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What is Forxiga and what it is used
Forxiga contains the active substance dapagliflozin. It belongs to the group of oral antidiabetic drugs.
These drugs are taken orally to treat diabetes.
They work by lowering blood sugar (glucose).
Forxiga used in adult patients (aged 18 years and above) with a type of diabetes called 'type 2 diabetes mellitus. "Type 2 diabetes is the kind of diabetes that usually develops in adulthood. If you have type 2 diabetes, this means that the pancreas does not produce enough insulin or your body can not utilize insulin, which the pancreas produces in sufficient quantity. This leads to high blood sugar. Forxiga acts as remove excess sugar from your body through urine.
Forxiga used when diabetes can be controlled with the aid of other drugs for diabetes, diet and exercise;
Your doctor may tell you to take only Forxiga, if you have an intolerance to metformin or taking it along with other medicines to treat diabetes. In the second case can be no question of medicines taken orally and / or insulin, which is administered by injection.
It is important to keep following the advice of your doctor or pharmacist your sister about diet and physical activity.
2. What you need to know before taking Forxiga
Do not take Forxiga:
if you are allergic to dapagliflozin 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 when the body does not produce insulin;
if you have a high concentration of "ketones" in urine or blood, as determined in laboratory tests. This is a sign of "diabetic ketoacidosis" - a problem that can develop in people with diabetes and whose signs include rapid weight loss, nausea or vomiting, sweet smell of your breath, sweet or metallic taste in the mouth, or changes in smell 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 you on a lower dose;
if you have a history of serious heart disease or if you have a stroke;
if you take medicines to lower blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). Additional information is provided below under "Other medicines and Forxiga";
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 in section 4, "Possible side effects". If you have any of these symptoms, tell your doctor before you start taking Forxiga;
if you have or develop nausea (feeling sick), 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 he recovers, to not become dehydrated;
if you develop frequent urinary tract infections;
if you are 75 years or older, you should not start taking Forxiga;
if you are taking another medicine to treat diabetes containing pioglitazone should not start taking Forxiga;
if you have an increased number of red blood cells, as determined by a blood test.
If any of these apply to you (or are not sure), talk to your doctor or pharmacist your sister before you start taking Forxiga.
Your kidney function should be assessed before starting and while taking this medicine.
Glucose in the urine
Because of the way the act Forxiga, laboratory urine tests will be reported polozhitelen result of glucose while taking this medicine.
Children and adolescents
Forxiga use in children and adolescents under 18 years of age is not recommended because not been studied in these patients.
Other medicines and Forxiga
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or, adopt other medicines.
Especially tell your doctor:
if you are taking water tablets (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 are taking other medicines that lower blood sugar as insulin or "sulfonylurea" derivatives. Your doctor may decide to reduce the dose of these drugs should not be too low blood sugar (hypoglycemia may develop).
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice about taking this medicine. If you become pregnant, you should stop taking this medicine, since its adoption in the second and third trimesters of pregnancy is not recommended. Discuss with your doctor the best way to 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 Forxiga, if you are breastfeeding. It is not known whether humans this medicine passes into breast milk.
Driving and using machines
Forxiga no or negligible influence on the ability to drive and use machines. Taking this medicine with other medicines called sulphonylureas or insulin may cause excessive lowering of blood sugar levels (hypoglycemia), which can cause the development of symptoms such as shaking, sweating and change in vision, and can affect the ability to drive and use machines. Do not drive or operate any tools or machines if while taking Forxiga feel dizzy.
Forxiga contains lactose
Forxiga contains lactose (milk sugar). If your doctor has said that you have an intolerance to some sugars, contact your doctor before you start taking this medicine.
3. How to take Forxiga
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor, pharmacist or nurse.
How much to take
The recommended dose is one 10 mg tablet daily.
Your doctor may start you on a dose of 5 mg, if you have liver problems.
Your doctor will prescribe the best dose for 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 the tablet at any time of day. However, try to take it at the same time. This will help you remember to take it.
Your doctor may prescribe Forxiga together with (an) other drug (s) to lower blood sugar. This can is (are) as well as drug (s), which (i) it is assumed (m) through the mouth and the insulin which is administered by injection. Remember to take another (and) it (is) medicine (a) what (i) it is you (are) prescribed (s) by 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 while taking this medicine. It is important to keep following the advice of your doctor or pharmacist your sister about diet and physical activity. Especially if you follow a diet for weight control in diabetes, you should continue to follow and while taking Forxiga.
If you take more dose Forxiga
If you take more dose Forxiga, talk to a doctor or go to hospital. Take the medicine pack with you.
If you forget to take Forxiga
What should you do if you forget to take a tablet depends on how long it is until your next dose.
If your next dose is 12 or more hours, take your dose Forxiga soon as you remember. Then take your next dose at the usual time;
If your next dose is less than 12 hours, skip the missed dose. Then take your next dose at the usual time;
Do not take a double dose Forxiga, to make up the missed dose.
If you stop taking Forxiga
Do not stop taking Forxiga, without first talking to your doctor. Without this medicine your blood sugar may be increased.
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 everybody gets them.
Stop taking Forxiga and as quickly as possible go to the doctor if you notice any of these serious side effects:
excessive loss of fluids (dehydration), as observed infrequently. Signs of dehydration include:
severe dry mouth or sticky mouth, thirst;
feeling drowsy or tired;
separation of very little or no urine;
urinary tract infections, as seen often. Signs of severe urinary tract infection are:
fever and / or chills;
burning when urinating;
pain in the back or side.
While this is not often, if you notice blood in your urine, tell your doctor immediately.
As quickly as possible to contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):
low blood sugar (hypoglycaemia) - when taking this medicine together with a sulphonylurea or insulin. Signs of low blood sugar are:
trembling, sweating, severe anxiety, fast heartbeat;
hunger, headache, vision changes;
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 while taking Forxiga:
Common (may affect up to 1 in 10 people):
genital infection of the penis or the vagina (the symptoms may include irritation, itching, unusual discharge or odor);
release more urine than usual or frequent urination than usual;
change in the concentration of cholesterol or fats in your blood (shown in blood tests);
change in the number of red blood cells (shown in blood tests);
Uncommon (may affect up to 1 in 100 people):
night becoming less necessary;
changes in laboratory blood tests (e.g.,. creatinine or urea);
decrease in renal function.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on 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 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 required. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is dapagliflozin.
Each film-coated tablet (tablet) Forxiga dapagliflozin 5 mg contains propanediol monohydrate equivalent to 5 mg dapagliflozin.
Each film-coated tablet (tablet) Forxiga dapagliflozin 10 mg contains propanediol monohydrate equivalent to 10 mg dapagliflozin.
Other ingredients are:
tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see. point 2 "Forxiga contains lactose '), crospovidone (E1201), silicon dioxide (E551), magnesium stearate (E470b);
film-coated tablet: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), iron oxide yellow (E172).
Forxiga looks like and contents of the pack
Forxiga film-coated tablets of 5 mg are yellow, round with a diameter of 0.7 cm. On one side are marked "5" on the other - "1427".
The film-coated tablets Forxiga 10 mg tablets are yellow, octagonal, with bevelled edges, with diagonals approximately 1,1 and 0,8 cm. On one side are marked "10" on the other - "1428".
Forxiga tablets 5 mg and 10 mg Forxiga are available in aluminum blister packs of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and packs of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
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