VILDAGLIPTIN/METFORMIN STADA 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Vildagliptin/Metformin Stada 50 mg/1000 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 Stada and what is it used for
2. What you need to know before you take Vildagliptin/Metformin Stada
3. How to take Vildagliptin/Metformin Stada
4. Possible side effects
5. Storage of Vildagliptin/Metformin Stada
6. Contents of the pack and other information

1. What is Vildagliptin/Metformin Stada 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 occurs if the body does not produce enough insulin or if the insulin produced does not work properly. It can also occur if 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 vildagliptin/metformin works

Both active substances, vildagliptin and metformin, help to 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 to use insulin better. This medicine has been shown to reduce blood sugar, which will help to prevent complications of your diabetes.

2. What you need to know before you take 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 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 of the 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 radiography (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the section “Warnings and precautions”.
• 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 taking vildagliptin/metformin for 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 taking vildagliptin/metformin and 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
• difficulty breathing
• reduction of 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 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 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

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 should consult your doctor immediately.

Surgery

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

Regular tests

You should have liver function tests 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 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 deteriorating.

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 and Vildagliptin/Metformin Stada

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
• 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)

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 are planning to have a baby, 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 machines.

Vildagliptin/Metformin Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Vildagliptin/Metformin Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is one film-coated tablet twice a day.

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.

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 after meals
• taking the tablet immediately after meals will reduce the risk of digestive discomfort

Kidney problems

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.

Additional aspects to consider

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

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 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 need medical attention. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 already time for your usual dose. Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop taking Vildagliptin/Metformin Stada

Continue taking this medicine while your doctor prescribes it for you to continue controlling your blood sugar. Do not stop taking vildagliptin/metformin unless your doctor tells you to.

If you have any doubts about the duration of treatment, consult your doctor.

If you have any other 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 taking vildagliptin/metformin and go to your doctor immediatelyif you experience any of the following side effects:

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

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

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

• angioedema.Symptoms that include swollen 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 that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine.
• pancreatitis (inflammation of the pancreas). Symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to the 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, uncontrolled 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, severe nausea and vomiting, abdominal pain, irregular heartbeat or rapid breathing
• redness of the skin, itching
• decrease in vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory changes)

Since the marketing of these medicines with vildagliptin/metformin, 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 spots, flat, red, and round patches under the skin surface or bruises

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date that appears on the packaging and blister after “EXP”. The expiry date is the last day of the month indicated.

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 the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vildagliptina/Metformina Stada

• The active ingredients are vildagliptin and metformin hydrochloride.

Vildagliptina/Metformina Stada 50 mg/850 mg:

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

Vildagliptina/Metformina Stada 50 mg/1,000 mg:

Each film-coated tablet contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

• The other components are:

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

Vildagliptina/Metformina 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), and red iron oxide (E 172).

Vildagliptina/Metformina Stada 50 mg/1,000 mg:

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

Product Appearance and Package Contents

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

Vildagliptina/Metformina Stada 50 mg/1,000 mg are dark yellow, oval, biconvex film-coated tablets, approximately 21 mm in length and 8 mm in width.

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

Vildagliptina/Metformina Stada is available in blister packs containing 10x1, 30x1, 60x1, 120x1, or 180x1 film-coated tablets in unit-dose blisters.

Only some 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 Zaprešić

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 tablet

Vildagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablet

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, film-coated tablet

Spain Vildagliptina/Metformina STADA 50 mg/850 mg film-coated tablets EFG

Vildagliptina/Metformina STADA 50 mg/1,000 mg film-coated tablets EFG

Italy VILDAGLIPTIN E METFORMINA EG

Denmark Vildagliptin/Metformin STADA 50 mg/850 mg film-coated tablet

Vildagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablet

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

Vildagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

Czech Republic Vildagliptin/Metformin STADA

Hungary Vildagliptin-Metformin Stada 50 mg/850 mg film tablet

Vildagliptin-Metformin Stada 50 mg/1,000 mg film tablet

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 film-coated tablet

Vildagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablet

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

Vildagliptin Metformin STADA 50 mg/1,000 mg film-coated tablets

Date of the last revision of this leaflet:May 2023

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/)