D Rozavel 10mg Tablet 10'S

INTRODUCTION

D ROZAVEL 10MG TABLET is a combination of Rosuvastatin and Cholecalciferol (or Vitamin D3) which belongs to the group of medicines called Cholesterol lowering agents and Vitamin D respectively. It is used to reduce high blood cholesterol levels (hyperlipidaemia) in patients when diet and lifestyle changes does not result in adequate response.

By reducing blood cholesterol levels, it can also be used to prevent the risk of heart attack, stroke, angina, atherosclerosis and other heart related problems. It can also be used to treat and prevent vitamin D3 deficiency and bone disorders (such as osteoporosis) among patients who have both hyperlipidemia and vitamin D3 deficiency.

Along with the treatment, you must follow a cholesterol-lowering diet, lifestyle changes and regular physical activity as instructed by your doctor to achieve better results. Avoid consuming alcohol while taking D ROZAVEL 10MG TABLET as it may lead to unwanted side effects.

Before taking D ROZAVEL 10MG TABLET inform your doctor if you have any lung, liver, kidney, or heart problems. You must also inform your doctor if you have diabetes, hypertension, thyroid problems, or a family history of muscle disorders.

Do not take D ROZAVEL 10MG TABLET if you are pregnant or breastfeeding without consulting your doctor. The most common side effects of taking D ROZAVEL 10MG TABLET are pain in joints and muscles, gastrointestinal problems such as constipation, diarrhoea, indigestion or nausea and headache. Contact your doctor if any of side effect worsens.

USES OF D ROZAVEL 10MG TABLET

• Treats hyperlipidemia (high blood cholesterol levels)
• Prevents the risk of heart attack, stroke, angina and other heart problems
• Treats and prevents Vitamin D3 deficiency
• Treats and prevents bone problems (such as osteoporosis)

HOW D ROZAVEL 10MG TABLET WORKS

D ROZAVEL 10MG TABLET contains two medicines namely, rosuvastatin and cholecalciferol. Rosuvastatin is a cholesterol lowering agent. It effectively reduces the levels of bad cholesterol (LDL) and triglycerides in the body by blocking the actions of an enzyme called HMG-CoA reductase that synthesizes cholesterol within the body. It also acts on the liver and improves the body’s ability to remove fat particles from the blood.

Cholecalciferol is a form of Vitamin D. It supplements your body with a sufficient amount of Vitamin D3 which prevents vitamin D3 deficiency and its associated bone problems. It also improves the cholesterol-reducing actions of rosuvastatin and can reduce the muscle pain and damage caused due to rosuvastatin within the body.

DIRECTIONS FOR USE

Take D ROZAVEL 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. D ROZAVEL 10MG TABLET can be taken with or without meals.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition. Do not stop taking D ROZAVEL 10MG TABLET without consulting your doctor.

SIDE EFFECTS OF D ROZAVEL 10MG TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting

Take D ROZAVEL 10MG TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume excessive alcohol. Reduce looking into bright light and try to get adequate sleep. Consult your doctor if your headache worsens.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

WARNING & PRECAUTIONS

PREGNANCY

D ROZAVEL 10MG TABLET is not recommended for use in pregnant women. Therefore, consult your doctor before taking it. Women of childbearing age must use a reliable contraceptive method to avoid pregnancy while undergoing therapy with D ROZAVEL 10MG TABLET. However, if you accidentally become pregnant while taking D ROZAVEL 10MG TABLET, stop taking it and consult your doctor immediately.

BREASTFEEDING

D ROZAVEL 10MG TABLET is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if you feel dizzy or sleepy after taking D ROZAVEL 10MG TABLET.

ALCOHOL

Avoid consumption of alcohol while taking D ROZAVEL 10MG TABLET as it may lead to unwanted side effects.

KIDNEY

D ROZAVEL 10MG TABLET is not recommended for use in patients with kidney stones. It should be used with caution in patients with other kidney problems. Therefore, consult your doctor before taking it.

LIVER

D ROZAVEL 10MG TABLET is not recommended for use in patients with severe liver diseases. It should be used with caution in patients with a history of liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Do not take D ROZAVEL 10MG TABLET if you are allergic to Rosuvastatin or Cholecalciferol.

LUNGS

D ROZAVEL 10MG TABLET should be used with caution in patients with lung diseases (such as severe respiratory failure). Therefore, consult your doctor before taking it.

