SIGLETIC 50 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Sigletic, 25 mg, film-coated tablets
3. Sigletic, 50 mg, film-coated tablets
4. Sigletic, 100 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Sigletic and what is it used for
6. Important information before taking Sigletic
   1. When not to take Sigletic
   2. Warnings and precautions
   3. Children and adolescents
   4. Sigletic and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sigletic contains sodium
7. How to take Sigletic
   1. Overdose of Sigletic
   2. Missing a dose of Sigletic
   3. Stopping Sigletic treatment
8. Possible side effects
   1. Reporting side effects
9. How to store Sigletic
10. Contents of the pack and other information
    1. What Sigletic contains
    2. What Sigletic looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet accompanying the packaging: patient information

Sigletic, 25 mg, film-coated tablets

Sigletic, 50 mg, film-coated tablets

Sigletic, 100 mg, film-coated tablets

Sitagliptin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sigletic and what is it used for

Sigletic 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.
The doctor has prescribed this medicine to reduce high blood sugar levels, a consequence 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 exercise.
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 health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sigletic

When not to take Sigletic

• 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 Sigletic, 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 bullous pemphigoid. The doctor may advise the patient to stop taking Sigletic.
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, past or present;
• an allergic reaction to Sigletic (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 derivative or insulin, it may cause low 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.

Sigletic and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 conditions). When taking Sigletic 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 baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy.
It is not known whether this medicine passes into breast milk. This medicine should not be taken during breastfeeding or if the patient plans to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, the patient should take into account that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive or use machines or work without safe foot support.

Sigletic contains sodium

Sigletic contains less than 1 mmol of sodium (23 mg) per dose, which means that the medicine is considered "sodium-free".

3. How to take Sigletic

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

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

If the patient has kidney problems, the doctor may prescribe a lower dose of Sigletic (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
The doctor may prescribe this medicine alone or with other medicines that lower blood sugar levels.
Diet and exercise help the body use the sugar in the blood better. When taking Sigletic, it is essential to follow the diet and exercise plan recommended by the doctor.
The 50 mg and 100 mg tablets of Sigletic can be divided into two equal doses.
If the doctor has prescribed half a 50 mg or 100 mg tablet, the patient should follow the instructions below for dividing the tablets.

• 1. Place the tablet on a flat, hard surface (e.g., a table, countertop), with the scored line facing up.
• 2. Break the tablet in half along the vertical line, pressing it against the surface with the index fingers of both hands, as shown in figures 1 and 2.

Figures 1 and 2: Dividing the Sigletic tablet into two equal doses.

Overdose of Sigletic

In case of taking a higher dose than prescribed, the patient should contact their doctor immediately.

Missing a dose of Sigletic

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

Stopping Sigletic treatment

To maintain control of blood sugar levels, the patient should take the medicine for as long as prescribed by the doctor. 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, Sigletic can cause side effects, although not everybody gets them.
The patient should STOP taking Sigletic and contact their doctor immediately 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 - these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling 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 contact their doctor immediately. 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 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 gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with a sulfonylurea derivative 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 or with other anti-diabetic medicines in clinical trials or after the medicine was marketed, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, osteoarthritis, arm or leg pain.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Sigletic

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot/LOT" means the batch number.
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 pack and other information

What Sigletic contains

• The active substance of Sigletic is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Sigletic looks like and contents of the pack

Sigletic, 25 mg: light pink, round, biconvex film-coated tablet; tablet diameter 5.9-6.3 mm.
Sigletic, 50 mg: light orange, round, biconvex film-coated tablet with a score line on one side and "50" embossed on the other side; tablet diameter: 7.9-8.3 mm. The tablet can be divided into two equal doses.
Sigletic, 100 mg: light brown, round, biconvex film-coated tablet with a score line on one side and "100" embossed on the other side; tablet diameter: 9.9-10.4 mm. The tablet can be divided into two equal doses.
PVC/PVDC/Aluminum blisters, in a cardboard box. Packs of 14, 28, 30, 56, 84, 90, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2
39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
Date of last revision of the leaflet:November 2024