Dapagliflozin Doc Generici

Package leaflet: Information for the user

DAPAGLIFLOZIN DOC 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Read this entire 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What DAPAGLIFLOZIN DOC is and what it is used for

DAPAGLIFLOZIN DOC 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 DOC is used for
DAPAGLIFLOZIN DOC 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 DOC may be 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 regarding 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 diabetes and how can DAPAGLIFLOZIN DOC help?

• In type 2 diabetes, the body either does not produce enough insulin or is unable to use the insulin it produces properly. 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 DOC works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can DAPAGLIFLOZIN DOC 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 hospital treatment.
• The most common symptoms of heart failure are shortness of breath, feeling tired or very tired all the time, and swelling in the ankles.
• DAPAGLIFLOZIN DOC 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 DOC help?

• When you have chronic kidney disease, your kidneys may gradually lose their function. This means they are no longer able 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 DOC 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 DOC

Do not take DAPAGLIFLOZIN DOC

• 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, unusual drowsiness or tiredness, sweet-smelling breath, sweet or metallic taste in the mouth, or a different 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 urine or blood, detectable by laboratory tests.
• The risk of developing diabetic ketoacidosis may be increased by prolonged fasting, excessive alcohol intake, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or serious illness.
• When treated with DAPAGLIFLOZIN DOC, 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 general malaise. 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 DOC

• 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 DOC 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 in section “Other medicines and DAPAGLIFLOZIN DOC” below.
• 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 DAPAGLIFLOZIN DOC 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 may lead to dehydration. Your doctor may ask you to stop taking DAPAGLIFLOZIN DOC 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 DOC.
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 DOC, urine tests will show the presence of sugar during treatment with this medicine.
Children and adolescents
DAPAGLIFLOZIN DOC can be used in children from 10 years of age and older for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
DAPAGLIFLOZIN DOC 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 DOC
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 "sulfonylurea" 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 DOC 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 DAPAGLIFLOZIN DOC is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to control blood sugar during pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use DAPAGLIFLOZIN DOC if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
DAPAGLIFLOZIN DOC has negligible or no effect on the ability to drive vehicles or use machines.
Taking this medicine together with other medicines called sulfonylureas or with insulin may cause excessively low blood sugar (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 DAPAGLIFLOZIN DOC.
DAPAGLIFLOZIN DOC contains lactose
DAPAGLIFLOZIN DOC contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DAPAGLIFLOZIN DOC

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.

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

Your doctor may prescribe DAPAGLIFLOZIN DOC 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 DOC.
If you take more DAPAGLIFLOZIN DOC than you should
If you take more DAPAGLIFLOZIN DOC tablets than prescribed, contact your doctor immediately or go to the hospital immediately. Take the medicine with you.
If you forget to take DAPAGLIFLOZIN DOC
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 DOC 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 a missed dose.

If you stop taking DAPAGLIFLOZIN DOC
Do not stop treatment with DAPAGLIFLOZIN DOC 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 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). 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 affect 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 blood or urine
  • 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 DAPAGLIFLOZIN DOC.
• 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 DOC 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). Symptoms of a severe urinary tract infection include:
  • 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 experience any of the following side effects:

• Low blood sugar levels (hypoglycaemia), very commonly observed (may affect 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 DAPAGLIFLOZIN DOC:
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 blood fat levels (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 absent urination, or rapid heartbeat)
• thirst
• constipation
• waking up during the night to urinate
• dry mouth
• weight loss
• increased creatinine (observed in blood tests) at the beginning of treatment
• increased urea (observed in blood 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DAPAGLIFLOZIN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DAPAGLIFLOZIN DOC contains
The active substance is dapagliflozin.
Each film-coated tablet (tablet) of DAPAGLIFLOZIN DOC contains 5 mg of dapagliflozin.
Each film-coated tablet (tablet) of DAPAGLIFLOZIN DOC contains 10 mg of dapagliflozin.
The other components are:

• Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2 “DAPAGLIFLOZIN DOC contains lactose”), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E470b).
• Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b). The 10 mg tablet also contains yellow iron oxide (E172).

Description of the appearance of DAPAGLIFLOZIN DOC and contents of the pack
DAPAGLIFLOZIN DOC 5 mg film-coated tablets are white, biconvex, oval film-coated tablets measuring 5 mm x 11 mm.
DAPAGLIFLOZIN DOC 10 mg film-coated tablets are yellow, biconvex, round film-coated tablets measuring 10 mm.

Pack sizes
14 film-coated tablets
28 film-coated tablets
56 film-coated tablets
98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121 Milan, Italy

Manufacturers
KeVaRo GROUP Ltd.
9 Tzaritza Elenora Str., Office 23,
Sofia 1618,
Bulgaria

Adalvo Limited
Malta Life Science Park, Building 1, Level 4,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Iceland: Dapagliflozin Adalvo 5 mg filmuhúðaðar töflur
Dapagliflozin Adalvo 10 mg filmuhúðaðar töflur
Germany: Dapagliflozin Adalvo 5 mg Filmtabletten
Dapagliflozin Adalvo 10 mg Filmtabletten
France: Dapagliflozin Adalvo 5 mg comprimés pelliculés
Dapagliflozin Adalvo 10 mg comprimés pelliculés
Spain: Dapagliflozin Adalvo 5 mg comprimidos recubiertos con película EFG
Dapagliflozin Adalvo 10 mg comprimidos recubiertos con película EFG