Anvildis

Package leaflet: Information for the patient

Anvildis, 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, as 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 a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Anvildis is and what it is 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 Anvildis is and what it is used for

The active substance in Anvildis is vildagliptin, which belongs to a group of medicines called "oral antidiabetic drugs".
Anvildis is a medicine used to treat adult patients with type 2 diabetes whose condition cannot be controlled by diet and physical exercise alone. Anvildis helps control blood glucose levels. Your doctor may prescribe Anvildis either 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 blood glucose levels.
Type 2 diabetes is a condition in which the body either 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 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 Anvildis works
Anvildis works by stimulating the pancreas to produce insulin and by reducing glucagon production. Therefore, Anvildis helps control blood glucose levels.
It has been shown that the medicine reduces 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 Anvildis

When not to use Anvildis:

• 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 Anvildis, they should not take this medicine, but inform their doctor.

Warnings and precautions
Before starting treatment with Anvildis, the patient should discuss this with their doctor, pharmacist or nurse

• if the patient has type 1 diabetes (i.e. if their body does not produce insulin) or if they have a condition called diabetic ketoacidosis,
• if the patient is taking an antidiabetic medicine called a sulfonylurea [the doctor may wish to reduce the dose of the sulfonylurea taken together with Anvildis to avoid low blood glucose levels (hypoglycaemia)],
• if the patient has moderate or severe kidney disease (a lower dose of Anvildis should be used),
• if the patient is on dialysis,
• if the patient has liver disease,
• if the patient has heart failure,
• if 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.
Skin complications are common in diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. While taking Anvildis, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
Before starting treatment with Anvildis and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows symptoms of increased liver enzyme activity to be detected as early as possible.

Children and adolescents
Anvildis is not recommended for use in children and adolescents under 18 years of age.

Anvildis and other medicines
The patient should tell their doctor or pharmacist about any medicines they are currently taking, have recently taken or plan to take.
The doctor may need to adjust the dose of Anvildis if the patient is taking any of the following medicines:

• 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, breastfeeding, thinks she may be pregnant or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Anvildis should not be used during pregnancy. It is not known whether vildagliptin passes into human milk.
Anvildis should not be used if the patient is breastfeeding or planning to breastfeed.

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

Anvildis contains lactose
Anvildis contains lactose (milk sugar). If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Anvildis

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.

What dose to take and when

The dose of Anvildis varies depending on the patient's condition. The doctor will determine exactly how many Anvildis tablets should be taken. The maximum daily dose is 100 mg.

The usual dose of Anvildis is:

• 50 mg once daily in the morning, when Anvildis is taken together with a medicine called sulfonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Anvildis is taken alone, with a medicine called metformin, with a glitazone, in combination with metformin and a sulfonylurea, or with insulin.
• 50 mg once daily in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Anvildis

• Tablets should be swallowed whole with water.

How long to take Anvildis

• Anvildis should be taken every day for as long as directed 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 desired effect.

Taking more Anvildis than prescribed

If too many Anvildis tablets have been taken or if someone else has taken this medicine, speak to a doctor immediately. Medical attention may be required. If it becomes necessary to visit a doctor's office or hospital, bring the medicine packaging.

If a dose of Anvildis is missed

If a dose of this medicine is forgotten, take it as soon as remembered. 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.

Stopping Anvildis

Do not stop taking Anvildis unless instructed by the doctor. If there are any questions about how long to take this medicine, consult the doctor.

4. Possible adverse reactions

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

• Angioedema (rare: may occur in no more than 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives. These may indicate a reaction called "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 unknown): Symptoms include severe and persistent abdominal (stomach area) pain which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have occurred in some patients taking wildagliptin and metformin:

• common (may occur in no more than 1 in 10 patients): tremor, headache, dizziness, nausea, low blood glucose levels,
• uncommon (may occur in no more than 1 in 100 patients): fatigue.

The following adverse reactions have occurred in some patients taking wildagliptin and a sulfonylurea:

• common: tremor, headache, dizziness, weakness, low blood glucose levels,
• uncommon: constipation,
• very rare (may occur in no more than 1 in 10,000 patients): sore throat, cold symptoms.

The following adverse reactions have occurred in some patients taking wildagliptin and a glitazone:

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

The following adverse reactions have occurred in some patients taking wildagliptin 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 occurred in some patients taking wildagliptin, metformin and a sulfonylurea:

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

The following adverse reactions have occurred in some patients taking wildagliptin and insulin (with or without metformin):

• common: headache, chills, nausea, low blood glucose levels, heartburn,
• uncommon: diarrhoea, flatulence.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder. By reporting
adverse reactions, additional information on the safety of the medicine can be collected.

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 pack and carton after "EXP"/"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• There are no special requirements for storage conditions of the medicinal product.
• Do not use Anvildis packaging that is damaged or shows signs of tampering.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps 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, pregelatinized corn starch,
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,
embossed with the code "VLD" on one side and smooth on the other side.
Blister packs made of OPA/Aluminium/PVC/Aluminium foil in cardboard boxes.
Anvildis 50 mg is available in pack sizes containing 7, 14, 28, 30, 56, 60, 90, 112, 180, or 336 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vipharm S.A.
A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturers
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 medicinal product is authorised in the following names in the European Economic Area countries:
Czech Republic: Anvildis
Poland: Anvildis
Slovakia: Anvildis 50 mg
Hungary: Anvildis 50 mg tabletta