Anvildis

Package Leaflet: Information for the Patient

Anvildis, 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 those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Anvildis and what is it used for

The active substance of Anvildis is vildagliptin, which belongs to a group of medicines called "oral antidiabetic medicines".
Anvildis is a medicine used to treat type 2 diabetes in adults who are not adequately controlled by diet and exercise. Anvildis helps to control blood sugar levels. Your doctor may prescribe Anvildis as the only antidiabetic medicine or in combination with other antidiabetic medicines that you are taking if they are not sufficient to control blood sugar levels.
Type 2 diabetes is a disease in which the body does not produce enough insulin or 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 of these substances are produced in the pancreas.

How Anvildis works

Anvildis works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Therefore, Anvildis 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 pharmacological treatment for diabetes, it is important for the patient to continue to follow a suitable diet and (or) perform recommended physical exercises.

2. Important information before taking Anvildis

When not to take Anvildis:

Warnings and precautions

Before taking Anvildis, discuss it with your doctor, pharmacist, or nurse

If you have previously taken vildagliptin but had to stop due to liver disease, you should not take this medicine.
Changes in 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 Anvildis, you should pay particular attention to the formation of new blisters or ulcers. If they occur, you should contact your doctor immediately.
Before starting treatment with Anvildis and at three-month intervals during the first year of treatment, and periodically thereafter, liver function tests should be performed. This will help to detect any signs of increased liver enzyme activity as soon as possible.

Children and adolescents

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

Anvildis and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Your doctor may need to adjust the dose of Anvildis 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.
Anvildis should not be used during pregnancy. It is not known whether vildagliptin passes into human breast milk.
Anvildis should not be used during breastfeeding or if you are planning to breastfeed.

Driving and using machines

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

Anvildis contains lactose

Anvildis 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.

3. How to take Anvildis

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 Anvildis varies depending on your condition. Your doctor will decide exactly how many Anvildis tablets to take. The maximum daily dose is 100 mg.
Usually, the recommended dose of Anvildis is:

• a dose of 50 mg once daily taken in the morning, when Anvildis is taken with a sulfonylurea.
• a dose of 100 mg once daily taken as two doses of 50 mg in the morning and 50 mg in the evening, when Anvildis is taken alone, with metformin, or with a glitazone in combination with metformin and a sulfonylurea or insulin.
• a dose of 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 Anvildis

• Swallow the tablets whole with water.

How long to take Anvildis

• Anvildis should be taken every day, as long as your doctor has prescribed it. Your doctor may decide on long-term treatment.
• Your doctor will regularly check your health to see if the treatment is working.

What to do if you take more Anvildis than you should

If you have taken too many Anvildis tablets or if someone else has taken your medicine, talk to your doctor immediately. You may need medical attention. If you need to go to a doctor's office or hospital, take the package leaflet and any remaining tablets with you.

What to do if you forget to take Anvildis

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 the 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 Anvildis

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

4. Possible side effects

Like all medicines, Anvildis 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 Anvildis 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 whites of the 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 vildagliptin and metformin, the following side effects have been reported:

• 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 vildagliptin and a sulfonylurea, the following side effects have been reported:

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

In some patients taking vildagliptin and a glitazone, the following side effects have been reported:

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

In some patients taking vildagliptin alone, the following side effects have been reported:

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

In some patients taking vildagliptin, metformin, and a sulfonylurea, the following side effects have been reported:

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

In some patients taking vildagliptin and insulin (with or without metformin), the following side effects have been reported:

• common: headache, chills, nausea (vomiting), low blood sugar levels, heartburn.
• uncommon: diarrhea, bloating.

After this medicine has been marketed, the following side effects have also been reported:

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported 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
Phone: 22 49-21-301
Fax: 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 medicine.

5. How to store Anvildis

• Keep this 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"/"Expiry date (EXP)". The expiry date refers to the last day of that month.
• There are no special storage conditions for this medicinal product.
• Do not use Anvildis packs that are damaged or show signs of opening.

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 Anvildis contains

The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
The other ingredients are: microcrystalline cellulose (PH102), lactose, cornstarch, magnesium stearate.

What Anvildis looks like and contents of the pack

Anvildis 50 mg tablets are white or almost white, round, flat with a nominal diameter of 8.1 mm with the inscription "VLD" on one side, smooth on the other side.
Blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.
Anvildis 50 mg is available in packs of 7, 14, 28, 30, 56, 60, 90, 112, 180, or 336 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.

• A. i F. Radziwiłłów 9 05-850 Ożarów Mazowiecki Poland

Manufacturer
Combino Pharm (Malta) Ltd.
HF60, Hal Far Industrial Estate
Hal Far BBG3000
Malta
Genepharm S.A.
18th km Marathonos Ave
15351 Pallini Attiki
Greece
Adipharm EAD
130 Simeonovsko shose Blvd.,
1700 Sofia
Bulgaria
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

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

Czech Republic:

Anvildis

Poland:

Anvildis

Slovakia:

Anvildis 50 mg

Hungary:

Anvildis 50 mg tablets

Date of last revision of the leaflet: