Jansitin

Package leaflet: Information for the patient

Jansitin, 25 mg, film-coated tablets
Jansitin, 50 mg, film-coated tablets
Jansitin, 100 mg, film-coated tablets
Sitagliptin
Please read carefully all of this leaflet 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not pass it on 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, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Jansitin is and what it is used for
2. What you need to know 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 Jansitin is and what it is 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 adult patients 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 lower high blood sugar levels caused by type 2 diabetes.
Jansitin may be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas or glitazones) that you may already be taking for diabetes, 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, or the insulin produced does not work properly. The body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss and limb amputation.

2. Important information before using Jansitin

When not to take Jansitin

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Jansitin (see section 4).
If the patient develops skin blisters, this may be a sign of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking Jansitin.
Inform the doctor if the patient has or has previously had:

• diseases of the pancreas (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 increase (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 diseases, either currently or in the past;
• an allergic reaction to Jansitin (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, hypoglycemia (low blood sugar) 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. 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
Tell the 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 Jansitin together with digoxin, the blood concentration of digoxin should be monitored.

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 a 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 when planning to breastfeed.

Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, dizziness and somnolence have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to low blood sugar levels (hypoglycemia), which may affect the ability to drive and operate machinery or to work without secure foot support.

Jansitin contains sodium and lactose
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
Lactose (only Jansitin 25 mg)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to take Jansitin

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should
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 recommend 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 recommend treatment with this medicine alone or this medicine together with other medicines
that lower blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively.
While taking Jansitin, it is important to follow the diet and physical activity regimen recommended by your doctor.
Taking more Jansitin than prescribed
If you take more Jansitin than prescribed, contact your doctor immediately.
Missing a dose of Jansitin
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 to make up for a missed dose.
Stopping Jansitin
To maintain control of blood sugar levels, you should take 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 experiences them.

You should DISCONTINUE Jansitin 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 unknown), including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you should stop taking the medicine and contact your doctor immediately. Your doctor may prescribe a treatment for the allergic reaction and another medicine for diabetes management.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:

Frequent (may occur in less than 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting.

Uncommon (may occur in less than 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 occurrence).

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:

Very frequent (may occur in more than 1 in 10 people): low blood sugar levels.

Frequent: constipation.

The following adverse reactions have been reported in some patients taking sitagliptin with pioglitazone:

Frequent: flatulence, swelling of hands or legs.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:

Frequent: swelling of hands or legs.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):

Frequent: influenza-like illness.

Uncommon: dry mouth.

The following adverse reactions have been reported in some patients taking sitagliptin alone in clinical trials, or alone or in combination with other antidiabetic medicines after marketing authorization:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose, sore throat, osteoarthritis, pain in arm or leg.

Uncommon: dizziness, constipation, pruritus (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 blistering skin condition).

Reporting of adverse reactions

If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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
Tel: +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 this medicine.

5. How to store the medicine Jansitin

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the blister, bottle, or carton after: "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Jansitin contains

• The active substance is sitagliptin.
  Jansitin 25 mg, film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
  Jansitin 50 mg, film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
  Jansitin 100 mg, film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• Other ingredients are:
  Tablet core: Calcium hydrogen phosphate, Microcrystalline cellulose, Sodium croscarmellose, 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, film-coated tablets: Pink, round, biconvex film-coated tablets with a diameter of approximately 6 mm, embossed with "LC" on one side and smooth on the other.
Jansitin 50 mg, film-coated tablets: Orange, round, biconvex film-coated tablets with a diameter of approximately 8 mm, embossed with the letter "C" on one side and smooth on the other.
Jansitin 100 mg, film-coated tablets: Beige, round, biconvex film-coated tablets with a diameter of approximately 9.8 mm, embossed with the letter "L" on one side and smooth on the other.
Blister packs made of OPAQUE PVC/PVDC-Aluminium containing 28 tablets.

Marketing Authorisation 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

For further information about this medicinal product, contact the representative of the marketing authorisation 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]