Package leaflet: Information for the user

Linatra 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, please 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

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

1. What Linatra is and what it is used for

Linatra 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.
Linatra is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled
by a single oral antidiabetic agent (metformin or sulfonylurea) or by diet and exercise alone.
Linatra 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 taking Linatra

When not to take Linatra

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 Linatra, discuss 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 characterised by high blood sugar levels, rapid weight loss, nausea, or vomiting). Linatra 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 Linatra is used concomitantly, to avoid excessively
low blood sugar levels.

if the patient has had an allergic reaction to any other medicines previously taken 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,
the patient should 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 Linatra.
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
Linatra 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.
Linatra with other medicines
The patient should inform the doctor or pharmacist about any medicines currently taken or
recently taken, as well as any medicines planned for use.
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 a doctor or pharmacist before using this medicine.
It is not known whether Linatra is harmful to unborn children, therefore it is recommended
to avoid taking Linatra during pregnancy.
It is not known whether Linatra passes into human breast milk. The doctor must decide whether breastfeeding should be discontinued or whether Linatra treatment should be stopped or withheld.
Driving and using machines
Linatra has no effect or has a negligible effect on the ability to drive
and operate machinery.
However, taking Linatra 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 sugar (glucose) levels is recommended to minimise the risk of hypoglycaemia, especially when Linatra is used in combination with sulfonylurea derivatives and (or) insulin.
Linatra contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
3. How to take Linatra
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the
doctor or pharmacist.
The recommended dose of Linatra is one 5 mg tablet once daily.
Linatra may be taken with or without food.
The doctor may recommend taking Linatra 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 Linatra than recommended
If more Linatra has been taken than recommended, contact a doctor immediately.
Missing a dose of Linatra

If the patient forgets to take a dose of Linatra, 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 Linatra
Do not stop taking Linatra without consulting a doctor. Stopping Linatra may cause blood sugar levels to increase.
If there are any further questions about the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some symptoms require immediate medical attention.
You should stop taking Linatra and contact your doctor immediately if you experience any of the following symptoms associated with low blood sugar levels: trembling, 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 Linatra when taken concomitantly with metformin and a sulfonylurea derivative.
Some patients may experience allergic reactions (hypersensitivity; frequency: not common, occurs in no more than 1 in 100 people) during treatment with Linatra as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and breathing difficulties (bronchospasm; frequency unknown, frequency cannot be estimated from available data). Some patients may develop rash (frequency: not common), urticaria (urticaria; frequency: rare, occurs in no more 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). If any of the above symptoms occur, treatment with Linatra should be discontinued immediately and medical advice should be sought without delay. The doctor may prescribe a medicine for the treatment of allergic reactions and switch to another antidiabetic medicine.
Pancreatitis (pancreatitis; frequency: rare, occurs in no more than 1 in 1,000 people) has been reported in some patients during treatment with Linatra as monotherapy or in combination with other antidiabetic medicines.
You should STOP taking Linatra 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, accompanied by nausea and vomiting, as these may be symptoms of pancreatitis.

During treatment with Linatra as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have been reported in some patients:

Common: increased lipase activity in blood.
Not common: nasopharyngitis, cough, constipation (in combination with insulin), increased amylase activity in blood.
Rare: development of skin blisters (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 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 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 Linatra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the cardboard
pack after: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
No special storage conditions apply for this medicine.
Do not use Linatra if the packaging is damaged or if there are visible 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 Linatra contains

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

Tablet core: mannitol, copovidone K-28, sodium carboxymethyl starch type A, microcrystalline cellulose, sodium stearyl fumarate;
Tablet coating: hypromellose (type 2910, 5 mPa·s), titanium dioxide (E 171), talc, macrogol 6000, iron oxide red (E 172).

What Linatra looks like and contents of the pack
Linatra 5 mg are round, biconvex, pink film-coated tablets with a diameter of 8 mm, imprinted with the number "5" on one side.

Linatra is available in blisters made of OPA/Aluminum/PVC//Aluminum laminate with a moisture-absorbing layer, packed in a cardboard box.
Pack sizes contain 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

This medicinal product is authorised in the European Economic Area under the following names:
Bulgaria: Линатра 5 mg филмирани таблетки
Slovakia: Linatra 5 mg filmom obalene tablety