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FORXIGA (DAPAGLIFLOZIN): CONSUMER INFORMATION

Read this carefully before you start taking Forxiga (Dapagliflozin) and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Forxiga.

What Forxiga (Dapagliflozin) tablets are used for?

Forxiga is used along with diet and exercise to improve blood sugar levels in adults with type 2 diabetes. This medication can be used:

  • alone, if you cannot take metformin
  • with metformin
  • with a sulfonylurea
  • with metformin and a sulfonylurea
  • with sitagliptin (with or without metformin)
  • with insulin (with or without metformin)


    What it does?

    Dapagliflozin (Forxiga) removes excess sugar from the body through the urine.


    When it should not be used?

    Do not take Dapagliflozin (Forxiga) tablets if you:

  • are allergic to dapagliflozin or any of the nonmedicinal ingredients listed below.
  • have diabetic ketoacidosis (DKA, a complication of diabetes) or a history of DKA.
  • have type 1 diabetes (a disease in which your body does not produce any insulin).
  • have moderate to severe kidney problems or you are on dialysis.
  • have bladder cancer.
  • have severe liver disease.
  • take pioglitazone, a drug to reduce the amount of sugar in the blood.
  • are pregnant or planning to become pregnant; it is not known if Forxiga will harm your unborn baby. Talk with your doctor, pharmacist, or other healthcare professional about the best way to control your blood sugar while you are pregnant.
  • are breast-feeding or plan to breast-feed; it is not known if Forxiga (Dapagliflozin Propanediol Monohydrate) will pass into your breast milk.

    Talk to your doctor if you would like to breast-feed.


    What Forxiga ingredient is?

    Dapagliflozin (as Dapagliflozin Propanediol Monohydrate).


    What the nonmedicinal ingredients are?

    Lactose anhydrous, magnesium stearate, crospovidone, microcrystalline cellulose, silicon dioxide. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide and yellow iron oxide.


    What dosage forms it comes in?

    Forxiga (Dapagliflozin) tablets 5 mg and 10 mg.


    Serious Warnings and Precautions

  • Diabetic ketoacidosis (DKA), is a serious and lifethreatening condition that requires urgent hospitalization. DKA has been reported in patients with type 2 diabetes mellitus (T2DM) with normal or high blood sugar levels who are treated with Forxiga (Dapagliflozin) tablets and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. Some cases of DKA have led to death.
  • Seek medical attention right away and stop taking Forxiga immediately if you have any of the following symptoms (even if your blood sugar levels are normal): difficulty breathing, nausea, vomiting, loss of appetite, stomach pain, confusion, feeling very thirsty, feeling unusually tired, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

    Do not use Dapagliflozin (Forxiga) if you have:

  • DKA or a history of DKA
  • type 1 diabetes.

    Before you use Dapagliflozin (Forxiga) tablets talk to your doctor or pharmacist if you:

  • have type 1 diabetes (your body does not produce any insulin). Forxiga should not be used in patients with type 1 diabetes.
  • have an increased chance of developing DKA, including if you:

    - are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
    - are on a very low carbohydrate diet;
    - drink a lot of alcohol;
    - have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
    - are hospitalized for major surgery, serious infection or serious medical illness;
    - have a history of diabetic ketoacidosis (DKA).
  • are older than 65 years of age
  • have or have had any kidney problems
  • have or have had any cases of liver disease
  • have heart disease or low blood pressure are taking a medicine for high blood pressure or taking a water pill (used to remove excess water from the body)
  • are taking medicines to lower your blood sugar such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking Forxiga (Dapagliflozin) with any of these medicines can increase the risk of having low blood sugar (hypoglycemia)
  • have a history of bladder cancer
  • have intolerance to some milk sugars. Forxiga tablets contain lactose
  • often get urinary tract infections

    Forxiga (Dapagliflozin) tablets are not recommended for use in patients under 18 years of age.

    This medication will cause your urine to test positive for sugar (glucose).

    Forxiga may cause changes in the amount of cholesterol or fats in your blood.

    This drug increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.

    Dapagliflozin (Forxiga) may cause abnormal kidney function. Your healthcare provider will do blood tests to monitor how well your kidneys are working while you are taking this medicine.

    Driving and using machines: Dapagliflozin (Forxiga) tablets may cause dizziness or lightheadedness. Do not drive or use machines until you know how the medicine affects you.


    Interactions with this medication

    Talk to your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

    Drugs that may interact with Forxiga (Dapagliflozin Propanediol Monohydrate) include:

  • medicines you take for diabetes, especially sulfonylurea medications or insulin. Low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes. Discuss with doctor how much of each medicine to take.


    Proper use of Forxiga

    Follow the directions given to you by your physician.

    Take Forxiga (Dapagliflozin) tablets:

  • once a day
  • at any time of the day
  • by mouth
  • with or without food

    Swallow whole. Do not cut or divide tablets.

    Usual adult dose

    Recommended adult starting dose: one 5 mg tablet a day. Your doctor may increase your dose to one 10 mg tablet, if needed to further control your blood sugar level.


    Overdose

    In case of overdose by Forxiga (Dapagliflozin), contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.


    Missed dose

    If you miss a dose of Dapagliflozin (Forxiga), take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.


    Side effects and what to do about them?

    These are not all the possible side effects you may feel when taking Dapagliflozin (Forxiga) tablets. If you experience any side effects not listed here, contact your healthcare professional.

    Side effects may include:

  • influenza
  • sore throat
  • constipation
  • nausea
  • diarrhea
  • back pain
  • headache
  • pain in the arms, legs, hands or feet
  • rash

    If any of these affects you severely, tell your doctor or pharmacist.

    Forxiga (Dapagliflozin Propanediol Monohydrate) can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check kidney function, blood fat levels (Low Density Lipoprotein cholesterol or LDL-C) and amount of red blood cells in your blood (hematocrit).

    Diabetic Ketoacidosis (DKA) is a serious medical condition normally seen at high blood sugar levels; however, it has also been seen at near normal blood sugar levels. Get medical help right away if you have any of the symptoms in the table below under DKA, even if your blood sugar levels are normal.


    How to store it?

    Store Forxiga (Dapagliflozin) tablets at room temperature (15-30 °C).

    Keep this medicine well out of reach of children.


    More information

    Note: This information for the consumer leaflet provides you with the most current information at the time of printing.

    The most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at Forxiga official website or by contacting the sponsor.

    Manufactured and distributed by AstraZeneca pharmaceutical company and its divisions.

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