Vildagliptin/metformin Cinfa 50 mg/1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin/Metformin cinfa 50 mg/1.000 mg film-coated tablets EFG

vildagliptin/metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substances in Vildagliptina/Metformina cinfa, vildagliptina and metformina, belong to a group of medicines 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. Vildagliptina/metformina is used when diabetes cannot be controlled by diet and exercise alone and/or with other antidiabetic medications (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 lower blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver and causes blood sugar levels to rise.

How Vildagliptina/Metformina cinfa works

Both active substances, vildagliptina and metformina, help control blood sugar levels.

The active substance vildagliptina stimulates the pancreas to produce more insulin and less glucagon.

The active substance metformina helps the body 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 starting to take Vildagliptin/Metformin cinfa

Do not take Vildagliptin/Metformin cinfa

• 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 components, consult your doctor before taking Vildagliptin/Metformin cinfa.
• 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 condition 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, unusual odor on your breath.
• if you have recently had a heart attack or if you have heart failure, serious 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 X-ray diagnostic 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 (daily or even occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vildagliptin/Metformin cinfa.

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, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), liver problems, or any medical condition in which 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.

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disorder (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 develop any of the following symptoms after starting treatment with metformin: seizures, cognitive impairment, 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 an illness 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 usual. 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 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 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 previously took 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 require major surgery, you must stop taking vildagliptin/metformin during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

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 done to detect as early as possible any signs of increased liver enzymes (transaminases).

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.

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 cinfa

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

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 and when to restart treatment with vildagliptin/metformin.

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
• 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 cinfa with alcohol

Avoid excessive alcohol consumption while taking Vildagliptin/Metformin cinfa, 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 cinfa”). Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Diabetes treatment with metformin as the sole medication (monotherapy) does not cause hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machines. However, if you take metformin together with other diabetes medicines, hypoglycemia may occur (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision disturbances, or difficulty concentrating), and therefore you should take extra precautions when driving or using dangerous machinery.

Due to the presence of vildagliptin, your ability to concentrate and react may be affected by symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This may be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor to determine whether it is advisable to drive or use machines.

3. How to take Vildagliptin/Metformin cinfa

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

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

The recommended dose is one tablet of 50 mg/850 mg or 50 mg/1,000 mg twice daily.

If you have reduced kidney function, your doctor may prescribe you 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 cinfa

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one at night with meals or just 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 with this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin cinfa than you should

If you have taken too many vildagliptin/metformin tablets, 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 Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin cinfa

If you forget to take a tablet, take it with the next meal, unless it is already time for your next scheduled dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Vildagliptin/Metformin cinfa

Continue taking this medicine for as long as your doctor prescribes it, so that your blood sugar remains under control. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about the duration of treatment, consult your doctor.

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

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 people):

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 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 tremor, constipation, nausea (feeling unwell), vomiting, diarrhoea, 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 (oedema), 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 medicine, the following adverse effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) which may cause skin rashes or flat, red, round pinpoint 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 they are possible adverse effects not listed in this leaflet. You may 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 cinfa

• 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 "EXP". The expiry date refers to the last day of the month indicated.
• Store in the original packaging (blister) to protect it from light and moisture.
• This medicine does not require any special storage temperature.
• Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin cinfa

• The active substances are vildagliptin and metformin hydrochloride.
• Each tablet contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride.
• The other components are: hydroxypropyl cellulose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide (E-171) and macrogol) and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Vildagliptin/Metformin cinfa 50 mg/1,000 mg are yellow, oblong, biconvex, unmarked tablets with "VM" printed on one side (size: 20.5 x 10.9 mm).

Vildagliptin/Metformin cinfa 50 mg/1,000 mg is available in packs containing 60 tablets.

Unit-dose blisters made of aluminium/aluminium.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

Other sources of information:

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85622/P_85622.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85622/P_85622.html