Forxiga

Package leaflet: Information for the user

Forxiga 5 mg film-coated tablets, 10 mg film-coated tablets

dapagliflozin
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Forxiga is and what it is used for

What Forxiga is
Forxiga contains the active substance dapagliflozin. It belongs to a class of medicines called
"sodium-glucose co-transporter 2 (SGLT2) inhibitors". These work by blocking the
SGLT2 protein in the kidneys. By blocking this protein, sugar in the blood (glucose),
salt (sodium), and water are removed from the body through the urine.

What Forxiga is used for
Forxiga is used to treat:

• Type 2 diabetes
  • In adults and children aged 10 years and older.
  • When type 2 diabetes cannot be controlled by diet and exercise.
  • Forxiga can be used alone or together with other medicines to treat diabetes.
  • It is important to continue following your doctor’s, pharmacist’s, or nurse’s advice on diet and exercise.
• Heart failure
  • In adults (aged 18 years and older) when the heart does not pump blood as well as it should.
• Chronic kidney disease
  • In adults with reduced kidney function.

What is diabetes and how can Forxiga help?

• In type 2 diabetes, the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high levels of sugar in the blood. This can result in serious problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
• Forxiga works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Forxiga help?

• This type of heart failure occurs when the heart does not pump blood to the lungs and the rest of the body as effectively as it should. This can lead to serious medical problems and the need for hospital treatment.
• The most common symptoms of heart failure are shortness of breath, feeling tired or very tired all the time, and swelling in the ankles.
• Forxiga helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalisation and may help some patients live longer.

What is chronic kidney disease and how can Forxiga help?

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they are unable to clean and filter the blood as they should. Loss of kidney function can lead to serious medical problems and the need for hospital treatment.
• Forxiga helps protect the kidneys from further loss of function. This may 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Contact your doctor or nearest hospital immediately
Diabetic ketoacidosis:

• If you have diabetes and experience nausea or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual tiredness, sweet-smelling breath, sweet or metallic taste in the mouth, or a different smell of urine or sweat, or rapid weight loss.
• The above symptoms may be signs of diabetic ketoacidosis, a rare but serious condition that can sometimes be life-threatening, caused by diabetes due to increased levels of "ketone bodies" in the urine or blood, detectable by laboratory tests.
• The risk of developing diabetic ketoacidosis may be increased by prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirements due to major surgery or serious illness.
• When being treated with Forxiga, diabetic ketoacidosis can occur even if blood sugar levels are normal. If you suspect you have diabetic ketoacidosis, contact your doctor or nearest hospital immediately and do not take this medicine.

Necrotizing fasciitis of the perineum:

• Seek medical advice immediately if you notice a combination of symptoms such as pain, tenderness, redness or swelling of the genitals or the area between the genitals and the anus, accompanied by fever or general malaise. These symptoms may indicate a rare but serious and potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys subcutaneous tissue.
  Fournier's gangrene requires immediate treatment.
  Talk to your doctor, pharmacist, or nurse before taking Forxiga

• if you have "type 1 diabetes"—the type of diabetes that usually develops at a young age and in which the body produces no insulin. Forxiga must not be used to treat this condition.

• if you have diabetes and have kidney problems—the doctor may prescribe an additional or different medicine to control blood sugar levels.

• if you have liver problems—the doctor may start you on a lower dose.

• if you are taking medicines to lower blood pressure (antihypertensives) and have previously experienced low blood pressure (hypotension). Further information is provided in section “Other medicines and Forxiga” below.

• if you have very high blood sugar levels that may lead to dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Forxiga if you have any of these signs.

• if you have or develop nausea (feeling unwell), vomiting, or fever, or if you are unable to eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.

• if you frequently have urinary tract infections.

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or
nurse before taking Forxiga.
Diabetes and foot care
If you have diabetes, it is important to regularly check your feet and follow any other foot care advice
provided by healthcare professionals.
Glucose in urine
Due to the mechanism of action of Forxiga, urine tests will show the presence of
sugar during treatment with this medicine.
Children and adolescents
Forxiga can be used in children aged 10 years and older for the treatment of type 2 diabetes.
Data are not available in children under 10 years of age.
Forxiga is not recommended for children and adolescents under 18 years of age for the treatment
of heart failure or chronic kidney disease, as it has not been studied in these patients.
Other medicines and Forxiga
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor:

• if you are taking a medicine to remove water from the body (diuretics).
• if you are taking other medicines that lower blood sugar levels, such as insulin or a medicine containing "sulphonylurea." Your doctor may consider reducing the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).
• if you are taking lithium, because Forxiga may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine. You must
stop taking this medicine if you become pregnant, as Forxiga is not
recommended during the second and third trimesters of pregnancy. Ask
your doctor how best to control blood sugar during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use
Forxiga if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Forxiga has negligible or no effect on the ability to drive or use machines.
Taking this medicine with other medicines called sulphonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which can cause symptoms such as
tremor, sweating, and visual disturbances, and may impair the ability to drive and use
machines.
Do not drive or operate tools or machinery if you experience dizziness while taking Forxiga.
Forxiga contains lactose
Forxiga contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Forxiga

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 once daily.
• Your doctor may start with a 5 mg dose if you have liver problems.
• Your doctor will prescribe the appropriate dose for you.

Taking this medicine

• Swallow the tablet whole with half a glass of water.
• You may take the tablet with or without food.
• You may take the tablet at any time of day. However, try to take it at the same time each day. This will help you remember to take it.

Your doctor may prescribe Forxiga together with other medicines. Remember to take these other medicines as directed by your doctor. This will help you achieve the best health outcomes.
Diet and exercise can help your body use blood sugar more effectively. If you have diabetes, it is important to follow the diet and exercise plan recommended by your doctor while taking Forxiga.
If you take more Forxiga than you should
If you take more Forxiga tablets than you should, contact your doctor immediately or go to the nearest hospital straight away. Take the medicine with you.
If you forget to take Forxiga
If you forget to take a tablet, what you should do depends on how long it is until your next dose.

• If there are 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 there are 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 to make up for a forgotten tablet.

If you stop taking Forxiga
Do not stop taking Forxiga without first talking to your doctor. If you have diabetes, your blood sugar may increase without this medicine.
If you have any questions about using 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.
Contact your doctor or go to the nearest hospital immediately if you experience any of the following
side effects:

• Angioedema, very rare (may occur in up to 1 in 10,000 people). Symptoms of angioedema include:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and breathing difficulties
• Diabetic ketoacidosis, which is rare in patients with type 2 diabetes (may occur in up to 1 in 1,000 people). Symptoms of diabetic ketoacidosis (see also section 2 “Warnings and precautions”) include:
  • increased levels of “ketone bodies” in the urine or blood
  • feeling unwell or being unwell
  • stomach pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • unusual drowsiness or tiredness
  • sweet smell on the breath, sweet or metallic taste in the mouth, or a different smell of urine or sweat
  • rapid weight loss. This may occur regardless of blood sugar levels. Your doctor may decide to temporarily or permanently discontinue treatment with Forxiga.
• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, observed very rarely.

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

• Urinary tract infections, commonly observed (may occur in up to 1 in 10 people). Symptoms of a serious urinary tract infection include:
  • fever and/or chills
  • burning sensation when urinating
  • back or side pain. Although uncommon, if you see blood in your urine, contact your doctor immediately.

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

• Low blood sugar levels (hypoglycaemia), very commonly observed (may occur in more than 1 in 10 people) in patients with diabetes taking this medicine with a sulphonylurea or insulin.

Symptoms of low blood sugar levels include:

• trembling, sweating, feeling very anxious, rapid heartbeat
• feeling of hunger, headache, changes in vision
• mood changes or feeling confused. Your doctor will advise you on how to treat low blood sugar levels and what to do if any of the symptoms listed above occur.

Other side effects when taking Forxiga:
Common

• genital infection (candidiasis) of the penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• increased amount of urine or increased urge to urinate more frequently
• changes in cholesterol or fat levels in the blood (observed in blood tests)
• increase in red blood cells (observed in blood tests)
• decrease in creatinine renal clearance (observed in blood tests) at the beginning of treatment
• dizziness
• rash

Uncommon (may occur in up to 1 in 100 people)

• excessive loss of body fluids (dehydration, signs may include very dry or sticky mouth, reduced or no urine output, or rapid heartbeat)
• thirst
• constipation
• waking up during the night to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the beginning of treatment
• increase in urea (observed in blood tests)

Very rare

• inflammation of the kidneys (tubulo-interstitial nephritis)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 pack and carton after
"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 via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Forxiga contains

• The active substance is dapagliflozin. Each film-coated tablet (tablet) of Forxiga 5 mg contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin. Each film-coated tablet (tablet) of Forxiga 10 mg contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
• The other components 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 (E1521), talc (E553b), yellow iron oxide (E172).

Description of the appearance of Forxiga and the contents of the pack
Forxiga 5 mg film-coated tablets are yellow, round, with a diameter of 0.7 cm. They are marked with “5” on one side and “1427” on the other side.
Forxiga 10 mg film-coated tablets are yellow, diamond-shaped, with a diagonal measuring approximately 1.1 x 0.8 cm. They are marked with “10” on one side and “1428” on the other side.
Forxiga 5 mg tablets are available in aluminum blisters in packs of 14, 28 or 98 film-coated tablets in non-perforated calendar blister packs, and 30x1 or 90x1 film-coated tablets in perforated single-dose blister packs.
Forxiga 10 mg tablets are available in aluminum blisters in packs of 14, 28 or 98 film-coated tablets in non-perforated calendar blister packs, and 10x1, 30x1 or 90x1 film-coated tablets in perforated single-dose blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
SK10 2NA
United Kingdom

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 (2) 44 55 000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2 106871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS OF THE
MARKETING AUTHORISATION

Scientific conclusions
Taking into account the evaluation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Reports (PSURs) for dapagliflozin, the PRAC's scientific conclusions are as follows:
Based on available data on polycythaemia from the literature and spontaneous reports, and considering a plausible mechanism of action, the PRAC considers there is sufficient evidence to justify a causal relationship between dapagliflozin and polycythaemia. The PRAC concluded that the product information for medicinal products containing dapagliflozin should be updated accordingly.
Having reviewed the PRAC's recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the general conclusions and the rationale of the recommendation.

Reasons for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on dapagliflozin, the CHMP considers that the benefit-risk balance of medicinal products containing dapagliflozin remains favourable, subject to the proposed changes to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.