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
Vildagliptinum + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Table of contents

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

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

The active substances in Anvildis Duo are vildagliptin and metformin, which belong to a group of oral antidiabetic medicines.
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 diabetes cannot be controlled by diet and physical exercise alone, and (or) when it is administered together with other antidiabetic medicines (insulin or sulfonylureas).
Type 2 diabetes is a condition in which the body either does not produce enough insulin or the insulin produced does not work properly. Type 2 diabetes may 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 sugar production in the liver and causes an increase in 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 glucagon production. Metformin, on the other hand, helps the body use insulin more effectively. It has been shown that the medicine reduces blood sugar levels, which may help prevent complications associated with diabetes.

2. Important information before using Anvildis Duo

When not to use Anvildis Duo

• If the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should inform their doctor before taking Anvildis Duo.
• If the patient has unstable diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketones accumulate in the blood and may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour of the breath.
• If the patient has recently had a heart attack or if they have heart failure, severe circulatory problems, or breathing difficulties that may be symptoms 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 large amount of fluid from the body).
• If the patient is due to undergo a contrast radiological examination (a special type of imaging procedure requiring injection of a contrast agent). For further information, see the section "Warnings and precautions".
• If the patient has liver disease.
• If the patient consumes excessive amounts of alcohol (either regularly or 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 serious side effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, they should consult their doctor for further instructions.
The use of Anvildis Duo should be temporarily discontinued if the patient develops a medical condition associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for further instructions.
The patient must stop taking Anvildis Duo and contact their doctor or nearest hospital immediately if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
The patient should contact their doctor immediately for further instructions if:

• they have a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• they experience any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

Anvildis Duo does not replace insulin. Therefore, Anvildis Duo must not be used to treat type 1 diabetes.
Before starting Anvildis Duo, the patient should discuss with their doctor, pharmacist, or nurse if they currently have or have previously had any pancreatic disorders.
Before starting Anvildis Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulfonylurea. The doctor may decide to reduce the dose of the sulfonylurea taken together with Anvildis Duo to avoid low blood glucose levels (hypoglycaemia).
If the patient previously took vildagliptin but had to stop due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow the doctor's or nurse's advice regarding skin and foot care. The patient should also pay particular attention to the development of new blisters or ulcers while taking Anvildis Duo. If these occur, the patient should speak to their doctor promptly.
If the patient is scheduled for major surgery, they must not take Anvildis Duo during the procedure and for a period afterwards. The doctor will decide when the patient should stop and restart treatment with Anvildis Duo.
Before starting treatment with Anvildis Duo and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows early detection of symptoms indicating increased liver enzyme activity.
While being treated 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 blood and urine glucose levels.

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

Anvildis Duo and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example during an X-ray or CT scan, they must 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 resume treatment with Anvildis Duo.
The patient should inform their doctor about all medicines they are currently taking, have recently taken, or plan to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Anvildis Duo. It is especially important to inform the doctor about the following medicines:

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

Using 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, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor before using this medicine. The doctor will discuss with her the potential risks associated with taking Anvildis Duo during pregnancy.
• Anvildis Duo should not be used during pregnancy or breastfeeding (see also "When not to use Anvildis Duo").

Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
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. Your doctor will determine the appropriate dose of Anvildis Duo for you.
This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice daily.
If you have impaired kidney function, your doctor may prescribe a lower dose. If you are taking an antidiabetic medicine called a sulfonylurea, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine to be taken alone (as monotherapy) or together with certain other medicines that lower blood sugar levels.
When and how to take Anvildis Duo

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with a meal or shortly after a meal. Taking the tablet immediately after a meal may help reduce the risk of gastrointestinal disturbances.

Continue to follow any dietary advice given by your doctor. Following a diet while taking Anvildis Duo is particularly important if you are on a weight-control diet.
Taking more Anvildis Duo than recommended
If you accidentally take too many Anvildis Duo tablets, or if someone else takes them, you should contact your doctor or pharmacist immediately. Medical attention may be required. If you need to visit a doctor or hospital, bring the medicine package and the leaflet with you.
If you forget to take Anvildis Duo
If you forget to take a tablet, take it with your next meal, unless it is almost time for your next dose. Do not take a double dose (two tablets at once) to make up for a missed tablet.
Stopping Anvildis Duo
To maintain blood sugar control, you should continue taking this medicine for as long as your doctor recommends. Do not stop taking Anvildis Duo without consulting your doctor. If you have any questions about how long to take Anvildis Duo, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Anvildis Duo and contact your doctor immediately if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in up to 1 in 10,000 patients): Anvildis Duo may very rarely cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Anvildis Duo must be discontinued and immediate contact made with a doctor or the nearest hospital, as lactic acidosis may 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 onset of rash or hives.
• Liver disease (hepatitis) (rare): Symptoms include yellowing of the skin or whites of the eyes, nausea, loss of appetite, or dark-coloured urine.
• Pancreatitis (frequency unknown): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients taking wildagliptin and metformin hydrochloride:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach or abdominal pain, loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, uncontrolled tremor, metallic taste in the mouth, low blood glucose levels.
• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of the hands, ankles or feet (oedema).
• Very rare (may affect up to 1 in 10,000 people): sore throat, cold symptoms, fever; symptoms of high blood lactic acid levels (called lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased vitamin B levels (pallor, fatigue, mental symptoms such as confusion or memory disturbances).

In some patients taking wildagliptin and metformin hydrochloride together with a sulfonylurea, the following adverse reactions have occurred:

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

In some patients taking wildagliptin and metformin hydrochloride together with insulin, the following adverse reactions have occurred:

• Common: headache, chills, nausea, low blood glucose levels, heartburn.
• Uncommon: diarrhoea, bloating.

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

• Frequency not known (frequency cannot be estimated from the available data): itchy rash, pancreatitis, localised 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 Drug Reactions of 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Anvildis Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP"/"Expiry date (EXP)". The expiry date refers to the last day of the specified month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Do not use this medicine if you notice any signs of damage or tampering with the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Anvildis Duo contains

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

What Anvildis Duo looks like and contents of the pack
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,
embossed with the code "MLV" 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,
embossed with the code "MHV" on one side and smooth on the other.
Blister pack made of OPA/Aluminium/PVC/Aluminium.
Anvildis Duo is available in packs containing 10, 30 or 60 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 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 medicinal product is authorised in the European Economic Area under the following names:
Hungary Anvildis Duo 50 mg/850 mg film-coated tablet
Anvildis Duo 50 mg/1000 mg film-coated tablet
Slovakia Anvildis Duo 50 mg/850 mg
Anvildis Duo 50 mg/1000 mg
Poland Anvildis Duo
Czech Republic Anvildis Duo