Package leaflet: Information for the patient

DALZIOR Plus, 100 mg + 10 mg, film-coated tablets
Sitagliptin + Dapagliflozin
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may
harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your
doctor or pharmacist. See section 4.

Contents of the leaflet

What DALZIOR Plus is and what it is used for
Important information before taking DALZIOR Plus
How to take DALZIOR Plus
Possible side effects
How to store DALZIOR Plus
Contents of the pack and other information

1. What DALZIOR Plus is and what it is used for

What DALZIOR Plus is:
DALZIOR Plus contains the active substances sitagliptin and dapagliflozin.
Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adult patients with type 2 diabetes.
Dapagliflozin belongs to a group of medicines called sodium-glucose cotransporter 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.

DALZIOR Plus is used to treat type 2 diabetes:

in adults aged 18 years and older
when type 2 diabetes cannot be controlled by diet and physical exercise
when metformin and sitagliptin do not provide adequate control of diabetes
when the patient is already being treated with sitagliptin and dapagliflozin as separate tablets. Your doctor may recommend switching to this medicine.

Diet and physical exercise can help your body use blood sugar more effectively.
If you have diabetes, it is important to follow your doctor's advice regarding diet and physical exercise while taking DALZIOR Plus.

What is type 2 diabetes and how does DALZIOR Plus help treat it?
Type 2 diabetes is a condition in which the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high blood sugar levels, which may cause serious health problems such as heart or kidney disease, vision loss, or poor circulation in the arms and legs.
This medicine helps increase the amount of insulin produced after meals, reduces the amount of sugar produced by the body, and removes excess sugar from the body.
Your doctor has prescribed this medicine to help lower your blood sugar level, which is too high due to type 2 diabetes.

2. Important information before using DALZIOR Plus

When not to use DALZIOR Plus
if the patient is allergic to sitagliptin, dapagliflozin, or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with DALZIOR Plus, consult your
doctor, pharmacist, or nurse:
if the patient has type 1 diabetes – a type of diabetes that usually occurs at a young age and is characterized by the body's inability to produce insulin. DALZIOR Plus must not be used in the treatment of this condition.
if the patient currently has or has previously had pancreas disorders (e.g. pancreatitis), gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These conditions may increase the risk of developing pancreatitis. Possible symptoms of pancreatitis are listed in section 4.
if the patient has or has previously had kidney problems
if the patient has or has previously had liver problems
if the patient has or has previously had very high blood sugar levels, which may lead to dehydration (loss of excessive amounts of bodily fluids). Possible symptoms of dehydration are listed in section 4. Before starting treatment with DALZIOR Plus, inform the doctor if any of these symptoms occur.
if the patient currently has nausea, vomiting, or fever, or if the patient is unable to eat or drink. This may cause dehydration. The doctor may advise temporarily discontinuing treatment with DALZIOR Plus until recovery to prevent dehydration.
if the patient has or has previously had diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Possible symptoms of diabetic ketoacidosis are listed in section 4.
if the patient frequently experiences urinary tract infections.

If any of the above warnings apply to the patient (or if the patient is unsure), consult a doctor, pharmacist, or nurse before using DALZIOR Plus.

Diabetes and foot care
It is important for patients with diabetes to regularly check the condition of their feet and follow all foot care recommendations provided by their doctor.

Glucose in urine
Due to the mechanism of action of DALZIOR Plus, urine glucose tests will show positive results during treatment with this medicine.

Children and adolescents
DALZIOR Plus must not be used in children and adolescents under 18 years of age, as studies have not been conducted in this age group.

DALZIOR Plus and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

In particular, inform the doctor if the patient is taking any of the following medicines:
Medicines used to treat heart rhythm disorders and other heart problems
(digoxin). When taking DALZIOR Plus, monitoring of digoxin blood levels may be necessary.
Medicines used to remove water from the body (diuretics).
Other medicines that lower blood sugar levels, such as insulin or sulfonylurea derivatives. The doctor may decide to reduce the dose of these medicines to prevent low blood sugar (hypoglycaemia).
Medicines that lower blood pressure (antihypertensives) and a history of low blood pressure (hypotension).
Lithium, used to treat psychiatric disorders; DALZIOR Plus may reduce lithium blood levels.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy. If pregnancy occurs, treatment with this medicine should be discontinued.
This medicine must not be used during breastfeeding or if the patient is planning to breastfeed. It is unknown whether this medicine passes into breast milk.

