Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - forxiga

Document Subject

Generated Narrative: MedicinalProductDefinition mp5acfed2f2c9cf41e7e877414a9fe07a2

identifier: http://ema.europa.eu/identifier/EU/1/12/795/001 14 film-coated tablets

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Forxiga 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-5acfed2f2c9cf41e7e877414a9fe07a2

identifier: http://ema.europa.eu/identifier/EU/1/12/795/001 14 film-coated tablets

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - forxiga

Attesters

What is in this leaflet

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

What Forxiga is Forxiga 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 Forxiga is used for Forxiga 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.

Forxiga 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) 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 does Forxiga 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.

Forxiga works by removing excess sugar from your body. It can also help prevent heart disease. What is heart failure and how does 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 well as it should. 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.

Forxiga helps protect your heart from getting worse 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 Forxiga 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.

Forxiga helps protect your kidneys from losing their function. That can help some patients to live longer.

Do not take Forxiga

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 Forxiga, 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 life- threatening 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 Forxiga

if you have type 1 diabetes the type that usually starts when you are young, and your body does not produce any insulin. Forxiga should not be used to treat this condition.

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 Forxiga .

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 Forxiga 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 Forxiga 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 Forxiga. 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 Forxiga works, your urine will test positive for sugar while you are on this medicine. Children and adolescents Forxiga 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. Forxiga 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 Forxiga 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 Forxiga 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 Forxiga if you are breast-feeding. It is not known if this medicine passes into human breast milk. Driving and using machines Forxiga 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 Forxiga. Forxiga contains lactose Forxiga 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.

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.

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 Forxiga 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 Forxiga. If you take more Forxiga than you should If you take more Forxiga 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 Forxiga 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 Forxiga 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 Forxiga to make up for a forgotten dose. If you stop taking Forxiga Do not stop taking Forxiga 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 1,000 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 Forxiga.

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 Forxiga 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 10 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 Forxiga: 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 heartbeat)

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

inflammation of the kidneys (tubulointerstitial nephritis) Reporting of side effects If you get 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 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 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. 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 to protect the environment.

What Forxiga contains

The active substance is dapagliflozin. Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

The other ingredients 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). What Forxiga looks like and contents of the pack Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm. They have 5 on one side and 1427 on the other side. Forxiga 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally. They have 10 on one side and 1428 on the other side. Forxiga 5 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters. Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 10x1, 30x1 or 90x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden AstraZeneca UK Limited Silk Road Business Park Macclesfield SK10 2NA United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 (2) 44 55 Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 2 106871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: