VILDAGLIPTIN/METFORMIN INTAS 50 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Vildagliptin/Metformin Intas 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Vildagliptin/Metformin Intas and what is it used for

The active substances of this medicine, vildagliptin and metformin, belong to a group of medicines 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 by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

Type 2 diabetes appears when the body does not produce enough insulin or when the insulin produced does not work properly. It can also appear when the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and increases blood sugar levels.

How it worksVildagliptin/Metformin

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

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

Do not takeVildagliptin/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 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 disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in 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 a sign of heart problems.
• if you have severe kidney function impairment.
• if you have a severe infection or severe dehydration (massive water loss from the body).
• if you are going to have a contrast radiology (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 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 very serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder 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/Metforminfor a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop takingVildagliptin/Metforminand contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• breathing difficulties
• decrease 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 to treat 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 medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin but had to stop taking it 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 happens, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking vildagliptin/metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when to restart it.

Liver function tests should be performed 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 (transaminases) 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 elderly person and/or if your renal function is worsening.

Your doctor will periodically check your blood and urine sugar levels.

Children and adolescents

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

Other medicines andVildagliptin/Metformina

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/metformin and when to restart it.

Tell your doctor if you are taking, have recently taken, or might 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, usually used to treat inflammation
• beta-2 agonists, usually 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific active substances that affect the thyroid, or
• specific active substances that affect the nervous system.
• specific active substances used to treat angina (e.g., ranolazine)
• specific active substances used to treat HIV infection (e.g., dolutegravir)
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• specific active substances used to treat stomach acid and peptic ulcers (e.g., cimetidine)

TakingVildagliptin/Metforminwith 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

• 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 using machines

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

3. How to take Vildagliptin/Metformin Intas

The dose of vildagliptin/metformin that you should take varies depending on your condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Follow your doctor's instructions for taking this medicine exactly. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1,000 mg film-coated tablet twice a day.

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 a diabetes medicine known as a sulfonylurea.

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

Method of use ofVildagliptin/Metformin

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

If you take moreVildagliptin/Metforminthan you should

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

If you forget to takeVildagliptin/Metformin

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

If you stop takingVildagliptin/Metformin

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop takingvildagliptin/metforminand contact your doctor immediatelyif you experience any of the following side effects:

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

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

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called "angioedema".
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side 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 (discomfort), vomiting, diarrhea, flatulence,

heartburn, stomach pain and abdominal area (abdominal pain).

• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood sugar, loss of appetite, swollen hands, ankles, or feet (edema), chills, pancreatitis, 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,

vomiting and severe nausea, abdominal pain, irregular heartbeat or rapid breathing, skin redness, itching; decreased levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory changes).

Since the marketing of this product, the following side 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) that can cause skin rashes or pinpoint red and flat spots under the skin surface or bruising.

Reporting of side effects

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

5. Storage of Vildagliptin/Metformin Intas

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging and blister after "EXP". The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Keep in the original packaging (blister) to protect it from moisture.
• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Vildagliptina/Metformina Intas

The active ingredients are vildagliptina and metformina hydrochloride.

Each film-coated tablet of Vildagliptina/Metformina Intas 50 mg/850 mg contains 50 mg of vildagliptina and 850 mg of metformina hydrochloride (corresponding to 660 mg of metformina).

Each film-coated tablet of Vildagliptina/Metformina Intas 50 mg/1,000 mg contains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride (corresponding to 780 mg of metformina).

The other components are: hydroxypropylcellulose (E-463), magnesium stearate (E-470b), microcrystalline cellulose (E-460), hypromellose (E-464), titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 (E1521), and talc (E-553b).

Appearance of the Product and Container Content

Vildagliptina/Metformina Intas 50 mg/850 mg film-coated tablets are film-coated tablets, yellow in color, oval, biconvex, with the inscription «GG2» on one face and the other face smooth. The dimensions of the tablet are approximately 20.15 × 8.00 mm.

Vildagliptina/Metformina Intas 50 mg/1,000 mg film-coated tablets are film-coated tablets, dark yellow in color, oval, biconvex, with the inscription «GG3» on one face and the other face smooth. The dimensions of the tablet are approximately 21.11 × 8.38 mm.

Vildagliptina/Metformina Intas is available in containers with 10, 30, or 60 film-coated tablets and in multiple containers with 120 (2x60), 180 (3x60), or 360 (6x60) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Intas Third Party Sales 2005, S.L.

World Trade Center, Moll Barcelona s/n

Edifici Est, 6a Planta, 08039

Barcelona, Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

or

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Estate,

PLA 3000, Paola

Malta

or

Synoptis Industrial Sp.

Z o.o., Rabowicka 15,

62-020 Swarzedz,

Poland

Date of the Last Revision of this Leaflet:05/2025

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