SITAFORMIL 50 mg/1000 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Sitaformil duo, 50 mg + 1000 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Sitaformil duo and what is it used for
4. Important information before taking Sitaformil duo
   1. When not to take Sitaformil duo
   2. Warnings and precautions
   3. The patient should temporarily stop taking Sitaformil duo if they have a condition that may lead to dehydration
   4. The patient should stop taking Sitaformil duo and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis
   5. Children and adolescents
   6. Sitaformil duo and other medicines
   7. Sitaformil duo and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Sitaformil duo contains sodium
5. How to take Sitaformil duo
   1. Adults
   2. Patients with kidney problems
   3. Taking a higher dose of Sitaformil duo than recommended
   4. Missing a dose of Sitaformil duo
   5. Stopping treatment with Sitaformil duo
6. Possible side effects
   1. Reporting side effects
7. How to store Sitaformil duo
8. Contents of the packaging and other information
   1. What Sitaformil duo contains
   2. What Sitaformil duo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet accompanying the packaging: patient information

Sitaformil duo, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sitaformil duo and what is it used for
• 2. Important information before taking Sitaformil duo
• 3. How to take Sitaformil duo
• 4. Possible side effects
• 5. How to store Sitaformil duo
• 6. Contents of the packaging and other information

1. What is Sitaformil duo and what is it used for

Sitaformil duo contains two different active substances: sitagliptin and metformin.

• sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body. The medicine is used in combination with diet and exercise to reduce blood sugar levels. This medicine can be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? Type 2 diabetes is a disease in which the body does not produce enough insulin, and the insulin produced does not work properly. The patient's body may also produce too much sugar. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sitaformil duo

When not to take Sitaformil duo

• if the patient is allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss,

lactic acidosis (see below: "Risk of lactic acidosis") or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,

• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. The patient should stop taking Sitaformil duo during the radiological examination and for at least 2 days, according to the doctor's recommendations, depending on the patient's kidney function,
• if the patient has recently had a heart attack or has had severe circulatory disorders, such as shock or breathing difficulties,
• if the patient has liver disease,
• if the patient consumes excessive amounts of alcohol (either daily or from time to time),
• if the patient is breastfeeding.

Do not take Sitaformil duo if any of the above contraindications apply. Consult a doctor to determine other methods of diabetes control. In case of doubts, before taking Sitaformil duo, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking the combination of sitagliptin and metformin, cases of pancreatitis (see section 4) have been reported. If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid. The doctor may recommend that the patient stop taking Sitaformil duo. Risk of lactic acidosis Sitaformil duo may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see below), kidney problems, liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions. The patient should contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or inherited diabetes and deafness from their mother (MIDD, maternal inherited diabetes and deafness).
• the patient has experienced any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

The patient should temporarily stop taking Sitaformil duo if they have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

The patient should stop taking Sitaformil duo and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis

because this condition can lead to coma. Symptoms of lactic acidosis include: vomiting, abdominal pain, muscle cramps, general feeling of being unwell with severe fatigue, breathing difficulties, decreased body temperature, and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Before taking Sitaformil duo, the patient should discuss it with a doctor or pharmacist if:

• the patient has or has had pancreatitis (e.g., pancreatitis),
• the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase,
• the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes,
• the patient has currently or has had allergic reactions to sitagliptin, metformin, or Sitaformil duo (see section 4),
• the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitaformil duo, as this may lead to excessive reduction of blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled to undergo major surgery, they should not take Sitaformil duo during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitaformil duo. In case of doubts, before taking Sitaformil duo, the patient should discuss it with a doctor or pharmacist. During treatment with Sitaformil duo, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has deteriorating kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. The medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether the medicine is safe and effective in children under 10 years of age.

Sitaformil duo and other medicines

If the patient is to receive an intravenous contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitaformil duo before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Sitaformil duo. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Sitaformil duo by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• diuretics,
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina pectoris,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Sitaformil duo with digoxin, the patient should have their digoxin levels checked.

Sitaformil duo and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitaformil duo, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy. The patient should not take this medicine while breastfeeding (see section 2, "When not to take Sitaformil duo").

Driving and using machines

Sitaformil duo has no or negligible influence on the ability to drive and use machines. However, while driving and using machines, the patient should take into account that dizziness and drowsiness have been reported in patients taking sitagliptin, which may affect the ability to drive and use machines. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Sitaformil duo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Sitaformil duo

This medicine should always be taken exactly as the doctor has instructed. In case of doubts, the patient should consult a doctor or pharmacist.

Adults

The recommended dose is one tablet, taken orally twice a day. This medicine should be taken with meals to reduce the likelihood of stomach upset. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. The doctor may recommend a higher dose of the medicine to control blood sugar levels.

Patients with kidney problems

If the patient has kidney problems, the doctor may recommend a lower dose of sitagliptin (e.g., 25 mg or 50 mg). Diet and exercise help the body use sugar in the blood better. While taking Sitaformil duo, it is essential to follow the diet and exercise recommended by the doctor. The patient should also pay attention to evenly distributing carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, the doctor may recommend a lower dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sitaformil duo than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact a doctor. The patient should go to the hospital if they experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sitaformil duo

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine.

Stopping treatment with Sitaformil duo

To maintain control of blood sugar levels, the patient should take the medicine for as long as the doctor recommends. The patient should not stop taking this medicine without consulting a doctor first. Stopping treatment with Sitaformil duo may lead to increased blood sugar levels. In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOP taking Sitaformil duo and contact a doctor immediately if they experience any of the following serious side effects:

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back and may be accompanied by nausea and vomiting, as these may be symptoms of pancreatitis.

Sitaformil duo may rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Sitaformil duo and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause breathing or swallowing difficulties, the patient should stop taking the medicine and contact a doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. In some patients taking metformin after starting sitagliptin, the following side effects have occurred:

• Common (may occur in less than 1 in 10 patients): low blood sugar, nausea, bloating, vomiting.
• Uncommon (may occur in less than 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness.

In some patients, diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (common). In some patients taking Sitaformil duo in combination with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:

• Very common (may occur in more than 1 in 10 patients): low blood sugar.
• Common: constipation.

In some patients taking Sitaformil duo in combination with pioglitazone, the following side effects have occurred:

• Common: swelling of the hands or feet.

In some patients taking Sitaformil duo in combination with insulin, the following side effects have occurred:

• Very common: low blood sugar,
• Uncommon: dry mouth, headache.

In clinical trials, some patients taking sitagliptin (one of the active substances of this medicine) alone or after marketing authorization, when taking sitagliptin alone or with other anti-diabetic medicines, or in combination with metformin, have experienced the following side effects:

• Common: low blood sugar, headache, upper respiratory tract infections, stuffy nose or sore throat, and joint or muscle pain.
• Uncommon: dizziness, constipation, itching.
• Rare: decreased platelet count.
• Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid (a type of blistering skin disease).

In some patients taking metformin alone, the following side effects have occurred:

• Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear.
• Common: metallic taste.
• Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sitaformil duo

The medicine should be stored out of sight and reach of children. Store in a temperature below 30°C. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. The batch number on the packaging is marked as "Lot". Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Sitaformil duo contains

• The active substances of the medicine are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• The other ingredients are: Tablet core: povidone (K29/32), microcrystalline cellulose, crospovidone, sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).

What Sitaformil duo looks like and contents of the pack

Sitaformil duo is a red to brown, oval, film-coated tablet with a score line between "S" and "B" on one side and a score line on the other side, measuring 21.3 ± 0.5 mm. The medicine is packaged in PVC/PVDC/Aluminum blisters. One pack contains 56 film-coated tablets in a carton.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, Tel. (42) 22-53-100

Manufacturer

SAG MANUFACTURING, S.L.U., Ctra. N-I, Km 36, 28750 San Agustin de Guadalix, Madrid, Spain, and GALenicUM HEALTH, S.L., Avda. Cornellá 144, 7º-1ª Edificio LEKLA, 08950 Esplugues de Llobregat, Barcelona, Spain. Date of last revision of the leaflet:26.03.2025