Liglinra

Package Leaflet: Information for the User

Liglinra, 5 mg, film-coated tablets

Linagliptin

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

• Keep this package 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. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Liglinra and what is it used for

Liglinra contains the active substance linagliptin, which belongs to a group of medicines called "oral anti-diabetic medicines". Oral anti-diabetic medicines are used to treat high blood sugar levels. These medicines help the body reduce the amount of sugar in the blood.
Liglinra is used to treat type 2 diabetes in adults when the disease cannot be controlled properly with a single oral anti-diabetic medicine (metformin or sulfonylurea) or diet and exercise alone. Liglinra can be used in combination with other anti-diabetic medicines, such as metformin, sulfonylurea (e.g., glimepiride, glipizide), empagliflozin, or insulin.
It is essential to continue with the diet and exercise recommended by your doctor or nurse.

2. Important information before taking Liglinra

When not to take Liglinra:

• if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Liglinra, discuss with your doctor, pharmacist, or nurse:

• if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Liglinra should not be used to treat these conditions;
• if you are taking a sulfonylurea medicine (e.g., glimepiride, glipizide), your doctor may recommend reducing the dose of the sulfonylurea to avoid too low blood sugar levels when taking Liglinra;

if you are taking Liglinra in combination with a sulfonylurea or insulin, to avoid too low blood sugar levels;

• if you have had an allergic reaction to any other medicine used to lower blood sugar levels;
• if you have or have had pancreatitis.

If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, nausea, and vomiting, contact your doctor immediately.
If you develop blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may recommend stopping Liglinra.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care recommendations given by your doctor or nurse.

Children and adolescents

Liglinra is not recommended for use in children and adolescents under 18 years of age. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medicine in children under 10 years of age have not been established.

Liglinra and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking medicines containing any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These medicines are used to treat epilepsy or chronic pain;
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of linagliptin during pregnancy is not recommended. It is not known if linagliptin is harmful to the unborn child.
It is not known if linagliptin passes into breast milk. Your doctor will decide whether you should stop breastfeeding or stop/wither therapy with Liglinra.

Driving and using machines

Liglinra has no or negligible influence on the ability to drive and use machines.
Taking Liglinra in combination with sulfonylurea and/or insulin may cause too low blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines or work without strong support for your legs.
However, it is recommended to check your blood sugar levels more frequently to minimize the risk of hypoglycemia, especially when taking Liglinra in combination with sulfonylurea and/or insulin.

3. How to take Liglinra

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended dose of Liglinra is one 5 mg tablet once a day.

Method of administration

Oral use. Liglinra can be taken with or without food.
Your doctor may recommend taking Liglinra in combination with another oral anti-diabetic medicine.
Take all medicines as recommended by your doctor to get the best possible treatment result.

Overdose of Liglinra

If you have taken more than the recommended dose of Liglinra, contact your doctor immediately.

Missed dose of Liglinra:

• if you forget to take a dose of Liglinra, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose;
• do not take a double dose to make up for a missed dose. Never take two doses on the same day.

Stopping Liglinra treatment

Do not stop taking Liglinra without consulting your doctor. If you stop taking Liglinra, your blood sugar levels may increase.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention

STOP taking Liglinra and contact your doctor immediately if you experience any of the following serious side effects:

Very common(may affect more than 1 in 10 people):

• symptoms related to low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes, or confusion (hypoglycemia). Hypoglycemia is a known side effect of Liglinra when taken in combination with metformin and sulfonylurea. Rare(may affect up to 1 in 1000 people):
• severe, 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.

STOP taking Liglinra and contact your doctor immediately if you experience any of the following allergic reactions:

Uncommon(may affect up to 1 in 100 people):

• allergic reactions (hypersensitivity), including wheezing and shortness of breath (bronchospasm)
• rash

Rare(may affect up to 1 in 1000 people):

• hives
• swelling of the face, lips, tongue, and throat, which may cause difficulty breathing and swallowing (angioedema)

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Your doctor may prescribe a medicine to treat the allergic reaction and prescribe another medicine to treat diabetes.
Other side effects
Common(may affect up to 1 in 10 people):

• increased lipase activity in the blood

Uncommon(may affect up to 1 in 100 people):

• nasopharyngitis
• cough
• constipation (in combination with insulin)
• increased amylase activity in the blood

Rare(may affect up to 1 in 1000 people):

• blistering of the skin (bullous pemphigoid)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, 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
Al. Jerozolimskie 181C

• 02 - 222 Warszawa Tel.: + 48 22 49 21 301 Faks: + 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, you can help provide more information on the safety of this medicine.

5. How to store Liglinra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
The expiry date refers to the last day of that month.
There are no special storage requirements for this medicine.
Medicines should 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 Liglinra contains

The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
The other ingredients are:

• tablet core: microcrystalline cellulose, hypromellose 2208, crospovidone type A, colloidal anhydrous silica, magnesium stearate
• coating: hypromellose 2910, talc, titanium dioxide (E171), macrogol 3350, iron oxide red (E172).

What Liglinra looks like and contents of the pack

Liglinra 5 mg film-coated tablets are gray-red, round, biconvex, film-coated tablets.
The tablets (8 mm x 5 mm) are packaged in PVC/Aluminum/OPA/Aluminum blisters, in a cardboard box.
Pack sizes:
Blisters: 10, 28, 30, 56, 90, 100 tablets.
Single-dose blisters: 10x1, 28x1, 30x1, 56x1, 90x1, 100x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Limited
Waterford Road
Clonmel, Co.
Tipperary
E91 D768
Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia, Greece, Poland, Sweden:
Liglinra
Date of last revision of the package leaflet:10/2024