Package leaflet: Information for the patient

Liamell, 5 mg, coated tablets
Linagliptinum
Please read carefully the entire leaflet 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, 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 the patient experiences any side effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Liamell is and what it is used for
Important information before taking Liamell
How to take Liamell
Possible side effects
How to store Liamell
Contents of the packaging and other information

1. What Liamell is and what it is used for

Liamell contains the active substance linagliptin, which belongs to a group of medicines called
"oral antidiabetic drugs". Oral antidiabetic drugs are used to treat high blood sugar levels.
These medicines help the body reduce the amount of sugar in the blood.
Liamell is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled
by a single oral antidiabetic drug (metformin or sulfonylurea derivatives) or by diet and physical
exercise alone. Liamell 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 the diet and physical exercise regimen recommended by your doctor or nurse.

2. Important information before using Liamell

When not to take Liamell

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

Warnings and precautions
Before starting treatment with Liamell, 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). Liamell 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 taking Liamell concomitantly, in order to avoid excessively lowering blood sugar levels.
if the patient has previously experienced an allergic reaction to any other antidiabetic medicines.
if the patient currently has or has previously had a pancreatic disease.

If symptoms of acute pancreatitis occur, such as severe and persistent abdominal pain, the patient should contact a doctor immediately.
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 Liamell.
Diabetic skin changes are common complications of diabetes. The patient should follow the skin and foot care recommendations provided by the doctor or nurse.

Children and adolescents
Liamell 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.

Liamell and 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
It is not known whether Liamell is harmful to unborn children, therefore use of Liamell during pregnancy is not recommended. It is not known whether Liamell passes into human milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold treatment with Liamell.

Driving and operating machinery
Liamell has no effect or has a negligible effect on the ability to drive and operate machinery.
However, taking Liamell 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 operate machinery 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 taking Liamell in combination with sulfonylurea derivatives and/or insulin.

3. How to take Liamell

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose of Liamell is one 5 mg tablet once daily.
Liamell may be taken with or without food.
Your doctor may recommend taking Liamell together with another oral antidiabetic medicine.
All medicines should be taken in accordance with your doctor's instructions to achieve the best
possible treatment outcome.

Taking more than the recommended dose of Liamell
If you take more than the recommended dose of Liamell, you should contact your doctor immediately.

Missed dose of Liamell

If you forget to take a dose of Liamell, 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 treatment with Liamell
Do not stop taking Liamell without consulting your doctor. Stopping treatment with Liamell may lead to increased blood glucose 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 may cause adverse reactions, although not everyone experiences them.

Some symptoms require immediate medical attention:
You must stop taking Liamell 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, occurs in more than 1 in 10 people) is a known adverse effect of treatment with Liamell when taken concomitantly with metformin and a sulfonylurea derivative.

Allergic reactions (hypersensitivity; frequency: not very common, occurs in less than 1 in 100 people) have occurred in some patients during treatment with Liamell, used either as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and shortness of breath (bronchospasm; frequency: not known, frequency cannot be estimated from available data). Skin rash (frequency: not very common), urticaria (urticaria; frequency: rare, occurs in less than 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, you must stop taking Liamell and contact your doctor immediately. Your doctor may prescribe a medicine for treating allergic reactions and switch you to another antidiabetic medicine.

Pancreatitis (pancreatitis; frequency: rare, occurs in less than 1 in 1,000 people) has been reported in some patients treated with Liamell, either as monotherapy or in combination with other antidiabetic medicines. You must STOP taking Liamell and contact your doctor immediately if any of the following serious 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.

During treatment with Liamell, either as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have occurred in some patients:

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

Reporting of adverse reactions
If you experience any adverse symptoms, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 may also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Liamell

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.
There are no special storage instructions for this medicine.
Do not use Liamell if the packaging is damaged or if there are visible signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What Liamell contains

The active substance is linagliptin.
Each film-coated tablet (tablet) contains 5 mg of linagliptin.
The other ingredients are:
Tablet core: mannitol (E 421), copovidone, maize starch, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000, talc, iron oxide red (E 172).

What Liamell looks like and contents of the pack
Liamell 5 mg tablets are light red, round, biconvex film-coated tablets with bevelled edges, imprinted with the letter "I" on one side, with a diameter of 8.0 mm ± 0.5 mm.
Liamell is available in blisters made of OPA/Aluminium/PVC/Aluminium foil, packed in a cardboard box containing 10, 28, 30 or 90 film-coated tablets.
Not all pack sizes may be available in a given country.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
SAG MANUFACTURING, S.L.U.
Carretera Nacional 1 Km 36
San Agustín del Guadalix
28750 Madrid
Spain

GALENICUM HEALTH, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Malta Liamell 5mg film-coated tablets
Austria Liamell 5 mg Filmtabletten
Czech Republic Liamell
Poland Liamell
Slovakia Liamell 5 mg filmom obalené tablety

For more detailed information about this medicine, contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]