HEART DISEASE

D ROZAVEL 10MG TABLET should be used with caution in patients with high blood pressure. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

Before taking D ROZAVEL 10MG TABLET, inform your doctor if you are taking any of the following medicines such as:

• medicines used to prevent graft rejection (Ex. cyclosporine)
• medicines used to treat bacterial infection (such as fusidic acid, erythromycin, clarithromycin, telithromycin)
• other medicines used to reduce blood cholesterol levels (such as gemfibrozil, fenofibrate, cholestyramine, colestipol or ezetimibe)
• medicines used to treat heart problems (Ex. amlodipine, diltiazem, digoxin, verapamil, amiodarone)
• medicines used to treat viral infections such as HIV or Hepatitis C (Ex. letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir)
• warfarin, ticagrelor or clopidogrel (medicines used to prevent blood clots)
• oral contraceptives (used to prevent pregnancy) Ex. levonorgestrel
• medicines used to control epilepsy (such as phenytoin, stiripentol, phenobarbital)
• medicines used to treat stomach ulcers (such as cimetidine)
• antacids (used to neutralize stomach acid and to reduce heartburn) Ex. aluminium hydroxide or magnesium hydroxide
• regorafenib (a medicine used to treat cancer)
• laxatives (used to treat constipation) such as paraffin oil
• thiazide diuretics (used to remove excess water from the body) such as hydrochlorothiazide
• corticosteroids (used to treat pain and inflammation) such as prednisolone

Overdosage:

If you or anyone else accidentally took more D ROZAVEL 10MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep D ROZAVEL 10MG TABLET out of reach of children
• Store D ROZAVEL 10MG TABLET at room temperature

FAQs ABOUT D ROZAVEL 10MG TABLET

Q: What are the uses of D ROZAVEL 10MG TABLET?

A: D ROZAVEL 10MG TABLET is a lipid lowering medicine. It is used to control elevated blood cholesterol levels. By reducing blood cholesterol levels, D ROZAVEL 10MG TABLET can also prevent the risk of heart attack, stroke, angina and other heart problems. It can also be used to treat and prevent vitamin D3 deficiency and bone disorders (such as osteoporosis).

Q: Can the use of D ROZAVEL 10MG TABLET cause diabetes?

A: Yes. D ROZAVEL 10MG TABLET may increase blood sugar levels in some patients. This is most predominantly seen in patients who already have diabetes along with obesity and/or hypertension. Therefore, consult your doctor before taking this medicine if you are diabetic, obese or have hypertension. Your doctor will closely monitor your blood sugar levels while undergoing therapy with D ROZAVEL 10MG TABLET to avoid any unwanted side effects.

Q: What is the best time to take D ROZAVEL 10MG TABLET?

A: Take D ROZAVEL 10MG TABLET as advised by your physician. Your doctor will decide the best time for you to take D ROZAVEL 10MG TABLET. Try to take this medicine at the same time each day. It can be taken with or without food.

Q: What are the side effects of taking D ROZAVEL 10MG TABLET?

A: The most common side effects of taking D ROZAVEL 10MG TABLET are pain in joints and muscles, gastrointestinal problems such as constipation, diarrhoea, indigestion or nausea and headache. Contact your doctor if any of side effect worsens.

Q: Can I consume alcohol along with D ROZAVEL 10MG TABLET?

A: D ROZAVEL 10MG TABLET should be used with caution in patients who consume large amounts of alcohol. Therefore, it is advisable to avoid alcohol consumption while taking this medicine to achieve maximum benefits.

Q: Can the use of D ROZAVEL 10MG TABLET make me feel more tired?

A: Yes. The use of D ROZAVEL 10MG TABLET can make you feel more tired, because it acts by reducing the supply of energy to the muscles present in your body. However, you may also feel tired due to other reasons such as severe liver damage. Consult your doctor if you experience excessive tiredness with muscle pain.

Q: Who should not take D ROZAVEL 10MG TABLET?

A: D ROZAVEL 10MG TABLET is not recommended for use in patients with severe liver damage. It is also not suitable for use in patients having muscle problems, hypercalcemia and hypercalciuria. If you are pregnant or breastfeeding consult your doctor before taking D ROZAVEL 10MG TABLET. Before taking D ROZAVEL 10MG TABLET inform your doctor if you have diabetes or any kidney or heart problems. Do not take this medicine if you are undergoing therapy with antibiotics such as fusidic acid.

Q: What are the dietary restrictions that I need to follow while taking D ROZAVEL 10MG TABLET?

A: While taking D ROZAVEL 10MG TABLET, follow a low-cholesterol diet as instructed by your doctor and avoid excessive alcohol intake. Avoid eating oil rich or deep-fried foods. Limit your sugar intake by avoid eating biscuits, cakes, soft drinks, or pastries. Stick to a simple nutritious diet. Avoid consumption of alcohol while taking D ROZAVEL 10MG TABLET as it may reduce its effectiveness.

Q: What should I do if I forget to take a dose of D ROZAVEL 10MG TABLET?

A: If you forget to take a dose of D ROZAVEL 10MG TABLET, take it as soon as you remember. However, if it is time to take the next dose of D ROZAVEL 10MG TABLET, skip the missed dose and take the next one at regular times. Do not take a double dose of D ROZAVEL 10MG TABLET to compensate the missed dose, as it could lead to toxicity.

Q: Can I stop taking D ROZAVEL 10MG TABLET once my blood cholesterol level is controlled?

A: Do not stop taking this medicine without consulting your doctor, as it could once again increase your blood cholesterol levels. D ROZAVEL 10MG TABLET can only control your blood cholesterol levels and cannot cure them completely, therefore, it is important to take this medicine until your doctor advises you to stop.

Q: Can I take D ROZAVEL 10MG TABLET if I am diabetic?

A: D ROZAVEL 10MG TABLET may increase blood sugar levels in some patients. This is most predominantly seen in patients who already have diabetes along with obesity and/or hypertension. Therefore, consult your doctor before taking D ROZAVEL 10MG TABLET if you are diabetic, obese or have hypertension

Q: Does D ROZAVEL 10MG TABLET cause muscle pain?

A: D ROZAVEL 10MG TABLET is combination of two medicines namely rosuvastatin and cholecalciferol. Cholecalciferol present in this medicine, helps in reducing the muscle pain caused due to rosuvastatin. Therefore, this medicine has lower incidence to cause muscle disorders compared to medicines containing plain rosuvastatin. However, if you experience unexplained muscle pain or weakness, consult your doctor for advice.

Q: What is D ROZAVEL 10MG TABLET and what does it do?

A: D ROZAVEL 10MG TABLET is a lipid lowering medicine used to control elevated blood cholesterol and triglyceride levels. It effectively controls elevated blood cholesterol levels by blocking the action of an enzyme called HMG-CoA reductase which is involved in cholesterol production. 

Q: How long should I take D ROZAVEL 10MG TABLET to treat high cholesterol?

A: You should take D ROZAVEL 10MG TABLET as long as your doctor advises you to take. Because D ROZAVEL 10MG TABLET will only help you in managing your cholesterol levels and cannot completely cure them. If you stop using D ROZAVEL 10MG TABLET, your cholesterol levels may raise once again.

Q: Can D ROZAVEL 10MG TABLET be taken by pregnant or breast-feeding women?

A: D ROZAVEL 10MG TABLET is not recommended for use in pregnant or breast-feeding women. Therefore, consult your doctor before taking it. Women of childbearing age must use a reliable contraceptive method to avoid pregnancy while undergoing therapy with this medicine. However, if you accidentally become pregnant while taking this medicine, stop taking it and consult your doctor immediately.

REFERENCES

1. KD. Tripathi. Drugs Affecting Calcium Balance. Insulin, Hypolipidemic Drugs and Plasma Expanders. Essentials of medical pharmacology. Seventh edition. 2013. Page – 340 & 637.
2. Bharti Chogtu, Balaji Ommurugan, Sereen R. Thomson and Sneha G. Kalthur. Effect of Vitamin D Analogue on Rosuvastatin-Induced Myopathy in Wistar Rats. Hindawi. The Scientific World Journal. 2020. [Accessed on 7th January 2023] https://www.hindawi.com/journals/tswj/2020/4704825/
3. Glenmark Pharmaceuticals Europe Limited. Rosuvastatin. Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 7th January 2023] https://www.medicines.org.uk/emc/files/pil.9971.pdf
4. Labialfarma. Cholecalciferol 1000 IU Capsules. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 7th January 2023] https://www.medicines.org.uk/emc/files/pil.7247.pdf

USEFUL DIAGNOSTIC TESTS

• CBC
• Lipid Profile
• Liver Function Test
• Echocardiography

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 08 Jan 2023 | 01:27 PM(IST)