Simgliptin

Leaflet attached to the packaging: patient information

Symgliptin, 25 mg, film-coated tablets

Symgliptin, 50 mg, film-coated tablets

Symgliptin, 100 mg, film-coated tablets

Sitagliptin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Symgliptin and what is it used for

Symgliptin 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 reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels, which are a result of type 2 diabetes. The 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 for diabetes, along with diet and a physical exercise program.
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 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 diseases, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Symgliptin

When not to take Symgliptin

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

Warnings and precautions

In patients taking Symgliptin, 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 bullous pemphigoid. The doctor may advise the patient to stop taking Symgliptin.
The patient should inform their doctor if they 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 such 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 currently present;
• an allergic reaction to Symgliptin (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, it may cause low blood sugar levels (hypoglycemia). 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 when used in children under 10 years of age.

Symgliptin and other medicines

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.
In particular, the patient should inform their doctor if they are taking digoxin (a medicine used to treat heart rhythm disorders and other heart diseases). When taking Symgliptin with digoxin, the patient's digoxin blood levels should be monitored.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy.
It is not known whether this medicine passes into breast milk. This medicine should not be taken during breastfeeding or if breastfeeding is planned.

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, the patient should take into account that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause hypoglycemia, which can affect the ability to drive and use machines or work without safe foot support.

Symgliptin contains sodium

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

3. How to take Symgliptin

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is:

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

If the patient has kidney function disorders, the doctor may prescribe a lower dose of Symgliptin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks. The tablets should be swallowed whole; they should not be crushed or chewed.
The doctor may advise the patient to take only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and physical exercise help the body use the sugar in the blood better. When taking Symgliptin, it is essential to follow the diet and exercise program recommended by the doctor.

Taking a higher dose of Symgliptin than recommended

If the patient takes a higher dose of this medicine than recommended, they should immediately contact their doctor.

Missing a dose of Symgliptin

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 Symgliptin treatment

To maintain control of blood sugar levels, the patient should take this medicine for as long as their doctor recommends. The patient should not stop taking this medicine without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their 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 Symgliptin and contact their 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, with or without nausea and vomiting - this may be a sign of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, as well as swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing, the patient should stop taking the medicine and contact their doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients who added sitagliptin to metformin, the following side effects occurred:
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.
In some patients, various gastrointestinal disorders occurred after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects occurred:
Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.
In some patients who took sitagliptin and pioglitazone, the following side effects occurred:
Common: bloating, swelling of the hands or feet.
In some patients who took sitagliptin, pioglitazone, and metformin, the following side effects occurred:
Common: swelling of the hands or feet.
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects occurred:
Common: flu.
Uncommon: dry mouth.
In some patients who took sitagliptin alone in clinical trials or alone or with other anti-diabetic medicines after marketing authorization, the following side effects occurred:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, osteoarthritis, pain in the arm or leg.
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, bullous pemphigoid (a type of blisters on the skin).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, it is possible to gather more information on the safety of this medicine.

5. How to store Symgliptin

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Symgliptin contains

• The active substance of Symgliptin is sitagliptin. Each film-coated tablet of Symgliptin contains 25 mg (Symgliptin, 25 mg), 50 mg (Symgliptin, 50 mg), and 100 mg (Symgliptin, 100 mg) of sitagliptin in the form of monohydrate hydrochloride.
• The other ingredients are:
• microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium croscarmellose (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
• Tablet coating: Opadry II Pink 85F540099 (25 mg, 100 mg) and Opadry II Pink 85F540265 (50 mg) contain: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), iron oxide red (E172), and iron oxide yellow (E172).

What Symgliptin looks like and contents of the pack

Symgliptin, 25 mg, film-coated tablets
Round, pink film-coated tablets with a diameter of approximately 6.1 mm and a thickness of 3.0 mm, with the inscription "S17" on one side and the inscription "H" on the other side.
Symgliptin, 50 mg, film-coated tablets
Round, pink film-coated tablets with a diameter of approximately 7.9 mm and a thickness of 3.6 mm, with the inscription "S16" on one side and the inscription "H" on the other side.
Symgliptin, 100 mg, film-coated tablets
Round, pink film-coated tablets with a diameter of approximately 9.9 mm and a thickness of 4.7 mm, with the inscription "S15" on one side and the inscription "H" on the other side.
Blisters of PVC/PE/PVDC/Aluminum, in a cardboard box. The packs contain 14, 28, 30, 50, 56, 84, 90, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000,
Malta
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Date of last revision of the leaflet:May 2025