Forxiga 5 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Forxiga is and what it is used for
2. What you need to know before you take Forxiga
3. How to take Forxiga
4. Possible side effects
5. How to store Forxiga
6. Contents of the pack and other information

What Forxiga is

Forxiga contains the active substance dapagliflozin. It belongs to a group of medicines called “oral anti-diabetics”.

• These are medicines taken by mouth for diabetes.
• They work by lowering the amount of sugar (glucose) in your blood.

Forxiga is used in adult patients (aged 18 years and older).

What Forxiga is used for

Forxiga is used for the types of diabetes called:

• type 1 diabetes – where your body hardly produces any insulin. Forxiga should only be used in type 1 diabetes patients who are overweight or obese.
• type 2 - diabetes where your body does not make enough insulin or is not able to use the insulin it produces properly.

In both types of diabetes, this leads to a high level of sugar in your blood. Forxiga works by removing excess sugar from your body via your urine. If you have type 2 diabetes, it can also help prevent heart disease.

Forxiga and other diabetes medicines

Type 1 diabetes:

• Forxiga is used if your type 1 diabetes cannot be controlled with insulin alone.
• Forxiga is used together with insulin.

Type 2 diabetes:

• Forxiga is used if your type 2 diabetes cannot be controlled with diet and exercise.
• Your doctor may ask you to take Forxiga:
  • on its own - if you cannot tolerate metformin.
  • together with other medicines 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 Forxiga:

• if you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Contact a doctor or the nearest hospital straight away:

• If you experience feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, or rapid weight loss.
• The above symptoms could be a sign of “diabetic ketoacidosis” – a serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
• The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
• When you are treated with Forxiga, diabetic ketoacidosis can occur even if your blood sugar is normal.
• The risk of getting diabetic ketoacidosis is different in the two types diabetes:
  • in type 2 diabetes it is rare.
  • in type 1 diabetes the risk is higher - this is because your body hardly produces any insulin, and diabetic ketoacidosis may occur at sudden decreases in insulin dose (such as missed insulin injections, or issues with your insulin pen or pump).

If you have type 1 diabetes:

• Talk with your doctor about the risk of diabetic ketoacidosis before you start to take Forxiga.
• Your doctor will tell you when you may need to measure ketones in your blood or urine and what you need to do when your ketone levels are raised:
  • At blood ketone readings from 0.6 to 1.5 mmol/L (or urine ketones reading +) you may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates. Measure your ketone levels again in 2 hours. Seek medical advice immediately and stop taking Forxiga if levels persist and symptoms present.
  • At blood ketone readings over 1.5 to 3.0 mmol/L (or urine ketones reading ++) you may be developing diabetic ketoacidosis, seek medical advice immediately and stop taking Forxiga. You may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates. Measure your ketone levels again in 2 hours.
  • At blood ketone readings over 3.0 mmol/L (or urine ketones reading +++) you probably have diabetic ketoacidosis, go to the emergency department without delay and stop taking Forxiga. You may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates.

If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital straight away and do not take 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.

Talk to your doctor, pharmacist or nurse before taking Forxiga:

• if you have a kidney problem – your doctor may ask you to take a different medicine.
• if you have a liver problem.
• if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). More information is given below under ‘Other medicines and Forxiga’.
• if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). Possible signs of dehydration are listed at the top of section 4. Tell your doctor before you start taking Forxiga if you have any of these signs.
• if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
• if you often get infections of the urinary tract.

Like for all diabetic patients 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 Forxiga.

Kidney function

Your kidneys should be checked before you start taking and whilst you are on this medicine.

Urine glucose

Because of how Forxiga works, your urine will test positive for sugar while you are on this medicine.

Children and adolescents

Forxiga is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.

Other medicines 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 a medicine used to remove water from the body (diuretic). Your doctor may ask you to stop taking Forxiga. Possible signs of losing too much fluid from your body are listed at the top of section 4.
• if you have type 2 diabetes and are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypoglycaemia).

If you are taking Forxiga for type 1 diabetes, it is important that you keep using insulin.

Pregnancy and breast-feeding

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 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. Do not use Forxiga if you are breast-feeding. It is not known if this medicine passes into human breast milk.

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 with insulin can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.

Do not drive or use any tools or machines, if you feel dizzy taking Forxiga.

Forxiga contains lactose

Forxiga contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How much to take

If you are taking Forxiga for type 2 diabetes:

• The recommended dose is one 10 mg tablet each day.
• Your doctor may start you on a 5 mg dose if you have a liver problem.
• Your doctor will prescribe the strength that is right for you.

If you are taking Forxiga for type 1 diabetes:

• The recommended dose is one 5 mg tablet each day.

Taking this medicine

• Swallow the tablet 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 the day. However, try to take it at the same time each day. This will help you to remember to take it.

Your doctor may prescribe Forxiga together with other medicine(s) to lower the amount of sugar in your blood. Remember to take these other medicine(s) as your doctor has told you. This will help get the best results for your health.

Diet and exercise can help your body use its blood sugar better. It is important to stay on any diet and exercise program recommended by your doctor while taking Forxiga.

If you take more Forxiga than you should

If you take more Forxiga tablets than you should, talk to a doctor or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Forxiga

What to do if you forget to take a tablet depends on how long it is until your next dose.

• If it is 12 hours or more until your next dose, take a dose of Forxiga as soon as you remember. Then take your next dose at the usual time.
• If it is less than 12 hours until your next dose, 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 talking to your doctor first. Your blood sugar may increase without this medicine.

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

• angioedema, seen very rarely (may affect up to 1 in 10,000 people).

These are signs of angioedema:

• swelling of the face, tongue or throat
• difficulties swallowing
• hives and breathing problems

• diabetic ketoacidosis, this is common in patients with type 1 diabetes (may affect up to 1 in 10 people) and rare in patients with type 2 diabetes (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 your urine or blood
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat
• rapid weight loss.

This may occur regardless of blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with Forxiga.

• necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.

Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:

• loss of too much fluid from your body (dehydration), seen uncommonly (may affect up to 1 in 100 people).

These are signs of dehydration:

• very dry or sticky mouth, feeling very thirsty
• feeling very sleepy or tired
• passing little or no water (urine)
• fast heartbeat.

• urinary tract infection, seen commonly (may affect up to 1 in 10 people).

These are signs of a severe infection of the urinary tract:

• fever and/or chills
• burning sensation when passing water (urinating)
• pain in your back or side.

Although uncommon, if you see blood in your urine, tell your doctor immediately.

Contact your doctor as soon as possible if you have any of the following side effects:

Very common (may affect more than 1 in 10 people)

• low blood sugar levels (hypoglycaemia) - when taking this medicine with a sulphonylurea or insulin

These are the signs of low blood sugar:

• shaking, sweating, feeling very anxious, fast heart beat
• feeling hungry, headache, change in vision
• a change in your mood or feeling confused.

Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.

Other side effects when taking Forxiga:

Common

• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• passing more water (urine) than usual or needing to pass water more often
• changes in the amount of cholesterol or fats in your blood (shown in tests)
• increases in the amount of red blood cells in your blood (shown in tests)
• decreases in creatinine renal clearance (shown in tests) in the beginning of treatment
• dizziness
• rash

Uncommon

• thirst
• constipation
• awakening from sleep at night to pass urine
• dry mouth
• weight decreased
• increases in creatinine (shown in laboratory blood tests) in the beginning of treatment
• increases in urea (shown in laboratory blood tests)

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

What Forxiga contains

• The active substance is dapagliflozin.
  Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
• The other ingredients are:
  • tablet core: microcrystalline cellulose (E460i), lactose (see section 2 ‘Forxiga contains lactose’), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
  • film-coating: polyvinyl alcohol (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 and round with diameter of 0.7 cm. They have “5” on one side and “1427” on the other side.

Forxiga 5 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Manufacturer