INTRODUCTION

ROZUTION T is a combination of Rosuvastatin and Telmisartan which belongs to the group of medicines called HMG-CoA reductase inhibitors and Angiotensin-II receptor blockers respectively. It is used to manage hypertension (high blood pressure) and high blood cholesterol levels. It can also be used to reduce the risk of cardiovascular events such as heart attack or stroke in patients who are at risk of heart diseases.

Telmisartan is an angiotensin II receptor blocker. It reduces blood pressure by relaxing the blood vessels supplying the heart and other vital organs. Rosuvastatin is an HMG-CoA reductase inhibitor. It reduces the bad cholesterol levels in the body by the blocking the actions of certain enzymes that are involved in the cholesterol production. Collectively they decrease blood pressure and blood lipid levels.

Before taking ROZUTION T inform your doctor if you have diabetes, thyroid problems, any family history of muscle disorders or problems in your heart. You must also inform your doctor if you are severely dehydrated or on a low-salt diet or taking antibiotics (such as fusidic acid) to manage any existing infections.

ROZUTION T is strictly not recommended for use in patients with severe liver problems, kidney problems, or an abnormally low blood pressure. It is also not suitable for use in pregnant or breastfeeding women as it may cause serious harm to the growing baby. Stop taking ROZUTION T and inform your doctor immediately if you become pregnant while undergoing therapy with ROZUTION T.

ROZUTION T may make you feel dizzy while standing up suddenly or changing positions. Therefore, do not drive or operate any heavy tools or machines as a precaution. Also, avoid drinking alcohol as it might make you feel dizzier and drowsier.

ROZUTION T may alter your blood sugar levels and electrolyte levels. Therefore, your doctor will constantly monitor your blood sugar levels and kidney functions during therapy with ROZUTION T to avoid the risk of unwanted side effects.

The most common side effects of taking ROZUTION T are dizziness, headache, nausea, constipation, high blood potassium levels and high blood sugar levels. Consult your doctor if any of these side effect worsens. You must also inform your doctor if you experience severe muscle pain or cramps with fever and malaise after taking ROZUTION T.

USES OF ROZUTION T

It is used to:

• Manage high blood pressure
• Manage high cholesterol levels
• Prevent the risk of heart attack or stroke

HOW ROZUTION T WORKS

ROZUTION T effectively reduces high blood pressure and high blood cholesterol levels. It contains two medicines namely, telmisartan and rosuvastatin. Telmisartan reduces blood pressure by blocking the actions of certain hormones (angiotensin-II) in the body that causes narrowing of blood vessels and increase in blood pressure.

Rosuvastatin reduces the levels of bad cholesterol (LDL) and triglycerides in the body by the blocking the actions of certain enzymes (HMG-CoA reductase) that is involved in the cholesterol production. Collectively they decrease blood pressure, blood lipid levels, and reduces the risk of heart attack or stroke.

DIRECTIONS FOR USE

Take ROZUTION T as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. ROZUTION T can be taken with or without meals. Try to take ROZUTION T at the same time each day.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition. Continue to take ROZUTION T for the stipulated duration instructed by your doctor without interruption to achieve better results.

SIDE EFFECTS OF ROZUTION T

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting:

Take ROZUTION T 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.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before taking ROZUTION T inform your doctor, if you are taking any of the following:

