Leaflet: information for the user

Vildagliptin/Metformin Alter 50 mg/850 mg tablets EFG

Vildagliptin/Metformin Alter 50 mg/1,000 mg tablets EFG

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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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.

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

Vildagliptina/metformina 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 function 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 increase.

How Vildagliptina/Metformina Alter works

Both active ingredients, vildagliptina and metformina, help to control blood sugar levels. The active ingredient vildagliptina stimulates the pancreas to produce more insulin and less glucagon. The active ingredient metformina 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 takeVildagliptin/Metformin Alter

• if you are allergic to vildagliptin, metformin 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.
• 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 undergoing 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 (also see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Risk of lactic acidosis

Vildagliptin/metformin may cause a very 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 diseases).

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

Stop takingVildagliptin/Metformin Alterfor 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/MetforminAlter 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:

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 starting to take vildagliptin/metformin if you have or have had a pancreatic disease.

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

If you have taken vildagliptin in the past 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. If this occurs, you should consult your doctor immediately.

If you need to undergo 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.

Tests of liver function should be performed before starting treatment with vildagliptin/metformin, 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 (transaminases).

During treatment with vildagliptin/metformin, 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.

Consult your doctor quickly to tell you what to do if:

• you know you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and episodes similar to seizures) or maternal diabetes and hearing loss (MIDD).
• you experience any of the following symptoms after starting treatment with metformin: convulsions, deterioration of cognitive abilities, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine and hearing loss.

Children and adolescents

The administration of vildagliptin/metformin is not recommended in children and adolescents under 18 years old.

Other medicines andVildagliptin/Metformin Alter

If you need to be administered an injection of a contrast medium containing iodine, such as 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 medicine. You may need more frequent blood glucose and renal 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
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat hypertension (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 Alter with alcohol

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

Pregnancy and breastfeeding

Driving and operating machines

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

The dose ofvildagliptin/metforminthat each person should take varies depending on their condition. Your doctor will tell you exactly the dose ofvildagliptin/metforminthat you should take.

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

The recommended dose is a film-coated tablet of 50mg/850mg or 50mg/1000mg twice a day.

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.

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

Form of use ofVildagliptin/Metformin Alter

• Swallow the whole tablets with a glass of water
• Take one tablet in the morning and the other at night with meals or after meals. Taking the tablet after meals will reduce the risk of digestive discomfort.

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

If you take moreVildagliptin/Metformin Alterthan 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 takeVildagliptin/Metformin Alter

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 (two tablets at once) to make up for the missed doses.

If you interrupt the treatment withVildagliptin/Metformin Alter

Continue taking this medication while your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not stop takingvildagliptin/metforminunless 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 medicine can cause side effects, although not everyone will experience them.

You shouldstop takingvildagliptin/metforminand see your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1user in every10,000):

Vildagliptin/metformin can cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you should stop takingvildagliptin/metforminand 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,which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): symptoms that includeyellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (unknown frequency): symptoms that includeintense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

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

• 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 and a sulfonylurea:

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

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

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

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

• Unknown frequency (cannot be estimated from available data): skin rash with itching, 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 Vigilance 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 store above 86°F (30°C).

Store in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vildagliptin/Metformin Alter

• The active principles are vildagliptin and metformin hydrochloride.
• Each vildagliptin/metformin 50 mg/850 mg tablet contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (corresponding to 663 mg of metformin).
• Each vildagliptin/metformin 50 mg/1,000 mg tablet contains 50 mg of vildagliptin and 1,000 mg of hydrochloride of metformin (corresponding to 780 mg of metformin).
• The other components are: polyvinyl alcohol copolymer and polyethylene glycol, pregelatinized cornstarch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and content of the packaging

Vildagliptin/metformin 50 mg/850 mg are white, oblong, biconvex, scored tablets on one face.

The score should not be used to break the tablet.

Vildagliptin/metformin 50 mg/1,000 mg are white, oblong, biconvex, scored tablets on one face and with 1,000 engraved on the other.

The score should not be used to break the tablet.

Vildagliptin/Metformin Alter is available in packs of 10 and 60 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

FranceVildagliptin/Metformin Alter 50 mg/1000 tablets

PortugalMetformina + Vildagliptina Alter 850 mg + 50 mg tablets

Metformina + Vildagliptina Alter 1000 mg + 50 mg tablets

Last review date of this leaflet:March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.