MAYMETSI

Patient Information Leaflet

Maymetsi, 50 mg + 850 mg, film-coated tablets
Maymetsi, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
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, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm other people, 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 or pharmacist. See section 4.

Table of Contents

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

1. What Maymetsi is and what it is used for

Maymetsi 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 two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin release after meals and reduces the amount of glucose produced by the body. When used together with diet and exercise, it helps lower blood glucose levels. This medicine may be used alone as an antidiabetic treatment or in combination with certain other antidiabetic medicines (such as 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 as effectively as it should. The body may also produce too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Maymetsi

When not to use Maymetsi

• if the patient is allergic to sitagliptin and 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, e.g. 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 an unusual fruity odour of the breath.
• if the patient has severe infection or dehydration,
• if the patient is scheduled for a radiological examination with intravascular administration of contrast agents. The use of Maymetsi should be discontinued during the radiological examination and for 2 or more days thereafter, according to the physician's instructions, depending on the patient's kidney function.
• if the patient has recently suffered a heart attack 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 Maymetsi if any of the above contraindications apply.
Consult your doctor to determine alternative methods of diabetes control. In case of
doubt, discuss this with your doctor, pharmacist, or
nurse before using Maymetsi.
Warnings and precautions
Cases of pancreatitis have been reported in patients treated with sitagliptin in combination with metformin (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to discontinue Maymetsi.
Risk of lactic acidosis
Maymetsi 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 a 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 the doctor for further instructions.
Temporarily discontinue Maymetsi if the patient has a medical condition that may lead to 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 the doctor for further instructions.
Discontinue Maymetsi and contact the doctor or 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 combined with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact the doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (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, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Before starting Maymetsi, discuss with the 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 be increased (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 had allergic reactions to sitagliptin, metformin, or Maymetsi (see section 4),
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic medicines together with Maymetsi, as this may lead to excessively low blood glucose levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is undergoing major surgery, Maymetsi must not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Maymetsi.
In case of doubt, discuss this with the doctor or
pharmacist before using Maymetsi.
During treatment with Maymetsi, 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 medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Maymetsi and other medicines
If the patient is to receive an intravenous contrast agent containing iodine, for example for an X-ray or CT scan, the patient must discontinue Maymetsi before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Maymetsi.
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Maymetsi 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 and 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,
• 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 levels of digoxin should be monitored when taken with Maymetsi.

Maymetsi and alcohol
Avoid consuming excessive amounts of alcohol while taking Maymetsi, 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 her doctor or pharmacist before using this medicine. Do not use this medicine during pregnancy. This medicine must not be used during breastfeeding. See section 2 "When not to use Maymetsi".
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and drowsiness have been reported with sitagliptin use, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylurea derivatives or insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Maymetsi contains sodium
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 Maymetsi

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

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

While taking this medicine, you should continue following the diet recommended by your doctor and pay attention
to evenly distributing carbohydrate intake 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 used together with a sulphonylurea derivative or insulin – in such a case, your doctor may reduce the dose of the sulphonylurea derivative or insulin.
Taking more Maymetsi than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately. You should go to hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").
Missing a dose of Maymetsi
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.
Stopping Maymetsi
To maintain control of blood sugar levels, you should take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.
Stopping Maymetsi may cause an increase in blood sugar levels.
If you have any further questions about how to use 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 Maymetsi and immediately contact your doctor if any of the
following serious 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.

Maymetsi very rarely (may occur in no more than 1 in 10,000 patients) may cause a very
serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”).
If lactic acidosis occurs, you must stop taking Maymetsi immediately and contact your doctor or the nearest hospital
immediately, as lactic acidosis can 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 should stop taking the medicine and immediately
contact your doctor. Your doctor may prescribe medication to treat the allergic reaction and
may switch you to another medicine (change your medication) for the treatment of diabetes.
The following adverse reactions have been reported in some patients taking metformin who
started treatment with sitagliptin:

Frequent (may affect up to 1 in 10 patients): low blood sugar levels, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness

Some patients experienced diarrhoea, nausea, flatulence, constipation, stomach pain or
vomiting 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 affect more than 1 in 10 patients): low blood sugar levels
Frequent: constipation

In some patients taking this medicine in combination with pioglitazone, the following
adverse reactions occurred:

Frequent: swelling of hands or feet

In some patients taking this medicine in combination with insulin, the following adverse
reactions occurred:

Very common: low blood sugar levels
Uncommon: dry mouth, headache

In clinical studies and post-marketing experience, when sitagliptin (one of the active
substances in Maymetsi) was used alone or in combination with metformin or other
antidiabetic medicines, the following adverse reactions were observed in some patients:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, bone and joint inflammation, 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 blistering skin condition)

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 when starting metformin and usually resolve over time.
Frequent: metallic taste, reduced or low levels of vitamin B__ in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness sensations (paresthesia), or paleness or yellowing of the skin). Your doctor may order certain tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash) or itching.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your
doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
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 provide more information on the safety of the medicine.

5. How to store Maymetsi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the EXP abbreviation. The expiry date refers to the last day of the specified month.
OPA/Aluminium/PVC/Aluminium foil blister:
No special requirements regarding storage temperature of the medicinal product.
Store in the original packaging to protect from moisture.
PVC/PE/PVDC/PE/PVC/Aluminium foil blister:
Store below 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Maymetsi contains

• The active substances are sitagliptin and metformin hydrochloride.
  Maymetsi 50 mg + 850 mg, film-coated tablets
  Each film-coated tablet contains 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
  Maymetsi 50 mg + 1000 mg, film-coated tablets
  Each film-coated tablet contains 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.

• The other ingredients (excipients) are: povidone K30, microcrystalline cellulose, mannitol, sodium lauryl sulfate, magnesium stearate in the tablet core; and hypromellose type 2910 (6 cP), titanium dioxide (E 171), talc, propylene glycol, iron oxide red (E 172) in the tablet coating. See section 2, "Maymetsi contains sodium".

What Maymetsi looks like and contents of the pack
Maymetsi 50 mg + 850 mg, film-coated tablets
Pink, oval, biconvex film-coated tablets marked with "C4" on one side of the tablet (dimensions: approximately 20 x 11 mm).

Maymetsi 50 mg + 1000 mg, film-coated tablets
Dark pink, oval, biconvex film-coated tablets marked with "C3" on one side of the tablet (dimensions: approximately 21 x 11 mm).

Maymetsi is available in packs containing:

• 10, 14, 28, 30, 56, 60, 90, 196 and 200 film-coated tablets in blister packs,
• 14, 28, 56 and 196 film-coated tablets in blister packs in calendar packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names: