Package leaflet: Information for the patient

Sitagliptin Medreg, 100 mg, film-coated tablets
Sitagliptinum
Please read the entire leaflet carefully before taking this 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. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What is Sitagliptin Medreg and what is it used for
Important information before taking Sitagliptin Medreg
How to take Sitagliptin Medreg
Possible side effects
How to store Sitagliptin Medreg
Contents of the pack and other information

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

Sitagliptin Medreg 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 adult patients 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 lower high blood glucose levels caused by type 2 diabetes. This medicine 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 for diabetes, along with diet and an 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. Information before using Sitagliptin Medreg

When not to use Sitagliptin Medreg

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

Warnings and precautions
Before starting treatment with Sitagliptin Medreg, please discuss this with your doctor or pharmacist.
Cases of pancreatitis (see section 4) have been reported in patients taking Sitagliptin Medreg.
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 Medreg.
Inform the doctor if the patient has or has had in the past:

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 diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting)
any kidney disease in the past or currently present
allergic reaction to Sitagliptin Medreg (see section 4)

Since this medicine does not act when blood glucose levels are 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
This medicine must not be used in children and adolescents under 18 years of age. 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 in children under 10 years of age.
Sitagliptin Medreg and other medicines
Tell your 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 Medreg together with digoxin, monitoring of digoxin blood levels may be necessary.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine must not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. Nevertheless, when driving and using machines, 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 use machines or to work without secure foot support.
Sitagliptin Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Sitagliptin Medreg

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 coated tablet (100 mg) once daily.
If the patient has impaired kidney function, the doctor may prescribe a lower dose (e.g. 25 mg
or 50 mg).
This medicine may be taken regardless of meals or drinks.
The 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 the body to use more efficiently the sugar present in the blood.
While taking Sitagliptin Medreg, it is important to follow the diet and perform the physical
exercises recommended by your doctor.
Taking more Sitagliptin Medreg than prescribed
If you have taken more than the prescribed amount of this medicine, contact your doctor
immediately.
Missing a dose of Sitagliptin Medreg
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 to make
up for a missed dose.
Stopping Sitagliptin Medreg
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 everybody will experience them.
You should DISCONTINUE taking Sitagliptin Medreg 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 – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, treatment with the medicine must be stopped and immediate medical advice must be sought. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness
Gastrointestinal symptoms of various kinds have occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).
The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 patients): low blood sugar levels
Common: constipation
The following adverse reactions have been reported in some patients taking sitagliptin with pioglitazone:
Common: bloating, swelling of hands or feet
The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or feet
The following adverse reactions have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth
The following adverse reactions have been reported in some patients taking sitagliptin alone in clinical trials or after marketing approval, either alone or in combination with other antidiabetic medicines:
Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint pain, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare (may affect up to 1 in 1,000 patients): 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 blistering).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sitagliptin Medreg

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and
blister or label after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater 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 Medreg contains

The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, sodium stearyl fumarate
Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000 (E 1521), talc (E 553b), iron oxide red (E 172), iron oxide yellow (E 172)

What Sitagliptin Medreg looks like and contents of the pack
Round, pink, film-coated tablets with a diameter of approximately 9.9 mm and a thickness of 4.7 ± 0.3 mm, embossed with the code "S15" on one side and "H" on the other side.
Film-coated tablets are available in transparent blisters made of PVC/PE/PVdC/Aluminium, packed in a cardboard box.
Pack sizes: 28, 30, 56, 60, 68, 84, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Film-coated tablets are also available in HDPE containers with child-resistant polypropylene caps and cellulose mass inserts.
Pack size: 30 film-coated tablets

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Sitagliptin Medreg
Poland: Sitagliptin Medreg
Slovakia: Sitagliptin Medreg
Romania: Sitagliptin Gemax Pharma 100 mg film-coated tablets