LINATRA 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Linatra, 5 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the package leaflet
3. What is Linatra and what is it used for
4. Important information before taking Linatra
   1. When not to take Linatra
   2. Warnings and precautions
   3. Children and adolescents
   4. Linatra with other medicines
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. Linatra contains sodium
5. How to take Linatra
   1. If you take more Linatra than you should
   2. If you forget to take Linatra
   3. If you stop taking Linatra
6. Possible side effects
   1. Reporting of side effects
7. How to store Linatra
8. Contents of the pack and other information
   1. What Linatra contains
   2. What Linatra looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Linatra, 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Linatra and what is it used for

Linatra 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 to reduce the amount of sugar in the blood.
Linatra is used to treat type 2 diabetes in adults, when the disease cannot be controlled by diet and exercise alone.
It is important to continue with the diet and exercise as recommended by your doctor or nurse.

2. Important information before taking Linatra

When not to take Linatra

Warnings and precautions

Before taking Linatra, talk to your doctor, pharmacist, or nurse:

in the past.

If you get symptoms of acute pancreatitis, such as severe and persistent stomach pain,
contact your doctor.
If you get blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Linatra.
Diabetic skin changes are common complications of diabetes. You should follow the advice about skin and foot care given by your doctor or nurse.

Children and adolescents

Linatra is not recommended for use in children and adolescents below 18 years of age.

Linatra with other medicines

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

• 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if Linatra is harmful to the unborn child. Therefore, it is recommended to avoid taking Linatra during pregnancy.
It is not known if Linatra passes into breast milk. Your doctor will decide whether you should stop breast-feeding or stop/ interrupt Linatra therapy.

Driving and using machines

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

Linatra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to take Linatra

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Linatra is one 5 mg tablet once a day.
Linatra can be taken with or without food.
Take the medicine as advised by your doctor to get the best results.

If you take more Linatra than you should

If you take more Linatra than you should, contact your doctor immediately.

If you forget to take Linatra

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

If you stop taking Linatra

Do not stop taking Linatra without talking to your doctor first. If you stop taking Linatra, your blood sugar levels may increase.
If you have any further questions on the use of this product, 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 Linatra and contact your doctor immediately if you get any of the following symptoms of low blood sugar levels: shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, occurs in more than 1 in 10 people) is a known side effect of Linatra when taken with metformin and a sulphonylurea.

• Serious and persistent stomach pain (in the abdomen), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

When taking Linatra alone or with other diabetes medicines, some people may experience the following side effects:

• Common: increased activity of lipase in the blood.
• Uncommon: inflammation of the nose or throat, cough, constipation (when taken with insulin), increased activity of amylase in the blood.
• Rare: blistering of the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +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 Linatra

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 the carton after EXP. The expiry date refers to the last day of that month.
The packaging is marked with the expiry date and the batch number (Lot/LOT).
There are no special storage conditions for this medicine.
Do not use Linatra if the packaging is damaged or shows signs of tampering.
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 Linatra contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other ingredients are: Tablet core: mannitol, copovidone K-28, sodium carboxymethylcellulose type A, microcrystalline cellulose, sodium stearyl fumarate; Tablet coating: hypromellose (type 2910, 5 mPas), titanium dioxide (E 171), talc, macrogol 6000, iron oxide red (E 172).

What Linatra looks like and contents of the pack

Linatra 5 mg is a round, biconvex, pink film-coated tablet with a diameter of 8 mm, with the code number "5" embossed on one side.
Linatra is available in blisters of OPA/Aluminium/PVC//Aluminium with a desiccant, in a carton box.
Pack sizes include 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

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

Bulgaria: Линатра 5 mg филмирани таблетки
Slovakia: Linatra 5 mg filmom obalene tablety
Date of last revision of the package leaflet:June 2025