Patient Information Leaflet

Symgliptin, 25 mg, film-coated tablets
Symgliptin, 50 mg, film-coated tablets
Symgliptin, 100 mg, film-coated tablets
Sitagliptinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What is Symgliptin and what is it used for
What you need to know before taking Symgliptin
How to take Symgliptin
Possible side effects
How to store Symgliptin
Contents of the pack 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 glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels 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 for diabetes, along with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this occurs, sugar (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 taking Symgliptin

When not to take Symgliptin

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Symgliptin (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid.
The doctor may advise the patient to discontinue taking Symgliptin.
Inform the doctor if the patient has had or currently has:

pancreatic disease (e.g. pancreatitis);
gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). 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;
allergic reaction to Symgliptin (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar. However, if this medicine is taken together with a sulfonylurea derivative or insulin, hypoglycemia (low blood sugar) 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.
Symgliptin with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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). Blood digoxin levels should be monitored when taking Symgliptin together with digoxin.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. Nevertheless, when driving and using machines, consider 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 use machines or to work without secure foot support.
Symgliptin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered to be "sodium-free".

3. How to use Symgliptin

This medicine should always be taken as directed by the doctor. If in doubt, consult the 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 Symgliptin (e.g. 25 mg or 50 mg).
This medicine may be taken regardless of meals or drinks. Tablets should be swallowed whole; do not crush or chew them.
The doctor may recommend taking only this medicine or this medicine together with certain other medicines that lower blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively. While taking Symgliptin, it is important to follow the diet and perform the physical exercises recommended by the doctor.
Taking more Symgliptin than recommended
If more than the recommended dose of this medicine is taken, contact the doctor immediately.
Missing a dose of Symgliptin
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose of this medicine.
Stopping treatment with Symgliptin
To maintain control of blood sugar levels, the medicine should be taken for as long as directed by the doctor. Do not stop taking this medicine without first consulting the doctor.
If there are any further questions regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should DISCONTINUE Symgliptin and contact your doctor immediately 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.

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, treatment with the medicine should be stopped and medical advice sought immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:

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

Gastrointestinal disorders of various kinds have occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar.
Common: constipation.

The following adverse reactions have been reported in some patients taking sitagliptin with pioglitazone:

Common: flatulence, swelling of hands or feet.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

The following adverse reactions have been reported in some patients taking sitagliptin with insulin (with or without metformin):

Common: influenza.
Uncommon: dry mouth.

The following adverse reactions have been reported in some patients taking sitagliptin alone in clinical trials, or alone or in combination with other antidiabetic medicines after marketing:

Common: low blood sugar, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, osteoarthritis, 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 reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the 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 Authorisation Holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Symgliptin

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.
No special storage instructions apply.
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 Symgliptin contains

The active substance is sitagliptin. Each coated tablet of Symgliptin contains 25 mg (Symgliptin, 25 mg), 50 mg (Symgliptin, 50 mg), or 100 mg (Symgliptin, 100 mg) of sitagliptin as monohydrochloride monohydrate.
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) containing: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), red iron oxide (E172), and yellow iron oxide (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 thickness of 3.0 mm, embossed with "S17" on one side and "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 thickness of 3.6 mm, embossed with "S16" on one side and "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 thickness of 4.7 mm, embossed with "S15" on one side and "H" on the other side.
Blisters made of PVC/PE/PVDC/Aluminium, packed in a cardboard box. Pack sizes contain 14, 28, 30, 50, 56, 84, 90, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland
Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000,
Malta
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland