Dapagliflozin Viatris: detailed information

Package leaflet: Information for the patient

Dapagliflozin Viatris 5 mg film-coated tablets, 10 mg film-coated tablets

dapagliflozin
Please 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dapagliflozin Viatris is and what it is used for
What you need to know before taking Dapagliflozin Viatris
How to take Dapagliflozin Viatris
Possible side effects
How to store Dapagliflozin Viatris
Contents of the pack and other information

1. What Dapagliflozin Viatris is and what it is used for

What Dapagliflozin Viatris is
Dapagliflozin Viatris 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 Dapagliflozin Viatris is used for
Dapagliflozin Viatris 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.
- Dapagliflozin Viatris may be used alone or together with other medicines for treating diabetes.
- It is important to continue following your doctor’s, pharmacist’s, or nurse’s advice regarding diet and exercise.
Heart failure
- In adults (aged 18 years and over) when the heart does not pump blood as well as it should.
Chronic kidney disease
- In adults with reduced kidney function.

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

What is heart failure and how can Dapagliflozin Viatris 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 fatigued all the time, and swelling in the ankles.
Dapagliflozin Viatris 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 Dapagliflozin Viatris 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.
Dapagliflozin Viatris helps protect the kidneys from further loss of function. This may help some patients live longer.

2. What you need to know before taking Dapagliflozin Viatris Do not take Dapagliflozin

Viatris

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, a sweet or metallic taste in the mouth, or a different smell in your 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 treated with Dapagliflozin Viatris, 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 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 Dapagliflozin Viatris:
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. Dapagliflozin Viatris must not be used to treat this condition.
If you have diabetes and have kidney problems – your doctor may prescribe an additional or different medicine to control your 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 in section “Other medicines and Dapagliflozin Viatris” below.
If you have very high blood sugar levels that may cause dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting this medicine 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 Dapagliflozin Viatris until you recover to prevent dehydration.
If you frequently have urinary tract infections.

If any of the above conditions apply to you (or you are unsure), inform your doctor, pharmacist, or nurse before taking Dapagliflozin Viatris.
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 Dapagliflozin Viatris, urine tests will show the presence of sugar during treatment with this medicine.
Children and adolescents
Dapagliflozin Viatris can be used in children from 10 years of age for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
Dapagliflozin Viatris 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 Dapagliflozin Viatris
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"-based medicine. 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 Dapagliflozin Viatris may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must stop taking this medicine if pregnancy occurs, as it is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to manage your blood sugar levels during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Dapagliflozin Viatris if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Dapagliflozin Viatris does not affect or has a negligible effect on the ability to drive and 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 trembling, sweating, and vision disturbances, and may impair your ability to drive and use machines.
Do not drive or operate tools or machinery if you experience dizziness while taking Dapagliflozin Viatris.
Dapagliflozin Viatris contains lactose
Dapagliflozin Viatris contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Dapagliflozin Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Dapagliflozin Viatris

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

How much to take

The recommended dose is one 10 mg tablet once daily.
Your doctor may start you on 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. The tablet cannot be divided into equal doses.
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 Dapagliflozin Viatris together with other medicines. Remember to take these other medicines exactly as your doctor has instructed. This will help you achieve the best health outcomes.

Diet and physical 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 Dapagliflozin Viatris.

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

If you forget to take Dapagliflozin Viatris
If you forget to take a tablet, the action you should take 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 Dapagliflozin Viatris 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 of Dapagliflozin Viatris to make up for a forgotten dose.

If you stop taking Dapagliflozin Viatris
Do not stop treatment with Dapagliflozin Viatris without first talking to your doctor. If you have diabetes, your blood sugar may increase without this medicine.

If you have any questions about how to use 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 the nearest hospital immediately if you experience any of the following
side effects:

angioedema, very rarely observed (may affect up to 1 in 10,000 people). These are symptoms of angioedema:
- 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 affect up to 1 in 1,000 people). These are symptoms of diabetic ketoacidosis (see also section 2 “Warnings and precautions”):
- increased levels of “ketone bodies” in urine or blood
- feeling unwell or being unwell
- stomach pain
- excessive thirst
- rapid, deep breathing
- confusion
- unusual drowsiness or tiredness
- sweet smell on breath, sweet or metallic taste in 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 Dapagliflozin Viatris.

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, very rarely observed.

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

urinary tract infections, commonly observed (may affect up to 1 in 10 people). These are symptoms of a serious urinary tract infection:
- 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 have 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 who take this medicine with a sulphonylurea or insulin. These are symptoms of low blood sugar:
- 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 Dapagliflozin Viatris:
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 affect up to 1 in 100 people)

excessive fluid loss from the body (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 (may affect up to 1 in 10,000 people)

inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of side effects
If you experience any side effect, 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 Dapagliflozin Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, 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 Dapagliflozin Viatris contains

The active substance is dapagliflozin. Each film-coated tablet (tablet) of Dapagliflozin Viatris 5 mg contains 5 mg of dapagliflozin. Each film-coated tablet (tablet) of Dapagliflozin Viatris 10 mg contains 10 mg of dapagliflozin.
The other components are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate (see section 2 “Dapagliflozin Viatris contains lactose”), crospovidone (E1202), magnesium stearate (E470b), sodium lauryl sulfate (see section 2 “Dapagliflozin Viatris contains sodium”), anhydrous colloidal silica, mannitol. Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172).

Description of the appearance of Dapagliflozin Viatris and contents of the pack
The 5 mg film-coated tablets (tablets) of Dapagliflozin Viatris are yellow, round, biconvex, with a diameter of approximately 7.24 mm. One side is marked with “5” and the other side is blank.
The 10 mg film-coated tablets (tablets) of Dapagliflozin Viatris are yellow, diamond-shaped, biconvex, with dimensions of approximately 11 x 8 mm. One side is marked with “10” and the other side is blank.
Dapagliflozin Viatris 5 mg tablets are available in:
Aluminium blisters in packs of 14, 28, 30 or 98 film-coated tablets.
Calendar blister packs in packs of 28 or 98 film-coated tablets.
Perforated unit dose blisters in packs of 14 x 1, 28 x 1, 30 x 1 or 98 x 1 film-coated tablets.
Bottles in packs of 30 or 90 film-coated tablets.
Dapagliflozin Viatris 10 mg tablets are available in:
Aluminium blisters in packs of 14, 28, 30 or 98 film-coated tablets.
Calendar blister packs in packs of 28 or 98 film-coated tablets.
Perforated unit dose blisters in packs of 14 x 1, 28 x 1, 30 x 1 or 98 x 1 film-coated tablets.
Bottles in packs of 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturers
Mylan Hungary Kft.
Mylan Utca 1
Komárom, 2900, Hungary
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0) 2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: + 359 2 44 55 400 Tél/Tel: + 32 (0) 2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris Cz s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0) 20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 86390

España Polska
Viatris Pharmaceuticals, S.L Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: + 353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 2286 3100 Tel: + 46 (0) 8 630 19 00

Latvija
Viatris SIA
Tel: + 371 676 055 80

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