Package leaflet: information for the patient

Sitagliptin TZF, 25 mg, film-coated tablets
Sitagliptin TZF, 50 mg, film-coated tablets
Sitagliptin TZF, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Sitagliptin TZF is and what it is used for
Important information before taking Sitagliptin TZF
How to take Sitagliptin TZF
Possible side effects
How to store Sitagliptin TZF
Contents of the pack and other information

1. What Sitagliptin TZF is and what it is used for

Sitagliptin TZF 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.
This 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
an exercise programme.
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 may also produce too much glucose. When this happens, 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 Sitagliptin TZF
When NOT to take Sitagliptin TZF

if you are 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 sitagliptin (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking sitagliptin.
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 such cases, the risk of pancreatitis may be increased (see section 4);
type 1 diabetes;
diabetic ketoacidosis (a diabetes complication characterised by high blood glucose levels, rapid weight loss, nausea or vomiting);
any kidney problems in the past or present;
an allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when blood glucose levels are low, it is unlikely to cause excessively low blood glucose levels. However, if this medicine is taken together with a sulfonylurea or insulin, low blood glucose (hypoglycaemia) may occur. 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 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.

Sitagliptin TZF and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when taking Sitagliptin TZF with digoxin.

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

Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without secure foot support.

Sitagliptin TZF contains sodium
Sitagliptin TZF contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Sitagliptin TZF

This medicine should always be taken according to the doctor's instructions. 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 Sitagliptin
TZF (e.g. 25 mg or 50 mg).
This medicine can be taken regardless of meals or drinks.
The doctor may recommend taking only this medicine or this medicine in combination with other medicines
that lower blood sugar levels.
Diet and physical activity help the body use blood sugar more effectively. While taking Sitagliptin TZF,
it is important to follow the diet and perform the physical exercises recommended by the doctor.
Taking more Sitagliptin TZF than recommended
If more than the recommended dose of this medicine is taken, contact your doctor immediately.
Missing a dose of Sitagliptin TZF
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 Sitagliptin TZF
To maintain control of blood sugar levels, the medicine should be taken for as long as recommended by the
doctor. Do not stop taking this medicine without first consulting your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
DISCONTINUE Sitagliptin TZF and contact your doctor immediately if any of the following severe 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, hives, skin blistering or peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and another medicine to treat diabetes.
In some patients receiving metformin, the following adverse reactions occurred after adding sitagliptin:
Common (may occur in up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 people): abdominal pain, diarrhoea, constipation, drowsiness.
Gastrointestinal discomfort of various kinds occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).
In some patients receiving sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients receiving sitagliptin and pioglitazone, the following adverse reactions occurred:
Common: bloating, swelling of hands or feet
In some patients receiving sitagliptin in combination with pioglitazone and metformin, the following adverse reactions occurred:
Common: swelling of hands or feet
In some patients receiving sitagliptin in combination with insulin (with or without metformin), the following adverse reactions occurred:
Common: influenza-like illness
Uncommon: dry mouth
In some patients receiving sitagliptin alone in clinical trials, or alone or with other antidiabetic medicines after marketing authorization, the following adverse reactions occurred:
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 (may occur in up to 1 in 1000 people): decreased platelet count
Frequency not known (cannot be estimated from available data): 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 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sitagliptin TZF

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box after
"EXP". The expiry date refers to the last day of the specified month.
"Lot" means batch number.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin TZF contains
The active substance is sitagliptin.
Sitagliptin TZF, 25 mg
Each tablet contains 25 mg of sitagliptin as sitagliptin hydrochloride monohydrate.
Sitagliptin TZF, 50 mg
Each tablet contains 50 mg of sitagliptin as sitagliptin hydrochloride monohydrate.
Sitagliptin TZF, 100 mg
Each tablet contains 100 mg of sitagliptin as sitagliptin hydrochloride monohydrate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose type 102, sodium croscarmellose,
colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172),
red iron oxide (E 172).
The 25 mg coated tablets do not contain yellow iron oxide (E 172), but contain black iron oxide (E 172).

What Sitagliptin TZF looks like and contents of the pack
Sitagliptin TZF, 25 mg
Round, pink, film-coated tablet. Dimensions: 6.3 mm ± 0.5 mm in diameter.
Sitagliptin TZF, 50 mg
Round, light beige, film-coated tablet with the engraved mark "S" on one side.
Dimensions: 8.0 mm ± 0.5 mm in diameter.
Sitagliptin TZF, 100 mg
Round, beige, film-coated tablet. Dimensions: 10.0 mm ± 0.5 mm in diameter.

Packaging
PVC/PE/PVDC/Aluminium blister.
28 film-coated tablets packed with the leaflet in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14
To obtain further information about this medicinal product, please contact the Marketing Authorisation Holder.

Manufacturers
Galenicum Health S.L.
Calle De San Gabriel 50
08950 Esplugues de Llobregat
Spain
SAG Manufacturing S.L.
Carretera Nacional 1 Km 36
28750 San Augustin del Guadalix
Spain
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw