Package Insert: Information for the Patient

Vildagliptin/Metformin Aurovitas 50 mg/850 mg Film-Coated Tablets

Vildagliptin/Metformin Aurovitas 50 mg/1,000 mg Film-Coated Tablets

vildagliptin/metformin hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredients of this medication, vildagliptin and metformin hydrochloride, belong to a group of medications called “oral antidiabetics”.

Vildagliptina/Metformina Aurovitas is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not work properly. It can also appear if the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps to reduce blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and makes blood sugar levels increase.

How Vildagliptina/Metformina Aurovitas works

Both active ingredients, vildagliptin and metformin hydrochloride, help to control blood sugar levels. The active ingredient vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active ingredient metformin hydrochloride helps the body to use insulin better.This medication has shown to reduce blood sugar levels, which will help to prevent complications of your diabetes.

Do not takeVildagliptin/Metformin Aurovitas

• if you are allergic to vildagliptin, metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, consult your doctor before taking Vildagliptin/Metformin Aurovitas.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-coma diabetic state. Symptoms include stomach pain, rapid and deep breathing, drowsiness or if your breath develops an unusual fruity odor.
• if you have recently had a heart attack or if you have severe heart failure or circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function reduction.
• if you have a severe infection or severe dehydration (massive loss of body fluids).
• if you are to undergo a radiology contrast study (a specific type of diagnostic test using X-rays and an injectable contrast medium). For more information, see the "Warnings and precautions" section below.
• if you have liver problems.
• if you drink excessive alcohol (daily or occasionally).
• if you are breastfeeding (see also "Pregnancy and breastfeeding" below).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Vildagliptin/Metformin Aurovitas.

Risk of lactic acidosis

Vildagliptin/Metformin Aurovitas may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop takingVildagliptin/Metformin Aurovitasfor a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop takingVildagliptin/Metformin Aurovitasand contact a doctor or the nearest hospital immediately if you experience any of the symptoms that cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

Lactic acidosis is a medical emergency and should be treated in a hospital.

Vildagliptin/Metformin Aurovitas is not a substitute for insulin. Therefore, you should not take this medicine for the treatment of type 1 diabetes.

Consult your doctor, pharmacist or nurse before starting to take Vildagliptin/Metformin Aurovitas if you have or have had a pancreatic disease.

Consult your doctor, pharmacist or nurse before starting to take Vildagliptin/Metformin Aurovitas if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with Vildagliptin/Metformin Aurovitas to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin but had to stop taking it due to liver disease, you should not take this medicine.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care and pay special attention to the appearance of blisters or ulcers while taking Vildagliptin/Metformin Aurovitas. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking Vildagliptin/Metformin Aurovitas while the procedure is performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Vildagliptin/Metformin Aurovitas and when to restart it.

Tests of liver function should be performed before starting treatment with Vildagliptin/Metformin Aurovitas, at intervals of three months during the first year and thereafter periodically. This is done to detect as soon as possible any sign indicating an increase in liver enzymes.

During treatment with Vildagliptin/Metformin Aurovitas, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is deteriorating.

Your doctor will monitor your blood sugar levels and urine periodically.

Children and adolescents

The administration of Vildagliptin/Metformin Aurovitas is not recommended in children and adolescents under 18 years of age.

Other medicines andVildagliptin/Metformin Aurovitas

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or examination, you should stop taking Vildagliptin/Metformin Aurovitas before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Vildagliptin/Metformin Aurovitas. It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory disorders
• other active principles used to treat diabetes
• diuretics, which increase urine production
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines for high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• determined active principles that affect the thyroid, or
• determined active principles that affect the nervous system.

TakingVildagliptin/Metformin Aurovitaswith alcohol

Avoid excessive alcohol consumption while taking Vildagliptin/Metformin Aurovitas, as this may increase the risk of lactic acidosis (see "Warnings and precautions" section above).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

If you feel dizzy while taking Vildagliptin/Metformin Aurovitas, do not drive or operate tools or machines.

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as visual difficulties. This can be hazardous in situations where these skills are important (for example, driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

Vildagliptin/Metformin Aurovitas contains maltodextrin

This medicine contains glucose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.indications for your doctor. In case of doubt, consult your doctor or pharmacist again.

The dosage ofVildagliptina/Metformina Aurovitasthat each person should take varies depending on their condition. Your doctor will indicate exactly the dosage ofvildagliptina/metforminathat you should take.

The recommended dosage is a film-coated tablet of 50mg/850mg or 50mg/1,000mg twice a day.

If you have reduced renal function, your doctor may prescribe a lower dosage. Your doctor may also prescribe a lower dosage if you are taking a diabetes medication known as a sulfonylurea.

Your doctor may prescribe this medication alone or in combination with certain medications that lower blood sugar levels.

When and how to takeVildagliptina/Metformina Aurovitas

• Vildagliptina/Metformina Aurovitasis for oral use.
• Swallow the whole tablets with a glass of water.
• Take one tablet in the morning and the other in the evening with meals or after meals. Taking the tablet after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are following a weight control diet for diabetics, continue with the diet while takingVildagliptina/Metformina Aurovitas.

If you take moreVildagliptina/Metformina Aurovitasthan you should

If you have taken too many tablets of this medication or if someone else has taken your tablets,consult your doctor or pharmacist immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging and this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeVildagliptina/Metformina Aurovitas

If you forget to take a tablet, take it with the next meal, unless it is already time to take the usual dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withVildagliptina/Metformina Aurovitas

Continue taking this medication while your doctor prescribes it for you to continue monitoring your blood sugar levels. Do not interrupt treatment withVildagliptina/Metformina Aurovitasunless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

You shouldstop takingVildagliptina/Metformina Aurovitasand see your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1in 10,000 users):

This medicine may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you should stop taking Vildagliptina/Metformina Aurovitas and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare:may affect up to 1 in 1,000people): symptoms that includeswollen face, tongue, or throat,difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria.
• Liver disease (hepatitis) (rare): symptoms that includeyellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine.
• Pancreatitis (inflammation of the pancreas) (unknown: frequency cannot be estimated from available data): symptoms that includeintense and persistent abdominal pain (stomach area), which can reach your back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while takingvildagliptin/metformin hydrochloride:

• Very common (may affect more than 1 in 10people): nausea, vomiting, diarrhea, abdominal pain, loss of appetite.
• Common (may affect up to 1 in 10people): dizziness, headache, tremor, metallic taste, decreased blood glucose.
• Uncommon (may affect up to 1 in 100people): joint pain, fatigue, constipation, swollen hands, ankles, or feet (edema).

• Very rare (may affect up to 1 in 10,000people): sore throat, nasal congestion, and fever; signs of having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat, or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pale skin, fatigue, mental symptoms such as confusion or memory changes).

Some patients have experienced the following side effects while taking vildagliptin/metformin hydrochloride and a sulfonylurea:

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

Some patients have experienced the following side effects while takingvildagliptin/metformin hydrochlorideand insulin:

• Common: headache, chills, nausea (discomfort), low blood glucose, heartburn.
• Uncommon: diarrhea, flatulence.

Since the marketing of this medicine, the following side effects have also been reported:

• Unknown: itchy rash, pancreatitis,localized skin peeling or blisters, muscle pain.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofVildagliptin/Metformin Aurovitas

• The active ingredients are vildagliptin and hydrochloride of metformin.

Each film-coated tablet of Vildagliptin/Metformin Aurovitas 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (equivalent to 660 mg of metformin).

Each film-coated tablet of Vildagliptin/Metformin Aurovitas 50 mg/1,000 mg contains 50 mg of vildagliptin and 1,000 mg of hydrochloride of metformin (equivalent to 780 mg of metformin).

• The other components are: Copovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E 171), talc, yellow iron oxide (E 172), maltodextrin, medium-chain triglycerides.

Appearance of the product and contents of the package

Vildagliptin/Metformin Aurovitas 50 mg/850 mg film-coated tablets are yellow-colored, oval-shaped tablets with "50" printed on one side and "850" on the other, with the following dimensions: length 21.6 ± 0.2 mm, width 8.6 ± 0.2 mm, and thickness 7.4 ± 0.4 mm.

Vildagliptin/Metformin Aurovitas 50 mg/1,000 mg film-coated tablets are dark yellow-colored, oval-shaped tablets with "50" printed on one side and "1000" on the other, with the following dimensions: length 22.0 ± 0.2 mm, width 9.0 ± 0.2 mm, and thickness 8.1 ± 0.4 mm.

Vildagliptin/Metformin Aurovitas is presented in a cardboard box containing the corresponding number of OPA/Alu/PVC-Alu or PVC/PCTFE-Alu transparent blisters.

Vildagliptin/Metformin Aurovitas is available in packs of 60 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

or

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

This medicinal product is authorized in the member states of the European Economic Area with the following names:

DenmarkVEDFA

FranceVildagliptin/Metformine Arrow 50 mg/1000 mg, film-coated tablet

SpainVildagliptin/Metformin Aurovitas 50 mg/850 mg film-coated tablets EFG and Vildagliptin/Metformin Aurovitas 50 mg/1,000 mg film-coated tablets EFG

ItalyVildagliptin e Metformina Aurobindo

PortugalMetformin + Vildagliptin Generis

GreeceVEDFA

CyprusVEDFA

Date of the last review of this leaflet:July 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)