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What is the most important information I should know about Farxiga (Dapagliflozin)?

Farxiga can cause serious side effects, including:

  • Dehydration. This medication can cause some people to have dehydration (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 (Dapagliflozin) tablets 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 doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

  • Bladder cancer. In studies of Dapagliflozin (Farxiga) in people with diabetes, bladder cancer occurred in a few more people who were taking Farxiga than in people who were taking other diabetes medications. There were too few cases to know if bladder cancer was related to this drug. You should not take Dapagliflozin (Farxiga) tablets if you have bladder cancer. Tell your doctor or pharmacist right away if you have any of the following symptoms:

    - blood or a red color in your urine
    - pain while you urinate

    What is Farxiga (Dapagliflozin Propanediol Monohydrate)?

    Farxiga is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

    This medicine is not for people with type 1 diabetes.

    Farxiga (Dapagliflozin) 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.

    Who should not take Farxiga (Dapagliflozin) tablets?

    Do not take this medication if you:

  • are allergic to dapagliflozin or any of the ingredients in Farxiga. See the end of this Medication Guide for a list of ingredients in Farxiga tablets. Symptoms of a serious allergic reaction to this drug may include:

    - skin rash
    - raised red patches on your skin (hives)
    - swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

    If you have any of these symptoms, stop taking Dapagliflozin (Farxiga) and contact your healthcare provider or go to the nearest hospital emergency room right away.

  • have severe kidney problems or are on dialysis.

    What should I tell my doctor, pharmacist, or other healthcare professional before taking Farxiga?

    Before you take this medicine, tell your healthcare provider if you:

  • have type 1 diabetes or have had diabetic ketoacidosis.
  • have kidney problems.
  • have or have had bladder cancer.
  • are pregnant or plan to become pregnant. Dapagliflozin (Farxiga) tablets may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar.
  • are breastfeeding or plan to breastfeed. It is not known if Dapagliflozin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking Farxiga.

    Tell your physician about all the medicines you take, including prescription and OTC medicines, vitamins, and herbal supplements.

    How should I take Farxiga (Dapagliflozin Propanediol Monohydrate)?

  • Take this medicine exactly as your healthcare provider tells you to take it.
  • Do not change your dose of Farxiga without talking to your healthcare professional.
  • Take this medication 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 doctor 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 (Dapagliflozin).
  • Your doctor, pharmacist, or other healthcare professional may do certain blood tests before you start Farxiga (Dapagliflozin) tablets and during your treatment.
  • Your physician will check your diabetes with regular blood tests, including your blood sugar levels and your A1c.
  • Follow your healthcare provider's instructions for treating low blood sugar (hypoglycemia). Talk to your doctor or pharmacist 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 Dapagliflozin (Farxiga) at the same time.
  • If you take too much Farxiga, call your professional or go to the nearest emergency room right away.

    What are the possible side effects of Farxiga?

    This drug may cause serious side effects, including:

  • Low blood sugar (hypoglycemia). If you take Dapagliflozin (Farxiga) tablets 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
    - drowsiness
    - hunger
    - weakness
    - dizziness
    - fast heartbeat
    - confusion
    - irritability
    - shaking
    - sweating
    - feeling jittery

  • Kidney problems
  • Increased fats in your blood (bad cholesterol or LDL)

    The most common side effects of Farxiga (Dapagliflozin Propanediol Monohydrate) include:

  • vaginal yeast infections and yeast infections of the penis
  • stuffy or runny nose and sore throat
  • urinary tract infections
  • changes in urination, including urgent need to urinate more often, in larger amounts, or at night

    These are not all the possible side effects of Farxiga. For more information, ask your doctor or pharmacist.

    Call your physician for medical advice about side effects. You may report side effects to US FDA

    How should I store Farxiga (Dapagliflozin) tablets?

    Store this medication at room temperature between 68°F and 77°F (20°C and 25°C).

    General information about the safe and effective use of Farxiga

    This Medication Guide summarizes the most important information about Dapagliflozin (Farxiga). If you would like more information, talk to your doctor, pharmacist, or other healthcare professional. You can ask your pharmacist or healthcare provider for information about Dapagliflozin (Farxiga) tablets that is written for healthcare professionals.

    For more information about Farxiga (Dapagliflozin Propanediol Monohydrate), go to official Farxiga website.

    What are the ingredients in Farxiga tablets?

    Active ingredient: dapagliflozin.

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

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured and distributed by AstraZeneca, Bristol-Myers Squibb pharmaceutical companies and their divisions.

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