Rozavel F 5160 Mg Tablet 10

Rozavel F 5 Tablet 10

Sun Pharma Laboratories Ltd.

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STRIP of 10 Units

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Composition

Fenofibrate (160 Mg) + Rosuvastatin (5 Mg)

Rozavel F 5 Tablet is primarily used to manage hyperlipidemia, a condition where there are high levels of fats such as cholesterol and triglycerides in the blood. It's a combination medicine that falls under the class of lipid-lowering agents.

In addition to managing hyperlipidemia, this medicine is also used to reduce heart attack, stroke, and coronary revascularization procedures risks in patients with multiple cardiovascular risk factors. Furthermore, it is effective in managing hypertriglyceridemia either alone or with another lipid-lowering statin.

Before you begin taking this medicine, it is important to consult your doctor who will guide you on the correct dosage and frequency. Inform your doctor about any pre-existing conditions or ongoing medications. If you experience any side effects while on this medication, immediately report them to your doctor. For optimal results, continue taking the medicine for the duration prescribed by your doctor.

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Rozavel F 5 Tablet is used for managing the following health conditions:

Elevated cholesterol and triglyceride levels in the blood, also known as hyperlipidemia.
Primary hypercholesterolaemia, a condition where cholesterol levels are unusually high due to genetic factors.
Mixed dyslipidemia, where both cholesterol and triglyceride levels are higher than normal.
Reducing the risk of heart-related complications like heart attack and stroke.
Minimising the chances of undergoing coronary revascularization procedures, which are surgeries to restore blood flow in blocked arteries.

Directions for Use of Rozavel F 5 Tablet 10

Here's how you should take Rozavel F 5 Tablet:

Swallow the tablet whole with a glass of water. Avoid crushing or chewing it.
You can take this medicine with or without food.
Try to take it at the same time each day for consistency.
Consult your doctor if you feel that you need a change in dosage. Don't change it on your own.
Remember not to stop taking this medicine without speaking to your doctor first.

Rozavel F 5 Tablet is taken orally.

Taking Rozavel F 5 Tablet may lead to the following common side effects:

Headache
Myalgia: This is the medical term for muscle pain, which can occur anywhere in your body.
Abdominal pain
Back pain
Nausea
Abnormal liver function tests: This could indicate that your liver isn't working as it should be.

Managing the Side Effects:

Most side effects are temporary and generally harmless, which resolve on discontinuing the use of Rozavel F 5 Tablet. However, if you experience any serious side effects or worsening of any of the symptoms, please consult your doctor.

Here is how you can manage some common side effects:

Headache: Consider taking this medicine at night if it causes you headache during the day.
Nausea: Try taking Rozavel F 5 Tablet with food to lessen this effect.

Rozavel F 5 Tablet contains two active ingredients that work together:

Fenofibrate (160 mg): This component activates a receptor called PPAR-α in your body. This activation leads to more breaking down of particles rich in triglyceride and reduces apolipoprotein C-III production. As a result, plasma triglycerides decrease, and LDL composition changes from small, dense particles to larger ones that are less likely to promote the hardening of arteries. Fenofibrate also slightly increases HDL cholesterol levels.
Rosuvastatin (5 mg): This ingredient works by competitively blocking HMG-CoA reductase, an enzyme crucial for cholesterol formation in your body. This increases LDL uptake and breakdown on liver cells’ surfaces and reduces the liver's synthesis of VLDL, the precursor to LDL. The overall effect is a significant reduction in total cholesterol, LDL-C, non-HDL-C and apo B.

Pregnancy

Rozavel F 5 Tablet should not be taken during pregnancy; it could potentially harm the unborn baby. If you are pregnant or planning to conceive, make sure to discuss this with your doctor before starting this medicine.

Breastfeeding

This medicine is not recommended for breastfeeding women as both fenofibrate and rosuvastatin can pass into breast milk. Consult your doctor to understand the potential risks and benefits.

Alcohol

Heavy alcohol users should exercise caution while taking Rozavel F 5 Tablet, as it might increase the risk of liver damage. It's best to consult a doctor if you regularly consume alcohol.

Liver

Patients with liver problems should be cautious while taking this medicine. Rozavel F 5 Tablet is contraindicated in cases of severe liver disease and in cases where your liver enzymes are persistently elevated three times above the normal limit.

Kidney

This medicine is contraindicated for patients with severe kidney dysfunction. If you have a history of kidney problems, ensure to discuss them with your doctor before starting Rozavel F 5 Tablet.

Using Machines & Driving

Rozavel F 5 Tablet does not usually affect your ability to drive or operate machinery. However, if you experience side effects like dizziness or fatigue, avoid driving or operating heavy machinery.

Allergy

If you are allergic to either fenofibrate or rosuvastatin, do not take Rozavel F 5 Tablet. Ensure to discuss any known allergies with your doctor before starting this medication.

Children

Rozavel F 5 Tablet is not recommended for children under 18 years of age. Always consult a doctor before giving any medicine to a child.

Older Patients

Older patients should take Rozavel F 5 Tablet under medical supervision as they may be more susceptible to its side effects. Caution is advised if patients are above 70 years of age as they might also have liver and kidney issues. Your doctor will guide you based on your health status.

