Liglinra

Package leaflet: Information for the user

Liglinra 5 mg, coated tablets
Linagliptin
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 you only. 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.

Contents of the leaflet

1. What Liglinra is and what it is used for
2. What you need to know 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 Liglinra is and what it is used for

Liglinra 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.
Liglinra is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled with diet and exercise alone or with one oral antidiabetic medicine (metformin or sulfonylurea). Liglinra may be used together with other antidiabetic medicines such as metformin, sulfonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue the diet and exercise regimen recommended by your doctor or nurse.

2. Important information before using Liglinra

When not to use Liglinra:

• 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 Liglinra, 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 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 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

if Liglinra is used concomitantly, to avoid excessive lowering of blood sugar levels;

• if the patient has experienced an allergic reaction to any other medicines previously used to lower blood sugar levels;
• if the patient has or has had a history of 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 Liglinra.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care
advice provided by the 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. It is unknown whether this medicine is safe and
effective when used in children under 10 years of age.
Liglinra 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 linagliptin is harmful to unborn children, therefore use of Liglinra during
pregnancy is not recommended.
It is unknown whether linagliptin passes into breast milk. The doctor must decide whether to
discontinue breastfeeding or to discontinue/withhold treatment with Liglinra.
Driving and operating machinery
Liglinra has no effect or a negligible effect on the ability to drive and operate machinery.
However, taking Liglinra in combination with sulfonylurea derivatives and (or) insulin may cause
low blood sugar levels (hypoglycaemia), which may affect the ability to drive and operate machinery or work without strong leg support.
Nevertheless, more frequent monitoring of blood glucose levels is recommended to minimize
the risk of hypoglycaemia, especially when Liglinra is used in combination with sulfonylurea derivatives and (or) insulin.

3. How to take Liglinra

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Dosage
The recommended dose of Liglinra is one 5 mg tablet once daily.
Method of administration
Oral administration. Liglinra may be taken with or without food.
The doctor may recommend taking Liglinra 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 Liglinra than prescribed
If more Liglinra than prescribed has been taken, contact a doctor immediately.
Missed dose of Liglinra:

• if the patient forgets to take a dose of Liglinra, 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 a missed dose. Never take two doses on the same day. Stopping Liglinra Do not stop taking Liglinra without consulting your doctor. Stopping treatment with Liglinra 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.
STOP using Liglinra and contact a doctor immediately if the patient experiences any of the following severe adverse reactions:

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

• symptoms related to low blood sugar levels: trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia is a known adverse effect of treatment with Liglinra when taken concomitantly with metformin and a sulfonylurea derivative.

Rare (may occur in no more than 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 using Liglinra and contact a doctor immediately if the patient experiences any of the following objective or subjective symptoms of an allergic reaction:

Uncommon (may occur in no more than 1 in 100 people):

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

Rare (may occur in no more than 1 in 1000 people):

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

⇒ The doctor may prescribe a medicine for the treatment of allergic reactions and switch to another medicine for the treatment of diabetes.

Other adverse reactions

Common (may occur in no more than 1 in 10 people):

• increased lipase activity in blood

Uncommon (may occur in no more than 1 in 100 people):

• inflammation of the nose or throat
• cough
• constipation (in combination with insulin)
• increased amylase activity in blood

Rare (may occur in no more than 1 in 1000 people):

• formation 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, 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 Liglinra

Keep this medicine 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.
No special storage conditions apply 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Liglinra contains
The active substance is linagliptin. Each 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 coated tablets are greyish-red, round, biconvex coated tablets.
The tablets (measuring 8 mm x 5 mm) are supplied in PVC/Aluminium/OPA/Aluminium blisters, packed in a cardboard box.
Pack sizes:
Blister packs: 10, 28, 30, 56, 90, 100 tablets.
Unit dose blister packs: 10x1, 28x1, 30x1, 56x1, 90x1, 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the following European Economic Area countries under the following names:
Croatia, Greece, Poland, Sweden: Liglinra