Package leaflet: Information for the user

Pligant, 5 mg, coated tablets
Linagliptinum
Please read all of this leaflet carefully 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Pligant is and what it is used for

This medicine 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 your body reduce the amount of sugar in the blood. Pligant is used to treat type 2 diabetes in adults when the condition cannot be adequately controlled by one oral antidiabetic medicine (metformin or sulfonylurea derivatives) or by diet and exercise alone. Pligant may be used together with other antidiabetic medicines such as metformin, sulfonylurea derivatives (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue following the diet and exercise regimen recommended by your doctor or nurse.

2. Information before taking Pligant

When not to take Pligant

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 Pligant, 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). Pligant must not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a sulfonylurea derivative (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea derivative when Pligant is taken concomitantly, in order to avoid excessively low 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 previously had pancreatic disease.

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 Pligant.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care advice provided by the doctor or nurse.

Children and adolescents
Pligant 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 not known whether this medicine is safe and effective when used in children under 10 years of age.

Pligant with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 baby, she should consult her doctor or pharmacist before using this medicine.
It is not known whether Pligant is harmful to unborn children. Therefore, use of Pligant during pregnancy is not recommended.
It is not known whether Pligant passes into human milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold Pligant treatment.

Driving and using machines
Pligant has no effect or a negligible effect on the ability to drive and use machines.
However, taking Pligant in combination with sulfonylurea derivatives and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines or work without strong support for the legs.
Nevertheless, more frequent monitoring of blood glucose levels is recommended to minimize the risk of hypoglycaemia, especially when Pligant is used in combination with sulfonylurea derivatives and/or insulin.

3. How to take Pligant

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

If the patient forgets to take a dose of Pligant, it should be taken 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 a missed dose. Never take two doses on the same day.

Stopping Pligant treatment
Do not stop taking Pligant without consulting the doctor. Stopping Pligant may lead to increased blood glucose levels.
If you have any further questions about 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.
You should STOP taking Pligant and contact your doctor immediately 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 – may occur in more than 1 in 10 people) is a known adverse effect of treatment with linagliptin when taken concomitantly with metformin and a sulphonylurea.

Allergic reactions (hypersensitivity; frequency: not very common – may occur in up to 1 in 100 people) have occurred in some patients during treatment with linagliptin, used as monotherapy or in combination with other antidiabetic medicines. These reactions may be severe and include wheezing and shortness of breath (bronchial hyperreactivity; frequency: not known – frequency cannot be estimated from available data). Some patients experienced rash (frequency: not very common), urticaria (frequency: rare – may occur 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). If any of the above signs of illness occur, you should STOP taking Pligant and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and may switch you to another medicine for diabetes.

Pancreatitis (frequency: rare – may occur in up to 1 in 1,000 people) has occurred in some patients during treatment with linagliptin, used as monotherapy or in combination with other antidiabetic medicines.

You should STOP taking Pligant and contact your doctor immediately if you experience any of the following serious adverse reactions:

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 been reported during treatment with linagliptin, used as monotherapy or in combination with other antidiabetic medicines:

Common: increased blood lipase activity.
Not very common: nasopharyngitis, 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 your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pligant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Do not use Pligant if the packaging is damaged or if there are any signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Pligant contains

The active substance is linagliptin. Each coated tablet contains 5 mg of linagliptin.
Other ingredients are:
Core of the tablet: mannitol (E 421), povidone K 90, crospovidone, and magnesium stearate.
Tablet coating: hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), talc (E 553b), and iron oxide red (E 172).

What Pligant looks like and contents of the pack

Pligant is a light brown, round, biconvex coated tablet, with the imprint “L” on one side and “5” on the other side.
Pligant is available in blisters containing 28, 30 or 90 coated tablets, and in perforated single-dose blisters containing 28 × 1, 30 × 1 or 90 × 1 coated tablet, packed in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147
{logo of the marketing authorisation holder}
Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Slovenia: Pligant 5 mg filmsko obložene tablete
Czech Republic: Pligant
Slovakia: Pligant
Poland: Pligant