Driving and operating machinery
This medicine has no or negligible influence on the ability to drive and operate machinery. However, dizziness and somnolence have been reported, which may affect the ability to drive or operate machinery. Do not drive or operate tools or machines if dizziness occurs while taking DALZIOR Plus.
Taking this medicine together with other medicines known as sulfonylurea derivatives or with insulin may cause low blood sugar (hypoglycaemia), which may manifest as tremor, sweating, and visual disturbances, and may also affect the ability to drive and operate machinery.

DALZIOR Plus contains lactose and sodium
DALZIOR Plus contains lactose (milk sugar). If the patient has been diagnosed with intolerance to certain sugars, inform the doctor before using DALZIOR Plus.
DALZIOR contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use DALZIOR Plus

This medicine should always be used exactly as prescribed by the doctor. In case of doubts,
consult a doctor, pharmacist, or nurse.
The usual recommended dose is:
one coated tablet of DALZIOR Plus. The doctor will prescribe the dose appropriate for
the patient;
taken once daily;
the tablet should be swallowed whole with a glass of water to ensure accurate
dosing and to avoid an unpleasant taste;
the tablet may be taken independently of meals.
The doctor may prescribe DALZIOR Plus alone or in combination with other medicines
that lower blood sugar levels. It is important to take these medicines as directed by the
doctor. This will help achieve the best treatment outcomes.
Taking more than the recommended dose of DALZIOR Plus
If an overdose of DALZIOR Plus is taken, contact a doctor immediately or go to a hospital.
Bring the medicine packaging with you.
Missed dose of DALZIOR Plus
What to do if a dose of DALZIOR Plus is missed:

If 12 hours or more remain until the next dose, take the missed dose of DALZIOR Plus as soon as remembered.
Then take the next dose at the usual time.
If less than 12 hours remain until the next dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose of DALZIOR Plus to make up for a missed dose.

