Sitagliptin bioton

Package leaflet: Information for the patient

SITAGLIPTIN BIOTON, 50 mg, film-coated tablets
Sitagliptinum
Please read carefully the entire leaflet before using this 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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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

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 known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels 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. It may be used alone or in combination with other glucose-lowering medicines (such as 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, the insulin produced does not work properly, or the body produces 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 (inflammation of the pancreas) have been reported in patients taking Sitagliptin Bioton (see section 4).
If the patient develops blisters on the skin, this may be a sign 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 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 characterised 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 is low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative 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 with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 digoxin blood levels should be monitored.
Taking Sitagliptin Bioton with food and drink
This medicine can be taken independently of meals and drinks.
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 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 a negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, it should be taken into account that dizziness and somnolence have been reported.
Taking this medicine together with medicines called sulfonylurea derivatives 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 Bioton contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. the medicine is considered "sodium-free".

3. How to use SITAGLIPTIN BIOTON

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult 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 (e.g. 25 mg or 50 mg).

Your doctor may recommend treatment with this medicine alone or in combination with other medicines that lower blood sugar levels.

Diet and physical exercise help your body use blood sugar more effectively. While taking SITAGLIPTIN BIOTON, it is important to follow the diet and perform the physical activities 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 your next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose.

Stopping SITAGLIPTIN BIOTON
To maintain blood sugar control, continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.

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 SITAGLIPTIN BIOTON and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent abdominal 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 skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or swallowing, you must 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 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, 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 when sitagliptin was used in combination with a sulfonylurea and metformin:

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

In some patients, the following adverse reactions occurred when sitagliptin was used with pioglitazone:

Common: bloating, swelling of hands or feet

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

Common: swelling of hands or feet

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

Common: influenza-like illness
Uncommon: dry mouth

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

Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy 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 skin blister)

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products 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 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 the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Sitagliptin Bioton contains

• The active substance is sitagliptin. Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
• The other ingredients (excipients) are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (PH 102), 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)

What Sitagliptin Bioton looks like and contents of the pack
Round, light beige, film-coated tablets with the letter "S" embossed on one side.
Opaque blister made of PVC/PE/PVDC/Aluminum. Packs containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
BIOTON S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

Manufacturers
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 countries under the following names:
Malta: Sitagliptin Adair 50 mg film-coated tablets
Poland: SITAGLIPTIN BIOTON
France: SITAGLIPTINE BGR 50 mg, comprimé pelliculé