MAYSIGLU 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Maysiglu 25 mg Coated Tablets
3. Maysiglu 50 mg Coated Tablets
4. Maysiglu 100 mg Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is Maysiglu and what is it used for
6. Important information before taking Maysiglu
   1. When not to take Maysiglu
   2. Warnings and precautions
   3. Children and adolescents
   4. Maysiglu and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Maysiglu contains sodium
7. How to take Maysiglu
   1. Taking a higher dose of Maysiglu than recommended
   2. Missing a dose of Maysiglu
   3. Stopping treatment with Maysiglu
8. Possible side effects
   1. Reporting side effects
9. How to store Maysiglu
10. Contents of the pack and other information
    1. What Maysiglu contains
    2. What Maysiglu looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Maysiglu 25 mg Coated Tablets

Maysiglu 50 mg Coated Tablets

Maysiglu 100 mg Coated Tablets

Sitagliptin

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

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Maysiglu and what is it used for

Maysiglu contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken with meals and a program of physical exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Maysiglu

When not to take Maysiglu

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In patients taking Maysiglu, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Maysiglu.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase;
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney disease that has occurred in the past or is present;
• an allergic reaction to Maysiglu (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea derivative or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.

Maysiglu and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Maysiglu with digoxin, your doctor may need to check your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you plan to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive or use machines or work without safe foot support.

Maysiglu contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is considered to be essentially sodium-free.

3. How to take Maysiglu

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

• one 100 mg coated tablet;
• once a day;
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose of Maysiglu (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food.
Maysiglu 50 mg and 100 mg tablets can be divided into equal doses.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and physical exercise help your body make better use of the sugar in your blood.
While taking Maysiglu, it is important to follow the diet and exercise program recommended by your doctor.

Taking a higher dose of Maysiglu than recommended

If you take more of this medicine than you should, contact your doctor immediately.

Missing a dose of Maysiglu

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 to make up for a missed dose.

Stopping treatment with Maysiglu

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Maysiglu and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis.

If you experience a severe allergic reaction (frequency not known - cannot be estimated from the available data), including rash, hives, blisters on the skin, or peeling skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
In some patients, when sitagliptin was taken in combination with a sulfonylurea derivative and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients, when sitagliptin and pioglitazone were taken, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin, pioglitazone, and metformin were taken, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin and insulin (with or without metformin) were taken, the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was taken alone or with other anti-diabetic medicines in clinical studies or after marketing authorization, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint pain, pain in the arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Maysiglu

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 after: "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Maysiglu contains

• The active substance is sitagliptin. Maysiglu 25 mg coated tabletsEach coated tablet contains 25 mg of sitagliptin. Maysiglu 50 mg coated tabletsEach coated tablet contains 50 mg of sitagliptin. Maysiglu 100 mg coated tabletsEach coated tablet contains 100 mg of sitagliptin.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carmellose, sodium stearyl fumarate, and magnesium stearate Tablet coating:Opadry 85F280010 II HP white containing polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172), and iron oxide yellow (E172). See section 2 "Maysiglu contains sodium".

What Maysiglu looks like and contents of the pack

Maysiglu 25 mg coated tablets (tablets)
Pink, round, slightly convex coated tablets with the mark K25 engraved on one side of the tablet (diameter approximately 7 mm, thickness 2.0 - 3.2 mm).
Maysiglu 50 mg coated tablets
Light orange, round, convex coated tablets with a score line on one side of the tablet. The tablet is engraved with the mark K on one side of the score line and the mark 50 on the other side of the score line (diameter approximately 9 mm, thickness 2.8 - 3.8 mm). The tablet can be divided into equal doses.
Maysiglu 100 mg coated tablets
Brown-orange, round, convex coated tablets with a score line on one side of the tablet. The tablet is engraved with the mark K on one side of the score line and the mark 100 on the other side of the score line (diameter approximately 11 mm, thickness 3.3 - 4.5 mm). The tablet can be divided into equal doses.
Maysiglu is available in cardboard boxes containing 14, 28, 30, 56, 60, 90, or 98 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, contact your local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:26.05.2024