• other medicines used to manage elevated blood pressure (such as aliskiren, captopril, enalapril, lisinopril, losartan, valsartan)
• other medicines used to reduce blood cholesterol levels (Ex. gemfibrozil, ezetimibe, fenofibrate)
• medicines used to manage angina or other heart problems (Ex. amlodipine, diltiazem, verapamil, amiodarone, and digoxin)
• lithium, St. John’s wort (medicines used to manage depression)
• potassium supplements or potassium-sparing diuretics such as spironolactone, triamterene or amiloride (used to retain or increase potassium levels in the body)
• non-steroidal anti-inflammatory drugs (used for pain relief) such as indomethacin, celecoxib, ibuprofen, aspirin
• medicines to prevent graft rejection (Ex. cyclosporin, tacrolimus, sirolimus)
• diuretics (used to manage edema and hypertension) such as furosemide
• corticosteroids (used to manage pain and inflammation) Ex. prednisolone
• narcotics (used for pain relief) Ex. morphine, pethidine, fentanyl
• barbiturates (used to induce sleep) Ex. pentobarbital, phenobarbital
• antidepressants (used to manage depression) such as sertraline, fluoxetine, escitalopram, amitriptyline, nortriptyline, imipramine
• baclofen (a medicine used for relaxing muscles)
• amifostine (a kidney protectant used along with chemotherapeutic agents)
• medicines used to manage Hepatitis C infection (Ex. telaprevir, boceprevir and combination of elbasvir/grazoprevir, or sofosbuvir/velpatasvir/voxilaprevir)
• medicines used to manage fungal infection (Ex. ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole)
• medicines used to manage bacterial infections (Ex. fusidic acid, erythromycin, trimethoprim)
• medicines used to manage HIV infection (Ex. ritonavir, lopinavir, atazanavir, indinavir, darunavir)
• warfarin, ticagrelor or clopidogrel (used to prevent or manage blood clots)
• letermovir (a medicine used to manage cytomegalovirus)
• oral contraceptives (birth control pill) Ex. levonorgestrel, ethinylestradiol
• cimetidine (a medicine used to manage heartburn and stomach ulcers)
• antacids (used to neutralize stomach acid) Ex. aluminium hydroxide, milk of magnesia
• darolutamide (a medicine used to manage cancer)
• hormone replacement therapy (used to manage hormonal imbalance) Ex. dydrogesterone, estradiol

Overdosage:

If you or anyone else accidentally take too much of this medicine, consult your doctor immediately. Overdosage may cause side effects such as low blood pressure, increased or decreased heartbeat, low blood pressure and dizziness.

SYNOPSIS

MORE INFORMATION

• Keep ROZUTION T out of reach of children
• Store ROZUTION T at room temperature

FAQs ABOUT ROZUTION T

Is ROZUTION T safe to use in diabetic patients?

ROZUTION T may alter the blood sugar levels in your body. Therefore, it is necessary to inform your doctor if you have diabetes before taking ROZUTION T as a precaution. Your doctor will closely monitor you blood sugar levels to avoid the risk of side effects. Also, inform your doctor if you experience any unusual tiredness, hunger or thirst while undergoing therapy with ROZUTION T.

What precautions should be followed while taking ROZUTION T?

Before taking ROZUTION T inform your doctor if you have any kidney or heart problems. You must also inform your doctor if you have diabetes, family history of muscle problems or are severely dehydrated. Regularly visit your doctor and take all the necessary tests which your doctor recommends to you without fail. Consult your doctor before taking ROZUTION T if you have any severe liver or heart diseases (such as low blood pressure). If you are pregnant or become pregnant while taking ROZUTION T stop taking it immediately and consult your doctor.

Can ROZUTION T causes electrolyte imbalance?

Yes. ROZUTION T may the levels of certain electrolytes (sodium or potassium) in the body. To avoid this, your doctor will closely monitor the electrolytes levels in the blood periodically. However, if you experience any unusual symptoms such as chest pain, muscle weakness, irregular heartbeat, confusion, drowsiness, nausea, or vomiting, consult your doctor for advice.

Can I consume alcohol while taking ROZUTION T?

Avoid consumption of alcohol while taking ROZUTION T as it might make you feel dizzier and drowsier.

What happens if I accidentally take more ROZUTION T?

If you or anyone else accidentally took more ROZUTION T, consult your doctor immediately. Overdosage may cause low blood pressure and abnormal heartbeat.

Can I take ROZUTION T daily?

Take ROZUTION T as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take ROZUTION T every day or not.

Can I stop taking ROZUTION T if my blood pressure reduces?

Do not stop taking ROZUTION T without consulting your doctor as your blood pressure may raise once again. Make sure to take ROZUTION T for the stipulated duration recommended by your doctor to achieve maximum results.

What is ROZUTION T used for?

ROZUTION T is used to manage hypertension (high blood pressure) and high blood cholesterol levels. It can also be used to reduce the risk of cardiovascular events such as heart attack or stroke in patients who are at risk of heart diseases.

What are the side effects of ROZUTION T?

The most common side effects of taking ROZUTION T are dizziness, headache, nausea, constipation, high blood potassium levels and high blood sugar levels. Consult your doctor if any of these side effect worsens. You must also inform your doctor if you experience severe muscle pain or cramps with fever and malaise after taking ROZUTION T.

Can I stop taking ROZUTION T once my symptoms subside?

No. Do not stop taking ROZUTION T without consulting your doctor. As high blood pressure and high blood cholesterol levels are chronic conditions, long term management is necessary to control its symptoms. Therefore, take ROZUTION T as advised by your doctor for the stipulated duration. Premature discontinuation of therapy may cause the symptoms to reappear.

What should I do if I forget to take a dose of ROZUTION T?

If you forget to take a dose of ROZUTION T, take it as soon as you remember. However, if it is time to take the next dose, skip the missed dose of ROZUTION T and take the next one at the regular time. Do not take a double dose of ROZUTION T to compensate the missed dose.

Can the use of ROZUTION T affect the liver?

Yes. ROZUTION T may affect the way your liver work. It can elevate the levels of certain liver enzymes in your body. Therefore, it is strictly not recommended for use in patients with severe liver diseases. It should be used with caution in patients with other minor liver problems. Therefore, consult your doctor before taking it.

Which medicines should I avoid while taking ROZUTION T?

While undergoing therapy with ROZUTION T, avoid concomitant use of antibiotics (erythromycin), antifungals (ketoconazole) and antiviral medicines (ritonavir) without consulting your doctor.

Can ROZUTION T cause muscle pain?

Yes. ROZUTION T may lead to abnormal muscle breakdown known as rhabdomyolysis which can be identified by symptoms such as muscle pain, tenderness or weakness, red-brown discoloration of urine and high fever. Consult your doctor immediately, if you experience any such symptoms.

What foods should I avoid while taking ROZUTION T?

While taking ROZUTION T avoid eating foods high in fat or cholesterols such as fried or processed foods, grapefruit juice, dairy products, and red meat which can lead to poor therapeutic outcome in manageing the disease.

For how long should I take ROZUTION T?

You should continue taking ROZUTION T unless your doctor tells you to stop the medicine. ROZUTION T will be usually taken for lifetime to prevent complications due to high blood pressure and high cholesterol levels. Therefore, consult your doctor for advice regarding the duration of therapy.

Can ROZUTION T be taken during pregnancy?

No. ROZUTION T is not recommended for use in pregnancy as it may cause serious   harm to the baby. Women of childbearing age should follow effective method of birth control to prevent pregnancy while taking ROZUTION T. In case of accidental pregnancy immediately, stop taking ROZUTION T and contact your doctor.

Is ROZUTION T safe to use in kidney disease?

ROZUTION T should be used with caution in patients with kidney diseases (such as those having renal artery stenosis, kidney transplant or in those undergoing haemodialysis). Your doctor will access your health condition and suggest a suitable dose for you. Therefore, it is important to inform your doctor if you have any kidney problems before taking ROZUTION T as a precaution.

REFERENCES

1. KD. Tripathi. Drugs affecting renin angiotensin system and plasma kinins & Hypolipidaemic Drugs and Plasma Expanders. Essentials of medical pharmacology. Seventh edition. 2013. Page –507 & 636-637.

2. Zhendong Liu, Yingxin Zhao, Fang Wei, Lin Ye, Fanghong Lu, Hua Zhang, Yutao Diao, Hongbin Song, Zayden Qi. Management with telmisartan/rosuvastatin combination has a beneficial synergistic effect on ameliorating Th17/Treg functional imbalance in hypertensive patients with carotid atherosclerosis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 2014. [Accessed on 13th July 2022] https://pubmed.ncbi.nlm.nih.gov/24495792/

3. Actavis Ltd. Health Products Regulatory Authority (HPRA). [Revised in July 2021]. [Accessed on 13th July 2022] http://www.hpra.ie/img/uploaded/swedocuments/8c0fc811-cf88-4bd5-818e-609e07fe1190.pdf

4. AstraZeneca Pharmaceuticals LP. U.S. Food & Drug Administration. [Revised in May 2010] [Accessed on 13th July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney Function Test
• Lipid profile