Package leaflet: Information for the user

AGNIS, 50 mg, tablets
(Vildagliptinum)
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 give it 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

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

1. What Agnis is and what it is used for

The active substance in Agnis is vildagliptin, which belongs to a group of medicines called oral
antidiabetic agents.
Agnis is a medicine used to treat adult patients with type 2 diabetes mellitus whose condition cannot be controlled by diet and exercise alone. This medicine helps maintain appropriate blood sugar levels. Your doctor may prescribe Agnis either as the only antidiabetic medicine or in combination with other antidiabetic medicines you have previously taken, if they have not been sufficiently effective in maintaining proper blood glucose levels.
Type 2 diabetes is a condition in which the body does not produce enough insulin, or the insulin produced does not work properly. Diabetes may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after meals.
Glucagon is a substance that stimulates the liver to produce sugar and increases blood sugar levels.
Both of these substances are produced in the pancreas.
How Agnis works
This medicine works by stimulating the pancreas to produce insulin and reducing the production of
glucagon. Therefore, it helps maintain proper blood sugar levels. It has been shown that the medicine reduces blood sugar levels, which may help prevent complications associated with diabetes. Even after starting pharmacological treatment for diabetes, it remains important for the patient to continue following an appropriate diet and (or) performing recommended physical exercise.

2. What you need to know before taking Agnis
Do not 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 this medicine, you should not take it and should inform your doctor.

Warnings and precautions
Before starting Agnis, please talk to your doctor, pharmacist or nurse if:

you have type 1 diabetes (i.e. your body does not produce insulin) or you have a condition called diabetic ketoacidosis,
you are taking an antidiabetic medicine called a sulfonylurea [your doctor may wish to reduce the dose of the sulfonylurea taken together with Agnis to avoid low blood glucose levels (hypoglycaemia)],
you have moderate or severe kidney disease (a lower dose of Agnis should be used),
you are undergoing dialysis,
you have liver disease,
you have heart failure,
you have had or currently have pancreatic disorders.

If you have previously taken vildagliptin but had to stop due to liver problems, you should not take this medicine.
Skin changes are common complications of diabetes. You should follow the advice of your doctor or nurse regarding skin and foot care. While taking Agnis, you should pay particular attention to the development of new blisters or ulcers. If these occur, you should contact your doctor immediately.
Before starting Agnis and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows early detection of signs of increased liver enzyme activity.
Children and adolescents
Agnis is not recommended for use in children and adolescents under 18 years of age.
Agnis and other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken or might take in the future.
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 inflammatory conditions),
medicines used to treat thyroid disorders,
certain medicines affecting the nervous system.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, please consult your doctor or pharmacist before taking this medicine.
Do not take Agnis during pregnancy. It is not known whether it 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 (milk sugar). If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Agnis contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".
3. How to take Agnis
Always take this medicine exactly as your doctor has told you. If you are unsure, please consult your doctor or pharmacist.
What dose to take and when
The dose may vary depending on your condition. Your doctor will determine exactly how many tablets you should take. The maximum daily dose is 100 mg.
The usual dose is:

50 mg once daily in the morning, when Agnis is taken with a medicine called a sulfonylurea;
100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Agnis is taken alone, or with metformin or a glitazone, or in combination with metformin and a sulfonylurea or insulin;
50 mg once daily in the morning, if you have moderate or severe kidney disease or are undergoing dialysis.

How to take Agnis

Swallow the tablets whole with water.

How long to take Agnis

You should take this medicine every day for as long as your doctor recommends. Your doctor may decide on long-term treatment.
Your doctor will regularly monitor your health to check whether the treatment is effective.

Taking more Agnis than you should
If you take too many tablets, contact your doctor immediately. You may require medical attention. If you need to visit a doctor's office or hospital, please bring the medicine pack with you.
If you forget to take Agnis
If you forget to take a dose, take it as soon as you remember. Then take the 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.
Stopping Agnis
Do not stop taking Agnis unless your doctor tells you to. If you have any questions about how long to take this medicine, please consult your doctor.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking the medicine immediately and contact your doctor:

Angioedema (rare: may occur in up to 1 in 1,000 patients): symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives. These may indicate a reaction known as angioedema;
Liver disease (hepatitis) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis);
Pancreatitis (frequency not known): symptoms include severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients taking medicine A and metformin:

Common (may occur in up to 1 in 10 patients): tremor, headache, dizziness, nausea, low blood glucose levels;
Uncommon (may occur in up to 1 in 100 patients): fatigue.

The following adverse reactions have been reported in some patients taking medicine A and a sulfonylurea:

Common: tremor, headache, dizziness, weakness, low blood glucose levels;
Uncommon: constipation;
Very rare (may occur in up to 1 in 10,000 patients): sore throat, cold symptoms.

The following adverse reactions have been reported in some patients taking medicine A and a glitazone:

Common: weight gain, swollen hands, ankles or feet (oedema);
Uncommon: headache, weakness, low blood glucose levels.

The following adverse reactions have been reported in some patients taking medicine A as monotherapy:

Common: dizziness;
Uncommon: headache, constipation, swollen hands, ankles or feet (oedema), joint pain, low blood glucose levels;
Very rare: sore throat, cold symptoms, fever.

The following adverse reactions have been reported in some patients taking medicine A, metformin and a sulfonylurea:

Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating.

The following adverse reactions have been reported in some patients taking AGNIS and insulin (with or without metformin):

Common: headache, chills, nausea, low blood glucose levels, heartburn;
Uncommon: diarrhoea, flatulence.

After the introduction of the medicine containing 50 mg of vildagliptin to the market, the following adverse reactions have also been reported:

Frequency not known (frequency cannot be estimated from available data): itchy rash, pancreatitis, localised skin peeling or blistering, muscle pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 the medicine.

5. How to store medicine A

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

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

What A looks like and contents of the pack
A, 50 mg are white or almost white, bevelled-edge tablets, 8 mm in diameter, round, uncoated, with the imprint "50" on one side and smooth on the other side.
The medicine is available in packs containing 28, 30, 56, 60 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia AGNIS 50 mg tablets
Czech Republic AGNIS
Poland AGNIS
Slovakia AGNIS 50 mg tablety
Slovenia AGNIS 50 mg tablete