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Rozavel F (20/160 mg) Tablet

Manufactured bySun Pharma Laboratories Ltd.
ContainsRosuvastatin (20 mg) + Fenofibrate (160 mg)
Description
Rozavel F (20/160 mg) Tablet is a combination of Rosuvastatin and Fenofibrate. It is used orally to reduce the level of bad cholesterol and fats in the body. High levels of cholesterols and fats increase the risk of heart attack and stroke. This medicine works by reducing the formation of cholesterol and fats in the body. It also increases the natural fat breakdown in your body. It is used when the diet (low-fat diet) alone has failed to normalize the fat levels. The common side effects of Rozavel F (20/160 mg) Tablet use are nausea, stomach pain, constipation, headache and excessive gas in your stomach. Usually, these side effects resolve on their own. Consult your doctor if any of the side effects persist or worsen. Avoid taking this medicine if you are previously allergic to it. While on Rozavel F (20/160 mg) Tablet treatment, notify your doctor if you are more tired than usual, do not feel hungry, or if you have yellow eyes and skin. Consult your doctor at the earliest if you experience muscle pain or weakness, particularly if it is accompanied by fever. Take Rozavel F (20/160 mg) Tablet with or without food. Take this medicine at the same time every day for ease of remembering and to avoid missing a dose. Do not stop taking it until you have finished the complete course, even when you feel better. Avoid taking this medicine if you have liver disease. You should also let your doctor know about your medical history and regarding all other medicines you are taking as they may affect this medicine. Diabetic patients should monitor their blood sugar levels while taking Rozavel F (20/160 mg) Tablet, as it may lead to an increase in blood sugar levels. Inform your doctor if you are pregnant, planning a pregnancy or are breastfeeding.

Side effects

Major & minor side effects for Rozavel F (20/160 mg) Tablet

  • Muscle pain
  • Tenderness
  • Weakness
  • Headache
  • Joint pain
  • Acid or sour stomach
  • Diarrhoea
  • Excessive air or gas in stomach
  • Blood in urine
  • Redness of the skin especially on the face and neck
  • Itching and skin rash
  • Nausea and Vomiting
  • Runny Nose
  • Stuffy Nose
  • Increase in blood glucose level

Uses of Rozavel F (20/160 mg) Tablet

What is it prescribed for?

  • Combined hyperlipidemia
Read More
Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    Rozavel F (20/160 mg) Tablet may start to show its action in 4-5 hours. However, it can take up to few days to weeks to make you feel better.
  • How long do the effects of this medicine last?
    Rozavel F (20/160 mg) Tablet may remain active in your body for about 19 hours.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    Rozavel F (20/160 mg) Tablet has no habit forming tendency.
  • Can this medicine be taken during pregnancy?
    Rozavel F (20/160 mg) Tablet is not recommended for use in pregnant women as it may potentially harm your foetus. Your doctor may prescribe a safer alternative based on your clinical condition.
  • Can this medicine be taken while breast-feeding?
    Rozavel F (20/160 mg) Tablet passes into your breastmilk. This may harm your infant potentially. Discontinue breastfeeding while on Rozavel F (20/160 mg) Tablet treatment. Discuss the benefits and risks with your doctor before taking this medicine.

Allergy

Avoid taking Rozavel F (20/160 mg) Tablet if you are previously allergic to it. Seek an immediate medical attention if you notice any symptoms of allergic reactions such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulties, etc.

Liver Disease

Rozavel F (20/160 mg) Tablet is converted into its active form by liver. The presence of liver disease may impair the conversion of this medicine into its active form leading to the accumulation of this medicine in your liver. This accumulation may worsen the liver condition. Hence, Rozavel F (20/160 mg) Tablet is not recommended for use if there is an active liver disease.

Kidney Disease

Rozavel F (20/160 mg) Tablet is excreted by your kidneys. Kidney disease may lead to impaired filtration of this medicine leading to the accumulation of this medicine in your kidneys. This accumulation may worsen your liver condition. Hence, Rozavel F (20/160 mg) Tablet is not recommended for use in case of kidney disease (CrCl < 30 ml/min).

Gallbladder disease

Rozavel F (20/160 mg) Tablet is not recommended for use if you have gallbladder diseases due to the increased risk of gallbladder stones.
Warnings for special population

Pregnancy

Rozavel F (20/160 mg) Tablet is not recommended for use in pregnant women as it may potentially harm your foetus. Your doctor may prescribe a safer alternative based on your clinical condition.

Breast-feeding

Rozavel F (20/160 mg) Tablet passes into your breastmilk. This may harm your infant potentially. Discontinue breastfeeding while on Rozavel F (20/160 mg) Tablet treatment. Discuss the benefits and risks with your doctor before taking this medicine.
General warnings

Cognitive impairment

Rozavel F (20/160 mg) Tablet may cause forgetfulness, memory loss, confusion, etc. These side effects are reversible and usually disappear once the medicine is discontinued.

Myopathy and Rhabdomyolysis

Rozavel F (20/160 mg) Tablet may cause myopathy (muscle pain) and rhabdomyolysis, a condition that can be harmful. This may cause symptoms such as severe tiredness and weakness. This risk is especially higher in the elderly population and in patients with active muscle disorders.

Alcohol consumption

Rozavel F (20/160 mg) Tablet may cause liver and kidney injuries in patients consuming alcohol very frequently and in large quantities. Hence, consumption of alcohol should be avoided during treatment with this medicine.

Use in pediatrics

Since the safety and efficacy of Rozavel F (20/160 mg) Tablet use are not clinically established, this medicine may be used in children below 18 years of age only under the close supervision of your doctor.

Increase in serum creatinine levels

Close monitoring of kidney function is recommended in patients receiving Rozavel F (20/160 mg) Tablet due to the increased risk of elevated serum creatinine levels. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on your clinical condition.

Missed Dose

If you forget to take a Rozavel F (20/160 mg) Tablet dose, make sure that you remember to take your next dose on time. Do not take two doses together to make up for a forgotten dose.

Overdose

Never take Rozavel F (20/160 mg) Tablet more than the prescribed dose. If you suspect that you might have taken an overdose of this medicine, go to the emergency department of your local hospital.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Leflunomide

Atazanavir

Cyclosporine

Gemfibrozil

Hypoglycemic agents

Warfarin

Disease interactions

Diabetes

Caution should be exercised while taking Rozavel F (20/160 mg) Tablet in diabetic patients. This medicine may alter blood sugar levels. Your doctor may advise you to monitor the blood sugar levels frequently while you are on treatment with Rozavel F (20/160 mg) Tablet.

Rhabdomyolysis

Caution should be exercised while taking Rozavel F (20/160 mg) Tablet if you have Rhabdomyolysis. Rhabdomyolysis is a very serious condition in which damaged muscle fibres enter the bloodstream, leading to kidney failure.
Food interactions
Information not available.
Lab interactions
Information not available.
Take Rozavel F (20/160 mg) Tablet orally with food to avoid an upset stomach. It should be taken in addition to regular exercise and a low-fat diet to lower levels of fat in your blood. Notify your doctor if you experience muscle symptoms (pain or weakness), particularly if accompanied by fever. Notify your doctor if you experience stomach pain, loss of hunger, a sick feeling or dark urine. Do not discontinue Rozavel F (20/160 mg) Tablet without consulting your doctor even if you feel better. Avoid alcohol consumption (includes wine, beer, and liquor). Do not crush, break or chew the tablet in your mouth.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Effect on sleep is not established

How it works
Rozavel F (20/160 mg) Tablet is a combination of Rosuvastatin and Fenofibrate. Rosuvastatin reduces the production of cholesterol from the liver. Fenofibrate increases the natural lipid breakdown process with the help of the enzyme lipoprotein lipase. This removes the bad cholesterol (LDL) and triglycerides from your blood and increases the levels of good cholesterol (HDL).
Legal Status

Approved

Unknown

Unknown

Unknown

Classification

Category

Statins, Fibric acid derivatives, Antihyperlipidemic combinations

Schedule

Schedule H

Medicines.org.uk. 2021. Rosuvastatin 20mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 13 August 2021].

https://www.medicines.org.uk/emc/product/4366/smpc#PHARMACOKINETIC_PROPS>

nhs.uk. 2021. Rosuvastatin: a medicine used to lower cholesterol. [online] Available at: < [Accessed 13 August 2021].

https://www.nhs.uk/medicines/rosuvastatin/>

Medicines.org.uk. 2021. Fenofibrate 160mg Tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 16 August 2021].

https://www.medicines.org.uk/emc/product/5267#PHARMACOKINETIC_PROPS>

Drugs, H., 2021. Fenofibrate: MedlinePlus Drug Information. [online] Medlineplus.gov. Available at: < [Accessed 16 August 2021].

https://medlineplus.gov/druginfo/meds/a601052.html>

Dailymed.nlm.nih.gov. 2021. DailyMed - FENOFIBRATE tablet. [online] Available at: < [Accessed 16 August 2021].

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8f09ab1-74db-4123-b85a-6337dc2582a0>
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Information on this page was last updated on 17 Aug 2021

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