Sitagliptin Polpharma

Package Leaflet: Information for the Patient

Sitagliptin Polpharma, 25 mg, film-coated tablets

Sitagliptin Polpharma, 50 mg, film-coated tablets

Sitagliptin Polpharma, 100 mg, film-coated tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, 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 or pharmacist.
• This medicine has been prescribed for you. 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Sitagliptin Polpharma 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 decrease the amount of sugar made by the body.
Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high due to type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking together with diet and exercise.

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 health problems, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Sitagliptin Polpharma

When not to take Sitagliptin Polpharma

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

Warnings and precautions

Before taking Sitagliptin Polpharma, discuss this with your doctor or pharmacist.
Patients taking Sitagliptin Polpharma have reported cases of pancreatitis (see section 4).
If you develop blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Polpharma.
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 problems, past or present;
• an allergic reaction to Sitagliptin Polpharma (see section 4).

Because 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 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 when used in children under 10 years of age.

Sitagliptin Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Polpharma with digoxin, your doctor should check your digoxin blood levels.

Pregnancy and breastfeeding

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

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, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive or use machines or work without safe foot support.

Sitagliptin Polpharma contains sodium

Sitagliptin Polpharma contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially 'sodium-free'.

3. How to take Sitagliptin Polpharma

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 orally.

If you have kidney problems, your doctor may prescribe a lower dose of Sitagliptin Polpharma (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and exercise help your body use blood sugar better. While taking Sitagliptin Polpharma, it is important to follow the diet and exercise plan recommended by your doctor.

Taking a higher dose of Sitagliptin Polpharma than recommended

If you take more of this medicine than you should, contact your doctor immediately.

Missing a dose of Sitagliptin Polpharma

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.

Stopping treatment with Sitagliptin Polpharma

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you. 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 Polpharma and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back and may be accompanied by nausea and vomiting or not - these may be symptoms of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and 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 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
Some patients experienced various stomach discomforts after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination 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, pioglitazone, and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone or with other anti-diabetic medicines in clinical studies or 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, 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 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, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. 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 Polpharma

There are no special storage instructions for this medicine.
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 month.
The inscription on the packaging after the abbreviation 'EXP' means the expiry date, and after the abbreviation 'Lot/LOT' means the batch number.
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 Polpharma contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, sodium carboxymethylcellulose, magnesium stearate, sodium stearyl fumarate. Tablet coating contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

What Sitagliptin Polpharma looks like and contents of the pack

Sitagliptin Polpharma, 25 mg: light pink, round, biconvex film-coated tablet
Sitagliptin Polpharma, 50 mg: light orange, round, biconvex film-coated tablet
Sitagliptin Polpharma, 100 mg: light brown, round, biconvex film-coated tablet
Aluminium/PVC/PVDC blisters in a cardboard box. Packs of 14, 28, 56, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: