INTRODUCTION

EPNONE T 10 COMBI KIT is a combination of Eplerenone and Torsemide which belongs to the group of medicines called Diuretics. It is used in adults to treat high blood pressure and edema (swelling due to fluid retention) related to heart failure.

Hypertension is defined as persistently increased blood pressure, that can show symptoms like headache, sweating, fast heartbeat or throbbing sensation. Fluid regularly drains into body tissues from the blood. When this fluid isn’t removed from the tissue, fluid retention (edema) occurs, causing symptoms like swelling and aching of affected body parts such as feet, ankles or hands.

During course of the treatment your doctor might regularly monitor your kidney or liver function test to avoid any untoward side effects.

Before taking EPNONE T 10 COMBI KIT, inform your doctor if you have any kidney, heart or liver problems, high or low blood potassium levels, diabetes, low blood volume or difficulty in passing urine.

EPNONE T 10 COMBI KIT is not recommended for use in pregnant and breastfeeding women, so consult your doctor before taking it. It is not recommended for use in children and adolescents due to lack of safety and effectiveness.

The most common side effects of taking EPNONE T 10 COMBI KIT are muscle cramps, diarrhoea, nausea, dizziness, headache and constipation. Consult your doctor if any of the above side effects worsen.

USES OF EPNONE T 10 COMBI KIT

• Treat high blood pressure and edema related to heart failure

HOW EPNONE T 10 COMBI KIT WORKS

EPNONE T 10 COMBI KIT lowers edema where eplerenone blocks aldosterone, which is a mineralocorticoid acting on epithelial (e.g., kidney) and nonepithelial (e.g., heart and blood vessels) receptors to cause sodium and water reabsorption, and torsemide induces excretion of sodium, chloride and water by inhibiting sodium and chloride reabsorption in kidney tubules.

DIRECTIONS FOR USE

Take EPNONE T 10 COMBI KIT as advised by your physician. Swallow EPNONE T 10 COMBI KIT with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking EPNONE T 10 COMBI KIT unless your doctor advises you to stop.

SIDE EFFECTS OF EPNONE T 10 COMBI KIT

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take this medicine with or just after a meal or a snack and stick to simple meals and do not eat oil rich or spicy food. Consult your doctor if the symptom does not improve.

Headache:

Take rest and drink plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching the screen for long time. Consult your doctor if the symptom persists for long or gets worsened.

Dizziness:

Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. Consult your doctor if the symptom gets worse.

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate treatments for constipation.

Diarrhea:

Drink lot of fluids such as water or fruit juice to keep yourself hydrated. Do not consume any medicine other than EPNONE T 10 COMBI KIT without consulting your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking EPNONE T 10 COMBI KIT, inform your doctor if you are taking any of the following medicines:

• medicines used to treat fungal infections (Ex. itraconazole, ketoconazole, fluconazole, miconazole)
• medicines used to treat HIV (Ex. ritonavir, nelfinavir, saquinavir)
• medicines used to treat bacterial infections (Ex. clarithromycin, telithromycin, erythromycin, trimethoprim, rifampicin, streptomycin, gentamycin, cephalexin, ceftriaxone)
• medicines used to treat depression (Ex. nefazodone, amitriptyline, amoxapine, St. John’s Wort)
• drugs which help you to excrete excess body fluid (Ex. spironolactone, amiloride)
• medicines used to treat heart conditions like high blood pressure or heart insufficiency (Ex. lisinopril, enalapril, olmesartan, candesartan, prazosin, alfuzosin, digoxin, amiodarone, diltiazem, verapamil)
• lithium (used to treat bipolar disorder)
• medicines used after organ transplantation (Ex. cyclosporin, tacrolimus)
• medicines used to relieve pain, stiffness, and inflammation (Ex. aspirin, ibuprofen, indomethacin)
• medicines used to treat psychiatric disorders (Ex. chlorpromazine, haloperidol)
• medicines used during cancer chemotherapy (Ex. amifostine, cisplatin)
• baclofen (used to treat muscle spasm)
• medicines used to treat inflammation and certain skin conditions (Ex. hydrocortisone, prednisone, dexamethasone)
• tetracosactide (used in diagnosis and treatment of adrenal cortex disorders)
• medicines used to treat fits (Ex. carbamazepine, phenytoin, phenobarbital)
• medicines used to treat high blood sugar (Ex. chlorpropamide, glibenclamide, glipizide, tolbutamide)
• adrenaline (used to treat low blood pressure)
• cholestyramine (used to treat high blood cholesterol levels)
• medicines used to treat constipation (Ex. methylcellulose, psyllium)
• probenecid (used to treat gout)
• theophylline (used to treat asthma)
• oxandrolone (used to promote weight gain)
• substances used to enhance the visibility of internal structures in CT scan and other tests (Ex. iodinated contrast media, ionic iodinated contrast media)

Overdosage:

If you or anyone else accidentally takes too much of EPNONE T 10 COMBI KIT, contact your doctor immediately or visit the nearby hospital. Symptoms of EPNONE T 10 COMBI KIT overdose includes low blood pressure (signs include light-headedness, dizziness, blurred vision, weakness, acute loss of consciousness), high blood potassium levels (signs include muscle cramps, diarrhea, nausea, dizziness, headache), passing a lot of urine, sleepiness, confusion, fainting or dizzy and stomach upset.

SYNOPSIS

MORE INFORMATION

• Keep EPNONE T 10 COMBI KIT out of reach of children
• Store EPNONE T 10 COMBI KIT at room temperature

FAQs ABOUT EPNONE T 10 COMBI KIT

Q: Can EPNONE T 10 COMBI KIT be used in children?

A: EPNONE T 10 COMBI KIT is not recommended for use in children and adolescents as its safety and effectiveness have not been established. Your doctor will decide the correct dose or select a suitable alternative therapy for your child.

Q: Is EPNONE T 10 COMBI KIT safe during pregnancy?

A: EPNONE T 10 COMBI KIT is not recommended for use in pregnant women, as it is not known if it causes any potential harm to the unborn baby. If you are pregnant, think you may be pregnant or are planning to get pregnant, inform your doctor before taking EPNONE T 10 COMBI KIT.

Q: What precautions do I need to follow while taking EPNONE T 10 COMBI KIT?

A: Patients taking EPNONE T 10 COMBI KIT must inform their doctor if they have diabetes, kidney, liver or heart problems, if they are pregnant, breast-feeding, having any allergies, high or low blood potassium levels, low blood volume or difficulty in passing urine. Contact your doctor immediately if you have any unusual symptoms while taking EPNONE T 10 COMBI KIT.

Q: Can EPNONE T 10 COMBI KIT cause constipation?

A: Yes, constipation is a common side effect of EPNONE T 10 COMBI KIT. In such case, eat plenty of fiber rich foods such as fresh fruits, vegetables, cereals and drink plenty of water and exercise more regularly. Tell your doctor if your constipation doesn’t resolve.

Q: Is EPNONE T 10 COMBI KIT safe to use in patients with kidney problems?

A: EPNONE T 10 COMBI KIT is not recommended for use in patients with kidney problems. It should be used with caution in patients with kidney disease. Consult your doctor before taking it.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Hypertension. Pharmacotherapy Handbook. Ninth edition. Page-87

2. Tejaswi Kanderi; Pradeep Vaitla. Torsemide. StatPearls [Internet]. July 2021. [Accessed on 3rd June 2022] https://www.ncbi.nlm.nih.gov/books/NBK559175/#:~:text=Go%20to%3A-,Mechanism%20of%20Action,K%2B%2F2Cl%2D%20cotransport%20mechanism

3. Jonathan C. Hughes; Manouchkathe Cassagnol. Eplerenone. StatPearls [Internet]. May 2022. [Accessed on 3rd June 2022] https://www.ncbi.nlm.nih.gov/books/NBK553100/#article-21264.s3

4. S.C.Zentiva S.A. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 3rd June 2022] https://www.medicines.org.uk/emc/files/pil.3665.pdf

5. MEDA Pharma GmBH and Co. KG. Electronic Medicines Compendium (EMC). [Revised in August 2019] [Accessed on 3rd June 2022] https://www.medicines.org.uk/emc/files/pil.6663.pdf

6. Torsemide. DailyMed; National Library of Medicine; National Institute of Health. [Revised in February 2022] [Accessed on 3rd June 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=55e88727-864e-4313-860c-31a6ca45168f#Section_5.3

7. Eplerenone. DailyMed; National Library of Medicine; National Institute of Health. [Revised in March 2022] [Accessed on 3rd June 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d953457e-0aff-6c38-e053-2995a90a7d32

USEFUL DIAGNOSTIC TESTS

• Kidney function test