Xigduo - Consumer Medicine Information
|Condition:||Type 2 Diabetes (Diabetes, Type 2)|
|Ingredients:||dapagliflozin (as dapagliflozin propanediol monohydrate), metformin hydrochloride, cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate (extragranular) and sodium starch glycolate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, macrogol/polyethylene glycol, talc, titanium dioxide, yellow iron oxide and/or red iron oxide|
About this Medication
What the medication is used for:
XIGDUO is used along with diet and exercise in adults with type 2 diabetes to help control their blood sugar levels. XIGDUO can be used:
- in patients taking dapagliflozin (FORXIGA) and metformin as separate tablets, or
- in patients taking dapagliflozin (FORXIGA), metformin and insulin.
What it does:
XIGDUO contains dapagliflozin and metformin hydrochloride.
Dapagliflozin removes excess glucose from the body through the urine.
Metformin helps your body respond better to the insulin it makes naturally. It helps to lower the amount of sugar made by the liver and lower the amount of sugar moved from the gut into the blood.
When it should not be used:
Do not take XIGDUO if you:
- have unstable and/or insulin-dependent (Type I) diabetes mellitus.
- have increased ketones in the blood or urine (metabolic acidosis or diabetic ketoacidosis) or have had ketoacidosis with or without coma.
- have a history of too much acid in the blood (lactic acidosis).
- have or ever had kidney or liver problems.
- consume large amounts of alcohol all the time or shortterm ‘binge’.
- have heart failure or other severe heart problems.
- are stressed, have a serious infection, have recently had a trauma, are about to have surgery or are recovering from surgery.
- are dehydrated (have lost a lot of water from your body).
- are allergic (hypersensitive) to dapagliflozin, metformin hydrochloride or any of the ingredients listed below.
- have bladder cancer.
- 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 XIGDUO will harm your unborn baby. Talk with your doctor 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 XIGDUO will pass into your breast milk. Talk to your doctor if you would like to breast feed.
- will have certain x-ray tests with injectable dyes or contrast agents. Talk to your physician or pharmacist about when to stop XIGDUO and when to start again.
What the medicinal ingredients are:
XIGDUO contains dapagliflozin (as dapagliflozin propanediol monohydrate) and metformin hydrochloride.
What the nonmedicinal ingredients are:
cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate (extragranular) and sodium starch glycolate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, macrogol/polyethylene glycol, talc, titanium dioxide, yellow iron oxide and/or red iron oxide.
What dosage forms it comes in:
XIGDUO is supplied as tablets containing dapagliflozin/metformin hydrochloride 5 mg/850 mg or 5 mg/1000 mg.
Warnings and Precautions
|Serious Warnings and Precautions|
XIGDUO contains metformin and it can rarely cause a serious condition that can cause death called lactic acidosis. Alcohol may increase the risk of lactic acidosis. Do not drink a lot of alcohol while taking XIGDUO (see Lactic Acidosis section below).
Stop taking XIGDUO and tell your doctor if you get the following symptoms of lactic acidosis:
- You feel very weak and tired.
- You have unusual (not normal) muscle pain.
- You have trouble breathing or fast breathing.
- You have stomach pain with nausea and vomiting, or diarrhea.
- You feel cold, especially in your arms and legs.
- You feel dizzy or lightheaded.
- You feel unusual fatigue and drowsiness.
- You have a slow or irregular heart beat.
- Your medical condition suddenly changes.
- You develop or experience a worsening of heart problems and particularly heart failure.
BEFORE you use XIGDUO talk to your doctor or pharmacist if you:
- are older than 65 years of age.
- are dehydrated (have lost a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and don’t drink enough fluids.
- have heart problems or low blood pressure.
- are taking medicines for high blood pressure or taking a water pill (used to remove excess water from the body).
- are taking medicines to lower blood sugar such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking XIGDUO with any of these medications can increase the risk of having low blood sugar (hypoglycemia).
- have a problem with your adrenal glands (found on top of your kidneys) or pituitary gland (found in your brain).
- have a history of bladder cancer.
- will be having surgery.
- have had a heart attack, severe infection, or stroke.
- feel very weak and tired.
- are 80 years of age or older and have not had your kidney function tested.
- have low B12 levels.
- have had an allergic reaction to SGLT2 inhibitors (used to treat Type 2 diabetes).
XIGDUO is not recommended for use in patients under 18 years of age.
XIGDUO will cause your urine to test positive for sugar (glucose).
XIGDUO may cause changes in the amount of cholesterol or fats in your blood.
XIGDUO 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.
Driving and using machines: XIGDUO may cause dizziness or lightheaded-ness. 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.
Some drugs may interact with XIGDUO. Tell your doctor if you are taking:
- Medicines for diabetes; low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes.
- Nifedipine (used to treat high blood pressure and chest pain).
- Cationic drugs (e.g. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin).
- Certain “blood thinners” (phenprocoumon or other Vitamin K anticoagulants).
- Diuretics (water pills), especially loop diuretics, that may increase the risk of lactic acidosis (e.g. furosemide).
- Other drugs that tend to produce high blood sugar (hyperglycemia) and may lead to a loss of blood sugar control. Some example of drugs that can increase the blood sugar include:
- Thiazide and other diuretics (water pills)
- Corticosteroids (used to treat joint pain and swelling)
- Phenothiazines (used to treat schizophrenia)
- Thyroid products
- Estrogens or estrogens plus progestogen
- Oral contraceptives (birth control pills)
- Phenytoin (used to treat epilepsy)
- Nicotinic Acid
- Sympathomimetics (used for heart problems)
- Calcium channel blocking drugs (used for high blood pressure)
- Isoniazid (used to treat tuberculosis)
- Beta-2-agonists (used to treat breathing problems)
- ACE inhibitor drugs (may lower blood glucose).
Proper Use of this Medication
Follow the directions given to you by your doctor. Your doctor will tell you how many XIGDUO tablets to take and how often you need to take them.
USUAL ADULT DOSE:
The recommended adult dose is one tablet (5 mg/850 mg or 5 mg/1000 mg), twice daily, taken with a meal.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you miss a dose of XIGDUO, wait for the next dose at the usual time. 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 XIGDUO. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
Side effects may include:
- sore throat
- the flu
- back pain
- pain in the arms, legs, hands or feet
If any of these affects you severely, tell your doctor or pharmacist.
XIGDUO can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check how well your kidneys are working, blood fat levels (cholesterol) and the amount of red blood cells in your blood (hematocrit). The doctor will interpret the results.
Serious Side Effects, how often they Happen and what to do about them
|Symptom / effect||Talk with your|
increased need to
|Yeast infection of|
irritation, and a
whitish or whitishgray
|Yeast infection of|
red, swollen, itchy,
head of penis.
passing urine or
or sticky mouth,
or urinating less
often than normal
May occur when
you go from lying
to sitting to standing
|Low blood sugar|
change in vision,
and change in
- Feeling very
weak, tired or
- Unusual or
- Feeling cold
- Feeling dizzy
develop a slow
This is not a complete list of side effects. For any unexpected effects while taking XIGDUO, contact your doctor or pharmacist.
How to Store it
Store at room temperature (15-30°C).
Keep XIGDUO well out of sight and reach of children.
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect ( http://hc-sc.gc.ca/dhpmps/ medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels and the Consumer Side Effects Reporting Form are available at MedEffect ( http://hc-sc.gc.ca/dhpmps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.
The Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at: www.astrazeneca.ca or by contacting AstraZeneca Canada, at: Customer Inquiries - 1-800-668-6000, Renseignements – 1-800-461-3787.