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FARXIGA- dapagliflozin tablet, film coated


  1. Patient Information
  2. Farxiga Can Cause Serious Side Effects, Including:
  3. Farxiga Is A Prescription Medicine Used In Adults With Type 2 Diabetes To:
  4. Do Not Take Farxiga If You:
  5. Before You Take Farxiga, Tell Your Healthcare Provider If You:
  6. How Should I Take Farxiga?
  7. Farxiga May Cause Serious Side Effects, Including:
  8. Ketoacidosis Can Happen With Farxiga Even If Your Blood Sugar Is Less Than 250 Mg/dl. Stop Taking Farxiga And Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms:
  9. Active Ingredient:
  10. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hypotension

Inform patients that symptomatic hypotension may occur with FARXIGA and advise them to contact their healthcare provider if they experience such symptoms[

Farxiga Can Cause Serious Side Effects, Including: 

Dehydration.FARXIGA can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you:
have low blood pressure
take medicines to lower your blood pressure, including water pills (diuretics)
are 65 years of age or older
are on a low salt diet
have kidney problems
Vaginal yeast infection.Women who take FARXIGA may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
vaginal odor
white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
vaginal itching
Yeast infection of the penis (balanitis).Men who take FARXIGA may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
redness, itching, or swelling of the penis
rash of the penis
foul smelling discharge from the penis
pain in the skin around the penis

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

Farxiga Is A Prescription Medicine Used In Adults With Type 2 Diabetes To: 

improve blood sugar (glucose) control along with diet and exercise
reduce the risk of hospitalization for heart failure

FARXIGA is not for people with type 1 diabetes.

FARXIGA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if FARXIGA is safe and effective in children younger than 18 years of age.

Do Not Take Farxiga If You: 

are allergic to dapagliflozin or any of the ingredients in FARXIGA.

Before You Take Farxiga, Tell Your Healthcare Provider If You: 

have type 1 diabetes or have had diabetic ketoacidosis.
have kidney problems.
have liver problems.
have a history of urinary tract infections or problems urinating.
are going to have surgery.
are eating less due to illness, surgery or a change in your diet.
have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
drink alcohol very often, or drink a lot of alcohol in the short term ( binge drinking).
are pregnant or plan to become pregnant. FARXIGA may harm your unborn baby. If you become pregnant while taking FARXIGA, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
are breastfeeding or plan to breastfeed. It is not known if FARXIGA passes into your breast milk. You should not breastfeed if you take FARXIGA.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How Should I Take Farxiga? 

Take FARXIGA exactly as your healthcare provider tells you to take it.
Do not change your dose of FARXIGA without talking to your healthcare provider.
Take FARXIGA by mouth 1 time each day, with or without food.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider s instructions.
Stay on your prescribed diet and exercise program while taking FARXIGA.
FARXIGA will cause your urine to test positive for glucose.
Your healthcare provider may do certain blood tests before you start FARXIGA and during your treatment.
Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
Follow your healthcare provider s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of FARXIGA at the same time.
If you take too much FARXIGA, call your healthcare provider or go to the nearest emergency room right away.

Farxiga May Cause Serious Side Effects, Including: 

Ketoacidosis (increased ketones in your blood or urine).Ketoacidosis has happened in people who havetype 1 diabetes or type 2 diabetes,during treatment with FARXIGA. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death.

Ketoacidosis Can Happen With Farxiga Even If Your Blood Sugar Is Less Than 250 Mg/dl. Stop Taking Farxiga And Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms: 

nausea
vomiting
stomach area (abdominal) pain
tiredness
trouble breathing
If you get any of these symptoms during treatment with FARXIGA, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
Kidney problems.Sudden kidney injury has happened to people taking FARXIGA. Call your healthcare provider right away if you:
reduce the amount of food or liquid you drink, for example, if you are sick and cannot eat or
you start to lose liquids from your body, for example, from vomiting, diarrhea or being in the sun too long.
Serious urinary tract infections.Serious urinary tract infections that may lead to hospitalization have happened in people who are taking FARXIGA. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
Low blood sugar (hypoglycemia).If you take FARXIGA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take FARXIGA. Signs and symptoms of low blood sugar may include:
headache
shaking or feeling jittery
irritability
fast heartbeat
weakness
drowsiness
sweating
confusion
dizziness
hunger
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum).Necrotizing fasciitis of the perineum has happened in women and men who take FARXIGA. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death.

Store FARXIGA at room temperature between 68 F to 77 F (20 C to 25 C).

General information about the safe and effective use of FARXIGA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FARXIGA for a condition for which it is not prescribed. Do not give FARXIGA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about FARXIGA. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about FARXIGA that is written for healthcare professionals.

For more information about FARXIGA, go towww.farxiga.comor call 1-800-236-9933.

Active Ingredient: 

dapagliflozin.

Inactive Ingredients: 

microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. The film coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.


Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

FARXIGA is a registered trademark of the AstraZeneca group of companies.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 10/2019



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