Maysiglu

Package leaflet: Information for the patient

Maysiglu 25 mg coated tablets
Maysiglu 50 mg coated tablets
Maysiglu 100 mg coated tablets
Sitagliptinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• 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 Maysiglu is and what it is 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 Maysiglu is and what it is 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 glucose levels in adults with
type 2 diabetes.
This medicine helps increase the amount of insulin released after meals and reduces the amount of
glucose produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2
diabetes. The medicine may be used alone or in combination with other glucose-lowering medicines
(insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and
an exercise program.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced
does not work properly, or the body produces too much glucose. When this occurs, 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 Maysiglu

When not to use Maysiglu

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

Warnings and precautions
Cases of pancreatitis (inflammation of the pancreas) have been reported in patients taking Maysiglu (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Maysiglu.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• 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);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• 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 excessively low blood sugar. However, if this medicine is used together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycemia) may occur. The 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 with other medicines
Tell the doctor or pharmacist 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 the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When Maysiglu is taken with digoxin, blood levels of digoxin should be monitored.
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.
It is not known whether this medicine passes into human breast milk. Do not use this medicine during breastfeeding or if breastfeeding is planned.
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, it should be noted that dizziness and somnolence have been reported.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Maysiglu contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. this medicine is considered sodium-free.

3. How to use Maysiglu

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has impaired kidney function, the doctor may recommend a lower dose of Maysiglu
(e.g. 25 mg or 50 mg).
This medicine may be taken with food or independently of meals.
Maysiglu 50 mg and 100 mg tablets may be divided into equal doses.
The doctor may recommend treatment with this medicine alone or in combination with other
medicines that reduce blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively.
While taking Maysiglu, it is important to follow the diet and exercise regimen recommended by
your doctor.
Taking more Maysiglu than recommended
If you take more than the recommended dose of this medicine, 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 the next dose, skip the missed
dose and continue with your regular dosing schedule. Do not take a double dose to make up for
the missed dose.
Stopping Maysiglu
To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor
recommends. Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should DISCONTINUE Maysiglu and contact your doctor immediately if any of the following severe adverse effects 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.

In case of a severe allergic reaction (frequency unknown – cannot be estimated from available data), 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 contact your doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

In some patients, the following adverse effects occurred when sitagliptin was added to metformin:
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, diarrhoea, constipation, drowsiness
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse effects occurred during treatment with sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

In some patients, the following adverse effects occurred during treatment with sitagliptin and pioglitazone:
Common: bloating, swelling of hands or feet

In some patients, the following adverse effects occurred during treatment with sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or feet

In some patients, the following adverse effects occurred during treatment with sitagliptin in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth

In some patients, the following adverse effects occurred during treatment with sitagliptin alone and/or with other antidiabetic medicines in clinical trials or during post-marketing use:
Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arm or leg
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)

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the 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 stated month.
Do not store above 25°C.
Keep 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. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is sitagliptin.
  Maysiglu 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of sitagliptin.
  Maysiglu 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of sitagliptin.
  Maysiglu 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of sitagliptin.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, 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 film-coated tablets (tablets)
Pink, round, slightly biconvex film-coated tablets with the imprint K25 on one side of the tablet (diameter approximately 7 mm, thickness 2.0 – 3.2 mm).

Maysiglu 50 mg film-coated tablets
Light orange, round, biconvex film-coated tablets with a division line on one side of the tablet. The imprint K is engraved on one side of the division line and 50 on the other side (diameter approximately 9 mm, thickness 2.8 – 3.8 mm). The tablet can be divided into equal doses.

Maysiglu 100 mg film-coated tablets
Brown-orange, round, biconvex film-coated tablets with a division line on one side of the tablet. The imprint K is engraved on one side of the division line and 100 on the other side (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 film-coated tablets in blisters.
Not all pack sizes may be marketed.

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

For further information, contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00