Sitagliptin Tzf

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

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Sitagliptin TZF is and what it is used for
• 2. Important information before taking Sitagliptin TZF
• 3. How to take Sitagliptin TZF
• 4. Possible side effects
• 5. How to store Sitagliptin TZF
• 6. 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 sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin produced after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high because of your type 2 diabetes. This medicine can be used alone or in combination with other medicines that lower blood sugar levels (insulin, metformin, sulfonylureas, or glitazones), which you may already be taking for your diabetes, together 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 that it does produce does not work properly. The body may also produce too much sugar.
If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and foot amputation.

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

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).
If you get a skin rash or blisters, this may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking sitagliptin.

Tell Your Doctor if You Have or Have Had:

• pancreatic disease (such as 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 be increased;
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney problems, past or present;
• an allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when your blood sugar levels are low, it is unlikely to cause low blood sugar levels (hypoglycemia). However, when 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 medicine. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if 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 the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeats and other heart conditions). When taking Sitagliptin TZF with digoxin, your doctor may check your digoxin levels.

Pregnancy and Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant.
It is not known if this medicine passes into breast milk. Do not take this medicine while breast-feeding or if you are planning to breast-feed.

Driving and Using Machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect your ability to drive or use machines or work without safe support for your feet.

Sitagliptin TZF Contains Sodium

Sitagliptin TZF contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to Take Sitagliptin TZF

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

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

If you have kidney problems, your doctor may prescribe a lower dose of Sitagliptin TZF (such as 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may prescribe this medicine alone or in combination with other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking Sitagliptin TZF, it is important to follow the diet and exercise program recommended by your doctor.

If You Take More Sitagliptin TZF Than You Should

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

If You Forget to Take Sitagliptin TZF

If you miss a dose, take it as soon as you remember. 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 medicine.

If You Stop Taking Sitagliptin TZF

To control your blood sugar levels, you should keep taking this medicine as long as your doctor tells you to.
Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop Taking Sitagliptin TZF and Contact Your Doctor Immediatelyif you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the area of the stomach), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters, or peeling of the skin, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your diabetes.

In Some Patients Taking Metformin and Then Sitagliptin, the Following Side Effects Have Been Reported:

The Following Side Effects Have Been 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): abdominal pain, diarrhea, constipation, drowsiness
Some patients have reported gastrointestinal symptoms when taking sitagliptin in combination with metformin (commonly).

In Some Patients Taking Sitagliptin in Combination with a Sulfonylurea and Metformin, the Following Side Effects Have Been Reported:

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

In Some Patients Taking Sitagliptin and Pioglitazone, the Following Side Effects Have Been Reported:

Common: bloating, swelling of the hands or feet

In Some Patients Taking Sitagliptin in Combination with Pioglitazone and Metformin, the Following Side Effects Have Been Reported:

Common: swelling of the hands or feet

In Some Patients Taking Sitagliptin in Combination with Insulin (with or without Metformin), the Following Side Effects Have Been Reported:

Common: flu
Uncommon: dry mouth

In Some Patients Taking Sitagliptin Alone in Clinical Trials or Alone or with Other Anti-Diabetic Medicines After Marketing Authorization, the Following Side Effects Have Been Reported:

Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose, sore throat, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare(may affect up to 1 in 1,000 people): reduced number of platelets
Frequency Not Known(cannot be estimated from the available data): kidney problems (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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C; 02-222 Warsaw
phone: +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, you can help provide more information on the safety of this medicine.

5. How to Store Sitagliptin TZF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Lot number means batch number.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 film-coated tablet contains 25 mg of sitagliptin as sitagliptin phosphate monohydrate.
Sitagliptin TZF, 50 mg
Each film-coated tablet contains 50 mg of sitagliptin as sitagliptin phosphate monohydrate.
Sitagliptin TZF, 100 mg
Each film-coated tablet contains 100 mg of sitagliptin as sitagliptin phosphate monohydrate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose type 102, sodium carmellose, 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 film-coated tablets do not contain yellow iron oxide (E 172) and contain black iron oxide (E 172) instead.

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 "S" engraved 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/Aluminum blister pack.
28 film-coated tablets packed with a leaflet in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
For more information about this medicine, contact the marketing authorization holder.
Manufacturer
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" S.A.
ul. A. Fleminga 2
03-176 Warsaw

Date of Last Revision of the Leaflet: October 2023