If there are any further doubts regarding the use of this medicine, consult a doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking DALZIOR Plus and contact your doctor or nearest hospital immediately if any of the following serious adverse reactions occur:
Pancreatitis – severe and persistent pain in the abdomen (stomach area), which may radiate to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis (frequency unknown).
Severe allergic reaction (anaphylactic reaction, angioedema) (very rare). Symptoms include:
swelling of the face, tongue, lips or throat
difficulty swallowing and/or breathing
urticaria and breathing problems
rash
blisters on the skin and/or skin peeling
Diabetic ketoacidosis – occurs rarely in patients with type 2 diabetes (may occur in no more than 1 in 1,000 people). Symptoms include:
increased concentration of "ketone bodies" in urine or blood
nausea or vomiting
abdominal pain
excessive thirst
rapid and deep breathing
confusion
unusual drowsiness or tiredness
sweet smell from the mouth, sweet or metallic taste in the mouth, or altered smell of urine or sweat
rapid weight loss
These symptoms may occur regardless of blood sugar levels. Your doctor may decide to interrupt or discontinue treatment with DALZIOR Plus.
Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a severe and potentially life-threatening infection of the soft tissues of the genital organs or the area between the genitals and the anus, occurring very rarely. Symptoms include a combination of pain, tenderness, redness or swelling of the genital organs or the area between the genitals and the anus, accompanied by fever or general malaise. Fournier's gangrene requires immediate treatment (frequency: very rare).
Stevens-Johnson syndrome, a blistering skin disease, which usually begins with flu-like symptoms, followed by a painful red or purple rash that spreads and forms blisters on the skin (frequency: unknown).
Bullous pemphigoid – skin inflammation, a type of large fluid-filled skin blisters (frequency: unknown).
You must stop taking DALZIOR Plus and seek immediate medical advice if any of the following serious adverse reactions occur:
Urinary tract infection, observed frequently (may affect up to 1 in 10 people). Symptoms of severe urinary tract infection include:
fever and/or chills
burning sensation during urination
back or side pain
Blood in the urine may occasionally occur; if this happens, consult your doctor immediately.
Contact your doctor immediately if any of the following adverse reactions occur:
Low blood sugar (hypoglycaemia), observed very commonly (may occur in more than 1 in 10 people) in diabetic patients taking this medicine together with a sulfonylurea derivative or insulin. Symptoms of low blood sugar include:
tremor, sweating, strong feeling of anxiety, rapid heartbeat
feeling of hunger, headache, vision disturbances
mood changes or feeling confused.
Your doctor will inform you how to treat low blood sugar and what to do if any of the above symptoms occur.
Other adverse reactions during the use of DALZIOR Plus:
Common (may affect up to 1 in 10 people)
fungal infection (candidiasis) of the penis or vagina (symptoms may include irritation, itching, unusual discharge or odour)
back pain
passing larger amounts of urine than usual or increased need to pass urine
changes in blood cholesterol or fat levels (detected in laboratory tests)
increase in red blood cells in blood (detected in laboratory tests)
decrease in renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
dizziness
rash
headache
Uncommon (may affect up to 1 in 100 people)
excessive loss of body fluids (dehydration, symptoms may include strong feeling of dryness or stickiness in the mouth, passing small amounts of urine or no urine, rapid heartbeat)
thirst
constipation
waking up at night to pass urine
dry mouth
weight loss
increase in creatinine levels (detected in laboratory blood tests) at the beginning of treatment
increase in urea levels (detected in laboratory blood tests)
fungal infection
itching, genital and vaginal pruritus, itching of genital organs
Rare (may affect up to 1 in 1,000 people)
low platelet count (thrombocytopenia)
Very rare (may affect up to 1 in 10,000 people)
kidney inflammation
Frequency not known (frequency cannot be estimated from the available data):
pulmonary fibrosis (interstitial lung disease)
vomiting
urticaria, itchy skin rash
inflammation of small blood vessels of the skin (cutaneous vasculitis)
joint pain
muscle pain
joint disorders or joint problems
kidney problems (sometimes requiring dialysis)
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: 22 49 21 301, Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store DALZIOR Plus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What DALZIOR Plus contains
The active substances in DALZIOR Plus are sitagliptin and dapagliflozin.

DALZIOR Plus, 100 mg + 10 mg, film-coated tablets: each film-coated tablet contains 100 mg of sitagliptin (as sitagliptin hydrochloride monohydrate) and 10 mg of dapagliflozin (as amorphous dapagliflozin base).

The other ingredients are microcrystalline cellulose, lactose monohydrate,
sodium carboxymethyl starch (type A), magnesium stearate.
The tablet coating contains polyvinyl alcohol, yellow iron oxide, macrogol, talc, red iron oxide.

What DALZIOR Plus looks like and contents of the pack
DALZIOR Plus, 100 mg + 10 mg, film-coated tablets are light brown, round, film-coated tablets, embossed with the code "101" on one side, with a diameter of 9.9 mm.

Pack sizes
Cardboard boxes containing 28, 30, 60, or 98 film-coated tablets in blister packs.
Cardboard boxes containing 28 × 1, 98 × 1 film-coated tablet in unit-dose blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. +48 22 345 93 00

Manufacturer
Rontis Hellas, Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012, 41 500 Larissa
Greece

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Sitagliptin/Dapagliflozin 100mg/10 mg ratiopharm Filmtabletten
Bulgaria Далзиор S Комбо 100 mg/10 mg филмирани таблетки
Dalzior S Combo 100 mg/10 mg film-coated tablets
Croatia Dalzior Plus
Estonia Sitagliptin/Dapagliflozin Teva
Lithuania Sitagliptin/Dapagliflozin Teva 100mg/10mg plėvelės dengtos tabletės
Latvia Sitagliptin/Dapagliflozin Teva 100mg/10mg apvalkotas tabletes
Germany Sitagliptin/Dapagliflozin-ratiopharm 100 mg/10 mg Filmtabletten
Poland DALZIOR Plus
Romania Sitagliptin/Dapagliflozin 100mg/10mg Teva comprimate filmate
Sweden Sitagliptin/Dapagliflozin Teva
Hungary Sitagliptin/Dapagliflozin Teva 100mg/10mg filmtabletta
Italy Dapagliflozin e Sitagliptin Teva