Leaflet: information for the user

Vildagliptina/Metformina Stada 50 mg/850 mg film-coated tablets

Vildagliptina/Metformina Stada 50 mg/1.000 mg film-coated tablets

vildagliptin/metformin hydrochloride

Read this leaflet carefully before you start 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 questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Vildagliptina/Metformina Stada and what it is used for

2.What you need to know before starting to take Vildagliptina/Metformina Stada

3.How to take Vildagliptina/Metformina Stada

4.Possible side effects

5.Storage of Vildagliptina/Metformina Stada

6.Contents of the pack and additional information

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

Vildagliptin/metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus. Vildagliptin/metformin is used when diabetes cannot be controlled with diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

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 causes blood sugar levels to rise.

How vildagliptin/metformin works

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

Do not take Vildagliptin/Metformin Stada

-if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medication (listed in section 6). If you think you may be allergic to any of these ingredients, consult your doctor before taking vildagliptin/metformin.

-if you have uncontrolled diabetes, 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 with X-rays and an injectable contrast medium). For more information, see the "Warnings and Precautions" section.

-if you have liver problems.

-if you drink excessive alcohol (daily or occasionally).

-if you are breastfeeding (see also "Pregnancy and Breastfeeding").

Warnings and Precautions

Risk of Lactic Acidosis

Vildagliptin/metformin may cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning 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 disease).

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

Stop taking vildagliptin/metformin for 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 taking vildagliptin/metformin and 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:

-vomiting

-stomach pain (abdominal pain)

-muscle cramps

-general feeling of discomfort, with intense fatigue

-difficulty breathing

-reduction in body temperature and heart rate

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

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take vildagliptin/metformin for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before taking this medication if:

• you have or have had a pancreatic disease
• you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taking vildagliptin/metformin together to avoid low blood sugar (hypoglycemia).

If you have taken vildagliptin in the past but had to stop taking it due to liver disease, do not take this medication.

Skin Lesions

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

Surgery

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

You should undergo liver function tests before starting treatment with vildagliptin/metformin, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes as soon as possible.

During treatment with vildagliptin/metformin, your doctor will check your kidney function at least once a year or more frequently if you are an older 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 is not recommended in children and adolescents under 18 years of age.

Other Medications and Vildagliptin/Metformin Stada

If you need to receive an injection of a contrast medium containing iodine, for example, in the context of a radiography or exploration, you should stop taking vildagliptin/metformin 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.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/metformin. 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.

-medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).

-medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists).

-substances that affect the thyroid.

-substances that affect the nervous system.

• substances used to treat angina pectoris (e.g., ranolazine).
• substances used to treat HIV infection (e.g., dolutegravir).
• substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib).
• substances used to treat stomach acid and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Stada with Alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see "Warnings and Precautions" section).

Pregnancy and Breastfeeding

Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also "Do not take Vildagliptin/Metformin Stada").

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machines.

Vildagliptin/Metformin Stada contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Dosage

The recommended dose is one film-coated tablet twice a day.

The dose of vildagliptin/metformin that each person should take varies depending on their condition. Your doctor will indicate exactly the dose of vildagliptin/metformin that you should take.

When and how to take vildagliptin/metformin

• swallow the tablet whole with a glass of water.
• take one tablet in the morning and the other in the evening with meals or after them.
• taking the tablet just after meals will reduce the risk of digestive discomfort.

Kidney problems

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

Additional aspects to consider

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

Follow your doctor's dietary advice. In particular, if you follow a weight control diet for diabetics, continue with the diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Stada than you should

If you have taken too many vildagliptin/metformin tablets, or if someone else has taken your tablets,consult your doctor or pharmacist immediately.You may need medical attention. 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 forgot to takeVildagliptin/Metformin Stada

If you forget to take a tablet, take it with the next meal, unless it is already time for the usual dose. Do not take a double dose (two tablets at once) to make up for the missed doses.

If you interrupt treatment with Vildagliptin/Metformin Stada

Continue taking this medication while your doctor prescribes it for you to continue monitoring your blood sugar levels. Do not interrupt treatment with vildagliptin/metformin unless your doctor tells you to.

If you have any doubts about the duration of treatment, consult your doctor.

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

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

You shouldstop taking vildagliptin/metformin and see your doctor immediatelyif you experience any of the following side effects:

Very rare(may affect up to 1 in 10,000 people)

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

Rare(may affect up to 1 in 1,000 people)

• angioedema.Symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria.

