Vildagliptin/metformin Combix 50 mg/850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin/Metformin Combix 50 mg/850 mg film-coated tablets EFG

Vildagliptin/Metformin hydrochloride

Read the entire 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, and you should not give it to other people, 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.

Leaflet contents

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

1. What Vildagliptine/Metformin Combix 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. Vildagliptine/metformin is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

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 reduce blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver and causes blood sugar levels to rise.

How Vildagliptine/Metformin 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 use insulin more effectively. This medicine has been shown to reduce blood sugar, which will help prevent complications from your diabetes.

2. What you need to know before starting to take Vildagliptin/Metformin

Do not take Vildagliptin/Metformin

• 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 hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, 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 deep breathing, drowsiness, or a fruity odor 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 serious infection or severe dehydration (massive loss of body water).

• if you are scheduled to undergo contrast radiology (a specific type of diagnostic X-ray procedure 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 only occasionally).

• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

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

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

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disease (components that produce energy 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 hearing loss.

Stop taking Vildagliptin/Metformin temporarily if you develop a condition that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin 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 extreme 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 wish to reduce your sulfonylurea dose when taken together with Vildagliptin/Metformin to prevent low blood glucose levels (hypoglycemia).

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 development 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 a period afterward. 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, repeated every three months during the first year, and periodically thereafter. This is to detect as early as possible any signs indicating elevated liver enzymes.

During treatment with Vildagliptin/Metformin, your doctor will monitor 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.

Vildagliptin/Metformin contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

Children and adolescents

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

Other medicines and Vildagliptin/Metformin

If you need to receive an intravenous injection of an iodine-containing contrast agent, 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.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine. You may require 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
• certain active substances affecting the nervous system
• certain active substances used to treat angina pectoris (e.g., ranolazine)
• certain active substances used to treat HIV infection (e.g., dolutegravir)
• certain active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain active substances used to treat stomach acid and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin 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 may 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”). Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

3. How to take Vildagliptin/Metformin Combix

The dose of vildagliptin/metformin 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 your doctor's instructions for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one film-coated tablet of 50 mg/850 mg or 50 mg/1.000 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 blood sugar levels.

How to take Vildagliptin/Metformin

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening 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 weight-control diet, continue this diet while taking vildagliptin/metformin.

The tablet score line is not intended to divide the tablet into equal doses.

If you take more Vildagliptin/Metformin 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 packaging 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 name of the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin

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

Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about how long you should continue treatment, 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 will experience 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) (uncommon: may affect up to 1 in 100 people): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (uncommon: may affect up to 1 in 100 people): 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:

• Common (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable trembling, constipation, nausea (feeling unwell), vomiting, diarrhea, flatulence, heartburn, stomach 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 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 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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

• Frequency not known (cannot be estimated from the available data): localized peeling of the skin or blisters, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Combix

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after “CAD”/”EXP”. The expiry date is the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Vildagliptin/Metformin

• The active substances are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin/Metformin 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• The other components are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, stearic fumarate and sodium, and ready-to-use coating material (hypromellose, titanium dioxide, macrogol, talc, yellow iron oxide (E 172)).

Appearance of the product and contents of the container

Vildagliptin/Metformin 50 mg/850 mg film-coated tablets are yellow, oval, oblong tablets with a score line on one side and "VA" on the other side.

Tablet dimensions: 19.4 ± 0.5 mm.

Vildagliptin/Metformin is available in Alu/OPA-Alu-PVC blisters in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets, and in multiple packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 – Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix (Madrid)

Spain

Date of the most recent revision of this leaflet: February 2025.

Detailed 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).