Drug-Drug Interactions

Rozavel F 5 Tablet interacts with the following medicines:

Anticoagulants: Medicines like warfarin can interact with Rozavel F 5 Tablet, potentially enhancing their effects. This may require monitoring of INR and adjustment of anticoagulant dosage.
Lipid-lowering agents: Medicines like gemfibrozil and niacin can increase the risk of muscle problems when taken with Rozavel F 5 Tablet. Avoid simultaneous use.

Drug-Food Interactions

There are no specific food items known to interact negatively with Rozavel F 5 Tablet. However, maintaining a balanced diet is always beneficial when managing your lipid levels.

Drug-Disease Interactions

Rozavel F 5 Tablet interacts with the following conditions:

Liver disease: If you have liver disease, caution is advised as this medicine could worsen your condition.
Hypothyroidism or Diabetes: Extra care is needed if you have hypothyroidism or diabetes, as these conditions could increase the risk of muscle problems when on this medication.

Daily Dose

The daily dosage of Rozavel F 5 Tablet should be as instructed by your doctor. This may vary depending on individual factors like how severe your condition is and how you respond to the medicine. Always stick to the prescribed dosage without changing it without consulting your doctor.

Over Dose

If you accidentally take more than your prescribed dose, you might experience common side effects like headache, muscle pain, or abdominal pain. It's important to inform your doctor if you've taken too much of this medicine.

Missed Dose

If you forget to take your Rozavel F 5 Tablet, take it as soon as you remember. But if it's nearly time for your next dose, don't take the missed one; just continue with your regular schedule from the next dose onwards. Never increase your dosage without speaking to your doctor.

Store your Rozavel F 5 Tablet at normal room temperature.
Protect it from direct light and moisture.
Always keep it in its original packaging to maintain quality.
Ensure it is out of reach and sight of children.
Check the expiry date before use; if it has expired or is no longer needed, safely dispose of it.

Consider adopting a low-fat, cholesterol-conscious diet to aid in managing hyperlipidemia and to enhance the effectiveness of Rozavel F 5 Tablet. This means reducing intake of saturated fats, trans fats, and cholesterol-rich foods like fatty meats and dairy.
Engage in regular physical activity such as brisk walking, cycling, or swimming for at least 30 minutes a day, 5 days a week. Regular exercise can help lower your cholesterol levels and reduce cardiovascular risk.

Fact Box

Drug Category	HMG CoA Reductase Inhibitor, PPAR-α Activator
Therapeutic Category	Lipid-Lowering Agent
Available Dosage Types	Tablet
Habit Forming	No
Ailment	Primary Hypercholesterolemia, Mixed Dyslipidemia, Hypertriglyceridemia

What is Rozavel F 5 Tablet used for?

This medicine manages high blood levels of lipids, reducing the risk of heart attacks and strokes. It also helps in managing high triglyceride levels.

How does Rozavel F 5 Tablet work?

It contains two active ingredients, fenofibrate and rosuvastatin, that work together to lower lipid levels. They reduce bad cholesterol, triglycerides and increase good cholesterol.

Can I take Rozavel F 5 Tablet with food?

Yes, it can be taken with or without food. It's best to take it around the same time each day to maintain consistent blood levels.

What are the common side effects of Rozavel F 5 Tablet?

Common side effects include headache, muscle pain, abdominal pain, back pain, nausea, and changes in liver function tests. Consult your doctor if these persist.

What should I do if I suspect a serious side effect?

If you experience severe muscle pain or persistent abdominal pain, consult your doctor immediately. These could indicate serious adverse events that need immediate attention.

Are there any precautions to consider while using Rozavel F 5 Tablet?

Yes. Avoid its use if you have severe liver or kidney problems. Also, elderly people, diabetics, hypothyroid patients and heavy alcohol users should exercise caution.

Can Rozavel F 5 Tablet interact with other medicines?

Yes. Certain medicines such as gemfibrozil, cyclosporine, niacin, and some antifungals can increase the risk of muscle problems when taken with this medicine.

Certified Content

Written by

Dr Vatsalya D Ghanekar

Medical Content Writer | 5 years

MD Ayurveda

Reviewed by

Dr. Chhavi Rosha

Health & Medical Content Writer | 8 years

BMS, FMC, MD Resident

Check out Editorial Policy

Manufacturer details

SUN HOUSE CTS No. 201, 201, Western Express Hwy, Ram Nagar, Goregaon, Mumbai, Maharashtra 400063

Country of origin: INDIA

References

Rosuvastatin: Uses, interactions, mechanism of action | DrugBank Online. (n.d.). DrugBank. https://go.drugbank.com/drugs/DB01098
HIGHLIGHTS OF PRESCRIBING INFORMATION. (2018). [Prescribing information]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021656s029lbl.pdf
Fenofibrate: Uses, interactions, mechanism of action | DrugBank Online. (n.d.). DrugBank. https://go.drugbank.com/drugs/DB01039
Martin, P. D., Dane, A. L., Schneck, D. W., & Warwick, M. J. (2003). An open-label, randomized, three-way crossover trial of the effects of coadministration of rosuvastatin and fenofibrate on the pharmacokinetic properties of rosuvastatin and fenofibric acid in healthy male volunteers. Clinical Therapeutics, 25(2), 459–471. https://doi.org/10.1016/s0149-2918(03)80089-9

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