Forxiga 5 mg film-coated tablets
dapagliflozin

1. What Forxiga is and what it is used for

What Forxiga is

Forxiga contains the active substance dapagliflozin. It belongs to a group of medicines called ‘sodium-glucose transporter (SGLT2)’ inhibitors’. They work by blocking the SGLT2‑ protein in your kidneys. By blocking this protein, blood sugar ( glucose ), salt ( sodium ), and water are removed from your body via the urine.

What Forxiga is used for

Forxiga is used in adult patients (18 years and older) to treat:

  • Type 1 diabetes:
    • in overweight or obese patients
    • if your type 1 diabetes cannot be controlled with insulin alone.
    • Forxiga is used with insulin.
  • Type 2 diabetes:
    • if your type 2 diabetes cannot be controlled with diet and exercise.
    • Forxiga can be used alone or in combination with other medicines to treat diabetes.
    • It is important to continue to follow the advice on diet and exercise that you have received from your doctor, pharmacist, or nurse.
  • Heart failure
    • in patients with symptoms due to weak pumping function of the heart.

What is diabetes and how can Forxiga help?

There are 2 types of diabetes:

  • In type 1 diabetes, your body produces almost no insulin.
  • In type 2 diabetes, your body does not produce enough insulin or cannot use the insulin that is formed properly.
  • In both types of diabetes, this leads to a high blood sugar level. This can lead to serious problems such as heart or kidney disease, blindness, and poor circulation in your arms and legs.
  • Forxiga works by removing excess sugar from your body. If you have type 2 diabetes, it can also help prevent heart disease.

What is heart failure and how can Forxiga help?

  • This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. This can lead to serious medical problems and the need for hospital care.
  • The most common symptoms of heart failure are shortness of breath, feeling tired or very tired all the time, and swollen ankles.
  • Forxiga helps protect your heart from getting weaker and improves your symptoms. It can reduce the need to go to the hospital and can help some patients live longer.

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 cautions

Contact a doctor or nearest hospital immediately:

Diabetic ketoacidosis:

  • If you have diabetes and experience nausea or vomiting, abdominal pain, thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet taste or metallic taste in the mouth, a different smell of urine or sweat, or rapid weight loss.
  • The above symptoms may be signs of “diabetic ketoacidosis” – a serious, sometimes life-threatening problem that you can get in diabetes due to increased levels of “ketone bodies” in the urine or blood. This is shown in tests.
  • The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, a sudden decrease in insulin dose, or a greater need for insulin due to major surgery or a serious illness.
  • When you are treated with Forxiga, diabetic ketoacidosis can occur even if your blood sugar level is normal.
  • The risk of developing diabetic ketoacidosis is different for the two types of diabetes:
    • in type 2 diabetes it is uncommon.
    • with type 1 diabetes the risk is higher – this is because your body produces almost no insulin at all and diabetic ketoacidosis can occur with sudden decreases in insulin dose (such as missed insulin injections or problems with your insulin pen or an insulin pump).

If you have type 1 diabetes:

  • Talk to your doctor about the risk of diabetic ketoacidosis before you start using Forxiga.
  • Your doctor will tell you when you may need to measure ketones in your blood or urine and what to do when your ketone levels are elevated:
    • For blood ketone measurements between 0.6 and 1.5 mmol / l (or urine ketone measurement +) you may need to take extra insulin, drink water, and if your blood sugar level is normal or low, you may need to eat carbohydrates. Measure your ketone levels again after two hours. Seek immediate medical attention and stop taking Forxiga if levels persist and symptoms occur.
    • With blood ketone measurements between 1.5 and 3.0 mmol / l (or urinary ketone measurement ++), you may be on the verge of developing diabetic ketoacidosis. Seek medical advice immediately and stop taking Forxiga. You may need to take extra insulin, drink water, and if your blood sugar level is normal or low, you may need to eat carbohydrates. Measure your ketone levels again after two hours.
    • For blood ketone measurements above 3.0 mmol / l (or urinary ketone measurement +++), you probably have diabetic ketoacidosis. Go immediately to the emergency room and stop taking Forxiga. You may need to take extra insulin, drink water, and if your blood sugar level is normal or low, you may need to eat carbohydrates.

If you suspect you have diabetic ketoacidosis, contact your doctor or nearest hospital immediately and do not take this medicine.

Necrotizing fasciitis in the perineum:

  • Talk to your doctor immediately if you experience a combination of symptoms such as pain, soreness, redness, or swelling in the genitals or the area between the genitals and the rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case 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.

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

  • If you have diabetes and kidney problems – your doctor may ask you to take additional or different medicine to control your blood sugar.
  • if you have type 1 diabetes and heart failure – your doctor may ask you to take another medicine for your heart failure.
  • if you have liver problems.
  • if you are taking medicines that lower blood pressure (blood pressure-lowering drugs) and have had 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 that can cause you to become dehydrated (lose too much body fluid). Possible symptoms of dehydration are listed in section 4. Tell your doctor before you start taking Forxiga if you have any of these signs.
  • if you get nausea, vomiting, or fever or if you can not eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Forxiga until you have recovered to prevent dehydration.
  • if you often get urinary tract infections.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking Forxiga.

Diabetes and foot care

If you have diabetes, it is important to check your feet regularly and follow the advice on foot care provided by healthcare professionals.

Renal function

If you have diabetes, your kidneys should be checked before you start and while you are taking this medicine.

Sugar in the urine

Because of the effect of Forxiga, your urine will show positive test results for sugar when you take this medicine.

Children and young people

Forxiga is not recommended for use in children and adolescents below 18 years of age, as 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.

In particular, tell your doctor:

  • if you are taking a medicine that is used to remove fluid from the body ( diuretics ).
  • if you have type 2 diabetes and are taking other medicines that lower your blood sugar, such as insulin or medicine containing ‘sulphonylureas’. Your doctor may want to lower the dose of one of the other medicines to prevent you from getting low blood sugar (hypoglycemia).

If you are taking Forxiga for type 1 diabetes, you must continue to use insulin.

Pregnancy and breastfeeding

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, as it is not recommended during the second and third trimesters of pregnancy (last six months of pregnancy). Talk to your doctor about the best way to control your blood sugar when you are pregnant.

Talk to your doctor if you want to breast-feed or breast-feeding before taking this medicine. Do not use Forxiga if you are breast-feeding. It is not known if this medicine passes into breast milk.

Driving and using machines

Forxiga has no or negligible effect on the ability to drive and use machines.

Taking this medicine with other medicines called sulphonylureas or with insulin may cause low blood sugar (hypoglycemia), which may cause symptoms such as shaking, sweating, and altered vision and affect your ability to drive and use machines.

Do not drive or use any tools or machines if you feel dizzy while 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.

3. How to take Forxiga

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How much to take

If you are taking Forxiga for type 1 diabetes:

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

If you are taking Forxiga for type 2 diabetes or heart failure:

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

Take this medicine

• Swallow the tablet whole with half a glass of water.

• You can take the 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. It will help you remember to take it.

Your doctor may prescribe Forxiga with other medicines. Remember to take these other medicines according to your doctor’s instructions. It gives the best result for your health.

Diet and exercise can help your body make better use of blood sugar. If you have diabetes, you must continue to follow the diet and exercise programs recommended by your doctor during the time you are taking Forxiga.

If you take more Forxiga than you should

If you have taken too many Forxiga tablets, 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 much time is left until the next dose.

  • If it is 12 hours or more until you take the next dose, take one dose of Forxiga as soon as you remember. Then take the next dose at the usual time.
  • If it is less than 12 hours until you take the next dose, skip the missed dose. Then take the 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. If you have diabetes, your blood sugar may rise if you do not take this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or nearest hospital immediately if you get any of the following side effects:

  • angioedema is very rare (may affect up to 1 in 10,000 people). These are the signs of angioedema:
    • swelling of the face, tongue, or throat
    • difficulty swallowing
    • hives and difficulty breathing
  • Diabetic ketoacidosis – this is common in patients with type 1 diabetes (may occur in up to 1 in 10 people) and rare in patients with type 2 diabetes (may occur in up to 1 in 1,000 people). These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
    • elevated levels of “ketone bodies” in the urine or blood
    • nausea or vomiting
    • abdominal pain
    • strong thirst
    • rapid and deep breathing
    • confusion
    • unusual drowsiness or fatigue
    • a sweet smell on the breath, a sweet taste or metallic taste in the mouth, or a different smell of urine or sweat.
    • rapid weight loss

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

  • necrotizing fasciitis of the perineum or Fournier’s gangrene, a severe soft tissue infection of the genitals or the area between the genitals and the rectum, is very rare.

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

  • urinary tract infection is common (may affect up to 1 in 10 people). The following are symptoms of severe urinary tract infection:
    • fever and/or chills
    • burning sensation when urinating (urination)
    • back or side pain.

Although unusual, tell your doctor immediately if you notice any blood in your urine.

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

  • low blood sugar levels (hypoglycemia), this is very common (may affect more than 1 in 10 people) in patients with diabetes who take this medicine with sulphonylureas or insulin. The following are symptoms of low blood sugar:
    • tremors, sweating, strong anxiety, rapid heartbeat
    • feeling hungry, headache, vision changes
    • mood swings or feelings of confusion.

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

Other side effects when using Forxiga:

Usual

  • genital infection (cod) on the penis or vagina (may cause irritation, itching, abnormal discharge, or odor)
  • back pain
  • the greater amount of urine than usual or need to urinate more often
  • changes in blood cholesterol or blood fat levels (shown in tests)
  • increases in the number of red blood cells in the blood (shown in tests)
  • reduction of creatinine clearance, a measure of renal function (shown in tests) at the beginning of treatment
  • dizziness
  • rash

Uncommon (may affect up to 1 in 100 people)

  • loss of too much fluid from your body ( dehydration, signs may include the very dry or sticky mouth, urinating little or nothing at all, or rapid heartbeat
  • thirst
  • constipation
  • waking up at night to pee
  • dry mouth
  • weight loss
  • increase in creatinine (shown by laboratory blood tests) at the beginning of treatment
  • increase in urea (shown by laboratory blood tests)

5. How to store Forxiga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via 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 packaging and other information

Content declaration

  • The active substance is dapagliflozin. Each Forxiga 5 mg film-coated tablet (tablet) contains a dapagliflozin-propanediol monohydrate equivalent to 5 mg dapagliflozin.
  • Other ingredients are:
    • tablet core: microcrystalline cellulose (E460i), lactose (see section 2 “Forxiga contains lactose”), crospovidone (E1202), silica (E551), magnesium stearate (E470b).
    • film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Forxiga 5 mg film-coated tablets are yellow and round with a diameter of 0.7 cm. They have “5” on one side and “1427” on the other side.

Forxiga 5 mg tablets are available in aluminum blisters in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and 30×1 or 90×1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

SK10 2NA

UK

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11
LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 (2) 44 55 000
Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111
HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62
MaltaAssociated Drug Co. Ltd.Tel: + 356 2277 8000
GermanyAstraZeneca GmbHTel: + 49 41 03 7080
The NetherlandsAstraZeneca BVTel: + 31 79 363 2222
EestiAstraZenecaTel: + 372 6549 600 NorwayAstraZeneca ASTel: + 47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: + 30 2 106871500 AustriaAstraZeneca Österreich GmbHTel: + 43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00
PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000
RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100
SloveniaAstraZeneca UK LimitedTel: + 386 1 51 35 600
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: + 421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1
Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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