Viglita

Package leaflet: Information for the user

Viglita, 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Viglita is and what it is used for
2. What you need to know 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 Viglita is and what it is used for

The active substance in Viglita is vildagliptin, which belongs to a group of medicines called "oral antidiabetic agents".
Viglita is a medicine used to treat adult patients with type 2 diabetes. It is used when the disease cannot be controlled by diet and physical exercise alone. The medicine helps control blood glucose levels. Your doctor may prescribe Viglita as the only antidiabetic medicine or in combination with other antidiabetic medicines you may be taking, if they have not been sufficiently effective in controlling 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 may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood glucose levels, especially after a meal.
Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels. Both of these substances are produced in the pancreas.
How Viglita works
Viglita works by stimulating the pancreas to produce insulin and reducing glucagon production. This helps control blood glucose levels. The medicine has been shown to reduce blood glucose 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. Important information before using Viglita

When not to use Viglita:

• if the patient is allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to vildagliptin or any of the other ingredients of Viglita, they should not take this medicine and should inform their doctor.

Warnings and precautions
Before starting treatment with Viglita, discuss with your doctor, pharmacist or
nurse if:

• the patient has type 1 diabetes (i.e. their body does not produce insulin) or if the patient has a condition called diabetic ketoacidosis,
• the patient is taking an antidiabetic medicine called a sulphonylurea [to avoid excessive lowering of blood glucose (hypoglycaemia), the doctor may decide to reduce the dose of the sulphonylurea taken together with Viglita],
• the patient has moderate or severe kidney disease (a lower dose of Viglita should be used),
• the patient is on dialysis,
• the patient has liver disease,
• the patient has heart failure,
• the patient has had or currently has pancreatic diseases.

If the patient previously took vildagliptin but had to stop due to liver disease, they should not use this medicine.
A common complication of diabetes is diabetic skin changes. The patient should follow the doctor's or nurse's advice regarding skin and foot care. While taking Viglita, special attention should also be paid to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
Before starting treatment with Viglita and every three months during the first year of treatment, and thereafter periodically, liver function tests should be performed. This allows any signs of increased liver enzyme activity to be detected as early as possible.

Children and adolescents
Use of Viglita is not recommended in children and adolescents under 18 years of age.

Viglita and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
The doctor may adjust the dose of Viglita if the patient is 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Viglita should not be used during pregnancy. It is not known whether Viglita passes into human milk. If the patient is breastfeeding or planning to breastfeed, she should not use Viglita.

Driving and operating machinery
If the patient experiences dizziness while taking Viglita, they should not drive or operate machinery.

Viglita contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Viglita

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
When and how to take Viglita
The dose of Viglita varies depending on the patient's condition. The doctor will inform you exactly how many tablets of Viglita should be taken. The maximum daily dose is 100 mg.
The usual dose of Viglita is:

• 50 mg once daily in the morning, if the patient is taking Viglita together with another medicine from the sulfonylurea group.
• 100 mg per day, i.e. 50 mg in the morning and 50 mg in the evening, if the patient is taking Viglita alone, together with another medicine called metformin or glitazone, in combination with metformin and sulfonylureas, or with insulin.
• 50 mg once daily in the morning, if the patient has moderate or severe renal impairment or is undergoing dialysis. How to take Viglita
• The tablets should be swallowed whole with water.

How long to use Viglita

• Viglita should be taken every day for as long as prescribed by the doctor. The doctor may decide on long-term treatment.
• The doctor will regularly monitor the patient's health to check whether the treatment is achieving the intended effect.

Taking more Viglita than recommended
If too many tablets of Viglita have been taken or if someone else has taken this medicine, you must
contact a doctor immediately. Medical attention may be required. If it becomes necessary to visit a doctor's office or hospital, bring the medicine packaging along.
Missing a dose of Viglita
If the patient forgets to take a dose of this medicine, it should be taken as soon as remembered. The next dose should then be taken at the usual time. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Do not take a double dose to make up for a missed tablet.
Stopping Viglita treatment
Do not stop using Viglita unless instructed by the doctor. If you have any questions about how long to use this medicine, consult your doctor.

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
Viglita immediately and seek medical advice:

• Angioedema (rare: may occur in up to 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency unknown): Symptoms include yellowing of the skin or whites of the eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).
• Pancreatitis (rare: may occur in up to 1 in 1,000 patients): 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
In some patients taking vildagliptin, the following adverse reactions have occurred:

• Very common (may affect more than 1 in 10 patients): sore throat, cold symptoms, fever.
• Common (may affect up to 1 in 10 patients): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea, blurred vision.
• Uncommon (may affect up to 1 in 100 patients): weight gain, chills, fatigue, sexual dysfunction, low blood glucose levels, bloating.
• Rare (may affect up to 1 in 1,000 patients): pancreatitis.

After the medicine was placed on the market, the following adverse reactions have also been reported:

• Frequency unknown (frequency cannot be estimated from the available data): localised skin peeling or blistering, vasculitis, which may cause skin rash or spotty, flat, red, circular spots under the skin or bruising.

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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Viglita

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 outer carton following “Expiry date (EXP)”. The expiry date refers to the last day of the specified month.
There are no special temperature requirements for storing this medicine.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

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

What the medicine Viglita looks like and contents of the pack
Viglita is white to almost white, marbled, round tablets with a diameter of 8.00 ± 0.5 mm.
Viglita 50 mg tablets are available in pack sizes containing 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., Bdul Theodor Pallady no. 50, sector 3, 032266 Bucharest, Romania

This medicine is authorised in the following European Economic Area countries 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