skin, swelling in the mouth, which may be associated with high fever and joint pains)
• unexplained muscle pain or weakness, especially if accompanied by fever, weakness or reddish-brown urine
• lupus-like disease syndrome characterized by rash, muscle pain, joint disorders, pain and swelling
• severe stomach pain due to inflammation of pancreas
• signs of blood clots in the body (chest pain, shortness of breath, pain, redness and swelling in the legs)

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before taking ROZAVEL F 5 TABLET inform to your doctor if you are taking any of the following medicines such as:

• Antibiotics (Ex. actinomycin, regorafenib, erythromycin, fusidic acid)
• Immunosuppressants (Ex. cyclosporin)
• Anticoagulants (Ex. warfarin, acenocoumarol, clopidogrel)
• Anti-viral agents (Ex. lamivudine, stavudine, ritonavir, dasabuvir, sofosbuvir, velpatasvir, voxilaprevir, lopinavir, atazanavir)
• Estrogen hormone (Ex. ethinylestradiol)
• Anti-diabetics (Ex. rosiglitazone, pioglitazone)
• Bile acid sequestrants (Ex. cholestyramine, colesevelam)
• Anti-arrhythmic agents (Ex. amiodarone)
• Antifungals (Ex. nystatin, amphotericin, ketoconazole)
• Anticonvulsants (Ex. carbamazepine, phenobarbital, phenytoin, primidone)
• Antidepressants (Ex. amitriptyline, amoxapine)
• Anti-gout agents (Ex. colchicine)
• Antacids (Ex. aluminium hydroxide)

B. Drug- Food Interactions:

Avoid drinking grapefruit juice while taking ROZAVEL F 5 TABLET as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally took more ROZAVEL F 5 TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS