Edistride

Package leaflet: Information for the user

Edistride 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 pass it on to others, even if their symptoms seem identical to yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Edistride is and what it is used for

What Edistride is
Edistride 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 Edistride is used for
Edistride is used to treat:

• Type 2 diabetes
  • In adults aged 10 years and older
  • When type 2 diabetes cannot be controlled by diet and exercise
  • Edistride is 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 it should
• Chronic kidney disease
  • In adults with reduced kidney function

What is type 2 diabetes and how can Edistride 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.
• Edistride works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Edistride help?

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

What is chronic kidney disease and how can Edistride 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 hospitalization.
• Edistride helps protect the kidneys from losing their function. This may help some patients live longer.

2. What you should know before taking Edistride

Do not take Edistride

• 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, unusual odour of urine or sweat, or rapid weight loss.
• The above symptoms may be signs of "diabetic ketoacidosis", a rare but serious condition, which 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 requirement due to major surgery or serious illness.
• When treated with Edistride, diabetic ketoacidosis may 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 immediate medical attention 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 a general feeling of being unwell. 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 Edistride

• if you have "type 1 diabetes" – the type of diabetes that usually develops at a young age and in which the body does not produce insulin. Edistride must not be used to treat this condition.
• if you have diabetes and have kidney problems – your doctor may ask you to take an additional or different medicine to control blood sugar levels.
• if you have liver problems – your 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 below in section “Other medicines and Edistride”.
• if you have very high blood sugar levels that may dehydrate you (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Edistride 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 can lead to dehydration. Your doctor may ask you to stop taking Edistride until you recover to prevent dehydration.
• if you frequently have urinary tract infections. This medicine may cause urinary tract infections, and your doctor may want to monitor you more closely. Your doctor may consider temporarily changing your treatment if a severe infection develops.

If any of the above conditions apply to you (or you are unsure), inform your doctor, pharmacist, or nurse before taking Edistride.
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 Edistride, urine tests will show the presence of sugar during treatment with this medicine.
Elderly (≥ 65 years and older)
If you are elderly, there may be a higher risk of reduced kidney function and of taking other medications (see also “Kidney function” above and “Other medicines and Edistride” below).
Children and adolescents
Edistride can be used in children aged 10 years and above for the treatment of type 2 diabetes.
No data are available in children under 10 years of age.
Edistride 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 Edistride
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 "sulphonylurea". Your doctor may decide to reduce the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).
• if you are taking lithium, because Edistride may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must stop taking this medicine if you become pregnant, as Edistride is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to control your blood sugar during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Edistride if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Edistride has negligible or no effect on the ability to drive or use machines.
Taking this medicine together 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 your ability to drive or use machines.
Do not drive or operate tools or machinery if you experience dizziness while taking Edistride.
Edistride contains lactose
Edistride contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Edistride

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dosage

• 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.

How to take 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 the tablet at the same time each day. This will help you remember to take it.

Your doctor may prescribe Edistride 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 physical exercise can help your body use blood sugars more effectively. If you have diabetes, it is important to follow the diet and physical activity plan recommended by your doctor while taking Edistride.

If you take more Edistride than you should
If you take more Edistride tablets than prescribed, contact your doctor immediately or go to the hospital immediately. Take the medicine with you.

If you forget to take Edistride
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 Edistride 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 the missed dose.

If you stop taking Edistride
Do not stop taking Edistride without first talking to your doctor. If you have diabetes, your blood sugar levels 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 everyone gets them.
Contact your doctor or 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 generally unwell
  • stomach pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • unusual drowsiness or tiredness
  • sweet breath odour, sweet or metallic taste in the mouth, or a different odour 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 Edistride.
• 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 Edistride 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 severe urinary tract infection include:
  • fever and/or chills
  • burning sensation when urinating
  • back or side pain. Although uncommon, if you notice 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 diabetic patients taking this medicine with a sulphonylurea or insulin. Symptoms of low blood sugar include:
  • trembling, sweating, feeling very anxious, rapid heartbeat
  • feeling hungry, 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 Edistride:
Common

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

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

• fungal infection
• excessive loss of body fluids (dehydration; signs may include very dry or sticky mouth, reduced or absent urination, or rapid heartbeat)
• thirst
• constipation
• waking up at night to urinate
• dry mouth
• weight loss
• increased creatinine levels (detected by laboratory tests) at the beginning of treatment
• increased urea levels (detected by laboratory tests)

Very rare

• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of side effects
If you experience 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edistride

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 and the 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 any medicine 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 Edistride contains

• The active substance is dapagliflozin.

Each film-coated tablet (tablet) of Edistride 5 mg contains dapagliflozin
propanediol monohydrate equivalent to 5 mg of dapagliflozin.
Each film-coated tablet (tablet) of Edistride 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 “Edistride 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 Edistride and package contents
The 5 mg film-coated tablets of Edistride are yellow, biconvex, round, with a diameter of 0.7 cm,
imprinted with “5” on one side and “1427” on the other.
The 10 mg film-coated tablets of Edistride 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.
Edistride 5 mg tablets and Edistride 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 30x1 or 90x1 film-coated tablets in single-dose perforated blisters.
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
Dr. Esteve Pharmaceuticals, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 93 446 60 00 Tel.: +48 22 245 73 00
Laboratorio Tau, S. A.
Tel: +34 91 301 91 00

France Portugal
AstraZeneca BIAL-Portela & Cª., S.A.
Tél: +33 1 41 29 40 00 Tel.: +351 22 986 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 GROUNDS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment 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 that 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 amended accordingly.
Having reviewed the PRAC's recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the overall conclusions and the rationale of the recommendation.

Grounds 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 amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.