VILDAGLIPTIN 50 mg/850 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Vildagliptin + Metformin hydrochloride +pharma and what is it used for
   1. How Vildagliptin + Metformin hydrochloride +pharma works
3. Important information before taking Vildagliptin + Metformin hydrochloride +pharma
   1. When not to take Vildagliptin + Metformin hydrochloride +pharma
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Vildagliptin + Metformin hydrochloride +pharma,
   5. The patient should stop taking Vildagliptin + Metformin hydrochloride +pharma and immediately contact their doctor or the nearest hospital if they experience
   6. If the patient is to undergo major surgery, they should not take Vildagliptin + Metformin hydrochloride +pharma during the surgery and for a certain period after it. The doctor will decide when the patient should stop and resume treatment with Vildagliptin + Metformin hydrochloride +pharma.Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo liver function tests. This will allow the detection of elevated liver enzyme levels as soon as possible.During treatment with Vildagliptin + Metformin hydrochloride +pharma, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and (or) has deteriorating kidney function.The doctor will regularly assess the patient's blood and urine sugar levels.Children and adolescents
   7. Vildagliptin + Metformin hydrochloride +pharma with other medicines
   8. Taking Vildagliptin + Metformin hydrochloride +pharma with alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Vildagliptin + Metformin hydrochloride +pharma contains lactose and sodium
4. How to take Vildagliptin + Metformin hydrochloride +pharma
   1. When and how to take Vildagliptin + Metformin hydrochloride +pharma
   2. Taking a higher dose of Vildagliptin + Metformin hydrochloride +pharma than recommended
   3. Missing a dose of Vildagliptin + Metformin hydrochloride +pharma
   4. Stopping treatment with Vildagliptin + Metformin hydrochloride +pharma
5. Possible side effects
   1. Other side effects
   2. Reporting side effects
6. How to store Vildagliptin + Metformin hydrochloride +pharma
7. Contents of the packaging and other information
   1. What Vildagliptin + Metformin hydrochloride +pharma contains
   2. What Vildagliptin + Metformin hydrochloride +pharma looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Vildagliptin + Metformin hydrochloride +pharma,50 mg + 850 mg, coated tablets
Vildagliptin + Metformin hydrochloride +pharma,50 mg + 1000 mg, coated tablets
Vildagliptin + Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vildagliptin + Metformin hydrochloride +pharma and what is it used for
• 2. Important information before taking Vildagliptin + Metformin hydrochloride +pharma
• 3. How to take Vildagliptin + Metformin hydrochloride +pharma
• 4. Possible side effects
• 5. How to store Vildagliptin + Metformin hydrochloride +pharma
• 6. Contents of the packaging and other information

1. What is Vildagliptin + Metformin hydrochloride +pharma and what is it used for

what it is used for
The active substances of Vildagliptin + Metformin hydrochloride +pharma are vildagliptin and metformin, which belong to the group of oral anti-diabetic medicines.
Vildagliptin + Metformin hydrochloride +pharma is used to treat adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Vildagliptin + Metformin hydrochloride +pharma is used when diet and exercise alone are not enough to control diabetes and (or) is given with other medicines used to treat diabetes (insulin or sulfonylureas).
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 as it should. Type 2 diabetes can also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after a meal. Glucagon is a substance that stimulates the production of sugar in the liver and causes an increase in blood sugar levels.

How Vildagliptin + Metformin hydrochloride +pharma works

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

2. Important information before taking Vildagliptin + Metformin hydrochloride +pharma

+pharma

When not to take Vildagliptin + Metformin hydrochloride +pharma

Warnings and precautions

Risk of lactic acidosis

Vildagliptin + Metformin hydrochloride +pharma 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 case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver disease, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g. acute severe heart disease).
If any of the above circumstances apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Vildagliptin + Metformin hydrochloride +pharma,

if the patient has a condition that may be associated with 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.

The patient should stop taking Vildagliptin + Metformin hydrochloride +pharma and immediately contact their doctor or the nearest hospital if they experience

any symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general poor condition with severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Vildagliptin + Metformin hydrochloride +pharma does not replace insulin. Therefore, Vildagliptin + Metformin hydrochloride +pharma should not be used to treat type 1 diabetes.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma, the patient should discuss this with their doctor, pharmacist or nurse if they have or have had pancreatic disease.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma, the patient should consult their doctor, pharmacist or nurse if they are taking a anti-diabetic medicine called a sulfonylurea. The doctor may want to reduce the dose of sulfonylurea taken with Vildagliptin + Metformin hydrochloride +pharma to avoid low blood sugar levels (hypoglycemia).
If the patient has taken vildagliptin before but had to stop taking it 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 recommendations for skin and foot care. It is also recommended that the patient pay special attention to the occurrence of new blisters or ulcers while taking Vildagliptin + Metformin hydrochloride +pharma. If they occur, the patient should quickly discuss this with their doctor.

If the patient is to undergo major surgery, they should not take Vildagliptin + Metformin hydrochloride +pharma during the surgery and for a certain period after it. The doctor will decide when the patient should stop and resume treatment with Vildagliptin + Metformin hydrochloride +pharma.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo liver function tests. This will allow the detection of elevated liver enzyme levels as soon as possible.
During treatment with Vildagliptin + Metformin hydrochloride +pharma, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and (or) has deteriorating kidney function.
The doctor will regularly assess the patient's blood and urine sugar levels.

Children and adolescents

Vildagliptin + Metformin hydrochloride +pharma should not be used in children and adolescents under 18 years of age.

Vildagliptin + Metformin hydrochloride +pharma with other medicines

If the patient is to be injected with a contrast agent containing iodine, for example for an X-ray examination or computed tomography, they should stop taking Vildagliptin + Metformin hydrochloride +pharma before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Vildagliptin + Metformin hydrochloride +pharma.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Vildagliptin + Metformin hydrochloride +pharma by the doctor. It is especially important to inform about the following medicines:

• corticosteroids, usually used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, usually used to treat respiratory disorders
• other medicines used to treat diabetes
• diuretics
• 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 that affect the thyroid gland
• certain medicines that affect 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 stomach ulcers (e.g. cimetidine).

Taking Vildagliptin + Metformin hydrochloride +pharma with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Vildagliptin + Metformin hydrochloride +pharma, 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 medicine. The doctor will discuss with the patient the possible risks associated with taking Vildagliptin + Metformin hydrochloride +pharma during pregnancy.

• Vildagliptin + Metformin hydrochloride +pharma should not be taken during pregnancy or breastfeeding (see also "When not to take Vildagliptin + Metformin hydrochloride +pharma").

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

Driving and using machines

If the patient experiences dizziness while taking Vildagliptin + Metformin hydrochloride +pharma, they should not drive or operate machinery.

Vildagliptin + Metformin hydrochloride +pharma contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Vildagliptin + Metformin hydrochloride +pharma

The dose of Vildagliptin + Metformin hydrochloride +pharma varies depending on the patient's condition. The doctor will determine what dose of Vildagliptin + Metformin hydrochloride +pharma to take.
This medicine should always be taken according to the doctor's recommendations. 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 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 anti-diabetic medicine called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine alone (as monotherapy) or with certain other medicines that lower blood sugar levels.

When and how to take Vildagliptin + Metformin hydrochloride +pharma

• 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 recommendations regarding diet. Following a diet while taking Vildagliptin + Metformin hydrochloride +pharma is especially important if the patient is following a weight-control diet.
The break line is not intended for breaking the tablet.

Taking a higher dose of Vildagliptin + Metformin hydrochloride +pharma than recommended

In case of accidental ingestion of too many Vildagliptin + Metformin hydrochloride +pharma tablets or if someone else has taken these tablets, the patient should immediately inform their doctor or pharmacist. The patient may need medical attention. If it is necessary to go to the doctor or hospital, the patient should take the medicine packaging and leaflet with them.

Missing a dose of Vildagliptin + Metformin hydrochloride +pharma

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

Stopping treatment with Vildagliptin + Metformin hydrochloride +pharma

In order to maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking Vildagliptin + Metformin hydrochloride +pharma without their doctor's advice. If the patient has any further questions about taking this medicine, they should consult their doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Vildagliptin + Metformin hydrochloride +pharma can cause side effects, although not everybody gets them.
The patient should stop taking Vildagliptin + Metformin hydrochloride +pharma and immediately contact their doctor, if they experience any of the following side effects:

• Lactic acidosis(very rare: may occur in up to 1 in 10,000 patients).

Vildagliptin + Metformin hydrochloride +pharma may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs in the patient, they should stop taking Vildagliptin + Metformin hydrochloride +pharma and immediately contact their doctor or the nearest hospital, 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. They may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (uncommon: may occur in up to 1 in 100 patients). Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite or dark-colored urine. They may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may occur in up to 1 in 100 patients). Symptoms include severe and persistent abdominal pain (around the stomach), which may radiate to the back, as well as nausea and vomiting.

Other side effects

In some patients taking Vildagliptin + Metformin hydrochloride +pharma, the following side effects have occurred:

• Common (may occur in up to 1 in 10 patients): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled trembling, constipation, nausea, vomiting, diarrhea, bloating, heartburn, stomach pain and around the stomach (abdominal pain).
• Uncommon (may occur in up to 1 in 100 patients): weakness, metallic taste in the mouth, low blood sugar levels, loss of appetite, swelling of the hands, feet or ankles (edema), chills, pancreatitis, muscle pain.
• Very rare (may occur in up to 1 in 10,000 patients): symptoms of high lactic acid levels in the blood (such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deepened, rapid breathing); skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, mental symptoms, such as confusion or memory disorders).

After the introduction of this medicine to the market, the following side effects have also been reported:

• Frequency not known (frequency cannot be estimated from the available data): local skin peeling or blistering, vasculitis, which can cause skin rash or flat, round, red spots under the skin surface or bruising.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 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 to gather more information on the safety of this medicine.

5. How to store Vildagliptin + Metformin hydrochloride +pharma

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the blister or carton after: "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vildagliptin + Metformin hydrochloride +pharma contains

• The active substances of Vildagliptin + Metformin hydrochloride +pharma are vildagliptin and metformin hydrochloride.
• Each 50 mg + 850 mg Vildagliptin + Metformin hydrochloride +pharma coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 663 mg of metformin).
• Each 50 mg + 1000 mg Vildagliptin + Metformin hydrochloride +pharma coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (which corresponds to 780 mg of metformin).
• Other ingredients are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium carmellose, sodium stearyl fumarate and ready-to-use coating material (hypromellose, titanium dioxide, macrogol, talc, yellow iron oxide (E 172))

What Vildagliptin + Metformin hydrochloride +pharma looks like and what the pack contains

Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, coated tablets
Yellow, elongated, oval coated tablet with a notch on one side and the inscription "VA" on the other side of the tablet. Tablet length: 19.4 ± 0.5 mm.
Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, coated tablets
Dark yellow, elongated, oval coated tablet with a notch between the inscription "V" and the inscription "B" on one side of the tablet and a notch on the other side of the tablet. Tablet length: 21.1 ± 0.5 mm.
Blisters with aluminum/OPA/aluminum/PVC foil in a cardboard box, containing 30 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

SAG Manufacturing, S.L.U
Carretera Nacional I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

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

Croatia
Vildagliptin/metformin hydrochloride Genericon 50 mg/850 mg film-coated tablets
Vildagliptin/metformin hydrochloride Genericon 50 mg/1000 mg film-coated tablets
Czech Republic
Vildagliptin/Metformin +pharma
Poland
Vildagliptin + Metformin hydrochloride +pharma
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:June 2024