INTRODUCTION

ROSUKEM F+ TABLET is a combination of Rosuvastatin and Fenofibrate which belongs to the group of medicines called Hypolipidemic drugs. It is used to treat hyperlipidemia (high blood lipid levels) in addition to proper diet, exercise, and lifestyle changes.

Hyperlipidemia is a condition characterized by increased levels of bad cholesterol and triglycerides (fats) in the blood. If left untreated, these fat particles get deposited in the blood vessels and may obstruct blood flow through them, leading to various complications such as heart attack or stroke.

By reducing lipid levels in the blood, ROSUKEM F+ TABLET can also be used to prevent the risk of heart attack, stroke, atherosclerosis and other circulatory disorders.

Take ROSUKEM F+ TABLET with meals. Along with the treatment, follow the diet, exercise and lifestyle changes instructed by your doctor to achieve better results. Avoid drinking large amount of alcohol while taking ROSUKEM F+ TABLET. If you are diabetic, work on your blood sugar levels and keep them under control.

Before taking ROSUKEM F+ 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.

ROSUKEM F+ 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 pains or in patients who had recently taken an antibiotic called Fusidic acid to treat bacterial infections.

Do not take ROSUKEM F+ TABLET if you are pregnant or breastfeeding. Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with ROSUKEM F+ TABLET. If you accidentally become pregnant while taking ROSUKEM F+ TABLET, stop taking this medicine and consult your doctor immediately.

During treatment with ROSUKEM F+ TABLET, your doctor will periodically monitor your 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 of taking ROSUKEM F+ TABLET are headache, constipation, bloating, muscle pain and liver problems. Consult your doctor if they bother you.

You must also inform your doctor if you experience severe unexplained muscle pain or weakness with fever, weakness or reddish-brown urine after taking ROSUKEM F+ TABLET.

USES OF ROSUKEM F+ TABLET

It is used to:

• Treat high blood cholesterol levels
• Prevent the risk of heart attack, stroke or atherosclerosis

HOW ROSUKEM F+ TABLET WORKS

ROSUKEM F+ TABLET is a lipid-lowering medicine. It 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, ROSUKEM F+ TABLET prevents fat deposition within the blood vessels and reduces the chances of heart attack, stroke, atherosclerosis or other circulatory problems.

DIRECTIONS FOR USE

Take ROSUKEM F+ TABLET as directed by your 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 ROSUKEM F+ TABLET without consulting your doctor.

SIDE EFFECTS OF ROSUKEM F+ TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take ROSUKEM F+ TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.

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.

Headache:  

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. 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.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

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

• medicines used to treat cancer (Ex. actinomycin, regorafenib)
• medicines used to suppress immune system after organ transplantation (Ex. cyclosporin)
• medicines used for blood thinning (Ex. warfarin, acenocoumarol)
• clopidogrel (a medicine used to treat blood clots)
• medicines used to treat bacterial infections (Ex. erythromycin, fusidic acid)
• medicines used to treat HIV and hepatitis C infections (Ex. lamivudine, stavudine, ritonavir, dasabuvir, sofosbuvir, velpatasvir, voxilaprevir, lopinavir, atazanavir)
• medicines used for contraception (Ex. ethinylestradiol)
• medicines used to treat diabetes (Ex. rosiglitazone, pioglitazone)
• other medicines used to treat high lipid levels in blood such as bile acid resins (Ex. cholestyramine, colesevelam)
• amiodarone (a medicine used to treat irregular heartbeat)
• medicines used to treat fungal infections (Ex. nystatin, amphotericin, ketoconazole)
• medicines used to treat epilepsy (Ex. carbamazepine, phenobarbital, phenytoin, primidone)
• medicines used to treat depression (Ex. amitriptyline, amoxapine)
• medicines used to treat gout (Ex. colchicine)
• medicines used for indigestion such as antacids (Ex. aluminium hydroxide)

B. Drug- Food Interactions:

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

Overdosage:
If you or anyone else accidentally took more ROSUKEM F+ TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep ROSUKEM F+ TABLET out of reach of children
• Store ROSUKEM F+ TABLET at room temperature

FAQs ABOUT ROSUKEM F+ TABLET

What are the uses of ROSUKEM F+ TABLET?

ROSUKEM F+ TABLET is a lipid lowering medicine. It is used to control elevated blood cholesterol levels in addition to proper diet, exercise and lifestyle changes. By reducing lipid levels in the blood, ROSUKEM F+ TABLET can also be used to prevent the risk of heart attack, stroke, atherosclerosis and other circulatory disorders.

Can the use of ROSUKEM F+ TABLET cause diabetes?

ROSUKEM F+ 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 ROSUKEM F+ TABLET to avoid any unwanted side effects.

What is the best time to take ROSUKEM F+ TABLET?

Take ROSUKEM F+ TABLET as advised by your physician. Your doctor will decide the best time for you to take ROSUKEM F+ TABLET. Try to take ROSUKEM F+ TABLET at the same time each day. It is preferably taken with meals.

What are the side effects of taking ROSUKEM F+ TABLET?

The most common side effects of taking ROSUKEM F+ 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. Also, inform your doctor if you experience severe unexplained muscle pain, tenderness, or weakness along with fever after taking this medicine.

Can I consume alcohol along with ROSUKEM F+ TABLET?

ROSUKEM F+ TABLET is not recommended for use in patients who consume large amounts of alcohol. It is advisable to avoid alcohol consumption while taking ROSUKEM F+ TABLET to achieve maximum benefits.

Can the use of ROSUKEM F+ TABLET make me feel more tired?

Yes. The use of ROSUKEM F+ 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.

Who should not take ROSUKEM F+ TABLET?

ROSUKEM F+ TABLET is not recommended for use in patients with severe liver or kidney problems. It is also not suitable for use in patients having muscle problems. If you are pregnant or breastfeeding consult your doctor before taking ROSUKEM F+ TABLET. Before taking ROSUKEM F+ TABLET inform your doctor if you have diabetes or any heart problems. Do not take this medicine if you are undergoing therapy with antibiotics such as fusidic acid.

What are the dietary restrictions that I need to follow while taking ROSUKEM F+ TABLET?

While taking ROSUKEM F+ 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.

What should I do if I forget to take a dose of ROSUKEM F+ TABLET?

If you forget to take a dose of ROSUKEM F+ TABLET, take it as soon as you remember. However, if it is time to take the next dose of ROSUKEM F+ TABLET, skip the missed dose and take the next one at regular times. Do not take a double dose of ROSUKEM F+ TABLET to compensate the missed dose, as it could lead to toxicity.

Can I stop taking ROSUKEM F+ TABLET once my blood cholesterol level is controlled?

Do not stop taking this medicine without consulting your doctor, as it could once again increase your blood cholesterol levels. ROSUKEM F+ 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.

Can I take ROSUKEM F+ TABLET if I am diabetic?

ROSUKEM F+ 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 ROSUKEM F+ TABLET if you are diabetic.

Does ROSUKEM F+ TABLET cause muscle pain?

ROSUKEM F+ TABLET may cause a rare but serious side effect of unexplained muscle pain or weakness called rhabdomyolysis. It might be an early sign of a potentially serious muscle degradation. Therefore, consult your doctor if you experience any signs of muscle problems after taking ROSUKEM F+ TABLET. Also, talk to your doctor before taking ROSUKEM F+ TABLET if you already have weak muscles or have a family history of any muscle disorders.

What is ROSUKEM F+ TABLET and what does it do?

ROSUKEM F+ TABLET is a lipid-lowering medicine. It 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 and reduces the chances of heart attack, stroke, atherosclerosis or other circulatory problems.

How long should I take ROSUKEM F+ TABLET to treat high cholesterol?

You should take ROSUKEM F+ TABLET as long as your doctor advises you to take. Because ROSUKEM F+ TABLET will only help you in managing your cholesterol levels and cannot completely cure them. If you stop using ROSUKEM F+ TABLET, your cholesterol levels may raise once again.

Can ROSUKEM F+ TABLET be taken by pregnant or breast-feeding women?

ROSUKEM F+ 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. Hypolipidemic Drugs and Plasma Expanders. Essentials of medical pharmacology. Seventh edition. Page- 637 & 639.

2. Gursharan Sidhu; Jayson Tripp. Fenofibrate. StatPearls [Internet]. NIH. National Library of Medicine. National Center for Biotechnology Information. March 2022. [Accessed on 13th October 2022] https://www.ncbi.nlm.nih.gov/books/NBK559219/

3. Paul N Durrington, Jaakko Tuomilehto, Andreas Hamann, David Kallend, Karen Smith. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidaemia. NIH. National Library of Medicine. National Center for Biotechnology Information. Pubmed.gov. May 2004. [Accessed on 13th October 2022] https://pubmed.ncbi.nlm.nih.gov/15063607/

4. Zentiva k.s. Electronic Medicines Compendium (EMC). [Revised in June 2022] [Accessed on 13th October 2022] https://www.medicines.org.uk/emc/files/pil.8866.pdf

5. Genus Pharmaceuticals. Electronic Medicines Compendium (EMC). [Revised in October 2020] [Accessed on 13th October 2022] https://www.medicines.org.uk/emc/medicine/28612#gref

6. Accord. Electronic Medicines Compendium (EMC). [Revised in April 2021] [Accessed on 13th October 2022] https://www.medicines.org.uk/emc/files/pil.5779.pdf

7. Cipla Ltd. ROSULIP-F Tablets (Rosuvastatin + Fenofibrate). Ciplamed.com. [Revised in December 2015]. [Accessed on 13th October 2022] https://www.ciplamed.com/content/rosulip-f-tablets

USEFUL DIAGNOSTIC TESTS

• Cholesterol - HDL
• Cholesterol - LDL
• Cholesterol - Total