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Xigduo 5 mg/850 mg. 56 tablets

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What is Xigduo and what it is used
This product contains two different substances called dapagliflozin and metformin. Both belong to the group of medicines called "oral antidiabetics".
This drug is used for a type of diabetes called 'type 2 diabetes' in adults (aged 18 and over) and usually occurs when you are older. If you have type 2 diabetes, your pancreas does not produce enough insulin or your body is unable to use the insulin it produces properly. This leads to higher levels of sugar (glucose) in the blood. Dapagliflozin acts as removes excess sugar from your body through urine and decreases the amount of sugar in the blood. Metformin acts primarily by inhibiting glucose production in the liver.
These are drugs that are taken orally to treat diabetes.
This drug is taken in combination with diet and physical activity.
It is used when diabetes can not be controlled by other medicines for diabetes along with diet and physical activity.
Your doctor may tell you to take this medicine alone or taking it with other medicines to treat diabetes. This may be another drug administered orally and / or insulin which is administered as an injection.
If you are already taking dapagliflozin and metformin as separate tablets, your doctor may want to switch to this medicine. To avoid overdose, do not continue taking dapagliflozin and metformin tablets if you are taking this medicine.
It is important to continue to follow advice on diet and physical activity given by your doctor, pharmacist or nurse.
2. What you need to know before taking 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 a condition called 'diabetic ketoacidosis', a problem you may have diabetes. The signs include rapid weight loss, nausea or vomiting, stomach pain, fast and deep breathing, lethargy, sweet odor of the breath, sweet or metallic taste in the mouth, or other urine odor or perspiration;
if you have kidney problems;
if you have severe infection;
if you lost a lot of water from your body (dehydration), for example. long- or severe diarrhea, or if you have vomited several times;
If you have recently had a heart attack or have heart failure, severe circulatory problems or breathing difficulties;
if you have liver problems;
if you consume large amounts of alcohol every day or only from time to time (please see section "Xigduo alcohol").
Do not take this medicine if any of the above applies to you.

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking this medicine, as well as during treatment:
if you have a "type 1 diabetes" - the type that typically develops at a young age, and when the body does not produce insulin;
if you have a high concentration of "ketones" in urine or blood, as determined by laboratory tests. This is a sign of "diabetic ketoacidosis" - a problem that can develop in people with diabetes. The signs include rapid weight loss, nausea or vomiting, stomach pain, fast and deep breathing, lethargy, Sweet-smelling breath, sweet or metallic taste in the mouth or a change in the smell of urine and sweat;
if you get "acidosis": metformin, one of the active ingredients of this medicine may cause a rare but serious side effect called "acidosis" (accumulation of lactic acid in the blood), which may lead to death. The signs include nausea or severe nausea, vomiting, abdominal pain, muscle cramps, fatigue or difficulty in breathing. Lactic acidosis is a medical emergency and must be treated in hospital. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking this medicine immediately and immediately contact a doctor or the nearest hospital (see section 4). Take the medicine pack with you;
if you have kidney problems. Your doctor will check your kidney function;
if you have very high levels of blood sugar, which can lead to dehydration (loss of too much fluid). Possible signs of dehydration are listed at the beginning of section 4. If you have any of these symptoms, talk to your doctor before you start taking this medicine;
if you are taking drugs for lowering blood pressure (antihypertensive drugs) or if you have low blood pressure (hypotension). More information is provided below under "Other medicines and Xigduo";
if you had a serious heart condition or if you received a stroke;
or if you experience nausea (feeling sick), vomiting or fever, or if you can not eat or drink liquids. These conditions can cause dehydration. Your doctor may tell you to stop taking this medicine unless recover, not to become dehydrated;
if often develop urinary tract infections. This drug can cause urinary tract infections and your doctor may want to monitor you more closely. Your doctor may decide to temporarily change your treatment if you develop a serious infection;
if you are 75 years or older, you should not start taking this medicine. This is because you may be more prone to some side effects;
if taking another medication for the treatment of diabetes comprising "pioglitazone", you should not start taking this medication;
if you have an increased number of red blood cells found in blood tests;
if you have an operation under anesthesia. You should stop taking Xigduo at least 48 hours before planned surgery with general anesthesia and should not renew at least 48 hours afterwards. Follow your doctor before you stop and resume drug;
if you need to be injected medicine called a 'contrast agent', which contains iodine, ie. before radiography or scanner. You should tell your doctor and stop taking this medicine for a certain period of time and for 2 or more days later, depending on your kidney function. be sure to seek advice from their doctor when to resume treatment.
If any of these apply to you (or you are not sure), talk to your doctor or pharmacist your sister before you start taking this medicine.

renal function
Your kidney function should be checked before you start taking this medicine and to examine at least once a year, while taking it.

Glucose in urine
Because of the way this medicine works in laboratory tests of urine will report a positive result for glucose while taking this medicine.

Children and adolescents
This drug is not recommended for children and adolescents under 18 years of age, because she has not been studied in these patients.

Other medicines and Xigduo
Tell your doctor, pharmacist or nurse if you are taking, you have recently taken or might take any other medicines.

Especially tell your doctor:
if you take water tablets (diuretics). Your doctor may tell you to stop taking this medicine. Possible signs of fluid loss are listed at the beginning of section 4 "Possible side effects";
if you are taking other drugs that lower blood sugar, such as insulin or "sulfonylurea" drug. Your doctor may decide to reduce the dose of these drugs should not be too low blood sugar (hypoglycemia develop);
if taking cimetidine, a medicine used for treating stomach problems;
if using bronchodilators (beta-2 agonists) which are applied for the treatment of asthma;
if the use of corticosteroids, which are used to treat inflammation in diseases such as asthma and arthritis.
Xigduo alcohol
Avoid alcohol consumption, including medicines containing alcohol while taking this medication since alcohol may increase the risk of lactic acidosis (see section 4 "Possible side effects").

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, contact your doctor or pharmacist for advice about taking this medicine. If you become pregnant should stop taking this medicine, since its adoption in second and third trimesters of pregnancy (last six months) is not recommended. Discuss with your doctor the best way for glycemic control during pregnancy.
If you want to breast-feed or breast-feeding, talk to your doctor before you start taking this medicine. Do not use this medicine if you are breastfeeding. It is not known whether this medication passes into breast milk.

Driving and using machines
This medicine or negligible influence on the ability to drive and use machines. Administration of this drug with other drugs that lower blood sugar, insulin, or "sulfonylurea" drug can cause excessive lowering of blood sugar levels (hypoglycemia),
How much to take
The quantity of this drug, which will take varies depending on your condition and the doses of metformin and / or the individual tablets dapagliflozin and metformin, which make the moment. Your doctor will tell you exactly what kind of tablets on drug use;
The recommended dose is one tablet twice daily.
How to take this medicine
Swallow the tablets whole with half a glass of water;
Take the tablet with food. This will reduce the risk of side effects in the stomach;
Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).
Your doctor may prescribe this medicine along with (an) other drug (s) to lower blood sugar. This may be / are as drug (s), which one (s) it is assumed (m) orally and insulin which is administered by injection. Remember to acknowledge and other (s) of drug (s) which (s) you it is / are prescribed (s) from your doctor. This will help to achieve the best results for your health.

Diet and physical activity
To control your diabetes, you should continue to follow a diet and be physically active, even taking this medicine. It is important to keep following the advice of your doctor, pharmacist or nurse about your diet and physical activity. Especially if you follow a diet for weight control in diabetes, you should continue to follow and while taking this medicine.

If you take more than the amount Xigduo
If you take more than the amount Xigduo, you can get lactic acidosis. Symptoms of lactic acidosis include nausea or severe nausea, vomiting, abdominal pain, muscle spasms, severe fatigue and difficulty breathing. If this happens, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking this medicine immediately and immediately contact a doctor or the nearest hospital (see section 4). Take the medicine pack with you.

