Patient Information Leaflet

Tingapla, 5 mg, coated tablets
Linagliptin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Tingapla is and what it is used for
What you need to know before taking Tingapla
How to take Tingapla
Possible side effects
How to store Tingapla
Contents of the pack and other information

1. What Tingapla is and what it is used for

Tingapla contains the active substance linagliptin, which belongs to a group of medicines
called "oral antidiabetic agents". Oral antidiabetic agents are used to treat high blood sugar levels.
These medicines help the body reduce the amount of sugar in the blood.
Tingapla is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled
by a single oral antidiabetic medicine (metformin or sulfonylurea derivatives) or by diet and physical exercise alone. Tingapla may be used together with other antidiabetic medicines, such as metformin, sulfonylurea derivatives (e.g. glimepiride, glipizide), or insulin.
It is important to continue the diet and physical exercise regimen recommended by your doctor or nurse.

2. Important information before taking Tingapla

When not to take Tingapla

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

Warnings and precautions
Before starting to take Tingapla, discuss this with your doctor, pharmacist or nurse:

if the patient has type 1 diabetes (the patient's body does not produce insulin) or diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting). Tingapla must not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a sulfonylurea (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea when Tingapla is taken concomitantly, to avoid excessively lowering blood sugar levels.
if the patient has previously experienced an allergic reaction to any other medicines used to lower blood sugar levels.
if the patient has or has had pancreas-related diseases in the past.

If symptoms of acute pancreatitis occur, such as severe and persistent abdominal pain, contact a doctor.
If blisters appear on the skin, this may be a sign of a condition called bullous pemphigoid. The doctor may advise the patient to stop taking Tingapla.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care recommendations provided by the doctor or nurse.

Children and adolescents
Tingapla must not be used in children and adolescents under 18 years of age. It is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Tingapla and 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 the doctor if the patient is taking medicines containing any of the following active substances:

Carbamazepine, phenobarbital or phenytoin. These medicines may be used to treat seizures (epilepsy) or chronic pain.
Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

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 her doctor or pharmacist before using this medicine.
It is unknown whether Tingapla is harmful to unborn children; therefore, use of Tingapla during pregnancy is not recommended.
It is unknown whether Tingapla passes into human breast milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold treatment with Tingapla.

Driving and operating machinery
Tingapla has no effect or has a negligible effect on the ability to drive and operate machinery.
However, taking Tingapla in combination with sulfonylureas and (or) insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and operate machinery or work without strong leg support. It is therefore recommended to monitor blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when Tingapla is used in combination with sulfonylureas and (or) insulin.

3. How to take Tingapla

This medicine should always be taken as directed by the doctor. In case of doubts,
consult the doctor or pharmacist.
The recommended dose of Tingapla is one 5 mg tablet once daily.
Tingapla may be taken with or without food.
The doctor may recommend using Tingapla together with another oral antidiabetic medicine.
All medicines should be taken as directed by the doctor to achieve the best possible treatment outcome.
Taking more than the recommended dose of Tingapla
If more than the recommended dose of Tingapla has been taken, contact the doctor immediately.
Missing a dose of Tingapla

If the patient forgets to take a dose of Tingapla, they should take it as soon as they remember. However, if it is almost time for the next dose, the missed dose should not be taken.
Do not take a double dose to make up for the missed dose. Never take two doses on the same day.

Stopping Tingapla treatment
Do not stop taking Tingapla without consulting the doctor. Stopping Tingapla may lead to increased blood sugar levels.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some symptoms require immediate medical attention.

Treatment with Tingapla should be discontinued and immediate medical advice sought if any of the following symptoms of low blood sugar occur: tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, occurs in more than 1 in 10 people) is a known adverse effect of treatment with Tingapla when taken concomitantly with metformin and a sulfonylurea derivative.

Allergic reactions (hypersensitivity; frequency: not very common, occurs in up to 1 in 100 people) have occurred in some patients during treatment with Tingapla, either as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and breathing difficulties (bronchospasm; frequency: not known, frequency cannot be estimated from the available data).

Skin rash (frequency: not very common), urticaria (urticaria; frequency: rare, occurs in up to 1 in 1,000 people), and swelling of the face, lips, tongue and throat, which may cause difficulty in breathing or swallowing (angioedema; frequency: rare), have also occurred in some patients.

If any of the above symptoms occur, treatment with Tingapla should be stopped immediately and a doctor contacted without delay. The doctor may prescribe medication to treat the allergic reaction and switch the patient to another antidiabetic medicine.

Pancreatitis (pancreatitis; frequency: rare, occurs in up to 1 in 1,000 people) has occurred in some patients during treatment with Tingapla as monotherapy or in combination with other antidiabetic medicines.

Treatment with Tingapla should be DISCONTINUED and immediate medical advice sought if any of the following severe adverse reactions occur:

Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

The following adverse reactions have occurred in some patients during treatment with Tingapla as monotherapy or in combination with other antidiabetic medicines:

Common: increased blood lipase activity.
Not very common: inflammation of the nose or throat (pharyngitis), cough, constipation (in combination with insulin), increased blood amylase activity.
Rare: development of blisters on the skin (bullous pemphigoid).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tingapla

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
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 Tingapla contains

The active substance is linagliptin. Each coated tablet (tablet) contains 5 mg of linagliptin.
The other ingredients are:
Tablet core: mannitol (E421), crospovidone (type B) (E1202), hypromellose (2910, 5mPa·s) (E464), crospovidone (type A) (E1202), colloidal anhydrous silica (E551) and magnesium stearate (E470b).
Tablet coating: hypromellose (2910, 5mPa·s) (E464), titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521) and iron oxide red (E172).

What Tingapla looks like and contents of the pack
Tingapla 5 mg film-coated tablets are light pink, round, biconvex, film-coated tablets with a diameter of approximately 8 mm, imprinted with the symbol "5" on one side.
Tingapla is available in aluminium blisters. Pack sizes are 10, 14, 28, 30, 60, 90, 100 and 120 tablets.
Tingapla is also available in perforated unit-dose aluminium foil blisters. Pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 90 x 1, 100 x 1 and 120 x 1 tablet.
Tingapla is also available in a plastic bottle with a child-resistant plastic cap and a desiccant (silica gel) to absorb moisture. Pack size: 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. 22 209 70 00
{Logo of the Marketing Authorisation Holder}

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbuga, BBG3000
Malta
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
144 52 Metamorfossi
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Hungary: Tingapla 5 mg filmtabletta
Cyprus: TINGAPLA 5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Estonia: TINGAPLA
Greece: TINGAPLA
Croatia: Tingapla 5 mg filmom obložene tablete
Lithuania: Tingapla 5 mg plėvele dengtos tabletės
Latvia: Tingapla 5 mg apvalkotās tabletes
Poland: Tingapla