JELIGO 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Jeligo, 5 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Jeligo and What is it Used For
4. Important Information Before Taking Jeligo
   1. When Not to Take Jeligo
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Jeligo and Other Medications
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machinery
5. How to Take Jeligo
   1. Taking a Higher Dose of Jeligo Than Recommended
   2. Missing a Dose of Jeligo
   3. Stopping Jeligo Treatment
6. Possible Side Effects
   1. Some Symptoms Require Immediate Medical Attention
   2. Reporting Side Effects
7. How to Store Jeligo
8. Contents of the Package and Other Information
   1. What Jeligo Contains
   2. What Jeligo Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Jeligo, 5 mg, Film-Coated Tablets

Linagliptin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. 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 those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Jeligo and What is it Used For
• 2. Important Information Before Taking Jeligo
• 3. How to Take Jeligo
• 4. Possible Side Effects
• 5. How to Store Jeligo
• 6. Contents of the Package and Other Information

1. What is Jeligo and What is it Used For

Jeligo contains the active substance linagliptin, which belongs to a group of medications called "oral anti-diabetic drugs". Oral anti-diabetic drugs are used to treat high blood sugar levels. These medications help the body reduce blood sugar levels. Jeligo is used to treat type 2 diabetes in adults when the condition cannot be controlled by a single oral anti-diabetic medication (metformin or sulfonylurea derivatives) or by diet and exercise alone. Jeligo can be used in combination with other anti-diabetic medications, such as metformin, sulfonylurea derivatives (e.g., glimepiride, glipizide), empagliflozin, or insulin. It is essential to continue with the diet and exercise recommended by your doctor or nurse.

2. Important Information Before Taking Jeligo

When Not to Take Jeligo

• if you are allergic to linagliptin or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before taking Jeligo, discuss with your doctor, pharmacist, or nurse:

• if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Jeligo should not be used to treat these conditions.
• if you are taking a sulfonylurea derivative (e.g., glimepiride, glipizide), your doctor may recommend reducing the dose of the sulfonylurea derivative if you are taking Jeligo to avoid excessive blood sugar reduction.
• if you have experienced an allergic reaction to any other medication used to reduce blood sugar levels.
• if you have or have had pancreatitis in the past.

If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, contact your doctor. If you develop blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may recommend stopping Jeligo. Diabetic skin changes are common complications of diabetes. Follow the skin and foot care recommendations provided by your doctor or nurse.

Children and Adolescents

Jeligo should not be used in children and adolescents under 18 years of age. This medication is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medication is safe and effective when used in children under 10 years of age.

Jeligo and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. In particular, inform your doctor if you are taking medications containing any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These medications are used to treat epilepsy or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication. It is not known if Jeligo is harmful to unborn babies, so it is recommended to avoid taking Jeligo during pregnancy. It is not known if Jeligo passes into breast milk. Your doctor will decide whether to stop breastfeeding or stop/discontinue Jeligo treatment.

Driving and Operating Machinery

Jeligo has no influence or negligible influence on the ability to drive and operate machinery. Taking Jeligo with sulfonylurea derivatives and/or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and operate machinery or work without strong support for the feet. However, it is recommended to check blood sugar levels more frequently to minimize the risk of hypoglycemia, especially when taking Jeligo in combination with sulfonylurea derivatives and/or insulin.

3. How to Take Jeligo

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The recommended dose of Jeligo is one 5 mg tablet once a day. Jeligo can be taken with or without food. Your doctor may recommend taking Jeligo with another oral anti-diabetic medication. All medications should be taken as recommended by your doctor to achieve the best treatment outcome.

Taking a Higher Dose of Jeligo Than Recommended

If you have taken more Jeligo than recommended, contact your doctor immediately.

Missing a Dose of Jeligo

• If you forget to take a dose of Jeligo, 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 Jeligo Treatment

Do not stop taking Jeligo without consulting your doctor first. If you stop taking Jeligo, your blood sugar levels may increase. If you have any further questions about taking this medication, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Jeligo can cause side effects, although not everybody gets them.

Some Symptoms Require Immediate Medical Attention

Stop taking Jeligo and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar levels: shaking, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes, or confusion (hypoglycemia). Hypoglycemia (very common, may occur in more than 1 in 10 people) is a known side effect when Jeligo is taken with metformin and a sulfonylurea derivative. Some patients have experienced allergic reactions (hypersensitivity; uncommon, may occur in up to 1 in 100 people) when taking Jeligo alone or in combination with other diabetes medications, which can be severe, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, cannot be estimated from the available data). Some patients have experienced rash (uncommon), hives (rare, may occur in up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing (angioedema; rare). If you experience any of these symptoms, stop taking Jeligo and contact your doctor immediately. Your doctor may prescribe a medication to treat the allergic reaction and another medication to treat diabetes.

When taking Jeligo alone or in combination with other diabetes medications, some patients have experienced pancreatitis (pancreatitis; rare, may occur in up to 1 in 1,000 people). You must stop taking Jeligo and contact your doctor immediately if you experience any of the following severe side effects:

• 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.

When taking Jeligo alone or in combination with other diabetes medications, some patients have experienced the following side effects:

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

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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. 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 medication.

5. How to Store Jeligo

Keep this medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for this medication. Do not use this medication if you notice that the packaging is damaged or shows signs of tampering. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Jeligo Contains

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

What Jeligo Looks Like and Contents of the Package

• 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/Aluminum/PVC/Aluminum blisters. The pack sizes are 30 tablets.
• The packaging may also be available in the form of single-dose blisters: 30 x 1 film-coated tablet (single dose).

Marketing Authorization Holder

Egis Pharmaceuticals PLC, Keresztúri út 30-38, H-1106 Budapest, Hungary

Manufacturer

Genepharm S.A., 18th Km Marathonos Avenue, 15351 Pallini, Greece. This medication is authorized 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 more information about this medication, contact the local representative of the marketing authorization holder: EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Tel.: +48 22 417 92 00

Date of Last Revision of the Package Leaflet: