Sitagliptin bioton

Patient Information Leaflet

SITAGLIPTIN BIOTON, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Sitagliptin Bioton is and what it is 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 Sitagliptin Bioton is and what it is 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 increase the levels of insulin released after a meal and reduces the amount of sugar
produced by the body.
Your doctor has prescribed this medicine to help lower high blood sugar levels caused by type 2 diabetes.
It may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and exercise.

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 as effectively as it should, or the body produces too much sugar. As a result, sugar (glucose) builds up in the blood. This can lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Sitagliptin Bioton

When not to use Sitagliptin Bioton

• if the patient is allergic to sitagliptin or to 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 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 act when blood glucose levels are low, it is unlikely to cause excessively low blood sugar. However, if this medicine is used 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 your 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 together with digoxin, the blood concentration of digoxin should be monitored.
Taking Sitagliptin Bioton with food and drink
This medicine can be taken regardless 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 using 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 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 taken into account that dizziness and somnolence 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 Bioton contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use SITAGLIPTIN BIOTON

This medicine should always be taken as directed 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 kidney function impairment, the doctor may prescribe a lower dose (e.g. 25 mg or 50 mg).

Your doctor may recommend taking only this medicine or this medicine 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 physical activity regimen 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. However, 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 your blood sugar levels, you should 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 will experience them.
You should DISCONTINUE treatment with SITAGLIPTIN BIOTON and contact your doctor immediately if
any of the following serious adverse reactions occur:

• Severe and persistent pain in the abdomen (upper 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 of the skin, and swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing, treatment must be stopped immediately and medical advice must be sought without delay. Your doctor may prescribe medication 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:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting.
Not frequent (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 (frequent).

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

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

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

Frequent: flatulence, swelling of hands or feet

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

Frequent: 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):

Frequent: influenza-like illness
Not frequent: dry mouth

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

Frequent: 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
Not frequent: dizziness, constipation, itching
Rare: decreased platelet count
Frequency unknown: 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 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, telephone: +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 Authorisation 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 stated on the blister and carton following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• 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, beige film-coated tablets.
Opaque PVC/PE/PVDC/aluminum blister. 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 for marketing in the European Economic Area under the following names:
Malta: Sitagliptin Adair 100 mg film-coated tablets
Poland: SITAGLIPTIN BIOTON
France: SITAGLIPTINE BGR 100 mg, comprimé pelliculé