VIGLITA 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Viglita, 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 Viglita and what is it used for
   1. How Viglita works
4. Important information before taking Viglita
   1. When not to take Viglita:
   2. Warnings and precautions
   3. Before taking Viglita, talk to your doctor, pharmacist, or nurse if
   4. Children and adolescents
   5. Viglita with other medicines
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Viglita contains lactose and sodium
5. How to take Viglita
   1. When and how to take Viglita
   2. How to take Viglita
   3. How long to take Viglita
   4. What to do if you take more Viglita than you should
   5. What to do if you forget to take Viglita
   6. What to do if you stop taking Viglita
6. Possible side effects
   1. Some side effects need immediate medical attention:
   2. Other side effects
   3. Reporting side effects
7. How to store Viglita
8. Contents of the pack and other information
   1. What Viglita contains
   2. What Viglita looks like and contents of the pack
   3. Marketing authorisation holder
   4. Importer/Manufacturer
   5. This medicine is authorised in the Member States of the European Economic Area under the following names:
   6. For further information about this medicine, contact the representative of the marketing authorisation holder in Poland:

Package Leaflet: Information for the User

Viglita, 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Viglita and what is it used for

The active substance of Viglita is vildagliptin, which belongs to a group of medicines called "oral antidiabetic medicines".
Viglita is a medicine used to treat adult patients with type 2 diabetes. The medicine is used when diet and exercise alone are not enough to control the condition. The medicine helps to control blood sugar levels. Your doctor may prescribe Viglita to be taken alone or in combination with other antidiabetic medicines that you may already be taking, if they are not sufficient to control your diabetes.
Type 2 diabetes develops when the body does not produce enough insulin or when the insulin produced by the body does not work properly. Diabetes can also develop when the body produces too much glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after a meal.
Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels. Both substances are produced in the pancreas.

How Viglita works

Viglita works by stimulating the pancreas to produce insulin and reducing the production of glucagon. This helps to control blood sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help to prevent complications of diabetes. Despite starting medication for diabetes, it is important for the patient to continue to follow a suitable diet and (or) exercise as recommended.

2. Important information before taking Viglita

When not to take Viglita:

• 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 Viglita, do not take this medicine and tell your doctor.

Warnings and precautions

Before taking Viglita, talk to your doctor, pharmacist, or nurse if

• you have type 1 diabetes (your body does not produce insulin) or if you have diabetic ketoacidosis,
• you are taking a sulphonylurea (a type of antidiabetic medicine) [your doctor may decide to reduce the dose of the sulphonylurea you are taking with Viglita to avoid low blood sugar (hypoglycaemia)],
• you have moderate or severe kidney disease (you may need to take a lower dose of Viglita),
• you are on dialysis,
• you have liver disease,
• you have heart failure,
• you have or have had pancreatitis.

If you have taken vildagliptin before but had to stop due to liver disease, you should not take this medicine.
A common complication of diabetes is diabetic skin changes. You should follow your doctor's or nurse's advice on skin and foot care. While taking Viglita, you should also pay particular attention to the appearance of new blisters or ulcers. If they appear, you should contact your doctor immediately.
Before starting treatment with Viglita 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

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

Viglita with other medicines

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

• thiazides or other diuretics (also known as water tablets),
• corticosteroids (usually taken to treat inflammation),
• medicines for thyroid disease,
• certain medicines affecting the nervous system.

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.
Do not take Viglita if you are pregnant. It is not known if Viglita passes into breast milk. If you are breast-feeding or plan to breast-feed, do not take Viglita.

Driving and using machines

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

Viglita contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Viglita

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

When and how to take Viglita

The dose of Viglita is different for each patient. Your doctor will tell you exactly how many tablets of Viglita to take. The maximum daily dose is 100 mg.
The usual dose of Viglita is:

• 50 mg once daily, taken in the morning, if you are taking Viglita with another medicine called a sulphonylurea.
• 100 mg once daily, taken as 50 mg in the morning and 50 mg in the evening, if you are taking Viglita alone, or with metformin, or a glitazone, or in combination with metformin and a sulphonylurea, or with insulin.
• 50 mg once daily in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Viglita

• Swallow the tablets whole with water.

How long to take Viglita

• Take Viglita every day, for as long as your doctor recommends. Your doctor may decide that you should take Viglita for a long time.
• Your doctor will regularly check your condition to ensure that the treatment is working.

What to do if you take more Viglita than you should

If you have taken too many Viglita tablets or if someone else has taken your medicine, contact your doctor immediately. You may need medical attention. If you go to a doctor or hospital, take the pack of Viglita with you.

What to do if you forget to take Viglita

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

What to do if you stop taking Viglita

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

4. Possible side effects

Like all medicines, Viglita 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 Viglita 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, which may indicate angioedema.
• Liver disease (hepatitis) (frequency not known). Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 people). Symptoms include severe and persistent stomach pain (abdominal pain) which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking vildagliptin have experienced the following side effects:

• very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• common (may affect up to 1 in 10 people): itching, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, feet or ankles (oedema), excessive sweating, vomiting, stomach pain and discomfort (abdominal pain), diarrhoea, heartburn, nausea, blurred vision
• uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar, bloating.
• rare (may affect up to 1 in 1,000 people): pancreatitis.

After marketing, the following side effects have also been reported:

• frequency not known (cannot be estimated from the available data): local skin exfoliation or blistering, vasculitis, which can cause skin rash or flat, red, round patches under the skin or bruising.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 authorisation holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viglita

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.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Viglita contains

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

What Viglita looks like and contents of the pack

Viglita is a white to almost white, mottled, round tablet with a diameter of 8.00 ± 0.5 mm.
Viglita 50 mg tablets are available in packs of 14, 28, 30, 56, 60 and 180 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer/Manufacturer

S.C. Zentiva S.A, B-dul Theodor Pallady nr.50, sector 3, 032266 Bucharest, Romania

This medicine is authorised in the Member States of the European Economic Area under the following names:

Czech Republic, Poland, Slovakia, Greece Viglita

For further information about this medicine, contact the representative of the marketing authorisation holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:April 2023