INTRODUCTION

JARDIANCE MET 5/500MG is a combination of Empagliflozin and Metformin which belongs to the group of medicines called Antidiabetic agents. JARDIANCE MET 5/500MG is indicated for the treatment of type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines. JARDIANCE MET 5/500MG can also be used in combination with other medicines (including insulin) to achieve better control of blood sugar level. Type 2 diabetes is a chronic medical condition in which the body does not make enough insulin, or the produced insulin does not work well. Symptoms include excessive urination, excessive thirst, hunger, fatigue, and blurred vision.

Metformin is a biguanide which effectively reduces the total amount of sugar released into the blood by the liver and empagliflozin is a SGLT2 inhibitor that blocks tubular reabsorption of glucose, leading to a marked decrease in blood glucose levels. Along treatment with JARDIANCE MET 5/500MG follow regular exercise and diet plan as advised by your doctor to achieve better results.

Avoid consumption of alcohol during treatment with JARDIANCE MET 5/500MG as it could aggravate your existing disease condition. Treatment with JARDIANCE MET 5/500MG must be discontinued for a short time, if you have any conditions that may be associated with dehydration (such as vomiting, diarrhea, fever, exposure to heat or less fluid intake). During treatment with JARDIANCE MET 5/500MG, your doctor will check your kidney function at least once a year or more frequently especially if you are elderly.

For diabetic patients, it is recommended to check their foot regularly and adhere to any other advice regarding foot care given by your doctor. JARDIANCE MET 5/500MG is generally not recommended for use in pregnant or breastfeeding women and in children (aged less than 18 years) due to lack of safety data. The most common side effects of taking JARDIANCE MET 5/500MG are hypoglycemia (low blood glucose), nausea, vomiting, diarrhea, excessive thirst, change in taste or dizziness. Contact your doctor if any of the symptoms worsen.

USES OF JARDIANCE MET 5/500MG

• To treat type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines

HOW JARDIANCE MET 5/500MG WORKS

JARDIANCE MET 5/500MG effectively reduces blood glucose levels, where empagliflozin acts by blocking the activity of a protein called sodium glucose co-transporter 2, which is responsible for the tubular reabsorption of glucose into the blood stream and metformin acts by reducing the amount of glucose released into the blood stream by the liver, thus helps in reducing blood glucose levels.

DIRECTIONS FOR USE

Take JARDIANCE MET 5/500MG as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Do not stop taking JARDIANCE MET 5/500MG without informing your doctor.   

SIDE EFFECTS OF JARDIANCE MET 5/500MG

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take this medicine with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom did not improve.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

Loss of appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Try to have a nutritious snack that is rich in calories and protein, such as dried fruit and nuts. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking JARDIANCE MET 5/500MG inform to your doctor, if you are taking any of these medicines:

• diuretics (medicines used to increase urine output) Ex. furosemide, chlorothiazide, hydrochlorothiazide
• other medicines used to treat diabetes (Ex. insulin, glipizide, glyburide, glimepiride)
• medicines that can alter the amount of metformin in blood (Ex. cimetidine, verapamil, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• bronchodilators (used to treat asthma) Ex. salbutamol, salmeterol, formoterol, ipratropium
• corticosteroids (used to treat inflammation) Ex. dexamethasone, prednisolone
• medicines used to treat pain and inflammation (such as ibuprofen and celecoxib)
• medicines used to treat high blood pressure (Ex. captopril, enalapril, losartan, valsartan)
• medicines containing alcohol (such as cough syrup)
• iodinated contrast agents (used during an X-ray or scan)
• lithium (used to treat mental illness)

Overdosage:

If you or anyone else take too much of JARDIANCE MET 5/500MG, contact your doctor immediately or go to a nearest hospital straight away as it could lead to a life-threatening condition called lactic acidosis. Symptoms of lactic acidosis might include nausea, vomiting, stomach pain with muscle cramps, decreased heartbeat, general weakness with severe tiredness, difficulty in breathing or reduced body temperature.

SYNOPSIS

MORE INFORMATION

• Keep JARDIANCE MET 5/500MG out of reach of children
• Store at room temperature

FAQs ABOUT JARDIANCE MET 5/500MG

Can I consume alcohol while taking JARDIANCE MET 5/500MG?

No. Avoid consumption of alcohol while taking JARDIANCE MET 5/500MG since it may increase the risk of lactic acidosis and diabetic ketoacidosis. Before taking JARDIANCE MET 5/500MG inform your doctor if you are alcoholic.

Can JARDIANCE MET 5/500MG makes me feel more tired?

Yes. JARDIANCE MET 5/500MG can cause severe tiredness, unusual thirst, lightheadedness, or dizziness upon standing in some individuals. Consult your doctor immediately if you experience any unusual symptoms after taking JARDIANCE MET 5/500MG.   

Is JARDIANCE MET 5/500MG safe to use in elderly patients?

Yes. JARDIANCE MET 5/500MG should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking JARDIANCE MET 5/500MG. Your doctor might check your kidney function at least once a year or more frequently to avoid kidney damage. 

Can JARDIANCE MET 5/500MG be used in patients with heart disease?

JARDIANCE MET 5/500MG is not recommended for use in patients with heart problems such as recent heart attack or failure, cardiogenic shock (problems in blood circulation) or abnormal breathing. Consult your doctor before taking JARDIANCE MET 5/500MG.  

What is JARDIANCE MET 5/500MG used for?

JARDIANCE MET 5/500MG is used to treat type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines. It is not recommended for use in patients with type-1 diabetes.

REFERENCES

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 275-276 & 278.

2. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 2451-2456.

3. Boehringer Ingelheim. Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients with Type 2 Diabetes. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2016] [Accessed on 8th October 2021] https://clinicaltrials.gov/ct2/show/NCT01719003

4. Boehringer Ingelheim. Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients with Type 2 Diabetes. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in September 2016] [Accessed on 8th October 2021] https://clinicaltrials.gov/ct2/show/NCT01167881

5. Jennifer D Goldman. Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy. NCBI; PMC US National Library of Medicine, National Institute of Health. July 2018. [Accessed on 8th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043932/

6. Matthew J. Levine. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. NCBI; PMC US National Library of Medicine, National Institute of Health. August 2017. [Accessed on 8th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543566/

7. Uche Anadu Ndefo, Nicole O. Anidiobi, Efrah Basheer, and Angie T. Eaton. Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2015. [Accessed on 8th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450666/

8. Samy Hadjadj, Julio Rosenstock, Thomas Meinicke , Hans J Woerle , Uli C Broedl. Initial Combination of Empagliflozin and Metformin in Patients with Type 2 Diabetes. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 2016. [Accessed on 8th October 2021] https://pubmed.ncbi.nlm.nih.gov/27493136/

9. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 8th October 2021] https://www.medicines.org.uk/emc/files/pil.11420.pdf

10. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in December 2016] [Accessed on 8th October 2021] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Glucose - Fasting Blood
• Glucose - Postprandial Blood
• Glycosylated Hemoglobin