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

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

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

vildagliptin/metformin hydrochloride

Read all of this 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 must not be given to other people, even if they have the same symptoms as you. It could 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 Teva is and what it is used for
2. What you need to know before taking Vildagliptin/Metformin Teva
3. How to take Vildagliptin/Metformin Teva
4. Possible side effects
5. How to store Vildagliptin/Metformin Teva
6. Contents of the pack and other information

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

The active substances in Vildagliptina/Metformina Teva, 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 antidiabetic medicines (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 glucose production by the liver and causes blood sugar levels to rise.

How Vildagliptina/Metformina Teva works

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 more effectively. This medicine has been shown to reduce blood sugar levels, which will help prevent complications from diabetes.

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

Do not take Vildagliptin/Metformin Teva:

• 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, 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 and deep breathing, drowsiness, or fruity-smelling breath,
• if you have recently had a heart attack or if you have heart failure, 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 (significant loss of body water),
• if you are scheduled to undergo contrast radiography (a specific type of diagnostic X-ray 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

Talk to your doctor or pharmacist before taking Vildagliptin/Metformin Teva.

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 uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives 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 temporarily if you develop a condition that may 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 a 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 profound fatigue,
• difficulty breathing,
• decreased body temperature and heart rate.

Lactic acidosis is a medical emergency and must be treated in a hospital.

Contact your doctor promptly for advice if:

• You are known to have a genetic mitochondrial disease (the components responsible for energy production within 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, signs of nerve damage (e.g., pain or numbness), migraine, or deafness.

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 or pharmacist before starting vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor or pharmacist 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 previously took vildagliptin but had to discontinue it due to liver disease, you must 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 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, every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating elevated 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.

Taking Vildagliptin/Metformin Teva with other medicines

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 and when to restart treatment with vildagliptin/metformin.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust your vildagliptin/metformin dose. It is especially important to mention the following:

• glucocorticoids, generally used to treat inflammation,
• beta-2 agonists, generally used to treat respiratory disorders,
• other medicines 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 hypertension (ACE inhibitors and angiotensin II receptor antagonists),
• certain medicines affecting the thyroid,
• certain medicines 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 acidity and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Teva 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 Teva”).

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 machinery.

3. How to take Vildagliptin/Metformin Teva

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.

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

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

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

When and how to take Vildagliptin/Metformin Teva

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

The “I”-shaped indentation is intended to facilitate tablet swallowing and splitting, but not for dividing the tablet into equal doses.

Follow any dietary advice given by your doctor. In particular, if you are following a diabetic weight control diet, continue with this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Teva than you should

If you have taken more Vildagliptin/Metformin Teva than you should, contact your doctor, pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken.

You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the package and this leaflet with you.

If you forget to take Vildagliptin/Metformin Teva

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

If you stop taking Vildagliptin/Metformin Teva

Continue taking this medicine for as long as your doctor prescribes it, so that your blood sugar levels remain under control. 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 using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets 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 effect 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.

Signs of high levels of lactic acid in the blood include drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat, or deep, rapid breathing.

• 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 pain in the abdomen (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, weakness, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, stomach pain, and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles or feet (oedema), chills, muscle pain, skin redness, hives.
  Very rare (may affect up to 1 in 10,000 people): 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 or blistering of the skin, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots beneath the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Teva

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.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina/Metformina Teva

• 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 660 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 excipients are:

Core: Hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate.

Coating: Hypromellose 2910, 6 cps, titanium dioxide (E171), copovidone, polydextrose, macrogol 3350, yellow iron oxide (E172), medium-chain triglycerides.

Appearance of the product and contents of the pack

Vildagliptina/Metformina Teva 50 mg/850 mg are yellow, film-coated, oval, biconvex tablets, 8.5 x 21 mm in size, with an "I"-shaped score line on one side and marked "A 8" on the other.

The "I"-shaped score line is intended to assist in tablet splitting and swallowing, but not for dividing the tablet into equal doses.

Vildagliptina/Metformina Teva 50 mg/1.000 mg are dark yellow, film-coated, oval, biconvex tablets, 9.2 x 23 mm in size, with an "I"-shaped score line on one side and marked "A 1" on the other.

The "I"-shaped score line is intended to assist in tablet splitting and swallowing, but not for dividing the tablet into equal doses.

Available in packs of 10, 12, 30, 60, 100 and 180 film-coated tablets, multiple packs of 60 (2 x 30) film-coated tablets, and unit dose packs with perforated blisters of 30 x 1 and 60 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

Teva Nederland BV

Swensweg 5,

2031GA Haarlem,

The Netherlands

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, 31-546 Kraków,

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

Blaubeuren 89143, Baden-Wuerttemberg,

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Local representative:

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Spain

Date of latest revision of the leaflet: March 2025

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