Package Insert: Information for the Patient

Vildagliptin Sandoz 50 mg Tablets EFG

vildagliptin

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Vildagliptin Sandoz and how is it used

2. What you need to know before starting to take Vildagliptin Sandoz

3. How to take Vildagliptin Sandoz

4. Possible adverse effects

5. Storage of Vildagliptin Sandoz

6. Contents of the package and additional information

The active ingredient of Vildagliptina Sandoz, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.

Vildagliptin is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely with diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medicines you are already taking if these are not effective enough to control diabetes.

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

Insulin is a substance that helps reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes sugar production by the liver and increases blood sugar levels. Both substances are produced in the pancreas.

How Vildagliptina Sandoz works

Vildagliptin works by making the pancreas produce more insulin and less glucagon. This helps control blood sugar levels. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes.

Although you start taking this medicine for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended.

Do not take Vildagliptina Sandoz

-if you are allergic to vildagliptin or to any of the other ingredients of this medication (listed in section 6).

If you think you may be allergic to vildagliptin or any other component of vildagliptin, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin.

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis,
• if you are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taking it with vildagliptin to avoid low blood sugar [hypoglycemia]),
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptin),
• if you are undergoing dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop taking it due to liver disease, do not take this medication.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking vildagliptin. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptin, at three-month intervals during the first year, and periodically thereafter.This is done to detect as soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medications and Vildagliptina Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may change your vildagliptin dose if you are taking other medications such as:

• thiazides or other diuretics (also called urine medications),
• corticosteroids (usually used to treat inflammation),
• thyroid medications,
• certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use vildagliptin during pregnancy. It is unknown whether vildagliptin passes into breast milk. Do not take vildagliptin if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

If you feel dizzy while taking vildagliptin, do not drive or operate tools or machinery.

Vildagliptina Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What amount should be taken and when

The dose of vildagliptin that each person should take varies depending on their condition. Your doctor will indicate exactly the number of vildagliptin tablets that you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin is:

• 50 mg once a day in the morning, if you are taking vildagliptin along with another medication known as a sulfonylurea.
• 100 mg per day in two doses (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptin alone, with another medication called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day in the morning if you have moderate to severe kidney disease or if you are undergoing dialysis.

How to take Vildagliptina Sandoz

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Sandoz

• Take vildagliptin every day as your doctor indicates. You may need to follow this treatment for a long period of time.
• Your doctor will perform regular checks to ensure that the treatment is having the desired effect.

If you take more Vildagliptina Sandoz than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medication,consult your doctor immediately, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount used. You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

If you forget to take Vildagliptina Sandoz

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at your usual time. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Vildagliptina Sandoz

Do not stop taking vildagliptin unless your doctor tells you to. If you have doubts about the duration of treatment with vildagliptin, consult your doctor.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

You should stop taking vildagliptin and seek medical attention immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”,
• Liver disease (hepatitis) (unknown frequency): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis),
• Pancreatitis (inflammation of the pancreas) (rare: may affect up to 1 in 1,000 people): symptoms that include intense and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptin:

• Very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain and abdominal pain, diarrhea, heartburn, nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis (inflammation of the pancreas).

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface or hematomas.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Vildagliptin Sandoz

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are anhydrous lactose, microcrystalline cellulose, sodium carboxymethylcellulose (type A, from potato) and magnesium stearate.

Appearance of the product and content of the container

Vildagliptin Sandoz are round white to slightly yellowish tablets, flat, with “NVR” on one face and “FB” on the other.

Aluminum/aluminum (PA/Alu/PVC/Alu) blister.

Vildagliptin Sandoz is available in containers that contain 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multiple containers that contain 336 tablets (3 containers of 112 tablets).

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179, Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

or

Novartis Pharmaceutical

Manufacturing LLC

Verovškova ulica 57,

1000 Ljubljana,

Slovenia

Last review date of thisleaflet:June 2023.

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