DAPAGLIFLOZINA 10 mg Film-Coated Tablets

2. What you need to know before you take Dapagliflozin Viatris

Do not take Dapagliflozin Viatris

• 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 immediately:

Diabetic ketoacidosis

• If you have diabetes and experience nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual tiredness, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat or rapid weight loss.
• The above symptoms may be a sign of "diabetic ketoacidosis" - a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in "ketone bodies" in your urine or blood, which is detected 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 greater need for insulin due to major surgery or serious illness.
• When you are taking Dapagliflozin Viatris, diabetic ketoacidosis may occur even if your blood sugar levels are normal.

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

Necrotizing fasciitis of the perineum

• Consult your doctor immediately if you have 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 general feeling of being unwell. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene needs to be treated immediately.

Consult your doctor, pharmacist, or nurse before you start taking Dapagliflozin Viatris:

• if you have "type 1 diabetes" - the type that usually occurs when you are young and your body does not produce any insulin.
• if you have diabetes and have any kidney problems - your doctor may ask you to take an additional medicine or a different one to control your blood sugar levels.
• if you have any liver problems - your doctor may start with a lower dose.
• if you are taking medicines to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in Taking Dapagliflozin Viatris with other medicines.
• if you have very high blood sugar levels that may cause dehydration (loss of too much fluid from the body). Possible signs of dehydration are listed in section 4. Tell your doctor before you start taking this medicine if you have any of these signs.
• if you have nausea (feeling sick), vomiting, or fever, or are unable to eat or drink. These conditions may cause dehydration. Your doctor may ask you to stop taking Dapagliflozin Viatris until you recover to prevent dehydration.
• if you often get urinary tract infections.

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

Diabetes and foot care

If you have diabetes, it is important that you regularly check your feet and follow any other foot care advice given to you by your healthcare professional.

Blood sugar in urine

Due to how Dapagliflozin Viatris works, your urine will test positive for glucose while you are taking this medicine.

Children and adolescents

Dapagliflozin Viatris can be used in children aged 10 years and older to treat type 2 diabetes. There is no data available in children under 10 years of age.

Dapagliflozin Viatris is not recommended in children and adolescents under 18 years of age to treat heart failure or to treat chronic kidney disease, as it has not been studied in these patients.

Taking Dapagliflozin Viatris with other medicines

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 fluid from the body (diuretic).
• if you are taking other medicines that lower your blood sugar levels, such as insulin or a "sulfonylurea" type medicine. Your doctor may decide to reduce the dose of these medicines to avoid you getting low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Dapagliflozin Viatris may lower the amount of lithium in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. Ask your doctor about the best way to control your blood sugar levels during pregnancy.

Ask your doctor if you want to breastfeed before taking this medicine. Do not take Dapagliflozin Viatris during breastfeeding. It is not known if this medicine passes into human breast milk.

Driving and using machines

Dapagliflozin Viatris has no or negligible influence on the ability to drive and use machines.

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

Do not drive or use tools or machines if you feel dizzy while taking Dapagliflozin Viatris.

Dapagliflozin Viatris contains lactose

Dapagliflozin Viatris contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Dapagliflozin Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Dapagliflozin Viatris

Follow exactly the instructions of your doctor. If you are not sure, ask your doctor, pharmacist, or nurse.

How much to take

• The recommended dose is one 10 mg tablet a day.
• Your doctor may start with a dose of 5 mg if you have a liver problem.
• Your doctor will prescribe the dose that is right 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 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. This will help you remember to take it.

Your doctor may prescribe Dapagliflozin Viatris with another medicine(s). Remember to take these other medicine(s) as instructed by your doctor. This will help you get the best results for your health.

Diet and exercise can help your body use blood sugar better. If you have diabetes, it is important that you follow any diet and exercise program recommended by your doctor while taking Dapagliflozin Viatris.

If you take more Dapagliflozin Viatris than you should

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

Take the medicine pack with you.

If you forget to take Dapagliflozin Viatris

What you should do if you forget to take a tablet depends on how much time is left 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 the next dose at the usual time.
• If there are less than 12 hours until the next dose, skip the missed dose. Take the 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 taking Dapagliflozin Viatris without first talking to your doctor. If you have diabetes, your blood sugar levels may increase without this medicine.

If you have any further questions on the use of 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 a doctor or the nearest hospital immediately if you get any of the following side effects:

• angioedema, seen very rarely (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 breathing problems

• diabetic ketoacidosis, this is 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):

• increase in "ketone bodies" in your urine or blood.
• nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• drowsiness and unusual tiredness
• sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat
• rapid weight loss

This may happen regardless of your blood sugar levels. Your doctor will decide whether to temporarily or permanently stop your treatment with Dapagliflozin Viatris.

• necrotizing fasciitis of the perineumor Fournier's gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely.

Stop taking Dapagliflozin Viatris and contact a doctor immediately if you notice any of these serious side effects:

• urinary tract infections, occur frequently (may affect up to 1 in 10 people).

These are the signs of a serious urinary tract infection:

• fever and/or chills
• burning sensation while urinating
• back or side pain.

Although not common, if you see blood in your urine, tell your doctor immediately.

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

• low blood sugar levels(hypoglycemia), very common (may affect more than 1 in 10 people) in patients with diabetes who take this medicine with a sulfonylurea or insulin. The signs of low blood sugar levels are:

• chills, sweating, feeling of great anxiety, fast heartbeat
• feeling hungry, headache, changes in vision
• mood changes or feeling confused

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

Other side effects of treatment with Dapagliflozin Viatris:

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and discharge or unusual odor)
• back pain
• increased need to urinate or more frequent urination
• changes in cholesterol or lipid levels in the blood (seen in tests)
• increases in the number of red blood cells in the blood (seen in tests)
• decreases in kidney function (seen in tests) at the start of treatment
• dizziness
• rash

Uncommon (may affect up to 1 in 100 people)

• excessive loss of fluids from the body (dehydration, signs may include a very dry or sticky mouth, reduced or no urination; or fast heartbeat)
• thirst
• constipation
• waking up at night to urinate
• dry mouth
• weight loss
• increase in creatinine (seen in blood tests) at the start of treatment
• increase in urea (seen in blood tests)

Rare (may affect up to 1 in 10,000 people)

• kidney inflammation (tubulointerstitial nephritis)

Reporting of side effects

If you experience 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 to the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dapagliflozin Viatris

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 expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Package Contents and Additional Information

Composition ofDapagliflozina Viatris

• The active ingredient is dapagliflozina.
• The other components are:

Core of the tablet: microcrystalline cellulose (E460i), lactose monohydrate (see section 2 "Dapagliflozina Viatris contains lactose"), crospovidone (E1202), magnesium stearate (E470b), sodium lauryl sulfate (see section 2 "Dapagliflozina Viatris contains sodium"), anhydrous colloidal silicon dioxide, mannitol.

Coating film: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of Dapagliflozina Viatris and Package Contents

Dapagliflozina Viatris 5 mg film-coated tablets are yellow, biconvex, round tablets with a diameter of approximately 7.24 mm, film-coated, with "5" engraved on one side and flat on the other.

Dapagliflozina Viatris 10 mg film-coated tablets are yellow, biconvex, rhomboid-shaped tablets with a diagonal of approximately 1.1 x 8 mm, with "10" engraved on one side and flat on the other.

Dapagliflozina Viatris 5 mg tablets are available in:

Aluminum blisters in package sizes of 14, 28, 30, or 98 film-coated tablets.

Calendar blisters of 28 or 98 film-coated tablets.

Pre-cut unit-dose blisters of 14 x 1, 28 x 1, 30 x 1, or 98 x 1 film-coated tablets.

Bottles in package sizes of 30 or 90 film-coated tablets.

Dapagliflozina Viatris 10 mg tablets are available in:

Aluminum blisters in package sizes of 14, 28, 30, or 98 film-coated tablets.

Calendar blisters of 28 or 98 film-coated tablets.

Pre-cut unit-dose blisters of 14 x 1, 28 x 1, 30 x 1, or 98 x 1 film-coated tablets.

Bottles in package sizes of 30 or 90 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer

Mylan Hungary Kft

Mylan Utca 1

Komárom, 2900, Hungary

Mylan Germany GmbH

Benzstrasse 1

61352 Bad Homburg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Spain

Viatris Pharmaceuticals, S.L.

Tel: + 34 900 102 712

Date of the Last Revision of this Leaflet:July 2024

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu