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
Sitagliptinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sitagliptin Polpharma is and what it is 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 Sitagliptin Polpharma is and what it is 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 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 help lower high blood glucose levels caused by type 2 diabetes. The medicine may be used alone or in combination with other glucose-lowering medicines (such as insulin, metformin, sulfonylurea derivatives, or glitazones) that you may already be taking, along with diet and exercise program.

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 produces 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 using Sitagliptin Polpharma

When not to use Sitagliptin Polpharma

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

Warnings and precautions
Before starting to take Sitagliptin Polpharma, please discuss this with your doctor or
pharmacist.
Cases of pancreatitis (see section 4) have been reported in patients taking Sitagliptin Polpharma.
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may advise the patient to stop taking Sitagliptin Polpharma.
Please inform your doctor if the patient has or has had:

• diseases of the pancreas (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 complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease, either currently or in the past;
• an allergic reaction to Sitagliptin Polpharma (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea or insulin, low blood sugar (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 for use in children under 10 years of age.
Sitagliptin Polpharma with other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular, inform your doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Polpharma with digoxin, blood levels of digoxin should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before using 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 when breastfeeding is planned.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. Nevertheless, when driving and operating machinery, it should be noted that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Sitagliptin Polpharma contains sodium
Sitagliptin Polpharma contains less than 1 mmol of sodium (23 mg) per dose, i.e. this medicine is considered "sodium-free".

3. How to use Sitagliptin Polpharma

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should contact 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 prescribe a lower dose of Sitagliptin Polpharma (e.g. 25 mg or 50 mg).
This medicine can be taken with food and drinks or independently of food and drinks.
Your 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 make better use of the sugar present in the blood.
While taking Sitagliptin Polpharma, it is important to follow the diet and perform the physical exercises recommended by your doctor.

Taking more Sitagliptin Polpharma than prescribed
If you take more than the prescribed dose of this medicine, 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 Sitagliptin Polpharma
To maintain control of blood sugar levels, this medicine should be taken for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.

If you have any further questions about 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 everybody will experience them.
You should DISCONTINUE Sitagliptin Polpharma and contact your doctor immediately
if any of the following serious adverse reactions occur:

• Severe and persistent pain in the abdomen (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 blisters or peeling skin, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you should stop taking the 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, the following adverse reactions occurred when sitagliptin was added to metformin:

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): stomach pain, diarrhoea, constipation, drowsiness

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with a sulfonylurea and metformin:

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

In some patients, the following adverse reactions occurred during treatment with sitagliptin and pioglitazone:

Common: bloating, swelling of hands or feet

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with insulin (with or without metformin):

Common: influenza-like illness
Uncommon: dry mouth

In some patients, the following adverse reactions occurred during treatment with sitagliptin alone and/or with other antidiabetic medicines in clinical studies or during post-marketing use:

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: 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 blistering skin disorder).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 provide more information on the safety of the medicine.

5. How to store Sitagliptin Polpharma

There are no special storage instructions for this medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following the
"EXP". The expiry date refers to the last day of the stated month.
The packaging mark following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Polpharma contains

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

What Sitagliptin Polpharma looks like and contents of the pack
Sitagliptin Polpharma, 25 mg: light pink, round, biconvex coated tablet
Sitagliptin Polpharma, 50 mg: light orange, round, biconvex coated tablet
Sitagliptin Polpharma, 100 mg: light brown, round, biconvex coated tablet
Aluminium/PVC/PVDC blisters in a cardboard box. Packs containing 14, 28, 56, or 98 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