Anvildis Duo

Package Leaflet: Information for the Patient

Anvildis Duo, 50 mg + 850 mg, Film-Coated Tablets

Anvildis Duo, 50 mg + 1000 mg, Film-Coated Tablets

Vildagliptin+ Metformin Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you; do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Anvildis Duo and What is it Used For
• 2. Important Information Before Taking Anvildis Duo
• 3. How to Take Anvildis Duo
• 4. Possible Side Effects
• 5. How to Store Anvildis Duo
• 6. Package Contents and Other Information

1. What is Anvildis Duo and What is it Used For

The active substances of Anvildis Duo are vildagliptin and metformin, which belong to the group of oral antidiabetic medications.
Anvildis Duo is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes. Anvildis Duo is used when diet and exercise alone are not enough to control diabetes, and it can be taken with other diabetes medications (insulin or sulfonylureas).
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced by the body does not work properly. Type 2 diabetes can also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after meals. Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels.

How Anvildis Duo Works

Both active substances, vildagliptin and metformin, help control blood sugar levels. Vildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Metformin helps the body use insulin better. It has been shown that the medication lowers blood sugar levels, which can help prevent complications of diabetes.

2. Important Information Before Taking Anvildis Duo

When Not to Take Anvildis Duo

• If the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medication (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should consult their doctor before taking Anvildis Duo.
• If the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of Lactic Acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketones accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.
• If the patient has recently had a heart attack or has heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure.
• If the patient has significantly reduced kidney function.
• If the patient has a severe infection or is severely dehydrated (has lost a lot of water from the body).
• If the patient is to undergo a contrast radiological examination (a special type of examination that requires the injection of a contrast agent). For more information, see also section "Warnings and Precautions".
• If the patient has liver disease.
• If the patient consumes excessive amounts of alcohol (both regularly and occasionally).
• If the patient is breastfeeding (see also section "Pregnancy and Breastfeeding").

Warnings and Precautions

Risk of Lactic Acidosis

Anvildis Duo may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, or any conditions where a part of the body is not getting enough oxygen (e.g., severe heart disease).
If any of these conditions apply to the patient, they should consult their doctor for more detailed instructions.

Temporary Discontinuation of Anvildis Duo is Recommended if the Patient has a Condition that May Lead to Dehydration

A condition that may lead to dehydration(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

Discontinue Anvildis Duo and Seek Medical Attention Immediately if the Patient Experiences any Symptoms of Lactic Acidosis

Lactic acidosis, as it can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell along with severe fatigue,
• breathing difficulties,
• lowered body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate medical attention.

Seek Medical Attention if the Patient Experiences any of the Following:

• The patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• The patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Anvildis Duo does not replace insulin. Therefore, it should not be used to treat type 1 diabetes.
Before starting Anvildis Duo, the patient should discuss it with their doctor, pharmacist, or nurse if they have or have had pancreatitis.
Before starting Anvildis Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking a diabetes medication called a sulfonylurea. The doctor may want to reduce the dose of the sulfonylurea taken with Anvildis Duo to avoid low blood sugar (hypoglycemia).
If the patient has previously taken vildagliptin but had to stop due to liver disease, they should not take this medication.
Diabetic skin changes are a common complication of diabetes. The patient should follow the doctor's or nurse's advice on skin and foot care. It is also recommended that the patient pay special attention to the occurrence of new blisters or ulcers while taking Anvildis Duo. If they occur, the patient should consult their doctor promptly.
If the patient is to undergo major surgery, they should not take Anvildis Duo during or for some time after the surgery. The doctor will decide when the patient should stop and restart Anvildis Duo.
Before starting treatment with Anvildis Duo and at three-month intervals during the first year of treatment, and periodically thereafter, the patient should undergo liver function tests. This will help detect any signs of increased liver enzyme activity as soon as possible.
During treatment with Anvildis Duo, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has worsening kidney function.
The doctor will regularly assess the patient's blood and urine sugar levels.

Children and Adolescents

Anvildis Duo is not recommended for children and adolescents under 18 years of age.

Anvildis Duo and Other Medications

If the patient is to receive an iodine-containing contrast agent intravenously, for example, for an X-ray examination or computed tomography, they should stop taking Anvildis Duo before or at the latest at the time of the injection. The doctor will decide when the patient should stop and restart Anvildis Duo.
The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The patient may require more frequent blood sugar checks or kidney function tests, or the doctor may need to adjust the dose of Anvildis Duo. It is especially important to inform about the following medications:

• glucocorticosteroids, usually used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, usually used to treat respiratory disorders
• other diabetes medications
• diuretics
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medications that affect the thyroid gland
• certain medications that affect the nervous system
• certain medications used to treat angina, such as ranolazine
• certain medications used to treat HIV infection, such as dolutegravir
• certain medications used to treat a specific type of thyroid cancer (medullary thyroid cancer), such as vandetanib
• certain medications used to treat heartburn and stomach ulcers, such as cimetidine.

Taking Anvildis Duo with Alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Anvildis Duo, as this may increase the risk of lactic acidosis (see section "Warnings and Precautions").

Pregnancy and Breastfeeding

• If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medication. The doctor will discuss the possible risks associated with taking Anvildis Duo during pregnancy.
• Anvildis Duo should not be taken during pregnancy or breastfeeding (see also section "When Not to Take Anvildis Duo").

Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and Operating Machinery

If the patient experiences dizziness while taking Anvildis Duo, they should not drive or operate machinery.

3. How to Take Anvildis Duo

The dose of Anvildis Duo varies depending on the patient's condition. The doctor will determine the dose of Anvildis Duo to be taken.
This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice a day.
If the patient has kidney problems, the doctor may prescribe a lower dose. If the patient is taking a diabetes medication called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medication alone (monotherapy) or with other medications that lower blood sugar levels.

When and How to Take Anvildis Duo

• Tablets should be swallowed whole with a glass of water.
• The patient should take one tablet in the morning and one in the evening with a meal or immediately after a meal. Taking the tablet immediately after a meal will help reduce the risk of stomach upset.

The patient should continue to follow their doctor's dietary advice while taking Anvildis Duo. Following a diet is especially important when the patient is on a weight-control diet.

Overdose of Anvildis Duo

In case of accidental ingestion of too many Anvildis Duo tablets or if someone else has taken them, the patient should immediately inform their doctor or pharmacist. The patient may require medical attention. If it is necessary to visit a doctor or hospital, the patient should take the medication packaging and package leaflet with them.

Missing a Dose of Anvildis Duo

If the patient forgets to take a tablet, they should take it with their next meal, unless it is almost time for their next dose. The patient should not take a double dose (two tablets at once) to make up for a missed tablet.

Stopping Anvildis Duo

To maintain control of blood sugar levels, the medication should be taken for as long as the doctor recommends. The patient should not stop taking Anvildis Duo without their doctor's advice. If the patient has any questions about how long to take Anvildis Duo, they should consult their doctor.
In case of any further doubts about taking this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Anvildis Duo can cause side effects, although not everyone will experience them.
The patient should stop taking Anvildis Duo and seek medical attention immediatelyif they experience any of the following side effects:

• Lactic Acidosis(very rare: may occur in up to 1 in 10,000 patients): Anvildis Duo may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and Precautions"). If this occurs, the patient should stop taking Anvildis Duo and seek medical attention immediately, as lactic acidosis can lead to coma.
• 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 appearance of rash or hives.
• Liver Disease (Hepatitis) (rare): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-colored urine.
• Pancreatitis (frequency not known): Symptoms include severe and persistent abdominal pain (around the stomach area), which 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 occurred:

• Very common (may occur in more than 1 in 10 patients): nausea, vomiting, diarrhea, stomach pain or abdominal pain, loss of appetite.
• Common (may occur in up to 1 in 10 patients): dizziness, headache, uncontrolled shaking, metallic taste in the mouth, low blood sugar.
• Uncommon (may occur in up to 1 in 100 patients): joint pain, fatigue, constipation, swelling of the hands, feet, or ankles (edema).
• Rare (may occur in up to 1 in 10,000 patients): sore throat, runny nose, fever; symptoms of high lactic acid levels in the blood (lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; skin redness, itching; decreased levels of vitamin B (pallor, fatigue, psychological symptoms, such as confusion or memory impairment).

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

• Common: dizziness, shaking, weakness, low blood sugar, excessive sweating.

In some patients taking vildagliptin and metformin and insulin, the following side effects have occurred:

• Common: headache, chills, nausea (nausea), low blood sugar, heartburn.
• Uncommon: diarrhea, bloating.

After the medication was placed on the market, the following side effects have also been reported:

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

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Anvildis Duo

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister and carton after "EXP" / "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not use this medication if there are any signs of damage or tampering with the packaging.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Anvildis Duo Contains

• The active substances of Anvildis Duo are vildagliptin and metformin hydrochloride. Each 50 mg + 850 mg film-coated tablet of Anvildis Duo contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 660 mg of metformin). Each 50 mg + 1000 mg film-coated tablet of Anvildis Duo contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (which corresponds to 780 mg of metformin).
• Other ingredients are: tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate; coating: hypromellose 2910, titanium dioxide (E 171), macrogol/poly(vinyl alcohol) copolymer 4000, talc, yellow iron oxide (E 172)

Appearance and Packaging of Anvildis Duo

Anvildis Duo, 50 mg + 850 mg, film-coated tablets
Yellow, oval film-coated tablets with a nominal length of 20.1 mm and a nominal width of 8.1 mm, with "MLV" embossed on one side and smooth on the other.
Anvildis Duo, 50 mg + 1000 mg, film-coated tablets
Dark yellow, oval film-coated tablets with a nominal length of 21.1 mm and a nominal width of 9.1 mm, with "MHV" embossed on one side and smooth on the other.
Blister pack of OPA/Aluminum/PVC/Aluminum foil.
Anvildis Duo is available in packs containing 10, 30, 60 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Vipharm S.A.
A. and F. Radziwiłłów Street 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Manufacturer

Adipharm EAD
130, Simeonovsko shose Blvd.,
1700 Sofia
Bulgaria
Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini Attiki
Greece

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Hungary
Anvildis Duo 50 mg/850 mg film-coated tablets
Anvildis Duo 50 mg/1000 mg film-coated tablets
Slovakia
Anvildis Duo 50 mg/850 mg
Anvildis Duo 50 mg/1000 mg
Poland
Anvildis Duo
Czech Republic
Anvildis Duo

Date of Last Revision of the Package Leaflet: 25.02.2025