JANSITIN 50 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Jansitin, 25 mg, coated tablets
3. Jansitin, 50 mg, coated tablets
4. Jansitin, 100 mg, coated tablets
   1. Table of contents of the leaflet
5. What is Jansitin and what is it used for
6. Important information before taking Jansitin
   1. When not to take Jansitin
   2. Warnings and precautions
   3. Children and adolescents
   4. Jansitin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Jansitin contains sodium and lactose
7. How to take Jansitin
   1. Taking a higher dose of Jansitin than recommended
   2. Missing a dose of Jansitin
   3. Stopping treatment with Jansitin
8. Possible side effects
   1. Reporting side effects
9. How to store Jansitin
10. Contents of the pack and other information
    1. What Jansitin contains
    2. What Jansitin looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:
    6. Date of last revision of the leaflet:

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 reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed 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 pack 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 decrease 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, sulfonylureas, 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 condition 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, loss of vision, and amputation of limbs.

2. Important information before taking Jansitin

When not to take Jansitin

• if you are 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 advise the patient to stop taking Jansitin.
You should inform your doctor if you 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 low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, it may cause low blood sugar levels (hypoglycemia). Your 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. This medicine is not effective in children and adolescents between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Jansitin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Jansitin with digoxin, you should have your digoxin levels checked.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. You should not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You should not take this medicine while breastfeeding or if you plan to breastfeed.

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 sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe support for your feet.

Jansitin contains sodium and lactose

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".
Lactose (only Jansitin 25 mg)
If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Jansitin

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose is:

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

If you have kidney problems, your doctor may prescribe a lower dose of Jansitin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that lower blood sugar levels, which you may already be taking for diabetes, along with diet and a physical exercise program.
Diet and physical exercise help your body make better use of the sugar in your blood. While taking Jansitin, it is important to follow the diet and exercise program recommended by your doctor.

Taking a higher dose of Jansitin than recommended

If you take more of this medicine than you should, you should contact your doctor immediately.

Missing a dose of Jansitin

If you miss a dose, you should take it as soon as possible. If it is almost time for your next dose, you should skip the missed dose and continue with your regular dosing schedule. You should not take a double dose to make up for a missed dose.

Stopping treatment with Jansitin

To maintain control of your blood sugar levels, you should keep taking this medicine for as long as your doctor tells you to. You should not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOP taking Jansitin and contact your doctor immediately if you 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, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, you should 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 who added sitagliptin to metformin, the following side effects were reported: 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, diarrhea, constipation, drowsiness.
Some patients experienced various stomach problems after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin, pioglitazone, and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:
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 were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, sore throat, and runny or stuffy nose, joint pain, pain in the arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced 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 you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Post-Marketing Surveillance 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jansitin

The medicine should be stored out of the sight and reach of children.
Do not use this medicine 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Jansitin contains

• The active substance of Jansitin is sitagliptin. Jansitin 25 mg, coated tablets: Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin. Jansitin 50 mg, coated tablets: Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin. Jansitin 100 mg, coated tablets: Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
• The other ingredients are: Core of the tablet: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, approximately 6 mm in diameter, with the inscription "LC" on one side and smooth on the other.
Jansitin 50 mg, coated tablets: orange, round, biconvex coated tablets, approximately 8 mm in diameter, with the letter "C" embossed on one side and smooth on the other.
Jansitin 100 mg, coated tablets: white, round, biconvex coated tablets, approximately 9.8 mm in diameter, 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 on this medicine, you 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: