Dapagliflozin/Metformin hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about XIGDUO XR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking XIGDUO XR against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What XIGDUO XR is used for
XIGDUO XR is a prescription medicine used with diet, exercise and sometimes other medicines such as insulin, a sulfonylurea, or a dipeptidyl peptidase (DPP-4) inhibitor, or a glucagon like peptide 1 (GLP-1) receptor agonist such as exenatide to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus.
Type 2 diabetes mellitus
Type 2 diabetes mellitus (also called non-insulin-dependent diabetes mellitus, or NIDDM) is the condition of having high levels of blood sugar (hyperglycaemia). This is usually because your body does not make enough insulin and /or the insulin that your body produces does not work as well as it should. Left uncontrolled, the build-up of high levels of sugar in your blood can lead to serious medical problems.
The main goal of treating type 2 diabetes is to control your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, which include kidney disease, blindness and amputation.
XIGDUO XR contains two active ingredients, dapagliflozin and metformin hydrochloride. Dapagliflozin is a member of a class of medicines you take by mouth called SGLT-2 (Sodium Glucose Cotransporter-2) inhibitors and metformin belongs to a class of medicines called biguanides. Dapagliflozin and metformin work together to lower blood sugar levels in patients with type 2 diabetes mellitus.
Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is only available with a doctor’s prescription.
XIGDUO XR is not addictive.
Before you take XIGDUO XR
When you must not take it
Do not take XIGDUO XR if you have an allergy to dapagliflozin, or metformin, the active ingredients in XIGDUO XR or any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin or you may feel faint.
Do not take XIGDUO XR if you have any of the following conditions:
type 1 diabetes mellitus that is well controlled by insulin alone
type 2 diabetes that is already well controlled by diet alone
diabetic ketoacidosis. This is a symptom of uncontrolled diabetes, in which substances called ketone bodies build up in the blood. You may notice this as rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
liver disease
excessive alcohol intake, binge drinking, alcohol dependence
poorly functioning kidneys, severe kidney disease or kidney failure
dehydration, severe blood loss, shock
a severe infection
certain heart or blood vessel problems, including a recent heart attack or severe heart failure (when the heart fails to pump blood effectively)
severe breathing difficulties
blood clots in the lungs (symptoms include coughing, shortness of breath, chest pain and a fast heart rate)
gangrene.
Do not take this medicine if you are pregnant or plan to become pregnant.
The safety of XIGDUO XR in pregnant women has not been established. Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace XIGDUO XR with insulin while you are pregnant.
Do not take XIGDUO XR if you are breastfeeding.
XIGDUO XR is not recommended while you are breastfeeding. Your doctor will discuss the options available to you.
Do not take XIGDUO XR after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
XIGDUO XR is not recommended for use in children.
It has not been studied in children younger than 18 years old.
If you are not sure whether you should start taking XIGDUO XR, talk to your doctor or pharmacist.
Before you start to take it
Discard any other medicines containing dapagliflozin or metformin that your doctor might have prescribed to you in the past and that you may still have in your possession.
XIGDUO XR contains dapagliflozin and metformin. If you have more than one medicine containing dapagliflozin or metformin in your possession, you may accidentally take too much (overdose). Accidentally taking too much metformin can cause a very serious side effect called lactic acidosis.
ACCIDENTAL METFORMIN OVERDOSING IS A SIGNIFICANT SAFETY RISK.
Ask your doctor or pharmacist if you are unsure if you have any other medicines containing metformin.
Your doctor or pharmacist will know which other medicines also contain metformin.
Tell your doctor if you have any allergies to:
any other medicines
any other substances such as foods, dyes or preservatives
Tell your doctor or pharmacist if you have, or have had, any medical conditions, especially the following:
kidney, liver or pancreas problems
heart failure
are taking a medicine for high blood pressure or taking a water pill (diuretic)
frequently get genital or urinary tract infections (infections of the bladder, kidney, or tubes that carry urine)
an illness that will make you dehydrated such as diarrhoea or a severe infection.
Your doctor will do some tests for kidney function at the start of treatment and regularly while you are on treatment.
Tell your doctor if you drink alcohol.
Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol while you are being treated with XIGDUO XR may also lead to serious side effects. Your doctor may suggest you stop drinking or reduce the amount of alcohol you drink.
Tell your doctor if you are lactose intolerant.
XIGDUO XR tablets contain lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
XIGDUO XR may affect how well other medicines work and some medicines can affect how well XIGDUO XR works.
These include:
other medicines used to treat diabetes
medicines that contain alcohol, such as cough and cold syrups
tetracosactrin, a medicine used in people with multiple sclerosis, and in young children to treat some types of seizures (fits)
danazol, a medicine used to treat endometriosis