If you forget to take Xigduo
Do not take a double dose of this medicine to make up the missed dose.

If you stop taking Xigduo
Do not stop taking this medication without first talking to your doctor. Without this medicine, your blood sugar may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
As with all drugs, this drug may cause side effects, although not everyone gets them.

Stop taking Xigduo and as quickly as possible go to the doctor if you notice any of the following serious or potentially serious side effects:
1. lactic acidosis. Metformin, one of the active ingredients in this medicine can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called 'lactic acidosis. " It is the accumulation of lactic acid in the blood, which may cause death. Lactic acidosis is a medical emergency and must be treated in hospital. It particularly affects patients whose kidneys are not working properly.
Signs of "lactic acidosis" are:
nausea or very sick;
vomiting, abdominal pain;
muscle spasms;
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 immediately contact a doctor or nearest hospital. Take the medicine pack with you.

2. Dehydration: excessive loss of fluids from your body, as observed uncommonly (may affect up to 1 in 100 people).
These are signs of dehydration:
severe dry mouth or sticky in the mouth, excessive thirst;
drowsiness or fatigue;
release of too little or no urine;
rapid heartbeat.
Urinary tract infections such as occur commonly (may affect up to 1 in 10 people).
These are signs of a severe urinary tract infection:
fever and / or chills;
burning urination;
pain in the back or buttocks.
While this is not often if you notice blood in your urine, tell your doctor immediately.

4. Low blood sugar (hypoglycaemia), as seen very often (may affect more than 1 in 10 people) - upon reception of this medicine with a sulphonylurea or other drugs that lower blood sugar, such as insulin.
These are the signs of low blood sugar:
trembling, sweating, severe anxiety, rapid heartbeat;
hunger, headaches, changes in vision;
change in mood or confusion.
Your doctor will tell you how to master the lowering of blood sugar and what to do if you have any of the above signs.

Other side effects include:
Very common (may affect more than 1 in 10 people):
nausea, vomiting;
diarrhea or abdominal pain;
loss of appetite.
Common (may affect up to 1 in 10 people):
genital infection (thrush) of the penis or the vagina (signs may include irritation, itching, unusual discharge or odor);
back pain;
separation of a larger quantity of urine of a regular or more frequent urination than usual;
change in the concentration of cholesterol or lipids in your blood (shown by blood test);
change in the number of red blood cells (shown by blood test);
changes in taste;
dizziness.
Uncommon (may affect up to 1 in 100 people):
thirst;
constipation;
night becoming less necessary;
dry mouth;
reduced weight;
changes in laboratory blood parameters (eg. creatinine or urea);
decrease in renal function.
Very rare (may affect up to 1 in 10,000 people):
reduced levels of vitamin B12 in the blood;
abnormal results of liver function tests, liver inflammation (hepatitis);
redness of the skin (hives), itching or an itchy rash (hives).
Adverse event reporting
If you get any side effects, contact your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can do your bit for obtaining more information on the safety of this medicine.

5. How to store Xigduo
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton respectively after "EXP" and "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
Contents of the pack and further information
What Xigduo
The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).
Each film-coated tablet (tablet) Xigduo 5 mg / 850 mg tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Each film-coated tablet (tablet) Xigduo 5 mg / 1000 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1000 mg metformin hydrochloride.

The other ingredients are:
tablet core: hydroxypropylcellulose (E463), microcrystalline cellulose (E460 (i)), magnesium stearate (E470b), sodium starch glycolate;
Film coating of tablet: polyvinyl alcohol (E1203), macrogol 3350 (E1520 (iii)), talc (E553b), titanium dioxide (E171), iron oxide (E172).
Xigduo looks like and contents of the pack
Xigduo 5 mg / 850 mg were 9,5 x 20 mm oval, beige film-coated tablets. From his side have "5/850" on the other - "1067".
Xigduo 5 mg / 1000 mg are 10,5 x 21,5 mm oval, yellow film-coated tablets. On one side are marked "5/1 000" on the other - "1069".

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