Sitagliptin bioton

Package leaflet: Information for the patient

SITAGLIPTIN BIOTON, 25 mg, film-coated tablets
Sitagliptinum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• 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 any adverse reactions not listed in this leaflet, inform 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 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 (insulin, metformin, sulfonylureas, 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, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this occurs, 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 taking Sitagliptin Bioton

When not to take Sitagliptin Bioton

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Sitagliptin Bioton (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking sitagliptin.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a form 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 in the past or currently;
• allergic reaction to sitagliptin (see section 4).

Since this medicine does not work 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. The 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 whether this medicine is safe and effective in children and adolescents under 18 years of age.

Sitagliptin Bioton and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Bioton with digoxin, the concentration of digoxin in the blood should be monitored.

Taking Sitagliptin Bioton with food and drink
This medicine can be taken regardless of meals and beverages.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.

Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without safe foot support.

Sitagliptin Bioton contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. this medicine is considered "sodium-free".

3. How to use SITAGLIPTIN BIOTON

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has kidney function impairment, the doctor may prescribe a lower dose (e.g. 25 mg or 50 mg).
The doctor may recommend treatment with this medicine alone or in combination with other medicines that lower blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively.
While taking SITAGLIPTIN BIOTON, it is important to follow the diet and perform the physical exercises recommended by your doctor.

Taking more SITAGLIPTIN BIOTON than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.

Missing a dose of SITAGLIPTIN BIOTON
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose.

Stopping SITAGLIPTIN BIOTON
To maintain control of blood sugar levels, continue taking this medicine 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 everyone experiences them.
You should DISCONTINUE use of Sitagliptin Bioton and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent pain in the stomach area, possibly radiating to the back, with or without nausea and vomiting, as 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 breathing or swallowing, treatment with the medicine must be stopped and medical advice sought immediately. Your doctor may prescribe medication to treat the allergic reaction and another medicine for the treatment of 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 receiving sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:

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

In some patients receiving sitagliptin and pioglitazone, the following adverse reactions occurred:

Common: bloating, swelling of hands or feet

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

Common: swelling of hands or feet

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

Common: influenza-like illness
Uncommon: dry mouth

In some patients receiving sitagliptin alone and/or with other antidiabetic medicines in clinical trials or after marketing authorization, the following adverse reactions occurred:

Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint pain, 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 condition).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 BIOTON

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
• The other ingredients (excipients) are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), colloidal anhydrous silica, 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.
Opaque blister pack made of PVC/PE/PVDC/Aluminium. Packs containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicinal product, please contact:
BIOTON S.A.
02-516 Warsaw
ul. Starościńska 5
Tel: + 48 (22) 721 40 00
[email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Malta: Sitagliptin Adair 25 mg film-coated tablets
Poland: SITAGLIPTIN BIOTON