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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vildagliptin/Metformin Alter 50 mg/850 mg tablets EFG

Vildagliptin/Metformin Alter 50 mg/1.000 mg tablets EFG

vildagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Vildagliptin/Metformin Alter is and what it is used for
2. What you need to know before taking Vildagliptin/Metformin Alter
3. How to take Vildagliptin/Metformin Alter
4. Possible adverse effects
5. How to store Vildagliptin/Metformin Alter
6. Contents of the pack and other information

1. What Vildagliptine/Metformin Alter is and what it is used for

The active substances in this medicine, vildagliptine and metformin, belong to a group of medicines called "oral antidiabetics".

Vildagliptine/metformin 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 occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It may also occur when 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 sugar production by the liver and causes blood sugar levels to rise.

How Vildagliptine/Metformin Alter works

Both active substances, vildagliptine and metformin, help control blood sugar levels. The active substance vildagliptine stimulates the pancreas to produce more insulin and less glucagon. The active substance metformin helps the body to use insulin more effectively. This medicine has been shown to reduce blood sugar levels, which will help prevent complications of your diabetes.

2. What you need to know before taking Vildagliptin/Metformin Alter

Do not take Vildagliptin/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 might be allergic to any of these components, consult your doctor before taking vildagliptin/metformin.
• if you have uncontrolled diabetes, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or a fruity odour on your breath.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are due to undergo contrast radiography (a specific type of diagnostic X-ray test using an injectable contrast agent). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink alcohol excessively (either daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), 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 apply to you, consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Alter temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Alter and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with intense fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and must 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 vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to prevent low blood glucose levels (hypoglycaemia).

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

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

If you need to undergo major surgery, you must stop taking vildagliptin/metformin during the procedure and for some time afterwards. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, at three-month intervals during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating increased 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 elderly and/or if your kidney function is deteriorating.

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

Contact your doctor promptly for advice if:

• You are known to have a genetic inherited disease affecting the mitochondria (the energy-producing components inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

Children and adolescents

Vildagliptin/metformin is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Vildagliptin/Metformin Alter

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example during an X-ray or scan, you must stop taking vildagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. You may need more frequent blood glucose 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 substances used to treat diabetes
• medicines that increase urine production (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 active substances affecting the thyroid gland, or
• certain active substances affecting the nervous system.

Taking Vildagliptin/Metformin Alter with alcohol

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

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin Alter”).

Driving and using machines

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

3. How to take/use Vildagliptin/Metformin Alter

The dose of vildagliptin/metformin required varies from person to person, depending on individual condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Always follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking another diabetes medicine such as a sulfonylurea.

Your doctor may prescribe this medicine alone or together with certain other medicines that lower your blood sugar levels.

How to take Vildagliptin/Metformin Alter

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one at night with meals or immediately 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 diabetic diet for weight control, continue this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Alter than you should

If you have taken too many tablets of this medicine or if someone else has taken your tablets, contact your doctor or pharmacist immediately. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the pack and this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin Alter

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

If you stop taking Vildagliptin/Metformin Alter

Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar levels. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about how long you should take this medicine, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You must stop taking vildagliptin/metformin and contact your doctor immediately if you experience any of the following adverse effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 users):

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

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (frequency not known): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients have experienced the following adverse effects while taking vildagliptin/metformin:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach-area pain (abdominal pain), loss of appetite.

• Common (may affect up to 1 in 10 people): dizziness, headache, uncontrollable tremor, metallic taste, decrease in blood glucose.

• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swollen hands, ankles or feet (oedema).

• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion and fever; signs of 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 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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

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

Some patients have experienced the following adverse effects while taking vildagliptin/metformin and insulin:

• Common: headache, chills, nausea (feeling unwell), low blood glucose levels, heartburn.
• Uncommon: diarrhoea, flatulence.

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

• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localized skin peeling or blistering, muscle pain.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin / Metformin Alter

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

Do not store above 30°C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin Alter

• The active substances are vildagliptin and metformin hydrochloride.
• Each vildagliptin/metformin 50 mg/850 mg tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• Each vildagliptin/metformin 50 mg/1.000 mg tablet contains 50 mg of vildagliptin and 1.000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• The other components are: polyvinyl alcohol-polyethylene glycol copolymer, pregelatinized corn starch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the pack

Vildagliptin/Metformin 50 mg/850 mg are white, oblong, biconvex tablets, scored on one side.

The score line should not be used to divide the tablet.

Vildagliptin/Metformin 50 mg/1.000 mg are white, oblong, biconvex tablets, scored on one side and engraved with "1.000" on the other.

The score line should not be used to divide the tablet.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

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

France: Vildagliptin/Metformin Alter 50 mg/1000 tablets
Portugal: Metformin + Vildagliptin Alter 850 mg + 50 mg tablets
Metformin + Vildagliptin Alter 1000 mg + 50 mg tablets

Date of the most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.