Package Insert: Information for the Patient

Vildagliptin Vir 50 mg Tablets EFG

Read this package insert carefully before starting to take this medication, 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 a specialized diabetes nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Vildagliptin Vir and what is it used for

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

3. How to take Vildagliptin Vir

4. Possible adverse effects

5. Storage of Vildagliptin Vir

6. Contents of the package and additional information

The active ingredient of this medication, vildagliptin, belongs to a group of medications 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 medications 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 function 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 causes blood sugar levels to increase. Both substances are produced in the pancreas.

How Vildagliptin Vir actsVir

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

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

Do not take Vildagliptin Vir

-if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you might be allergic to vildagliptin or any other ingredient ofthis medicine, do not take this medicine and consult your doctor.

Warnings and precautions

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

• 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 medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when you take it together 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 medicine.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse 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 intervals of three months during the first year, and periodically thereafter.This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medicines and Vildagliptin

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

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

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

Pregnancy and breastfeeding

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

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 machines

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

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as difficulty seeing. This can be dangerous in situations where these skills are important (for example, driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

Vildagliptin Vir contains lactose

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

Vildagliptin Vir contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, 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.

How much to take 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 VildagliptinVir

• Swallow the tablet whole with a little water.

Duration of treatment with VildagliptinVir

• Take vildagliptin every day as your doctor indicates. You may need to continue 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 VildagliptinVirthan you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medication,consult your doctor immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take VildagliptinVir

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 VildagliptinVir

Do not stop taking vildagliptin unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor.

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 see your doctor 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) (rare): 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).
• inflammation of the pancreas (pancreatitis) (unknown frequency): symptoms that include intense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptin and metformin:

• Frequent (may affect up to 1 in 10 people): tremors, headache, dizziness, nausea, decreased blood glucose levels.
• Infrequent (may affect up to 1 in 100 people): fatigue.

Some patients experienced the following side effects while taking vildagliptin and a sulfonylurea:

• Frequent: tremors, headache, dizziness, weakness, decreased blood glucose levels.
• Infrequent: constipation.
• Rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion.

Some patients experienced the following side effects while taking vildagliptin and a glitazone:

• Frequent: weight gain, swollen hands, ankles, or feet (edema).
• Infrequent: headache, weakness, decreased blood glucose levels.

Some patients experienced the following side effects while taking vildagliptin only:

• Frequent: dizziness.
• Infrequent: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, decreased blood glucose levels.
• Rare: sore throat, nasal congestion, fever.

Some patients have had the following side effects while taking vildagliptin, metformin, and a sulfonylurea:

• Frequent: dizziness, tremors, weakness, low blood glucose levels, excessive sweating.

Some patients have had the following side effects while taking vildagliptin and insulin (with or without metformin):

• Frequent: headache, chills, nausea (discomfort), low blood glucose levels, stomach burning.
• Infrequent: diarrhea, flatulence.

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

• Unknown frequency (cannot be estimated from available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.

Reporting of 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 and on the packaging after “CAD”. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Store in the original packaging to protect it from moisture.
• Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vildagliptin Vir

• The active ingredient is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

The other components are microcrystalline cellulose, lactose, carboxymethylstarch sodium (type A) from potato and magnesium stearate.

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Appearance of the product and contents of the packaging

Vildagliptin Vir are round white tablets (8.5 mm in diameter), flat, with beveled edges, engraved with "A013" on one face.

Vildagliptin Vir 50 mg is available in packaging containing 28 and 56 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Industrial Estate URTINSA II

28923 – Alcorcón (Madrid)

Spain

Responsible manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitza 2600

Bulgaria

Last review date of thisleaflet: March 2022

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