Sitagliptin/metformin hydrochloride polpharma

Package leaflet: Information for the patient

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 850 mg, film-coated tablets
Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 1000 mg, film-coated tablets
Sitagliptinum + Metformini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Sitagliptin/Metformin Hydrochloride Polpharma and what it is used for

Sitagliptin/Metformin Hydrochloride Polpharma 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 helps normalize blood glucose levels in adults with diabetes known as "type 2 diabetes". This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body. Used together with diet and physical exercise, it helps lower blood glucose levels. This medicine may be used as the sole antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylurea derivatives, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this happens, glucose accumulates in the blood. This may lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Sitagliptin/Metformin Hydrochloride Polpharma

Polpharma
When not to use Sitagliptin/Metformin Hydrochloride Polpharma:

• if the patient is allergic to sitagliptin or metformin, or to 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, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of breath.
• if the patient has severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravascular administration of contrast agents. The use of Sitagliptin/Metformin Hydrochloride Polpharma should be discontinued during the radiological examination and for 2 or more days thereafter, as advised by the physician, depending on the patient's kidney function.
• if the patient has recently experienced a myocardial infarction or has 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 occasionally),
• if the patient is breastfeeding.

Do not take Sitagliptin/Metformin Hydrochloride Polpharma if any of the above contraindications apply. Consult a doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before using Sitagliptin/Metformin Hydrochloride Polpharma.

Warnings and precautions

Before starting treatment with Sitagliptin/Metformin Hydrochloride Polpharma, discuss this with your doctor or pharmacist. Cases of pancreatitis have been reported in patients taking Sitagliptin/Metformin Hydrochloride Polpharma (see section 4). If the patient develops blisters on the skin, this may be a sign of a condition known as bullous pemphigoid. The doctor may advise the patient to discontinue taking Sitagliptin/Metformin Hydrochloride Polpharma.

Risk of lactic acidosis

Sitagliptin/Metformin Hydrochloride Polpharma may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).

If any of the above conditions apply to the patient, consult a doctor for further instructions.

Temporarily discontinue use of Sitagliptin/Metformin Hydrochloride Polpharma if the patient develops a medical condition associated with dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Discontinue use of Sitagliptin/Metformin Hydrochloride Polpharma and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs indicating nerve damage (e.g. pain or numbness), migraine or deafness.

Before starting treatment with Sitagliptin/Metformin Hydrochloride Polpharma, discuss the following with a doctor or pharmacist:

• if the patient has or has had pancreatic disease (e.g. pancreatitis).
• if the patient has or has had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may increase (see section 4).
• if the patient has been diagnosed with type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes.
• if the patient currently has or has previously experienced allergic reactions to sitagliptin, metformin, or Sitagliptin/Metformin Hydrochloride Polpharma (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin together with Sitagliptin/Metformin Hydrochloride Polpharma, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled for major surgery, treatment with Sitagliptin/Metformin Hydrochloride Polpharma should be discontinued during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Sitagliptin/Metformin Hydrochloride Polpharma.

If in doubt, discuss this with your doctor or pharmacist before using Sitagliptin/Metformin Hydrochloride Polpharma.

While being treated with Sitagliptin/Metformin Hydrochloride Polpharma, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age. The safety and efficacy of use in children and adolescents under 18 years of age have not been established.

Sitagliptin/Metformin Hydrochloride Polpharma and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray or CT scan, the use of Sitagliptin/Metformin Hydrochloride Polpharma must be discontinued before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Sitagliptin/Metformin Hydrochloride Polpharma.

Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or a dose adjustment of Sitagliptin/Metformin Hydrochloride Polpharma 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 conditions such as asthma or arthritis (corticosteroids),
• medicines that increase urine production (diuretics),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen or celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines used to treat bronchial asthma (β-sympathomimetics),
• iodine-containing contrast agents or medicines containing alcohol,
• some medicines used to treat gastrointestinal 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 specific type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when taking Sitagliptin/Metformin Hydrochloride Polpharma with digoxin.

Use of Sitagliptin/Metformin Hydrochloride Polpharma with alcohol

Avoid consuming excessive amounts of alcohol while taking Sitagliptin/Metformin Hydrochloride Polpharma, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy or breastfeeding. See section 2, When not to use Sitagliptin/Metformin Hydrochloride Polpharma.

Driving and operating machinery

This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive and operate machinery. Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.

Sitagliptin/Metformin Hydrochloride Polpharma contains sodium

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 850 mg film-coated tablets
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 1000 mg film-coated tablets
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Sitagliptyna/Chlorowodorek metforminy Polpharma

This medicine should always be taken as directed by the doctor. In case of doubt, consult a
doctor or pharmacist.

• Take one tablet:
• twice daily, orally;
• with meals to reduce the likelihood of gastrointestinal upset.
• To control blood sugar levels, the doctor may increase the dose of this medicine.
• If the patient has impaired kidney function, the doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by the doctor and pay attention to
consuming carbohydrates evenly throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycaemia).
Low blood sugar may occur when this medicine is taken together with a sulfonylurea derivative or insulin – in such a case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.
Taking more Sitagliptyna/Chlorowodorek metforminy Polpharma than prescribed
If more than the prescribed dose of this medicine is taken, contact a doctor immediately. Go to hospital if symptoms of lactic acidosis occur, such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").
Missing a dose of Sitagliptyna/Chlorowodorek metforminy Polpharma
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose of this medicine.
Stopping Sitagliptyna/Chlorowodorek metforminy Polpharma
To maintain control of blood sugar levels, take this medicine for as long as directed by the doctor. Do not stop taking this medicine without consulting a doctor first.
Stopping treatment with Sitagliptyna/Chlorowodorek metforminy Polpharma may cause blood sugar levels to rise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should STOP taking Sitagliptin/Metformin Hydrochloride Polpharma
and contact your doctor immediately if any of the following severe adverse reactions occur:

• Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

Sitagliptin/Metformin Hydrochloride Polpharma may very rarely (may occur in up to 1 patient in 10,000) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs, treatment with Sitagliptin/Metformin Hydrochloride Polpharma must be discontinued immediately and you must contact your doctor or nearest hospital immediately, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown), including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you must stop taking the medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and may also prescribe another medicine (change the medicine) to treat diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting sitagliptin:

Frequent (may occur in up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting.
Uncommon (may occur in up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Diarrhoea, nausea, bloating, constipation, stomach pain or vomiting may occur in some patients after starting treatment with sitagliptin in combination with metformin (frequent).
In some patients taking this medicine together with a sulfonylurea derivative such as glimepiride, the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar levels.
Frequent: constipation.
In some patients taking this medicine together with pioglitazone, the following adverse reactions occurred:
Frequent: swelling of hands or feet.
In some patients taking this medicine together with insulin, the following adverse reactions occurred:
Very common: low blood sugar levels.
Uncommon: dry mouth, headache.
In clinical trials, in some patients taking sitagliptin alone (one of the active substances in Sitagliptin/Metformin Hydrochloride Polpharma) or after marketing authorization of Sitagliptin/Metformin Hydrochloride Polpharma or sitagliptin alone or in combination with other antidiabetic medicines, the following adverse reactions occurred:
Frequent: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).
In some patients taking metformin alone, the following adverse reactions occurred:
Very common: nausea, vomiting, diarrhoea, stomach pain and loss of appetite. These symptoms may occur after starting metformin and usually resolve over time.
Frequent: metallic taste.
Very rare: decreased vitamin B levels, hepatitis (liver disease), urticaria, skin redness (rash) or itching.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 provide more information on the safety of the medicine.

5. How to store Sitagliptyna/Chlorowodorek metforminy Polpharma

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 following:
"EXP". The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot/LOT" indicates the batch number.
Do not store above 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Sitagliptyna/Chlorowodorek metforminy Polpharma contains
Sitagliptyna/Chlorowodorek metforminy Polpharma, 50 mg + 850 mg film-coated tablets

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Other ingredients are: tablet core: microcrystalline cellulose, povidone (K30), sodium lauryl sulfate, sodium stearyl fumarate. Additionally, the tablet coating contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).

Sitagliptyna/Chlorowodorek metforminy Polpharma, 50 mg + 1000 mg film-coated tablets

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients are: tablet core: microcrystalline cellulose, povidone (K30), sodium lauryl sulfate, sodium stearyl fumarate. Additionally, the tablet coating contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).

What Sitagliptyna/Chlorowodorek metforminy Polpharma looks like and contents of the pack
Sitagliptyna/Chlorowodorek metforminy Polpharma, 50 mg + 850 mg film-coated tablets: oval, biconvex pink film-coated tablet, embossed with "850" on one side. Tablet length is 19.9–20.4 mm, width 9.7–10.2 mm.
Sitagliptyna/Chlorowodorek metforminy Polpharma, 50 mg + 1000 mg film-coated tablets: oval, biconvex red film-coated tablet, embossed with "1000" on one side. Tablet length is 21.1–21.6 mm, width 10.3–10.8 mm.
Aluminum/PVC/PVDC blisters in cardboard boxes.
Pack sizes contain 28, 56, or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer
FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 and 15
08028 Barcelona, Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

For further information about this medicinal product and its names in the Member States of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6, 00-728 Warsaw
tel. 22 364 61 01