INTRODUCTION

ARBITEL AV is a combination of Atorvastatin 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. Atorvastatin 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 ARBITEL AV inform your doctor if you have diabetes, thyroid problems, any family history of muscle disorders or problems in your kidney or 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.

ARBITEL AV is strictly not recommended for use in patients with severe liver 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 ARBITEL AV and inform your doctor immediately if you become pregnant while undergoing therapy with ARBITEL AV.

ARBITEL AV 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.

ARBITEL AV 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 ARBITEL AV to avoid the risk of unwanted side effects.

The most common side effects of taking ARBITEL AV 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 ARBITEL AV.

USES OF ARBITEL AV

It is used to:

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

HOW ARBITEL AV WORKS

ARBITEL AV effectively reduces high blood pressure and high blood cholesterol levels. It contains two medicines namely, telmisartan and atorvastatin. 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.

Atorvastatin 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 ARBITEL AV as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. ARBITEL AV can be taken with or without meals. Try to take ARBITEL AV 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 ARBITEL AV for the stipulated duration instructed by your doctor without interruption to achieve better results.

SIDE EFFECTS OF ARBITEL AV

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting:

Take ARBITEL AV 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 ARBITEL AV 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, colestipol)
• 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)
• medicines used to manage fungal infection (Ex. ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole)
• medicines used to manage bacterial infections (Ex. fusidic acid, erythromycin, clarithromycin, telithromycin, trimethoprim)
• medicines used to manage HIV infection (Ex. ritonavir, lopinavir, atazanavir, indinavir, darunavir)
• warfarin, heparin (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)
• colchicine (a medicine used to manage gout)
• antacids (used to neutralize stomach acid) Ex. aluminium hydroxide, milk of magnesia
• stiripentol (a medicine used to manage fits)

B. Drug-Food Interaction:

While taking ARBITEL AV, avoid drinking grapefruit juice as it may interact with ARBITEL AV and reduce its effectiveness.

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 ARBITEL AV out of reach of children
• Store ARBITEL AV at room temperature

FAQs ABOUT ARBITEL AV

Is ARBITEL AV safe to use in diabetic patients?

ARBITEL AV may alter the blood sugar levels in your body. Therefore, it is necessary to inform your doctor if you have diabetes before taking ARBITEL AV 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 ARBITEL AV.

What precautions should be followed while taking ARBITEL AV?

Before taking ARBITEL AV 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 ARBITEL AV if you have any severe liver or heart diseases (such as low blood pressure). If you are pregnant or become pregnant while taking ARBITEL AV stop taking it immediately and consult your doctor.

Can ARBITEL AV causes electrolyte imbalance?

Yes. ARBITEL AV 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 ARBITEL AV?

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

What happens if I accidentally take more ARBITEL AV?

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

Can I take ARBITEL AV daily?

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

Can I stop taking ARBITEL AV if my blood pressure reduces?

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

What is ARBITEL AV used for?

ARBITEL AV 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 ARBITEL AV?

The most common side effects of taking ARBITEL AV 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 ARBITEL AV.

Can I stop taking ARBITEL AV once my symptoms subside?

No. Do not stop taking ARBITEL AV 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 ARBITEL AV 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 ARBITEL AV?

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

Can the use of ARBITEL AV affect the liver?

Yes. ARBITEL AV 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 ARBITEL AV?

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

Can ARBITEL AV cause muscle pain?

Yes. ARBITEL AV 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 ARBITEL AV?

While taking ARBITEL AV 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 ARBITEL AV?

You should continue taking ARBITEL AV unless your doctor tells you to stop the medicine. ARBITEL AV 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 ARBITEL AV be taken during pregnancy?

No. ARBITEL AV 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 ARBITEL AV. In case of accidental pregnancy immediately, stop taking ARBITEL AV and contact your doctor.

Is ARBITEL AV safe to use in kidney disease?

ARBITEL AV 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 ARBITEL AV as a precaution.

REFERENCES

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

2. O M Bochar. Combined effect of appointment telmisartan and atorvastatin on hemodynamic indicators and the indicators of lipid profile in patients with arterial hypertension combined with obesity and steatohepatitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2014. [Accessed on 13th July 2022] https://pubmed.ncbi.nlm.nih.gov/25796814/

3. Kevin A Bybee, John H Lee, James H O Keefe. Cumulative clinical trial data on atorvastatin for reducing cardiovascular events: the clinical impact of atorvastatin. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 2008. [Accessed on 13th July 2022] https://pubmed.ncbi.nlm.nih.gov/18358084/

4. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC). [Revised in April 2021] [Accessed on 13th July 2022] https://www.medicines.org.uk/emc/files/pil.3165.pdf

5. Sun Pharmaceutical Industries Europe B.V. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 13th July 2022] https://www.medicines.org.uk/emc/files/pil.4339.pdf

6. Telmisartan 40mg + Atorvastatin (as calcium) 10mg Tablets. Central Drugs Standard Control Organization. [Revised in May 2008]. [Accessed on 13th July 2022] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Kidney Function Test
• Lipid profile