Package leaflet: Information for the patient

Opventi, 100 mg + 10 mg, film-coated tablets
Sitagliptinum + Dapagliflozinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
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,
pharmacist, or nurse. See section 4.

Contents of the leaflet

What Opventi is and what it is used for
What you need to know before taking Opventi
How to take Opventi
Possible side effects
How to store Opventi
Contents of the pack and other information

1. What Opventi is and what it is used for

What Opventi is:
Opventi 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 glucose levels in adults with type 2 diabetes.
Dapagliflozin belongs to a group of medicines known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These work by blocking the SGLT2 protein in the kidneys. By blocking this protein, glucose (sugar), salt (sodium), and water present in the blood are eliminated from the body through urine.

Opventi is used to treat type 2 diabetes:

in adults aged 18 years and older
when adequate control of type 2 diabetes cannot be achieved with diet and physical activity alone
when adequate control cannot be achieved with metformin and sitagliptin
in patients already being treated with sitagliptin and dapagliflozin as separate tablets. Your doctor may recommend switching to Opventi.

Diet and physical activity can help your body use blood glucose more effectively. For patients with diabetes, it is important to follow all dietary and exercise recommendations provided by your treating physician while taking Opventi.

What is type 2 diabetes and how can Opventi help treat it?
In type 2 diabetes, the body either does not produce enough insulin or cannot properly use the insulin it produces. This leads to high blood glucose levels. Such a condition can cause serious complications, such as heart or kidney disease, blindness, and poor circulation in arms and legs.
This medicine helps increase insulin levels released after meals, reduces the amount of glucose produced by the body, and removes excess glucose from the body.
Your doctor has prescribed this medicine to help lower your blood glucose levels, which are too high due to type 2 diabetes.

2. Important information before taking Opventi

When not to use Opventi
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 Opventi, discuss this with your doctor, pharmacist, or
nurse:
if the patient has type 1 diabetes – a type of diabetes usually diagnosed in
young people and characterized by lack of insulin production by the body. Opventi must not be used to treat this condition.
if the patient has or has had pancreatic disease (e.g. pancreatitis), gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat)
in the blood. In such cases, the risk of pancreatitis may be increased. Possible symptoms of pancreatitis are listed in section 4.
if the patient has or has had kidney problems
if the patient has or has had liver disease
if the patient has very high blood sugar levels causing dehydration (excessive fluid loss). Possible symptoms of excessive fluid loss are listed in section 4.
Before starting treatment, inform your doctor if any of these symptoms occur.
if the patient has or develops nausea, vomiting, or fever, or if the patient is unable to eat or drink. This may lead to dehydration. Your doctor may advise temporarily stopping Opventi until the patient's condition improves, to prevent dehydration.
if the patient has or has had diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Possible symptoms of ketoacidosis are listed in section 4.
if the patient frequently experiences urinary tract infections.

If any of these warnings apply to the patient (or if the patient is unsure), consult a doctor, pharmacist, or nurse before taking Opventi.

Diabetes and foot care
For patients with diabetes, it is important to regularly check the condition of the feet and follow all foot care advice provided by the doctor.

Glucose in urine
Due to the mechanism of action of Opventi, laboratory tests will show the presence of sugar (glucose) in the urine.

Children and adolescents
Opventi must not be given to children and adolescents under 18 years of age, as it has not been studied in this age group.

Opventi and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking:
Medicines used to treat heart rhythm disorders and other heart conditions (digoxin). Blood digoxin levels may need to be monitored if digoxin is taken together with Opventi.
Medicines that help remove water from the body (diuretics).
Other medicines that lower blood sugar levels, such as insulin or sulfonylureas. Your doctor may recommend reducing the dose of these medicines to prevent low blood sugar (hypoglycaemia).
Medicines that lower blood pressure (antihypertensives) and if the patient has previously had low blood pressure (hypotension).
Lithium used to treat psychiatric disorders, as Opventi may reduce lithium levels in the blood.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy. If the patient becomes pregnant, she should stop taking Opventi.
Do not use this medicine during breastfeeding or if breastfeeding is planned. It is unknown whether this medicine passes into breast milk.

Driving and using machines
This medicine has no effect or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported.
Do not drive or operate machinery if the patient experiences dizziness after taking Opventi.
Taking this medicine together with other medicines such as sulfonylureas or insulin may cause excessively low blood sugar (hypoglycaemia), manifesting as muscle tremors, excessive sweating, and visual disturbances, which may affect the ability to drive and use machines.

Opventi contains lactose and sodium
Opventi contains lactose (a sugar found in milk). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Opventi contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Opventi

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor, pharmacist, or nurse.
The usual recommended dose is:
one Opventi coated tablet. Your doctor will prescribe the dose appropriate for you;
taken once daily;
the tablet should be swallowed whole with a glass of water to ensure proper dosing and to avoid an unpleasant taste;
tablets may be taken during or between meals.
Your doctor may recommend treatment with Opventi alone or Opventi in combination with other medicines that lower blood sugar levels. It is important to take these medicines exactly as directed by your doctor. This will help achieve the best treatment results.
Taking more Opventi than prescribed
If you take more Opventi than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine packaging with you.
If you forget to take Opventi
What to do if you miss a dose.

If there are 12 hours or more until the next dose is due, take Opventi as soon as you remember.
Take your next dose at the usual time.
If less than 12 hours remain until the next dose is due, skip the missed dose. Take your next dose at the usual time.
Do not take a double dose of Opventi to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Discontinue use of Opventi and immediately consult a doctor or the nearest hospital if the patient experiences any of the following serious adverse symptoms:
Pancreatitis – severe and persistent pain in the abdomen (stomach area), possibly radiating to the back, with or without nausea and vomiting – 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 difficulties
rash
blisters on the skin or skin peeling.
Diabetic ketoacidosis – this is rare 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
intense thirst
rapid and deep breathing
disorientation
unusual drowsiness or tiredness
sweet breath odour, sweet or metallic taste in the mouth, or change in the smell of urine or sweat
rapid weight loss.
Ketoacidosis may occur regardless of blood glucose levels. The doctor may decide to interrupt or discontinue treatment with Opventi.
Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a severe infection of the soft tissues of the external genital organs or the area between the genitals and the anus, observed very rarely. Symptoms include a combination of pain, tenderness, redness and swelling of the external genital organs or the area between the genitals and the anus, accompanied by fever and general malaise. Immediate treatment is required in case of Fournier's gangrene (frequency very rare).
Stevens-Johnson syndrome, i.e. a blistering skin disease, which usually begins with flu-like symptoms, followed by a painful red or purple rash spreading on the skin and leading to blister formation.
Bullous pemphigoid, a type of blistering skin disease characterized by the presence of large fluid-filled blisters.
Discontinue use of Opventi and consult a doctor as soon as possible if the patient experiences any of the following serious adverse symptoms:
Urinary tract infection, which occurs frequently (may occur in up to 1 in 10 people). Symptoms of severe urinary tract infection:
fever and (or) chills
burning sensation during urination
back or flank pain.
Blood in the urine may occur not infrequently in patients; in such a case, consult a doctor immediately.
Contact a doctor as soon as possible if the patient experiences any of the following adverse symptoms:
Low blood sugar (hypoglycaemia), which occurs very frequently (may occur in more than 1 in 10 people) – in patients with diabetes taking this medicine with a sulfonylurea derivative or insulin. Symptoms of low blood sugar:
tremor, sweating, feeling anxious, rapid heartbeat
feeling hungry, headache, visual disturbances
mood changes or feeling disoriented.
The doctor will advise how to treat low blood sugar and what to do if any of the above adverse symptoms occur.
Other adverse reactions during use of Opventi:
Common (may occur in up to 1 in 10 people)
infections (fungal) of the penis or vagina (symptoms may include irritation, itching, unusual discharge or unpleasant odour)
back pain
passing more urine than usual or need to urinate more frequently
changes in blood cholesterol or fat levels (detected in laboratory tests)
increase in red blood cell count (detected in laboratory tests)
reduction in renal creatinine clearance (detected in laboratory tests) at the beginning of treatment
dizziness
rash
headache.
Uncommon (may occur in up to 1 in 100 people)
excessive loss of body fluids (dehydration, symptoms of which may include extreme dryness or stickiness in the mouth, passing little or no urine, or rapid heartbeat)
thirst
constipation
getting up at night to pass urine
dry mouth
weight loss
increased creatinine levels (detected in blood laboratory tests) at the beginning of treatment
increased urea levels (detected in blood laboratory tests)
fungal infection
itching, vaginal itching and genital itching, itching of the external genital organs.
Rare (may occur in up to 1 in 1,000 people)
low platelet count (thrombocytopenia)
Very rare (may occur in up to 1 in 10,000 people)

kidney inflammation.

Frequency unknown
lung fibrosis (interstitial lung disease)
vomiting
urticaria, itchy skin rash
inflammation of small blood vessels of the skin
joint pain
muscle pain
joint disorders or joint problems
kidney function disorders (sometimes requiring dialysis)
Reporting adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 to provide more information on the safety of the medicine.

5. How to store Opventi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack after: 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. These measures will help
protect the environment.

6. Contents of the pack and other information

What Opventi contains
The active substances in this medicine are sitagliptin and dapagliflozin.

Each coated tablet contains 100 mg sitagliptin (as sitagliptin hydrochloride monohydrate) and 10 mg dapagliflozin (as amorphous base of dapagliflozin).

The other components of the tablet core are microcrystalline cellulose, lactose monohydrate,
sodium carboxymethyl starch (type A), magnesium stearate.
The tablet coating contains polyvinyl alcohol, yellow iron oxide (E172), macrogol, talc, red iron oxide (E172).

What Opventi looks like and contents of the pack
The coated tablets are round, light brown, film-coated tablets marked with "101" on one side, with a diameter of 9.9 mm.

Pack sizes
Cardboard boxes containing 30 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Poland

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Sweden: Sitagliptin/Dapagliflozin EGIS PLC 100 mg/10 mg film-coated tablet
Czech Republic: Opventi
Hungary: Datolin Plus 100 mg/10 mg filmtabletta
Latvia: Datolin Plus 100 mg/10 mg apvalkotās tabletes
Lithuania: Datolin Plus 100 mg/10 mg plėvele dengtos tabletės
Poland: Opventi
Slovakia: Opventi 100 mg/10 mg filmom obalené tablety

To obtain further detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Poland
Tel.: +48 22 417 92 00