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The product code(s) for this leaflet is: PLGB 17901/0343.
Xigduo 5 mg/850 mg & 5 mg/1,000 mg film-coated tablets
Xigduo® 5 mg/850 mg film-coated tablets
Xigduo® 5 mg/1,000 mg film-coated tablets
dapagliflozin/metformin hydrochloride
1. What Xigduo is and what it is used for
2. What you need to know before you take Xigduo
3. How to take Xigduo
4. Possible side effects
5. How to store Xigduo
6. Contents of the pack and other information
This medicine contains two different substances called dapagliflozin and metformin. Both belong to a group of medicines called oral anti-diabetics. These are medicines taken by mouth for diabetes.
Xigduo is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older. If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar (glucose) in your blood.
To treat diabetes:
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Do not take this medicine if any of the above apply to you.
Risk of lactic acidosis
Xigduo may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Xigduo for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking Xigduo and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
Lactic acidosis is a medical emergency and must be treated in a hospital.
If you need to have major surgery, you must stop taking Xigduo during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Xigduo.
It is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.
During treatment with Xigduo, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.
Because of how this medicine works, your urine will test positive for sugar while you are on this medicine.
This medicine is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Xigduo before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Xigduo.
Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Xigduo. It is especially important to mention the following:
Avoid excessive alcohol intake while taking Xigduo since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. You should not use this medicine if you are breast-feeding. Metformin passes into human milk in small amounts. It is not known if dapagliflozin passes into human breast milk.
This medicine has no or negligible influence on the ability to drive and use machines. Taking it with other medicines that lower the amount of sugar in your blood, such as insulin or a “sulphonylurea” medicine, can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heart beat, change in vision or difficulties concentrating, and may affect your ability to drive and use machines. Do not drive or use any tools or machines, if you start to feel these symptoms.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor may prescribe this medicine together with other medicine(s) to lower the amount of sugar in your blood. These may be medicine(s) by mouth or given by injection, such as insulin or a GLP-1 receptor agonist. Remember to take these other medicine(s) as your doctor has told you. This will help get the best results for your health.
To control your diabetes, you still need to keep to diet and exercise, even when you are taking this medicine. So it is important to keep following the advice about diet and exercise from your doctor, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
If you take more Xigduo tablets than you should, you may experience lactic acidosis. Symptoms of lactic acidosis include feeling or being very sick, vomiting, stomach ache, muscular cramps, severe tiredness or difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2). Take the medicine pack with you.
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine to make up for a forgotten dose.
Do not stop taking this medicine without talking to your doctor first. Your blood sugar may increase without this medicine.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Xigduo.
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.
Very common
Common
Uncommon
Very rare
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Xigduo 5 mg/850 mg film-coated tablets and Xigduo 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister. The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Not all pack sizes may be marketed.
This leaflet was last revised in August 2022.
© AstraZeneca 2022
XIGDUO is a registered trademark of the AstraZeneca group of companies.
CV 22 0108
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Xigduo 5mg+850mg film-coated tablets 17901/0343
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