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 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 those not listed in this leaflet, please inform 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 reduce your high blood sugar levels, which are a result of your type 2 diabetes. This medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulphonylureas or glitazones), which you may already be taking, along 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 it does produce does not work well. 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 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 it with your doctor or pharmacist.
There have been reports of pancreatitis (inflammation of the pancreas) in patients taking Sitagliptin Polpharma (see section 4).
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 Sitagliptin Polpharma.
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 cases, 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 Polpharma (see section 4).

Because this medicine only works when your blood sugar levels are high, it is unlikely to cause low blood sugar (hypoglycaemia). However, if you take this medicine with a sulphonylurea or insulin, you may experience hypoglycaemia. Your doctor may reduce the dose of the sulphonylurea 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 with 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 Polpharma with digoxin, your doctor may need to check your digoxin levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 during pregnancy.
It is not known if this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you are planning 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, you should take into account that dizziness and drowsiness have been reported.
Taking this medicine with sulphonylureas or insulin may cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe support for your feet.

Sitagliptin Polpharma contains sodium

Sitagliptin Polpharma contains less than 1 mmol sodium (23 mg) per dose, which is considered to be 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 (such as 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may advise you to take this medicine alone or in combination with other medicines that reduce blood sugar levels.
Diet and exercise help your body use blood sugar better. It is important to follow the diet and exercise programme recommended by your doctor while taking Sitagliptin Polpharma.

What to do if you take more Sitagliptin Polpharma than you should

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

What to do if you miss a dose of Sitagliptin Polpharma

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.

What to do if you stop taking Sitagliptin Polpharma

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor tells you. Do not stop taking this medicine 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 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 area of the stomach), which may radiate to the back, with or without nausea and vomiting - 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 of the 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 your diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Some patients experienced various stomach problems after starting treatment with sitagliptin in combination with metformin (common).
In some patients, when sitagliptin was added to a sulphonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
In some patients, when sitagliptin and pioglitazone were used together, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was used in combination with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was used in combination with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was used alone or in combination with other anti-diabetic medicines in clinical studies or after marketing, the following side effects were reported:
Common: low blood sugar, 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 problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
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 which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
The packaging imprint 'EXP' shows the expiry date, and 'Lot/LOT' shows 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, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate. Tablet coating: 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 authorisation holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Date of last revision of the leaflet: