Valkozin

Patient Information Leaflet: Information for the User

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

dapagliflozin
Please 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Valkozin is and what it is used for

What Valkozin is
Valkozin 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 Valkozin is used for
Valkozin 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.
• Valkozin can be used alone or together with other medicines for treating 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 type 2 diabetes and how can Valkozin 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. This can result in serious problems such as heart or kidney disease, blindness, and poor circulation in the arms and legs.
Valkozin works by removing excess sugar from the body. It may also help prevent heart disease.

What is heart failure and how can Valkozin help?
This type of heart failure occurs when the heart cannot pump blood to the lungs and the rest of the body as effectively 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 unusually fatigued all the time, and swelling in the ankles.
Valkozin helps protect the heart from worsening and improves symptoms. It may reduce the need for hospitalization and may help some patients live longer.

What is chronic kidney disease and how can Valkozin 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.
Valkozin helps protect the kidneys from further loss of function. This may help some patients live longer.

2. What you need to know before taking Valkozin

Do not take Valkozin

• 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, drowsiness or unusual tiredness, sweet-smelling breath, sweet or metallic taste in the mouth, or a different smell in your urine or sweat, or rapid weight loss.
• These symptoms listed above may be signs of diabetic ketoacidosis, a rare but serious condition that can sometimes be life-threatening, caused by diabetes due to increased levels of "ketone bodies" in the 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 being treated with Valkozin, 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 advice if you notice 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 a general feeling of being unwell. 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 Valkozin

• 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. Valkozin 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 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). More information is provided below in section “Other medicines and Valkozin”.
• if you have very high blood sugar levels that could dehydrate you (excessive loss of body fluids).

Possible signs of dehydration are listed in section 4. Inform your doctor before starting
Valkozin 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 Valkozin until you recover to prevent dehydration.
• if you frequently suffer from urinary tract infections.

If any of the above conditions apply to you (or you are unsure), inform your doctor, pharmacist, or nurse before
taking Valkozin.
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 Valkozin, urine tests will show the presence of sugar during
treatment with this medicine.
Children and adolescents
Valkozin may be used in children from the age of 10 years onwards for the treatment of type 2 diabetes. Data are not available in children under 10 years of age.
Valkozin 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 Valkozin
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". Your doctor may consider reducing the dose of these other medicines to prevent excessively low blood sugar levels (hypoglycaemia).
• if you are taking lithium, as Valkozin may reduce the amount of lithium in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine. You must stop taking this
medicine if pregnancy occurs, as Valkozin is not recommended during the second and third
trimesters of pregnancy. Ask your doctor how best to manage blood sugar control during
pregnancy.
Inform your doctor if you intend to breastfeed or are currently breastfeeding before taking this medicine. Do not use Valkozin if you are breastfeeding. It is not known whether this medicine passes into breast milk.
Driving and using machines
Valkozin has negligible or no effect on the ability to drive or use machines.
Taking this medicine with other medicines called sulfonylureas or with insulin may cause excessively low blood sugar levels (hypoglycaemia), which can cause symptoms such as tremor, 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 while taking Valkozin.

3. How to take Valkozin

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor,
pharmacist, or nurse.
How much to take

• The recommended dose is one 10 mg tablet once daily.
• Your doctor may start with 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 Valkozin together with other medicines. Remember to take these other medicines
as directed by your doctor. 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 dietary and physical activity plan recommended by your doctor while
taking Valkozin.
If you take more Valkozin than you should
If you take more Valkozin tablets than prescribed, contact your doctor immediately or go to hospital
immediately. Take the medicine with you.
If you forget to take Valkozin
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 the missed dose as soon as you remember. Then take the next dose at your usual time.
• If there are less than 12 hours until your next dose, skip the missed dose. Then take the next dose at your usual time.
• Do not take a double dose to make up for the missed dose.

If you stop taking Valkozin
Do not stop treatment with Valkozin without first talking to your doctor. If you have diabetes, your blood sugar
may increase without this medicine.
If you have any questions about using this medicine, consult 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 occur in up to 1 in 10,000 people).
These are symptoms of angioedema:

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

Diabetic ketoacidosis, which is rare in patients with type 2 diabetes (may occur in up to 1 in 1,000 people).
These are symptoms of diabetic ketoacidosis (see also section 2 “Warnings and precautions”):

• increased levels of “ketone bodies” in urine or blood
• feeling unwell or generally unwell
• stomach pain
• excessive thirst
• rapid, 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 Valkozin.
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 Valkozin and consult a doctor as soon as possible if you notice any of the following serious side effects:
Urinary tract infections, commonly observed (may occur in up to 1 in 10 people).
These are symptoms of a serious urinary tract infection:

• 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 occur in more than 1 in 10 people) in diabetic patients taking this medicine with a sulphonylurea or insulin.
These are symptoms of low blood sugar:

• 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 Valkozin:
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
• skin rash

Uncommon (may occur in 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
• 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 Valkozin

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 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 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 Valkozin Contains
The active substance is dapagliflozin.
Each Valkozin 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg of dapagliflozin.
Each Valkozin 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
The other components are:

• Tablet core: mannitol, silicified microcrystalline cellulose, crospovidone, talc, magnesium stearate.
• Film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol polyethylene glycol, talc, yellow iron oxide.

Description of the Appearance of Valkozin and Package Contents
The 5 mg film-coated tablets of Valkozin are yellow, round, with a diameter of 7.0 mm ± 0.2 mm, and marked "5" on one side.
The 10 mg film-coated tablets of Valkozin are yellow, oval-shaped, with a length of 11.5 mm ± 0.2 mm and a width of 7.0 mm ± 0.2 mm.
Valkozin 5 mg film-coated tablets are available in OPA/Al/PVC blisters containing 28 or 56 film-coated tablets.
Valkozin 10 mg film-coated tablets are available in OPA/Al/PVC blisters containing 28 or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I.B.N. Savio SRL
Via del Mare, 36
Pomezia (RM)
Italy

Manufacturer Responsible for Batch Release
Atlantic Pharma - Produções Farmacêuticas S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-228 Sintra
Portugal
Tecnimede - Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

This medicinal product is authorized in the EEA Member States under the following names:
Portugal: VALKOZIN
Italy: VALKOZIN