Sigletic

Package leaflet: Information for the patient

Sigletic, 25 mg, film-coated tablets
Sigletic, 50 mg, film-coated tablets
Sigletic, 100 mg, film-coated tablets
Sitagliptinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents

1. What Sigletic is and what it is used for
2. What you need to know 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 Sigletic is and what it is 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 increase the amount 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. The medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and exercise regimen.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or 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 amputations.

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
Before starting treatment with Sigletic, discuss this with your doctor or pharmacist.
Cases of pancreatitis have been reported in patients taking Sigletic (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid.
Your doctor may advise the patient to stop taking Sigletic.
Inform your doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat) in the blood. In such cases, the risk of pancreatitis may be increased (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 problems in the past or currently;
• an allergic reaction to Sigletic (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. 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 aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.
Sigletic with 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 your doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when taking Sigletic together with digoxin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy.
It is not known whether this medicine passes into human breast milk. Do not take this medicine while breastfeeding or if breastfeeding is planned.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and somnolence have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or to work without secure foot support.
Sigletic contains sodium
Sigletic contains less than 1 mmol of sodium (23 mg) per dose, i.e. the medicine is considered "sodium-free".

3. How to take Sigletic

This medicine should always be taken exactly as directed by your doctor. If in doubt, 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 prescribe a lower dose of Sigletic (e.g. 25 mg or 50 mg).

This medicine may be taken with food and drinks or independently of meals and beverages.

Your doctor may prescribe this medicine alone or in combination with other medicines that lower blood sugar levels.

Diet and physical exercise help the body to use blood sugar more effectively. While taking Sigletic, it is important to follow the diet and exercise regimen recommended by your doctor.

The 50 mg and 100 mg tablets of Sigletic may be divided into two equal doses.

If your doctor has prescribed half a 50 mg tablet or half a 100 mg tablet, please follow the instructions below for splitting Sigletic tablets.

Instructions for splitting a tablet

1. Place the tablet on a flat, hard surface (e.g. a table or countertop), with the side bearing the score line facing upwards.
2. Break the tablet along the vertical score line by pressing down with the index fingers of both hands, as shown in Figures 1 and 2.

Figures 1 and 2: Splitting a Sigletic tablet into two equal doses.

Taking more Sigletic than prescribed

If you take more Sigletic than prescribed, contact your doctor immediately.

Missing a dose of Sigletic

If you miss a dose, take it as soon as possible. However, 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.

Stopping treatment with Sigletic

To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor has instructed. 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 will experience them.
DISCONTINUE the medicine Sigletic and contact your doctor immediately if any of the following severe 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 skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with this medicine must be stopped immediately and medical advice must be sought without delay. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:

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, diarrhoea, constipation, drowsiness.
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.

In some patients, the following adverse reactions occurred when sitagliptin was used with pioglitazone:

Common: bloating, swelling of hands or feet.

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with insulin (with or without metformin):

Common: influenza-like illness.
Uncommon: dry mouth.

In some patients, the following adverse reactions occurred when sitagliptin was used alone and/or with other antidiabetic medicines in clinical trials or during post-marketing use:

Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arm or leg.
Uncommon: dizziness, constipation, 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 skin blistering).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Sigletic

There are no special storage requirements for this medicine.
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 stated month.
The marking on the packaging after "EXP" indicates the expiry date, and after "Lot/LOT" indicates
the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Sigletic contains

• The active substance is sitagliptin. Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg or 100 mg of sitagliptin, respectively.
• Other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (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 coated tablet; tablet diameter 5.9–6.3 mm.
Sigletic 50 mg: light orange, round, biconvex coated tablet with a score line on one side and the imprint “50” on the other; tablet diameter: 7.9–8.3 mm. The tablet can be divided into equal doses.
Sigletic 100 mg: light brown, round, biconvex coated tablet with a score line on one side and the imprint “100” on the other; tablet diameter 9.9–10.4 mm. The tablet can be divided into equal doses.
PVC/PVDC/Aluminium blisters, packed in a cardboard box. Pack sizes of 14, 28, 30, 56, 84, 90, or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Production Site in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

This medicine is authorised in the European Economic Area countries under the following names:
Bulgaria - Cиглетик 25 mg, 50 mg, 100 mg филмирани таблетки
Czech Republic - Sitagliptin Polpharma 100 mg potahované tablety
Lithuania - Sigletic 25 mg, 50 mg, 100 mg plėvele dengtos tabletės
Latvia - Sigletic 25 mg, 50 mg, 100 mg apvalkotās tabletes
Poland - Sigletic, 25 mg, 50 mg, 100 mg tabletki powlekane