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What Forxiga is and what it is used for
Forxiga contains the active substance dapaglyflozin. It belongs to the group of oral antidiabetes medicines.
These medicines are taken orally to treat diabetes.
They act by lowering blood sugar (glucose).
Forxiga is used in adults (over 18 years of age) with a type of diabetes called "type 2 diabetes mellitus". Diabetes mellitus type 2 is the type of diabetes that usually develops in adulthood. If you have type 2 diabetes, it means your pancreas does not produce enough insulin, or your body can not use the insulin that produces the pancreas in sufficient quantity. This leads to an increase in blood sugar. Forxiga works by removing excess sugar from your body through the urine.
Forxiga is used when diabetes can not be controlled with other medicines for diabetes, diet and physical activity;
Your doctor may tell you to take Forxiga only if you are intolerant to metformin or take it with other medicines to treat diabetes. In the latter case, it may be oral and / or insulin-administered medicines that are given by injection.
It is important to continue to follow the advice of your doctor, pharmacist or nurse about your diet and physical activity.
2. What you need to know before taking Forxiga
Do not take Forxiga:
If you are allergic to dapaglyflozine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Forxiga:
If you have type 1 diabetes, the type that usually develops at a young age and where your body does not produce insulin;
If you have an increased concentration of "ketotela" in the urine or blood that is found in laboratory tests. This is a sign of "diabetic ketoacidosis" - a problem that may develop in people with diabetes and whose features include rapid weight loss, nausea or vomiting, sweet smell of the breath, sweet or metallic taste in the mouth, or a change in the smell of Urine or sweat;
If you have kidney problems - your doctor may tell you to take another medicine;
If you have liver problems - then your doctor may start treatment with a lower dose;
If you have a history of serious heart disease or if you have a stroke;
If you are taking medicines to lower your blood pressure (antihypertensive medicines) or have a history of low blood pressure (hypotension). Additional information is provided below under "Other Drugs and Forxiga";
If you have very high blood sugar levels, which can lead to dehydration (loss of too much fluid). Possible signs of dehydration are listed at the beginning of section 4, "Possible Side Effects". If you have any of these signs, tell your doctor before taking Forxiga;
If you have or develop nausea (vomiting), vomiting or fever, or if you can not eat or drink fluids. These conditions can cause dehydration. Your doctor may tell you to stop taking Forxiga until you recover so that you do not become dehydrated;
If you frequently develop urinary tract infections;
If you are 75 years of age or older, you should not start taking Forxiga;
If you are taking another medicine to treat diabetes containing pioglitazone, you should not start taking Forxiga;
If you have an increased number of red blood cells, which is detected by a blood test.
If any of these apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Forxiga.
Your kidney function should be evaluated before you start taking this medicine.
Glucose in the urine
Because of the way Forxiga works, your laboratory urine test will report a beneficial result for glucose while you are taking this medicine.
Children and adolescents
The use of Forxiga in children and adolescents under 18 years of age is not recommended because it has not been studied in these patients.
Other Drugs and Forxiga
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Especially tell your doctor:
If you are taking drainage medicines (diuretics). Your doctor may tell you to stop taking Forxiga. Possible signs of fluid loss are listed at the beginning of section 4 "Possible side effects";
If you take other medicines that lower blood sugar like insulin or "sulphonylureas". Your doctor may decide to reduce the dose of these medicines in order not to lower your blood sugar too much (develop hypoglycaemia).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice on taking this medicine. If you become pregnant, you should stop taking this medicine because its ingestion during the second and third trimesters of pregnancy is not recommended. Discuss with your doctor the best way to get glycemic control during pregnancy.
If you want to breast-feed or breast-feed, talk to your doctor before taking this medicine. Do not use Forxiga if you are breast-feeding. It is not known whether this drug passes into breast milk in humans.
Driving and using machines
Forxiga has no or negligible influence on the ability to drive and use machines. Taking this medicine with other medicines, called sulphonylureas or insulin, can cause excessive blood sugar (hypoglycaemia) that causes symptoms such as trembling, sweating, and vision changes and may affect the ability You can drive and operate machines. Do not drive or operate instruments or machines if you experience dizziness while taking Forxiga.
Forxiga contains lactose
Forxiga contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Forxiga
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist or nurse.
How much to take
The recommended dose is one 10 mg tablet per day.
Your doctor may start treatment with a dose of 5 mg if you have liver problems.
Your doctor will prescribe the dose best suited to you.
How to take this medicine
Swallow the tablets whole with half a glass of water.
You can take your tablet with or without food.
You can take your tablet at any time of the day. However, try to take it at the same time. This will help you remember to take it.
Your doctor may prescribe Forxiga with another medicine (s) to lower your blood sugar. This may be either drug (s), which is taken orally, or insulin injected. Do not forget to take another medicine (s) that have been prescribed by your doctor. This will help you achieve the best for your health.
Diet and physical activity
To control your diabetes, you must continue to maintain a diet and be physically active, even if you are taking this medicine. Therefore, it is important to continue to follow the advice of your doctor, pharmacist or nurse about your diet and physical activity. Especially if you follow a diabetes control diet, you must continue to follow it while taking Forxiga.
If you take more than the prescribed dose of Forxiga
If you take more Forxiga than you should, talk to a doctor or go to hospital immediately. Take the medicine pack with you.
If you forget to take Forxiga
What you should do if you forget to take a tablet depends on how long it is until your next dose.
If your next dose remains for 12 hours or more, take your dose of Forxiga as soon as you remember. Then take your next dose at the usual time;
If your next dose remains less than 12 hours, skip the missed dose. Then take your next dose at the usual time;
Do not take a double dose of Forxiga to make up for a forgotten dose.
If you stop taking Forxiga
Do not stop taking Forxiga without first speaking 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
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Forxiga and go to the doctor as soon as possible if you notice any of the following serious side effects:
Excessive fluid loss (dehydration), which is uncommonly observed. Signs of dehydration are:
Strong dry mouth or mouth glue, strong thirst;
Drowsiness or tiredness;
Too little or no urine;
Accelerated cardiac activity;
Urinary tract infections that are commonplace. Signs of severe urinary tract infection are:
Fever and / or chills;
Burning while urinating;
Back or hip pain.
Although this is not common if you notice blood in your urine, tell your doctor immediately.
Contact your doctor as soon as possible if you get any of the side effects listed below:
Very common (may affect more than 1 in 10 people):
Lowering of blood sugar (hypoglycaemia) - when taking this medicine together with a sulphonylurea or insulin. Signs of lowering blood sugar are:
Trembling, sweating, severe anxiety, rapid heartbeat;
Hunger, headache, changes in vision;
Mood swings or confusion.
Your doctor will tell you how to control your blood sugar lowering and what to do if you have any of the signs listed above.
Other side effects with Forxiga:
Common (may affect up to 1 in 10 people):
Genital infection of the penis or vagina (signs may include irritation, itching, abnormal secretion or odor);
Generating more urine than usual or more frequent urination than usual;
A change in the concentration of cholesterol or fat in your blood (detected by a blood test);
A change in your red blood cell count (detected by a blood test);
Uncommon (may affect up to 1 in 100 people):
Night-time in need;
Changes in laboratory blood counts (eg creatinine or urea);
Decreased renal function.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Forxiga
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister or carton 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 medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Forxiga contains
The active substance is dapaglifosin.
Each Forxiga 5 mg film-coated tablet (tablet) contains dapangliosin propanediol monohydrate, equivalent to 5 mg dapaglifosin.
Each Forxiga 10 mg film-coated tablet (tablet) contains dapaglifosin propanediol monohydrate equivalent to 10 mg dapaglifosin.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 "Forxiga contains lactose"), crospovidone (E1201), silicon dioxide (E551), magnesium stearate (E470b);
Film coating of the tablet: polyvinylalcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172).
What Forxiga looks like and contents of the pack
Forxiga 5 mg film-coated tablets are yellow, round, 0.7 cm in diameter. On one side they have the inscription "5" and on the other side "1427".
Forxiga 10 mg film-coated tablets are yellow, octagonal, bevelled, with diagonals of approximately 1.1 and 0.8 cm. On one side they have the inscription "10" and on the other side "1428".
Forxiga 5 mg and Forxiga 10 mg tablets are supplied in aluminum blisters of 14, 28 or 98 film-coated tablets in unperforated calendar blisters and in packs of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Not all packs may be marketed in your country.
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