Jardiance

Uses

What is Jardiance® (empagliflozin) used for?

Jardiance® is an oral diabetes medicine that helps control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream.

Jardiance® is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Jardiance® is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Jardiance® is not for treating type 1 diabetes.

How should I take Jardiance® (empagliflozin)?

Jardiance® is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Jardiance® with or without food, but take it the same way each time.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Jardiance can cause life- threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Jardiance.

Jardiance® is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

How do I store Jardiance® (empagliflozin)?

Jardiance® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Jardiance® in the bathroom or the freezer. There may be different brands of Jardiance® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Jardiance® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Jardiance® (empagliflozin)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Jardiance® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Jardiance® if you have:

• Kidney disease (or if you are on dialysis)
• If you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin)

To make sure Jardiance® is safe for you, tell your doctor if you have:

• Kidney disease
• Congestive heart failure
• Low blood pressure
• High cholesterol levels
• Urination problems
• A history of bladder infections
• If you are on a low salt diet
• If you are 65 or older

Is it safe during pregnancy or breastfeeding?

There isn’t enough information about the safety of using Jardiance® during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Jardiance®.

Side effects

What side effects can occur from Jardiance® (empagliflozin)?

Get emergency medical help if you have any signs of an allergic reaction to Jardiance®: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• A light-headed feeling, like you might pass out
• Frequent urge to urinate
• Swelling, rapid weight gain, little or no urinating
• Dehydration symptoms–feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
• Ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing
• Signs of a bladder infection–pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back
• Signs of a genital infection (penis or vagina) -pain, burning, itching, rash, redness, odor, or discharge

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

• bladder infection
• genital infection

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Jardiance® (empagliflozin)?

Jardiance® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• Blood pressure medicine
• A diuretic or “water pill’
• Insulin or other oral diabetes medications
• NSAIDs (nonsteroidal anti-inflammatory drugs)- aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others

Does food or alcohol interact with Jardiance® (empagliflozin)?

Jardiance® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Jardiance® (empagliflozin)?

Jardiance® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Jardiance® (empagliflozin).

What is the dose of Jardiance® (empagliflozin) for an adult?

Usual Adult Dose for Diabetes Type 2:

Initial dose: 10 mg orally once in the morning

Maximum dose: 25 mg orally once in the morning

What is the dose of Jardiance® (empagliflozin) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Jardiance® (empagliflozin) available?

Jardiance® is available in the following dosage forms and strengths:

• Tablet 10mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Jardiance®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

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