Uncommon(may affect up to 1 in 100 people)

• liver disease (hepatitis). Symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine.
• inflammation of the pancreas (pancreatitis). Symptoms that include intense and persistent abdominal pain (stomach area), which can radiate to your back, as well as nausea and vomiting.

Other side effects

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

Common(may affect up to 1 in 10 people)

• sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremors.
• constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain, and abdominal pain.

Uncommon(may affect up to 1 in 100 people)

• fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles, or feet (edema), chills, inflammation of the pancreas, muscle pain.

Very rare(may affect up to 1 in 10,000 people)

• 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;
• decrease in vitamin B12 levels (pale skin, fatigue, mental symptoms such as confusion or memory disturbances).

Since the marketing of these medicines with vildagliptin/metformin, the following side effects have also been reported:

Frequency unknown(cannot be estimated from available data)

• localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin eruptions or flat, red, rounded spots under the skin's surface or bruises.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: 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.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light and moisture.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

Composition of Vildagliptin/Metformin Stada

-The active ingredients are vildagliptin and metformin hydrochloride.

Vildagliptin/Metformin Stada 50 mg/850 mg:

Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).

Vildagliptin/Metformin Stada 50 mg/1.000 mg:

Each film-coated tablet contains 50 mg of vildagliptin and 1.000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

-The other components are:

Tablet core:hydroxypropylcellulose (E463), copovidone, lactose monohydrate, and magnesium stearate (E470b).

Vildagliptin/Metformin Stada 50 mg/850 mg:

Film coating:hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), yellow iron oxide (E 172), and red iron oxide (E 172).

Vildagliptin/Metformin Stada 50 mg/1.000 mg:

Film coating: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), yellow iron oxide (E 172).

Appearance of the product and contents of the package

Vildagliptin/Metformin Stada 50 mg/850 mg are yellow film-coated, oval, biconvex tablets, approximately 20 mm in length and 8 mm in width.

Vildagliptin/Metformin Stada 50 mg/1.000 mg are dark yellow film-coated, oval, biconvex tablets, approximately 21 mm in length and 8 mm in width.

Vildagliptin/Metformin Stada is available in blister packs containing 10, 30, 60, 120, or 180 film-coated tablets.

Vildagliptin/Metformin Stada is available in blister packs containing 10x1, 30x1, 60x1, 120x1, or 180x1 film-coated tablets in single-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

IBS-Experts International, d.o.o

Ruševje 15

10290 Zaprešic

Republic of Croatia

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

SwedenVildagliptin/Metformin STADA 50 mg/850 mg film-coated tablet

Vildagliptin/Metformin STADA 50 mg/1.000 mg film-coated tablet

GermanyVildagliptin/Metforminhydrochlorid STADA 50 mg/850 mg Filmtabletten

Vildagliptin/Metforminhydrochlorid STADA 50 mg/1.000 mg Filmtabletten

FranceVildagliptin/Metformin EG 50 mg/1.000 mg, film-coated tablet

SpainVildagliptina/Metformina STADA 50 mg /850 mg film-coated tablets EFG

Vildagliptina/Metformina STADA 50 mg /1.000 mg film-coated tablets EFG

ItalyVILDAGLIPTIN E METFORMINA EG

DenmarkVildagliptin/Metformin STADA 50 mg/850 mg film-coated tablet

Vildagliptin/Metformin STADA 50 mg/1.000 mg film-coated tablet

FinlandVildagliptin/Metformin STADA 50 mg/850 mg film-coated tablets

Vildagliptin/Metformin STADA 50 mg/1.000 mg film-coated tablets

Czech RepublicVildagliptin/Metformin STADA

HungaryVildagliptin-Metformin Stada 50 mg/850 mg film-coated tablet

Vildagliptin-Metformin Stada 50 mg/1.000 mg film-coated tablet

PortugalMetformina + Vildagliptina Ciclum

AustriaVildagliptin/Metformin STADA 50 mg/850 mg Filmtabletten

Vildagliptin/Metformin STADA 50 mg/1.000 mg Filmtabletten

IslandVildagliptin/Metformin STADA 50 mg/850 mg film-coated tablet

Vildagliptin/Metformin STADA 50 mg/1.000 mg film-coated tablet

SlovakiaVildagliptin Metformin STADA 50 mg/850 mg film-coated tablets

Vildagliptin Metformin STADA 50 mg/1.000 mg film-coated tablets

Last revision date of this leaflet:May 2023

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