Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dapagliflozin

Document Subject

Generated Narrative: MedicinalProductDefinition mp47e609a7556335e73540caeda7f501b2

identifier: http://ema.europa.eu/identifier/EU/1/23/1721/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dapagliflozin Viatris 5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-47e609a7556335e73540caeda7f501b2

identifier: http://ema.europa.eu/identifier/EU/1/23/1721/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - dapagliflozin

Attesters

What is in this leaflet

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

What Dapagliflozin Viatris is

Dapagliflozin Viatris contains the active substance dapagliflozin. It belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors . They work by blocking the SGLT2 protein in your kidney. By blocking this protein, blood sugar (glucose), salt (sodium) and water are removed from your body via 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.
• if your type 2 diabetes cannot be controlled with diet and exercise.
• Dapagliflozin Viatris can be used on its own or together with other medicines to treat diabetes.
• It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.

• Heart failure

• in adults (aged 18 years and older) with symptoms due to a weak pump function of the heart.

• Chronic kidney disease

• in adults with reduced kidney function.

What is type 2 diabetes and how does Dapagliflozin Viatris help?

• In type 2 diabetes your body does not make enough insulin or is not able to use the insulin it makes properly. This leads to a high level of sugar in your blood. This can lead to serious problems like heart or kidney disease, blindness, and poor circulation in your arms and legs.
• Dapagliflozin Viatris works by removing excess sugar from your body. It can also help prevent heart disease.

What is heart failure and how does Dapagliflozin Viatris 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 need for hospital care.
• The most common symptoms of heart failure are feeling breathless, feeling tired or very tired all the time, and ankle swelling.
• Dapagliflozin Viatris helps protect your heart from getting weaker and improves your symptoms. It can lower the need to go to hospital and can help some patients to live longer.

What is chronic kidney disease and how does Dapagliflozin Viatris help?

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they would not be able to clean and filter your blood the way they should. Loss of kidney function can lead to serious medical problems and need for hospital care.
• Dapagliflozin Viatris helps protect your kidneys from losing their function. That can help some patients to live longer.

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 straight away:

Diabetic ketoacidosis

• If you have diabetes and experience feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat or rapid weight loss.
• The above symptoms could be a sign of diabetic ketoacidosis a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen 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 higher need of insulin due to major surgery or serious illness.
• When you are treated with Dapagliflozin Viatris, diabetic ketoacidosis can occur even if your blood sugar is normal.

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

Necrotising fasciitis of the perineum

• Talk to your doctor immediately if you develop 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 feeling generally unwell. These symptoms could be a sign of a rare but serious or even lifethreatening infection, called necrotising fasciitis of the perineum or Fournier s gangrene which destroys the tissue under the skin. Fournier s gangrene has to be treated immediately.

Talk to your doctor, pharmacist or nurse before taking Dapagliflozin Viatris:

• If you have type 1 diabetes the type that usually starts when you are young, and your body does not produce any insulin.
• If you have diabetes and have a kidney problem your doctor may ask you to take additional or a different medicine to control your blood sugar.
• If you have a liver problem your doctor may start you on a lower dose.
• If you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). More information is given below under Other medicines and Dapagliflozin Viatris .
• If you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). 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 or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Dapagliflozin Viatris until you recover to prevent dehydration.
• If you often get infections of the urinary tract.

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 to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.

Urine glucose

Because of how Dapagliflozin Viatris works, your urine will test positive for sugar while you are on this medicine.

Children and adolescents

Dapagliflozin Viatris can be used in children aged 10 years and older for the treatment of type 2 diabetes. No data are available in children below 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 for the treatment of chronic kidney disease, because it has not been studied in these patients.

Other medicines and Dapagliflozin Viatris

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 water from the body (diuretic).
• if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a sulphonylurea medicine. Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypoglycaemia).
• if you are taking lithium because Dapagliflozin Viatris can lower the amount of lithium in your blood.

Pregnancy and breast-feeding

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, since it is not recommended during the second and third trimesters of pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.

Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use Dapagliflozin Viatris if you are breast-feeding. 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 sulphonylureas or with insulin can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.

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

Dapagliflozin Viatris contains lactose

Dapagliflozin Viatris 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.

Dapagliflozin Viatris contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

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

Taking this medicine

• Swallow the tablet whole with half a glass of water. The tablet cannot be divided into equal doses.
• You can take your 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 to remember to take it.

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

Diet and exercise can help your body use its blood sugar better. If you have diabetes, it is important to stay on 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, talk to a doctor or go to a hospital immediately.

Take the medicine pack with you.

If you forget to take Dapagliflozin Viatris

What to do if you forget to take a tablet depends on how long it is until your next dose.

• If it is 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 it is 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 taking Dapagliflozin Viatris without talking to your doctor first. If you have diabetes, your blood sugar may increase without this medicine.

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

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

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

• angioedema, seen very rarely (may affect up to 1 in 10 000 people). These are signs of angioedema:

• swelling of the face, tongue or throat
• difficulties swallowing
• hives and breathing problems

• diabetic ketoacidosis - this is rare in patients with type 2 diabetes (may affect up to 1 in 1 people). These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

• increased levels of ketone bodies in your urine or blood
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat
• rapid weight loss.

This may occur regardless of blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with Dapagliflozin Viatris.

• necrotising fasciitis of the perineum or Fournier s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.

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

• urinary tract infection, seen commonly (may affect up to 1 in 10 people). These are signs of a severe infection of the urinary tract:

• fever and/or chills
• burning sensation when passing water (urinating)
• pain in your back or side.

Although uncommon, if you see blood in your urine, tell your doctor immediately.

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

• low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in people) in patients with diabetes taking this medicine with a sulphonylurea or insulin. These are the signs of low blood sugar:

• shaking, sweating, feeling very anxious, fast heart beat
• feeling hungry, headache, change in vision
• a change in your mood or feeling confused.

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

Other side effects when taking Dapagliflozin Viatris:

Common

• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• passing more water (urine) than usual or needing to pass water more often
• changes in the amount of cholesterol or fats in your blood (shown in tests)
• increases in the amount of red blood cells in your blood (shown in tests)
• decreases in creatinine renal clearance (shown in tests) in 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 very dry or sticky mouth, passing little or no urine or fast heart beat)
• thirst
• constipation
• awakening from sleep at night to pass urine
• dry mouth
• weight decreased
• increases in creatinine (shown in laboratory blood tests) in the beginning of treatment
• increases in urea (shown in laboratory 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 get any side effects, talk to your doctor, pharmacis or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Dapagliflozin Viatris contains

• The active substance is dapagliflozin.
• The other ingredients are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate (see section 2 Dapagliflozin Viatris contains lactose ), crospovidone (E1202),, magnesium stearate (E470b), sodium laurilsulfate (see section 2 Dapagliflozin Viatris contains sodium ), colloidal anhydrous silica, mannitol. Film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172).

What Dapagliflozin Viatris looks like and contents of the pack

Dapagliflozin Viatris 5 mg film-coated tablets are yellow coloured, round shaped, biconvex film- coated tablet with diameter of approximetely 7.24 mm. Debossed with 5 on one side and plain on the other side.

Dapagliflozin Viatris 10 mg film-coated tablets are yellow coloured, diamond shaped, biconvex with dimensions of approximately 11 x 8 mm. Debossed with 10 on one side and plain on the other side.

Dapagliflozin Viatris 5 mg tablets are available in: Aluminium blisters in pack sizes of 14, 28, 30 or 98 film-coated tablets. Calendar blisters of 28 or 98 film-coated tablets Perforated unit dose blisters of 14 x 1, 28 x 1, 30 x 1 or 98 x 1 film-coated tablets Bottles in pack sizes of 30 or 90 film-coated tablets.

Dapagliflozin Viatris 10 mg tablets are available in: Aluminium blisters in pack sizes of 14, 28, 30 or 98 film-coated tablets. Calendar blisters of 28 or 98 film-coated tablets Perforated unit dose blisters of 14 x 1, 28 x 1, 30 x 1 or 98 x 1 film-coated tablets Bottles in pack sizes of 30 or 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited Damastown Industrial Park Mulhuddart Dublin DUBLIN Ireland

Name and address of the manufacturer responsible for batch release

Mylan Hungary Kft Mylan Utca 1 Kom rom, 2900, Hungary

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

Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 Magyarorsz g Mylan EPD Kft Tel: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Mylan Pharmaceuticals, S.L Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 France Mylan S.A.S Tel: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 21 412 72 Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 sland Icepharma hf S m : +354 540 8Slovensk republika Mylan s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : +357 2220 7Sverige Mylan AB Tel: + 46 855 522 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: