AGNIS 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. AGNIS, 50 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is AGNIS and what is it used for
   1. How AGNIS works
4. Important information before taking AGNIS
   1. When not to take AGNIS:
   2. Warnings and precautions
   3. Before taking AGNIS, discuss with your doctor, pharmacist, or nurse:
   4. Children and adolescents
   5. AGNIS and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. AGNIS contains lactose
   9. AGNIS contains sodium
5. How to take AGNIS
   1. What dose to take and when
   2. How to take AGNIS
   3. How long to take AGNIS
   4. What to do if you take more AGNIS than you should
   5. What to do if you forget to take AGNIS
   6. What to do if you stop taking AGNIS
   7. If you have any further questions about taking this medicine, ask your doctor or pharmacist.
6. Possible side effects
   1. Some side effects need immediate medical attention:
   2. Other side effects
   3. Reporting side effects
7. How to store AGNIS
8. Contents of the pack and other information
   1. What AGNIS contains
   2. What AGNIS 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

AGNIS, 50 mg, tablets

(Vildagliptin)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is AGNIS and what is it used for

The active substance of AGNIS is vildagliptin, which belongs to a group of medicines called oral anti-diabetic medicines.
AGNIS is a medicine used to treat type 2 diabetes in adults who are unable to control their condition with diet and exercise alone. This medicine helps to keep blood sugar levels under control. Your doctor may prescribe AGNIS as the only anti-diabetic medicine or in combination with other anti-diabetic medicines that you have taken before, if they have not been effective enough in controlling your blood sugar levels.
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced by the body does not work properly. Diabetes can also develop if the body produces too much glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after meals.
Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels.
Both of these substances are produced in the pancreas.

How AGNIS works

The action of this medicine is to stimulate the pancreas to produce insulin and reduce the production of glucagon. Therefore, it helps to keep blood sugar levels under control. It has been shown that the medicine reduces blood sugar levels, which can help prevent complications of diabetes. Despite starting pharmacological treatment for diabetes, it is essential for the patient to continue following a suitable diet and (or) performing recommended physical exercises.

2. Important information before taking AGNIS

When not to take AGNIS:

• if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of the medicine, do not take this medicine, but tell your doctor.

Warnings and precautions

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

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis,
• if you are taking a sulfonylurea (a type of anti-diabetic medicine), your doctor may want to reduce the dose of the sulfonylurea taken with AGNIS to avoid low blood sugar levels (hypoglycemia),
• if you have moderate or severe kidney disease (a lower dose of AGNIS should be used),
• if you are on dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop due to liver disease, you should not take this medicine.
Skin conditions are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. While taking AGNIS, you should pay particular attention to the appearance of new blisters or ulcers. If they appear, you should contact your doctor immediately.
Before starting to take AGNIS and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests. This will help to find out as soon as possible if you have any signs of liver damage.

Children and adolescents

AGNIS should not be used in children and adolescents under 18 years of age.

AGNIS and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor may need to adjust the dose of AGNIS if you are taking other medicines, such as:

• thiazides or other diuretics (also known as water tablets),
• corticosteroids (usually used to treat inflammation),
• medicines used to treat thyroid disorders,
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take AGNIS if you are pregnant. It is not known if AGNIS passes into breast milk. Do not take AGNIS if you are breastfeeding or planning to breastfeed.

Driving and using machines

If you experience dizziness while taking AGNIS, do not drive or operate machinery.

AGNIS contains lactose

AGNIS contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

AGNIS contains sodium

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

3. How to take AGNIS

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take and when

The dose of AGNIS varies depending on your condition. Your doctor will decide exactly how many tablets of AGNIS to take. The maximum daily dose is 100 mg.
The usual dose is:

• 50 mg once daily, taken in the morning, if you are taking AGNIS with a sulfonylurea;
• 100 mg once daily, taken as two doses of 50 mg, one in the morning and one in the evening, if you are taking AGNIS alone, or with metformin or a glitazone, or with metformin and a sulfonylurea or insulin;
• 50 mg once daily, taken in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take AGNIS

• Swallow the tablets whole with water.

How long to take AGNIS

• Take this medicine every day, as long as your doctor has prescribed it. Your doctor may decide that you should take it for a long time.
• Your doctor will regularly check your condition to see if the treatment is working.

What to do if you take more AGNIS than you should

If you have taken too many tablets, contact your doctor immediately. You may need medical attention. If you need to go to a doctor's office or hospital, take the package leaflet with you.

What to do if you forget to take AGNIS

If you forget to take a dose, take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

What to do if you stop taking AGNIS

Do not stop taking AGNIS unless your doctor tells you to. If you have any questions about how long to take this medicine, ask your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, AGNIS can cause side effects, although not everybody gets them.

Some side effects need immediate medical attention:

If you experience any of the following side effects, stop taking AGNIS and contact your doctor immediately:

• angioedema (rare: may affect up to 1 in 1,000 people): symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives. These may be signs of angioedema;
• liver disease (hepatitis) (rare). Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine. These may be signs of liver disease (hepatitis);
• pancreatitis (frequency not known): symptoms include severe and persistent abdominal pain (around the stomach area) that may radiate to the back, as well as nausea and vomiting.

Other side effects

In some patients taking AGNIS and metformin, the following side effects have occurred:

• common (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, low blood sugar levels;
• uncommon (may affect up to 1 in 100 people): fatigue.

In some patients taking AGNIS and a sulfonylurea, the following side effects have occurred:

• common: tremor, headache, dizziness, weakness, low blood sugar levels;
• uncommon: constipation;
• very rare (may affect up to 1 in 10,000 people): sore throat, cold.

In some patients taking AGNIS and a glitazone, the following side effects have occurred:

• common: weight gain, swollen hands, ankles, or feet (edema);
• uncommon: headache, weakness, low blood sugar levels.

In some patients taking AGNIS alone, the following side effects have occurred:

• common: dizziness,
• uncommon: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar levels;
• very rare: sore throat, cold, fever.

In some patients taking AGNIS, metformin, and a sulfonylurea, the following side effects have occurred:

• common: dizziness, tremor, weakness, low blood sugar levels, excessive sweating.

In some patients taking AGNIS and insulin (with or without metformin), the following side effects have occurred:

• common: headache, chills, nausea (vomiting), low blood sugar levels, heartburn;
• uncommon: diarrhea, bloating. After the marketing of the 50 mg vildagliptin-containing medicine, the following side effects have also been reported:
• frequency not known (cannot be estimated from the available data): itchy rash, pancreatitis, localized skin peeling or blistering, muscle pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of 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
You can also report side effects 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 AGNIS

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 carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not use this medicine 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 AGNIS contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin. The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium carboxymethylcellulose (type A), and magnesium stearate.

What AGNIS looks like and contents of the pack

AGNIS 50 mg is a white or almost white, round, uncoated tablet with a diameter of 8 mm, with beveled edges, with the inscription "50" on one side and smooth on the other side.
The medicine is available in packs of 28, 30, 56, 60, or 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Belupo pharmaceuticals and cosmetics Inc.
Danica 5
48000 Koprivnica
Croatia

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

Croatia
AGNIS 50 mg tablets
Czech Republic
AGNIS
Poland
AGNIS
Slovakia
AGNIS 50 mg tablets
Slovenia
AGNIS 50 mg tablets
Date of last revision of the leaflet:04/2022