5 mg/850 mg, 5 mg/1000 mg film-coated tablets
dapagliflozin/metformin hydrochloride
What Xigduo is and what it is used for
This medicine contains two different substances called dapagliflozin and metformin. Both belong to a group of drugs called oral diabetes medications. It is a medicine taken by mouth for diabetes.
Xigduo is used for a type of diabetes called “type 2 diabetes” in adult patients (18 years and older) that usually occurs as you get older. If you have type 2 diabetes, your pancreas doesn’t produce enough insulin, or your body can’t use the insulin it makes properly. This leads to a high level of sugar ( glucose ) in the blood.
- Dapagliflozin works by removing excess sugar from the body via the urine and lowering the amount of sugar in the blood. It can also help prevent heart disease.
- Metformin works primarily by inhibiting glucose production in the liver.
For the treatment of diabetes:
- This medicine is used in combination with diet and exercise.
- This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes.
- Your doctor may ask you to take this medicine alone or together with other medicines to treat diabetes. It can be another drug that is taken as tablets and/or a drug that is given by injection, e.g. insulin or a GLP-1 receptor agonist (helps your body increase the production of insulin when your blood sugar is high).
- If you are already taking both dapagliflozin and metformin as separate tablets, your doctor may ask you to switch to this medicine. To avoid overdose, do not continue to take dapagliflozin and metformin tablets if you are taking Xigduo.
It is important to continue to follow the diet and exercise advice you have been given by your doctor, pharmacist, or nurse.
What you need to know before you take Xigduo
Do not take Xigduo
- if you are allergic to dapagliflozin, metformin, or any of the other ingredients of this medicine (listed in section 6).
- if you have ever had a diabetic coma.
- if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition where substances called ketone bodies to accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach ache, fast and deep breathing, sleepiness, or your breath having a different, fruity smell.
- if you have severely impaired kidney function.
- if you have a severe infection.
- if you have lost a lot of water from your body (dehydration), e.g. due to prolonged or severe diarrhea or if you have vomited several times in a row.
- if you have recently had a heart attack or if you have heart failure or severe problems with blood circulation or difficulty breathing.
- if you have liver problems.
- if you drink large amounts of alcohol (either every day or only occasionally) (see section “Xigduo with alcohol”).
Do not take this medicine if any of the above applies to you.
Warnings and precautions
Risk of lactic acidosis
Xigduo can cause the very rare, but very serious, side effect of lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where a part of the body has reduced oxygen supply (including acute severe heart disease).
If any of the above apply to you, talk to your doctor for more detailed instructions.
Stop taking Xigduo for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to your doctor for more detailed instructions.
Stop taking Xigduo and contact your doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition can lead to coma.
The symptoms of lactic acidosis include:
- vomiting
- abdominal pain (stomach)
- muscle cramps
- a general feeling of not feeling well and pronounced fatigue
- hard to breathe
- lowered body temperature and pulse.
Lactic acidosis is an emergency medical condition that must be treated in a hospital.
Talk to your doctor, pharmacist, or nurse before taking Xigduo and during treatment:
- if you have “type 1 diabetes” – the type of diabetes that usually starts when you are young, and the body does not produce any insulin. Xigduo should not be used to treat this condition.
- if you experience rapid weight loss, nausea or vomiting, stomach pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or tiredness, a sweet breath, a sweet or metallic taste in your mouth, or a different smell of urine or sweat, contact your doctor or nearest hospital immediately. These symptoms could be signs of ‘diabetic ketoacidosis’ – a rare but serious, sometimes life-threatening problem you can get with diabetes due to increased levels of ‘ketone bodies in your urine or blood. This shows in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, a sudden reduction in the insulin dose, or a greater need for insulin due to major surgery or a serious illness.
- if you have problems with your kidneys. The doctor checks your kidney function.
- if you have very high levels of glucose in your blood which can make you dehydrated (lose too much body fluid). Possible symptoms of dehydration are listed at the beginning of section 4. Tell your doctor before you start taking this medicine if you have any of these signs.
- if you take medicines that lower blood pressure (antihypertensive agents) and have had low blood pressure ( hypotension ). More information is given below under “Other medicines and Xigduo”.
- if you often get urinary tract infections. This medicine can cause urinary tract infections and your doctor may need to monitor you more closely. The doctor may consider changing your treatment temporarily if you get a serious infection.
If you are going to undergo a major operation, you must stop taking Xigduo during the operation and for a certain period after it. Your doctor will decide when you must stop taking Xigduo and when you should start taking it again.
It is important to check the feet regularly and to follow the advice on foot care given by the healthcare staff.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Talk to your doctor straight away if you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the rectum along with a fever or feeling generally unwell. These symptoms can be a sign of a rare but serious and, in the worst case, a life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.
Kidney function
During treatment with Xigduo, your doctor will check your kidney function at least once a year or more often if you are elderly and/or if your kidney function is deteriorating.
Sugar in the urine
Because of the way this medicine works, your urine will test positive for sugar while you are taking this medicine.
Children and young people
This medicine is not recommended for children and adolescents under the age of 18, as it has not been studied in these patients.
Other medicines and Xigduo
If you need to receive an injection into the blood with a contrast agent containing iodine, for example in connection with an X-ray or CT scan, you must stop taking Xigduo before or at the time of the injection. Your doctor will decide when you must stop taking Xigduo and when you should start taking it again.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
You may need to have more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Xigduo. You must mention the following:
- if you take medicines that increase urine production ( diuretics ). Your doctor may ask you to stop taking this medicine. Possible symptoms of losing too much fluid from the body are listed at the beginning of section 4.
- if you are taking other medicines that lower blood sugar levels, such as insulin or sulphonylurea. Your doctor may want to lower the dose of one of the other medicines to prevent you from getting blood sugar levels that are too low (hypoglycemia).
- if you are taking cimetidine, a medicine used to treat stomach problems.
- if you use bronchodilators (beta-2- agonists ) which are used to treat asthma.
- if you use corticosteroids (used to treat inflammation in diseases such as asthma and arthritis ) given by mouth, as an injection, or inhalation.
- if you are using medicines used to treat pain and inflammation ( NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
- if you use certain medicines for the treatment of high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).
Xigduo with alcohol
Avoid heavy alcohol intake while taking Xigduo as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should stop taking this medicine if you become pregnant, as it is not recommended during the second and third trimesters of pregnancy (the last six months of pregnancy). Talk to your doctor about the best way to control your blood sugar during pregnancy.
Talk to your doctor if you want to breastfeed or are breastfeeding before taking this medicine. Do not use this medicine if you are breastfeeding. Metformin passes into breast milk in small amounts. It is not known whether dapagliflozin passes into breast milk.
Driving ability and use of machinery
This medicine has no or negligible effect on the ability to drive and use machines. If you take it with other medicines that lower the amount of sugar in the blood, such as insulin or a sulphonylurea, this may cause blood sugar levels to be too low (hypoglycemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heartbeat, vision changes or difficulty concentrating and affect your ability to drive and use machines. Do not drive or use any tools or machines if you start to feel these symptoms.
Xigduo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to take Xigduo
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much medicine to take
- The amount of this medicine you will take will vary depending on your condition and the doses you are currently taking of metformin and/or individual dapagliflozin and metformin tablets. Your doctor will tell you exactly what dose of this medicine to take.
- The recommended dose is one tablet twice a day.
How to take the medicine
- Swallow the tablet whole with half a glass of water.
- Take the tablet with a meal. It reduces the risk of side effects in the stomach.
- Take the tablet twice daily, one in the morning (breakfast) and one in the evening (dinner).
Your doctor may prescribe this medicine along with one or more other medicines to lower your blood sugar levels. These can be medicines that are taken by mouth or that are given by injection, e.g. insulin or a GLP-1 receptor agonist. Remember to take these other medicines as directed by your doctor. It gives the best result for your health.
Diet and exercise
To control your diabetes, you need to eat the right diet and exercise, even while taking this medicine. Therefore, it is important to continue to follow the advice on diet and exercise that you have received from your doctor, pharmacist, or nurse. In particular, if you follow a diabetes diet for weight control, you should continue to follow it while taking this medicine.
If you have taken too much Xigduo
If you have taken too many Xigduo tablets, you may get lactic acidosis. The symptoms of lactic acidosis are severe nausea, vomiting, stomach pain, muscle cramps, severe fatigue, or difficulty breathing. If this happens to you, you may need immediate hospital care, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact your doctor or nearest hospital immediately (see section 4). Take the medicine package with you.
If you forget to take Xigduo
If you forget to take a dose, take it as soon as you remember. If you don’t remember until it’s time for the 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 missed dose.
If you stop taking Xigduo
Do not stop taking this medicine without first talking to your doctor. Your blood sugar may increase if you do not take this medicine.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Xigduo and see a doctor immediately if you notice any of the following serious or potentially serious side effects:
- Lactic acidosis: occurs very rarely (affects less than 1 in 10,000 people)
Xigduo can cause very rare (may affect up to 1 user in 10,000), but very serious side effects of lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Xigduo and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.
Contact your doctor or nearest hospital immediately if you experience any of the following side effects:
- Diabetic ketoacidosis, is rare (may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
- increased levels of ‘ketone bodies in the urine or blood
- rapid weight loss
- nausea or vomiting
- stomach pain
- severe thirst
- rapid and deep breathing
- confusion
- unusual sleepiness or tiredness
- a sweet smell on the breath, a sweet or metallic taste in the mouth, or a different smell in urine or sweat. This can occur regardless of the blood glucose level. Your doctor may decide to temporarily or permanently stop treatment with Xigduo.
- Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the rectum, is very rare.
Stop taking Xigduo and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
- Dehydration: loss of too much fluid from the body is less common (may affect up to 1 in 100 people).
These are signs of dehydration:
- very dry or sticky mouth, strong thirst
- very sleepy or tired
- little or no urine
- rapid heartbeat.
- Urinary tract infection is common (may affect up to 1 in 10 people).
These are signs of a severe urinary tract infection:
- fever and/or chills
- burning sensation when you urinate
- pain in the back or side.
Although less common, tell your doctor right away if you notice blood in your urine.
Contact a doctor as soon as possible if you notice any of the following side effects:
- Low blood sugar levels (hypoglycemia), are very common (may affect more than 1 in 10 people) – when you take this medicine with a sulphonylurea or other medicines that lower the amount of sugar in the blood, such as insulin.
These are signs of low blood sugar:- shaking, sweating, strong anxiety, rapid heartbeat
- feeling hungry, headache, vision changes
- mood changes or feeling confused.
Your doctor can tell you how to treat low blood sugar and what to do if you get any of the above symptoms. 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.
Other side effects are:
Very common
- nausea, vomiting
- diarrhea or stomach ache
- loss of appetite
Usual
- infection in the lower abdomen (cod) on the penis or in the vagina (can cause irritation, itching, abnormal discharge or smell)
- back pain
- discomfort when urinating, more urine than usual, or the need to urinate more often
- changes in blood cholesterol or blood fat levels (shown by tests)
- increases in the number of red blood cells in the blood (shown by tests)
- reduced excretion of creatinine by the kidneys (shown by tests) at the beginning of treatment
- taste changes
- dizziness
- rash
Less common
- thirst
- constipation
- waking up at night to urinate
- dry mouth
- weight loss
- increase in creatinine (shown by laboratory blood tests) at the beginning of treatment
- increases in urea (shown by laboratory blood tests)
Very rare
- reduced levels of vitamin B12 in the blood
- abnormal liver function tests, inflammation of the liver ( hepatitis )
- skin redness ( erythema ), itching, or an itchy rash (hives)
How to store Xigduo
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister or carton after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are dapagliflozin and metformin hydrochloride ( metformin HCl ).
Each Xigduo 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Each Xigduo 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride. - Other ingredients are:
- tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate (type A).
- film coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (Xigduo 5 mg/850 mg only).
Appearance and package sizes of the medicine
- Xigduo 5 mg/850 mg are 9.5 x 20 mm oval, brown, film-coated tablets. It says “5/850” on one side and “1067” on the other.
- Xigduo 5 mg/1000 mg are 10.5 x 21.5 mm oval, yellow, film-coated tablets. It says “5/1000” on one side and “1069” on the other.
Xigduo 5 mg/850 mg film-coated tablets and Xigduo 5 mg/1000 mg film-coated tablets are available in PVC/PCTFE/Alum blisters. Pack sizes are 14, 28, 56, and 60 film-coated tablets in non-perforated blisters, 60 x 1 film-coated tablet in perforated single-dose blisters, and multipacks containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienAstraZeneca SA/NVPhone: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaPhone: + 370 5 2660550 |
| BulgariaAstraZeneca Bulgaria EOODTel.: + 359 (2) 44 55 000 | Luxembourg/LuxembourgAstraZeneca SA/NVTél/Tel: +32 2 370 48 11 |
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| DenmarkAstraZeneca A/SPhone: +45 43 66 64 62 | MaltaAssociated Drug Co. LtdPhone: + 356 2277 8000 |
| DeutschlandAstraZeneca GmbHPhone: +49 40 809034100 | The NetherlandsAstraZeneca BVPhone: +31 79 363 2222 |
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| GreeceAstraZeneca iPhone: +30 2 106871500 | AustriaAstraZeneca Österreich GmbHPhone: +43 1 711 31 0 |
| SpainAstraZeneca Farmacéutica Spain, SAPhone: +34 91 301 91 00 | PolishAstraZeneca Pharma Poland Sp. z o. oTel.: +48 22 245 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | PortugalAstraZeneca Produtos Farmacêuticos, Lda.Phone: +351 21 434 61 00 |
| HrvatskaAstraZeneca dooPhone: + 385 1 4628 000 | RomaniaAstraZeneca Pharma SRLPhone: +40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACPhone: +353 1609 7100 | SlovenijaAstraZeneca UK LimitedPhone: + 386 1 51 35 600 |
| IcelandVistor hf.Telephone: + 354 535 7000 | Slovenian RepublicAstraZeneca AB, ozone: + 421 2 5737 7777 |
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| CyprusΑλέκτωρ Φαρµακευτική ΛτδPhone: +357 22490305 | SwedenAstraZeneca ABPhone: +46 8 553 26 000 |
| LatviaSIA AstraZeneca LatvijaPhone: + 371 67377100 | United Kingdom (Northern Ireland)AstraZeneca UK LtdPhone: +44 1582 836 836 |