Sitagliptin Bioton

Package Leaflet: Information for the Patient

SITAGLIPTIN BIOTON, 25 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, 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 experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Sitagliptin Bioton 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 (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 condition where the body does not produce enough insulin, and the insulin that is produced 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 amputation of limbs.

2. Important information before taking Sitagliptin Bioton

When not to take Sitagliptin Bioton

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

Warnings and precautions

In patients taking Sitagliptin Bioton, cases of pancreatitis (see section 4) have been reported. 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.
Tell your doctor if you have or have had:

• pancreatitis (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 (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels (hypoglycemia). However, if this medicine is taken with a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) 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. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Sitagliptin Bioton 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 heart rhythm disorders and other heart conditions). When taking Sitagliptin Bioton with digoxin, your doctor may need to check your digoxin blood levels.

Taking Sitagliptin Bioton with food and drink

This medicine can be taken with or without food and drink.

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 breastfeeding is planned.

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 may affect your ability to drive and use machines or work without safe foot support.

Sitagliptin Bioton contains sodium

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

3. How to take Sitagliptin Bioton

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 this medicine (e.g., 25 mg or 50 mg).
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking Sitagliptin Bioton, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Sitagliptin Bioton than you should

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

If you forget to take Sitagliptin Bioton

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.

If you stop taking Sitagliptin Bioton

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

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting, as these may be signs 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 for your 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 sitagliptin with metformin (common).
In some patients who took sitagliptin 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 with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin with 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: reduced 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 side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Bioton

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.
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 Bioton contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg of sitagliptin.
• The other ingredients (excipients) are: Tablet core: calcium phosphate, microcrystalline cellulose (E 460), sodium carmellose (E 468), silicon dioxide, sodium stearyl fumarate, magnesium stearate (E 470b) Coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000 (E 1521), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)

What Sitagliptin Bioton looks like and contents of the pack

Round, pink film-coated tablets.
Non-transparent PVC/PE/PVDC/Aluminum blister pack. Packs of 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

BIOTON S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

Manufacturer

SAG Manufacturing, S.L.U.
Ctra. N-I, Km 36
28750 San Agustín de Guadalix, Madrid
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50.
08950 Esplugues de Llobregat, Barcelona
Spain
For more information on this medicine, contact:
BIOTON S.A.
02-516 Warsaw
ul. Starościńska 5
Tel: + 48 (22) 721 40 00
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta: Sitagliptin Adair 25 mg film-coated tablets
Poland: SITAGLIPTIN BIOTON

Date of last revision of the leaflet: April 2024