Zinodap

Patient Information Leaflet

Zinodap 5 mg film-coated tablets, 10 mg film-coated tablets

dapagliflozin
Generic medicine
Please read all of this 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zinodap is and what it is used for

What is Zinodap
Zinodap 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 Zinodap is used for
Zinodap 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 alone. Zinodap 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 properly.
• Chronic kidney disease
  • In adults with reduced kidney function.

What is type 2 diabetes and how does Zinodap 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, which can cause serious problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
  Zinodap works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how does Zinodap 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, which can lead to serious medical problems and the need for hospital treatment.
• The most common symptoms of heart failure are shortness of breath, constant or extreme tiredness, and swollen ankles. Zinodap helps protect the heart from weakening and improves symptoms. It may reduce the need for hospitalisation and help some patients live longer.

What is chronic kidney disease and how does Zinodap 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 properly. Loss of kidney function can lead to serious medical problems and the need for hospital treatment.

• Zinodap helps protect the kidneys from losing function. This may help some patients live longer.

2. What you need to know before taking Zinodap

Do not take Zinodap

• 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 fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, unusual odour of urine or sweat, or rapid weight loss.

• These symptoms could be signs of "diabetic ketoacidosis", a rare but serious, sometimes potentially life-threatening condition that may be caused by diabetes due to increased levels of "ketone bodies" in the blood or urine, detectable by laboratory tests.
• The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or serious illness. When treated with Zinodap, diabetic ketoacidosis can occur even if blood sugar levels are within the normal range.

If you suspect you have developed diabetic ketoacidosis, contact your doctor or the nearest hospital immediately and do not take this medicine.
Necrotizing fasciitis of the perineum:

• Seek immediate medical attention if you develop a combination of symptoms such as pain, tenderness, redness, or swelling in the genital area or the region between the genitals and the anus, accompanied by fever or general malaise. These symptoms could indicate a rare but serious, 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 Zinodap:

• 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. Zinodap must not be used to treat this condition.
• if you have diabetes and have kidney problems – your doctor may advise you to take an additional or different medicine to control your blood sugar levels.
• if you have liver problems – your doctor may start your treatment with a lower dose.
• if you are taking medicines to lower your blood pressure (antihypertensives) and have previously experienced low blood pressure (hypotension). For further information, see section "Other medicines and Zinodap".
• if you have very high blood sugar levels that could lead to dehydration (excessive loss of body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting Zinodap if you experience 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 advise you to temporarily stop treatment with Zinodap until you recover, to prevent dehydration.
• if you frequently suffer from urinary tract infections.

If any of the above conditions apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before taking Zinodap.

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 Zinodap, urine tests will show the presence of glucose during treatment with this medicine.

Children and adolescents
Zinodap can be used in children aged 10 years and older for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
Zinodap 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 patient groups.

Other medicines and Zinodap
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 used to remove water from the body (diuretic).
• if you are taking other medicines that lower blood sugar levels, such as insulin or a "sulfonylurea". 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 Zinodap 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. If you become pregnant, you must stop treatment with this medicine, as Zinodap is not recommended during the second and third trimesters of pregnancy. Ask your doctor how best to control 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 Zinodap if you are breastfeeding. It is not known whether this medicine passes into breast milk.

Driving and using machines
Zinodap does not affect or has a negligible effect on the ability to drive and use machines.
However, taking this medicine together with other medicines called sulfonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which could lead to symptoms such as trembling, sweating, and visual disturbances, and may impair your ability to drive and use machines.
Do not drive or operate tools or machinery if you experience dizziness during treatment with Zinodap.

Zinodap contains lactose and sodium
Zinodap contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Zinodap

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage

• The recommended dose is one 10 mg tablet once daily.
• Your doctor may start you on a 5 mg dose if you have a liver problem.
• Your doctor will prescribe the dose suitable for you.

Taking the 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 Zinodap together with other medicines. Remember to take these other medicines as instructed by your doctor. This will help you achieve the best possible health outcomes.
Diet and 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 during treatment with Zinodap.
If you take more Zinodap than you should
If you take more Zinodap tablets than prescribed, contact your doctor immediately or go to hospital immediately. Take the medicine pack with you.
If you forget to take Zinodap
If you forget to take a tablet, the action you should take 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 Zinodap as soon as you remember. Then take your next dose at the usual time.
If less than 12 hours remain until your next dose, skip the missed dose. Then take your next dose at the usual time.
Do not take a double dose of Zinodap to make up for a forgotten dose.
If you stop taking Zinodap
Do not stop taking Zinodap without first talking to your doctor. If you have diabetes, your blood sugar levels may rise without this medicine.
If you have any questions about using 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). Signs of angioedema include:
  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and breathing problems.
• Diabetic ketoacidosis, rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people). Signs of diabetic ketoacidosis are (see also section 2 “Warnings and precautions”):
  • increased levels of “ketone bodies” in blood or urine
  • feeling unwell or generally unwell
  • stomach pain
  • excessive thirst
  • rapid and deep breathing
  • confusion
  • drowsiness or unusual 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 Zinodap.
• 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 Zinodap and consult your doctor as soon as possible if you notice any of the
following serious side effects:

• Urinary tract infection, commonly observed (may affect up to 1 in 10 people). Signs of a severe urinary tract infection include:
  • fever and/or chills
  • burning sensation when urinating
  • back or side pain. Although uncommon, if you notice blood in your urine, inform 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 patients with diabetes who are taking this medicine with a sulphonylurea or insulin. Signs of low blood sugar levels include:
  • trembling, sweating, feeling very anxious, rapid heartbeat
  • feeling hungry, headache, vision changes
  • mood changes or feeling confused. Your doctor will advise you on how to treat low blood sugar levels and what to do if you experience any of the above symptoms.

Other side effects during treatment with Zinodap:
Common

• genital infection (candidiasis) of the penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• increased amount of urine compared to normal or increased urge to urinate
• changes in cholesterol or blood fat levels (observed in blood tests)
• increases in red blood cell count (observed in blood tests)
• reduction 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 loss of body fluids (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
• increases in creatinine (observed in blood tests) at the beginning of treatment
• increases in urea (observed in blood tests).

Very rare

• inflammation of the kidneys (tubulo-interstitial 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 at
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 Zinodap

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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 temperature. Store in the original packaging, protected from light.
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 Zinodap contains

• The active substance is dapagliflozin. Each 5 mg film-coated tablet contains 5 mg of dapagliflozin. Each 10 mg film-coated tablet contains 10 mg of dapagliflozin.
• The other ingredients are microcrystalline cellulose, lactose, crospovidone, anhydrous colloidal silica, and sodium stearyl fumarate. The film coating contains polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), and sodium lauryl sulfate.

Description of the appearance of Zinodap and pack contents
The 5 mg film-coated tablets are yellow, film-coated, round, with a diameter of 6.8 mm, marked with "TV" on one side and "5D" on the other side.
The 10 mg film-coated tablets are yellow, film-coated, oval, with dimensions of 11.3 mm x 6.9 mm, marked with "TV" on one side and "1D" on the other side.
Zinodap is available in calendar blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Zinodap 5 mg Filmtabletten, Zinodap 10 mg Filmtabletten
Italy: Zinodap