VILDAGLIPTIN VIR 50 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Vildagliptina Vir 50 mg film-coated tablets

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Vildagliptina Vir and what is it used for
2. What you need to know before you take Vildagliptina Vir
3. How to take Vildagliptina Vir
4. Possible side effects
5. Storage of Vildagliptina Vir
6. Contents of the pack and further information

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

The active substance of this medicine, 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 by diet and exercise alone. It helps to control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medicines that you are already taking if they are not effective enough to control your diabetes.

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It can also occur when the body produces too much glucagon.

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

How Vildagliptina Vir works

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

Although you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise that your doctor has recommended.

2. What you need to know before you take Vildagliptina Vir

Do not take Vildagliptina Vir

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking vildagliptina

• 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 an antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when taken 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 on 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, you should not take this medicine.

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 intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (transaminases) as soon as possible.

Children and adolescents

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

Other medicines and Vildagliptina Vir

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use vildagliptin during pregnancy. It is not known if vildagliptin passes into breast milk. Do not take vildagliptin if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

Vildagliptina Vir 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.

Vildagliptina Vir contains sodium

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

3. How to take Vildagliptina Vir

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How much to take and when

The dose of vildagliptin that you should take varies depending on your condition. Your doctor will tell you exactly how many Vildagliptina Vir tablets to take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin is:

• 50 mg once daily in the morning if you are taking vildagliptin with another medicine known as a sulfonylurea.

• 100 mg daily in two doses (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptin alone, with another medicine called metformin, or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.

• 50 mg daily in the morning if you have moderate to severe kidney disease or if you are on dialysis.

How to take Vildagliptina Vir

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Vir

• Take vildagliptin every day for as long as your doctor recommends. You may need to take this treatment for a long time.
• Your doctor will check you regularly to ensure that the treatment has the desired effect.

If you take more Vildagliptina Vir than you should

If you have taken too many Vildagliptina Vir tablets or if someone else has taken your medicine, contact your doctor immediately. You may need medical attention. If you have to visit a doctor or go to the hospital, take the pack with you.

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 taken.

If you forget to take Vildagliptina Vir

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the 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 forgotten doses.

If you stop taking Vildagliptina Vir

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

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 including swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called "angioedema",
• liver disease (hepatitis) (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• pancreatitis (frequency not known): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

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

• Common (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, low blood sugar.
• Uncommon (may affect up to 1 in 100 people): fatigue.

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

• Common: tremor, headache, dizziness, weakness, low blood sugar.
• Uncommon: constipation.
• Very 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:

• Common: weight gain, swelling of hands, ankles, or feet (edema).
• Uncommon: headache, weakness, low blood sugar.

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

• Common: dizziness.
• Uncommon: headache, constipation, swelling of hands, ankles, or feet (edema), joint pain, low blood sugar.
• Very rare: sore throat, nasal congestion, fever.

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

• Common: dizziness, tremor, weakness, low blood sugar, excessive sweating.

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

• Common: headache, chills, nausea (discomfort), low blood sugar, heartburn.
• Uncommon: diarrhea, flatulence.

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

• Frequency not known (cannot be estimated from the available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Vir

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Store in the original package to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Vildagliptina Vir

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

The other ingredients are microcrystalline cellulose, lactose, sodium carboxymethyl starch (type A) potato, and magnesium stearate.

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Appearance of the product and pack size

Vildagliptina Vir are white, round (8.5 mm in diameter), flat, beveled-edge tablets, engraved with "A013" on one side.

Vildagliptina Vir 50 mg is available in packs containing 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Polígono Industria URTINSA II

28923 – Alcorcón (Madrid)

Spain

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitza 2600

Bulgaria

Date of last revision of this leaflet: March 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/