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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Vildagliptin/Metformin Stada 50 mg/1,000 mg film-coated 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 Stada is and what it is used for
2. What you need to know before taking Vildagliptin/Metformin Stada
3. How to take Vildagliptin/Metformin Stada
4. Possible side effects
5. How to store Vildagliptin/Metformin Stada
6. Contents of the pack and other information

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

The active substances in 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 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 sugar production by the liver, thereby increasing blood sugar levels.

How vildagliptin/metformin 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 of diabetes.

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

DO NOT take Vildagliptin/Metformin Stada

• 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.
• if you have uncontrolled diabetes, for example, with 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, deep and rapid breathing, drowsiness, or a fruity odor on your breath.
• if you have recently had a heart attack, or if you have heart failure or 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 (significant loss of body water).
• if you are scheduled 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

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 consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as severe acute 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 be associated with 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.

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 taking this medicine if:

• you have or have had a pancreatic disease
• 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

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.

Surgery

If you require major surgery, you must stop taking vildagliptin/metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

Regular tests

You should have liver function tests 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.

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 Stada

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.

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 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 acidity and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Stada 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

Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “DO NOT take Vildagliptin/Metformin Stada”).

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.

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.

Vildagliptin/Metformin Stada contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Vildagliptin/Metformin Stada

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

Dosage

The recommended dose is one film-coated tablet twice daily.

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

When and how to take vildagliptin/metformin

• Swallow the tablet whole with a glass of water.
• Take one tablet in the morning and the other in the evening with meals or immediately after meals.
• Taking the tablet just after meals will reduce the risk of gastrointestinal discomfort.

Kidney problems

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 a medicine used for diabetes known as a sulfonylurea.

Additional considerations

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

Follow your doctor's dietary advice. In particular, if you are following a diabetic weight-control diet, continue with the diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Stada than you should

If you have taken too many vildagliptin/metformin tablets, or if someone else has taken your tablets, consult your doctor or pharmacist immediately. You may require medical attention. 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 Stada

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

If you stop taking Vildagliptin/Metformin Stada

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 other questions about using 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:

Very rare (may affect up to 1 in 10,000 people)

• Lactic acidosis. Vildagliptin/metformin may cause a very rare but very 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.

Rare (may affect up to 1 in 1,000 people)

• Angioedema. Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives.

Uncommon (may affect up to 1 in 100 people)

• Liver disease (hepatitis). Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-coloured urine.
• Inflammation of the pancreas (pancreatitis). Symptoms include 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 pain and abdominal discomfort.

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 these medicines containing vildagliptin/metformin, the following adverse effects have also been reported:

Frequency not known (cannot be estimated from available data)

• Localized skin peeling or blisters, 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 national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin/Metformin Stada

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the outer packaging 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. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to get rid of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin Stada

• The active substances are vildagliptin and metformin hydrochloride.

Vildagliptin/Metformin Stada 50 mg/850 mg:

Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).

Vildagliptin/Metformin Stada 50 mg/1.000 mg:

Each film-coated tablet contains 50 mg of vildagliptin and 1.000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).

• The other components are:

Tablet core: hydroxypropyl cellulose (E463), copovidone, lactose monohydrate, and magnesium stearate (E470b).

Vildagliptin/Metformin Stada 50 mg/850 mg:

Film coating: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172).

Vildagliptin/Metformin Stada 50 mg/1.000 mg:

Film coating: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), yellow iron oxide (E 172).

Appearance of the product and contents of the pack

Vildagliptin/Metformin Stada 50 mg/850 mg are yellow, oval, biconvex film-coated tablets, approximately 20 mm in length and 8 mm in width.

Vildagliptin/Metformin Stada 50 mg/1.000 mg are dark yellow, oval, biconvex film-coated tablets, approximately 21 mm in length and 8 mm in width.

Vildagliptin/Metformin Stada is available in blister packs containing 10, 30, 60, 120 or 180 film-coated tablets.

Vildagliptin/Metformin Stada is also available in unit-dose blister packs containing 10x1, 30x1, 60x1, 120x1 or 180x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

IBS-Experts International, d.o.o

Ruševje 15

10290 Zaprešic

Republic of Croatia

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

Sweden Vildagliptin/Metformin STADA 50 mg/850 mg film-coated tablets

Vildagliptin/Metformin STADA 50 mg/1.000 mg film-coated tablets

Germany Vildagliptin/Metforminhydrochlorid STADA 50 mg/850 mg Filmtabletten

Vildagliptin/Metforminhydrochlorid STADA 50 mg/1.000 mg Filmtabletten

France Vildagliptin/Metformin EG 50 mg/1.000 mg, comprimé pelliculé

Spain Vildagliptina/Metformina STADA 50 mg /850 mg comprimidos recubiertos con película EFG

Vildagliptina/Metformina STADA 50 mg /1.000 mg comprimidos recubiertos con película EFG

Italy VILDAGLIPTIN E METFORMINA EG

Denmark Vildagliptin/Metformin STADA 50 mg/850 mg filmovertrukket tablet

Vildagliptin/Metformin STADA 50 mg/1.000 mg filmovertrukket tablet

Finland Vildagliptin/Metformin STADA 50 mg/850 mg kalvopäällysteiset tabletit

Vildagliptin/Metformin STADA 50 mg/1.000 mg kalvopäällysteiset tabletit

Czech Republic Vildagliptin/Metformin STADA

Hungary Vildagliptin-Metformin Stada 50 mg/850 mg filmtabletta

Vildagliptin-Metformin Stada 50 mg/1.000 mg filmtabletta

Portugal Metformina + Vildagliptina Ciclum

Austria Vildagliptin/Metformin STADA 50 mg/850 mg Filmtabletten

Vildagliptin/Metformin STADA 50 mg/1.000 mg Filmtabletten

Iceland Vildagliptin/Metformin STADA 50 mg/850 mg filmovertrukket tablet

Vildagliptin/Metformin STADA 50 mg/1.000 mg filmovertrukket tablet

Slovakia Vildagliptin Metformin STADA 50 mg/850 mg filmom obalené tablety

Vildagliptin Metformin STADA 50 mg/1.000 mg filmom obalené tablety

Date of the most recent revision of this leaflet: May 2023

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