Iansitin

Leaflet included in the packaging: patient information

Jansitin, 25 mg, coated tablets

Jansitin, 50 mg, coated tablets

Jansitin, 100 mg, coated tablets

Sitagliptin
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Jansitin and what is it used for

Jansitin 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 reduce the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels, which are a result of type 2 diabetes. The medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and a physical exercise program.
What is type 2 diabetes?
Type 2 diabetes is a disease in which the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases, such as heart disease, kidney disease, vision loss, and amputation of limbs.

2. Important information before taking Jansitin

When not to take Jansitin

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

Warnings and precautions

In patients taking Jansitin, cases of pancreatitis (see section 4) have been reported.
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Jansitin.
The patient should inform their doctor if they have or have 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 (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 disease that has occurred in the past or is currently present;
• an allergic reaction to Jansitin (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause excessive lowering of blood sugar levels. However, if this medicine is taken with a sulfonylurea derivative or insulin, it may cause a decrease in blood sugar levels (hypoglycemia). 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. 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.

Jansitin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking digoxin (a medicine used to treat heart rhythm disorders and other heart diseases). When taking Jansitin with digoxin, the patient's digoxin blood levels should be monitored.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy.
It is not known whether the medicine passes into breast milk. This medicine should not be used during 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, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylurea derivatives or insulin may lead to low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe foot support.

Jansitin contains sodium and lactose

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".
Lactose (only Jansitin 25 mg)
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Jansitin

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:

• one 100 mg coated tablet;
• once a day;
• taken orally.

If the patient has kidney function disorders, the doctor may recommend a lower dose of Jansitin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
The doctor may recommend taking only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and physical exercise help the body use the sugar in the blood better. When taking Jansitin, it is essential to follow the diet and physical exercise recommended by the doctor.

Taking a higher dose of Jansitin than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately consult their doctor.

Missing a dose of Jansitin

In case of missing a dose, the patient should take it as soon as possible. If it is close to the time for the next dose, the patient should skip the missed dose and continue taking the medicine according to the usual schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Jansitin treatment

To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking this medicine without consulting their doctor first.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOP taking Jansitin and immediately consult their doctor if they experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis.

In case of 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, the patient should stop taking the medicine and immediately consult their doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients who added sitagliptin to metformin, the following side effects occurred: Common (may occur in less than 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting. Uncommon (may occur in less than 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.
Some patients experienced various stomach discomforts after starting treatment with sitagliptin in combination with metformin (occurring frequently).
In some patients who took sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects occurred:
Common: bloating, swelling of the arms or legs
In some patients who took sitagliptin and pioglitazone and metformin, the following side effects occurred:
Common: swelling of the arms or legs
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects occurred:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone in clinical trials or alone or with other anti-diabetic medicines after marketing authorization, the following side effects occurred:
Common: low blood sugar levels, headache, upper respiratory tract infections, sore throat, and joint or muscle pain
Uncommon: dizziness, constipation, vertigo
Rare: decreased platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin).

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Jansitin

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister or bottle and carton after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Jansitin contains

• The active substance of the medicine is sitagliptin. Jansitin 25 mg, coated tablets: Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin. Jansitin 50 mg, coated tablets: Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin. Jansitin 100 mg, coated tablets: Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• Other ingredients are: Tablet core:Calcium hydrogen phosphate, Microcrystalline cellulose, Sodium carmellose, Sodium stearyl fumarate, Magnesium stearate Coating (25 mg):Lactose monohydrate, Hypromellose, Titanium dioxide (E 171), Triacetin, Iron oxide red (E 172) Coating (50 mg):Polyvinyl alcohol, Titanium dioxide (E 171), Macrogol 3350, Talc, Iron oxide red (E 172), Iron oxide yellow (E 172) Coating (100 mg):Polyvinyl alcohol, Titanium dioxide (E 171), Macrogol 3350, Talc, Iron oxide yellow (E 172), Iron oxide red (E 172)

What Jansitin looks like and contents of the pack

Jansitin 25 mg, coated tablets: pink, round, biconvex coated tablets with a diameter of about 6 mm, with the inscription "LC" on one side and smooth on the other.
Jansitin 50 mg, coated tablets: orange, round, biconvex coated tablets with a diameter of about 8 mm, with the letter "C" embossed on one side and smooth on the other.
Jansitin 100 mg, coated tablets: white, round, biconvex coated tablets with a diameter of about 9.8 mm, with the letter "L" embossed on one side and smooth on the other.
Opaque PVC/PVDC-Aluminum blisters containing 28 tablets.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach, Austria
Laboratorios Liconsa S.A.
C/Dulcinea S/N
E-28805 ALCALA DE HENARES, Madrid, Spain
Laboratorios Liconsa S.A.
Avda. Miralcampo 7, Poligono Industrial Miralcampo
E-19200 AZUQUECA DE HENARES (GUADALAJARA), Spain

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: