Simgliptin

Package Leaflet: Information for the Patient

Symgliptin, 25 mg, Film-Coated Tablets

Symgliptin, 50 mg, Film-Coated Tablets

Symgliptin, 100 mg, Film-Coated Tablets

Sitagliptin

Read the Package Leaflet Carefully Before Taking the Medication, 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 Package 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 medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medication helps achieve higher insulin levels after meals and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medication to reduce high blood sugar levels caused by type 2 diabetes. The medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition where 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, vision loss, and limb amputation.

2. Important Information Before Taking Symgliptin

When Not to Take Symgliptin

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

Warnings and Precautions

In patients taking Symgliptin, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Symgliptin.
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, past or present;
• an allergic reaction to Symgliptin (see section 4).

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

Children and Adolescents

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

Symgliptin and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
In particular, tell your doctor if you are taking digoxin (a medication used to treat heart rhythm disorders and other heart conditions). When taking Symgliptin with digoxin, your doctor may monitor your digoxin levels.

Pregnancy and Breastfeeding

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

Driving and Using Machines

This medication 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 medication with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without safe foot support.

Symgliptin Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to Take Symgliptin

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

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

If you have kidney problems, your doctor may prescribe a lower dose of Symgliptin (e.g., 25 mg or 50 mg).
This medication can be taken with or without food and drink. Swallow the tablets whole; do not crush or chew them.
Your doctor may prescribe this medication alone or with certain other medications that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking Symgliptin, it is important to follow the diet and exercise plan recommended by your doctor.

Taking More Than the Recommended Dose of Symgliptin

If you take more than the recommended dose of this medication, contact your doctor immediately.

Missing a Dose of Symgliptin

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 medication.

Stopping Symgliptin Treatment

To maintain control of your blood sugar levels, you should keep taking this medication for as long as your doctor recommends. Do not stop taking this medication 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 medications, Symgliptin can cause side effects, although not everybody gets them.
STOP taking Symgliptin and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking Symgliptin and contact your doctor immediately. Your doctor may prescribe a medication to treat the allergic reaction and another medication to treat your diabetes.
In some patients who added sitagliptin 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.
In some patients who started taking sitagliptin with metformin, various gastrointestinal symptoms (common) were reported.
In some patients who took sitagliptin with a sulfonylurea 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 who took sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet.
In some patients who took sitagliptin with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet.
In some patients who took sitagliptin with insulin (with or without metformin), the following side effects were reported:
Common: flu.
Uncommon: dry mouth.
In some patients who took sitagliptin alone in clinical trials or alone or with other anti-diabetic medications after marketing authorization, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose, and sore throat, joint pain, pain in the arm or leg.
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. You can also report side effects 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Symgliptin

Keep this medication out of the sight and reach of children.
Do not use this medication 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 storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Symgliptin Contains

• The active substance is sitagliptin. Each film-coated tablet contains 25 mg (Symgliptin, 25 mg), 50 mg (Symgliptin, 50 mg), and 100 mg (Symgliptin, 100 mg) of sitagliptin as sitagliptin phosphate monohydrate.
• The other ingredients are:
• microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium carmellose (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 Package

Symgliptin, 25 mg, film-coated tablets
Round, pink film-coated tablets, approximately 6.1 mm in diameter and 3.0 mm in thickness, with 'S17' embossed on one side and 'H' embossed on the other side.
Symgliptin, 50 mg, film-coated tablets
Round, pink film-coated tablets, approximately 7.9 mm in diameter and 3.6 mm in thickness, with 'S16' embossed on one side and 'H' embossed on the other side.
Symgliptin, 100 mg, film-coated tablets
Round, pink film-coated tablets, approximately 9.9 mm in diameter and 4.7 mm in thickness, with 'S15' embossed on one side and 'H' embossed 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