Patient Information Leaflet

Jeligo, 5 mg, film-coated tablets
Linagliptinum
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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

1. What Jeligo is and what it is used for

Jeligo contains the active substance linagliptin, which belongs to a group of medicines called "oral antidiabetic drugs". Oral antidiabetic drugs are used in the treatment of high blood sugar levels. These medicines help your body reduce the amount of sugar in the blood.
Jeligo is used to treat type 2 diabetes in adults when this condition cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulfonylurea derivatives) or with diet and exercise alone. Jeligo may be used together with other antidiabetic medicines, such as metformin, sulfonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue following the diet and exercise regimen recommended by your doctor or nurse.

2. Important information before using Jeligo

When not to use Jeligo

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 to take Jeligo, 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 diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting). Jeligo must not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a "sulfonylurea" (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea when Jeligo is used at the same time, to avoid excessively low blood sugar levels.
if the patient has had an allergic reaction to any other medicines previously used to lower blood sugar levels.
if the patient has or has had pancreas disease in the past.

If the patient develops symptoms of acute pancreatitis, such as severe and persistent stomach (abdominal) pain, contact a doctor.
If blisters appear on the patient's skin, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Jeligo.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care recommendations provided by the doctor or nurse.

Children and adolescents
Jeligo must not be used in children and adolescents under 18 years of age. This medicine 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.

Jeligo with 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 baby, she should consult her doctor or pharmacist before using this medicine.
It is not known whether Jeligo is harmful to unborn babies, therefore it is recommended to avoid taking Jeligo during pregnancy.
It is not known whether Jeligo passes into human breast milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold Jeligo treatment.

Driving and using machines
Jeligo has no effect or has a negligible effect on the ability to drive and use machines.
However, taking Jeligo together with medicines called sulfonylureas and (or) insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines or work without secure footing. Nevertheless, more frequent monitoring of blood sugar (glucose) levels is recommended to minimize the risk of hypoglycaemia, especially when Jeligo is used in combination with sulfonylureas and (or) insulin.

3. How to take Jeligo

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

Taking more Jeligo than recommended
If more Jeligo has been taken than recommended, contact your doctor immediately.

If you miss a dose of Jeligo

If the patient forgets to take a dose of Jeligo, it should be taken as soon as remembered. 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 Jeligo
Do not stop taking Jeligo without first consulting your doctor. Stopping treatment with Jeligo may lead to increased blood sugar 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
You should stop taking Jeligo and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common – may occur in more than 1 in 10 people) is a known adverse reaction when Jeligo is taken together with metformin and a sulfonylurea derivative.

Allergic reactions (hypersensitivity; frequency: not very common – may occur in up to 1 in 100 people) have occurred in some patients during treatment with Jeligo alone or in combination with other antidiabetic medicines, which may be severe, including wheezing and difficulty breathing (bronchospasm; frequency: unknown – cannot be estimated from available data). Skin rash (frequency: not very common), urticaria (frequency: rare – may occur in up to 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 been reported in some patients. If any of the above symptoms occur, treatment with Jeligo should be discontinued immediately and you should contact your doctor without delay. Your doctor may prescribe medication for the treatment of allergic reactions and switch you to another antidiabetic medicine.

Pancreatitis (inflammation of the pancreas; frequency: rare – may occur in up to 1 in 1,000 people) has occurred in some patients during treatment with Jeligo alone or in combination with other antidiabetic medicines.

You should STOP taking Jeligo 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.

The following adverse reactions have occurred in some patients during treatment with Jeligo alone or in combination with other antidiabetic medicines:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Jeligo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use this medicine if you notice that 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Jeligo contains
The active substance is linagliptin.
Each coated tablet contains 5 mg of linagliptin.
The other ingredients are:
Tablet core: mannitol (E 421), pregelatinized starch, povidone K30, maize starch,
magnesium stearate.
Coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172).

What Jeligo looks like and contents of the pack

Jeligo 5 mg film-coated tablets are round, red, biconvex film-coated tablets, with the number "5" embossed on one side and smooth on the other.
Jeligo is available in OPA/Aluminium/PVC/Aluminium blisters. Pack sizes: 30 tablets.
The product may also be available in single-dose blisters: 30 x 1 film-coated tablet (single dose).

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Manufacturer
Genepharm S.A.
18th Km Marathonos Avenue
15351 Pallini
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Lithuania Jeligo 5 mg plėvele dengtos tabletės
Czech Republic Jeligo
Hungary Jeligo 5 mg filmtabletta
Poland Jeligo
Romania Jeligo 5 mg comprimate filmate
Slovakia Jeligo

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00