VILDAGLIPTINA VIATRIS 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Vildagliptina Viatris 50 mg Tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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 and other information

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

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

The active substance vildagliptin belongs to a group of medicines called “oral antidiabetics”.

Vildagliptina 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 vildagliptina alone or in combination with other antidiabetic medicines that you are already taking, if these are not sufficiently effective 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 works

Vildagliptina stimulates the pancreas to 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. Before taking Vildagliptina Viatris

Do not take this medicine

• if you are allergic to vildagliptina or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptina 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 starting to take this medicine

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a disease 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 in combination with vildagliptina to avoid low blood sugar levels [hypoglycemia]),
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptina),
• if you are undergoing dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have had pancreatitis.

If you have previously taken vildagliptina 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 vildagliptina. If this happens, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptina, 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 vildagliptina is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptina Viatris

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 vildagliptina if you are taking other medicines such as:

• thiazides or other diuretics (also called water pills),
• corticosteroids (generally 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 vildagliptina during pregnancy. It is not known if vildagliptina passes into breast milk. Do not take vildagliptina if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking vildagliptina, 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 blurred vision. 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 Viatris 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 Vildagliptina Viatris

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

How much to take and when

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

The usual dose of vildagliptina is:

• 50 mg once a day in the morning, if you are taking vildagliptina with another medicine 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 vildagliptina alone, with another medicine 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 Viatris

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Viatris

• Take vildagliptina every day while your doctor tells you to. You may need to continue this treatment for a long time.
• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Vildagliptina Viatris than you should

If you have taken too many vildagliptina tablets, or if someone else has taken your medicine, consult your doctor immediately, or call the Toxicology Information Service, phone 91 562 04 20 .You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the package with you.

If you forget to take Vildagliptina Viatris

If you forget to take a dose of this medicine, 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 missed doses.

If you stop taking Vildagliptina Viatris

Do not stop taking vildagliptina unless your doctor tells you to. If you have doubts about the duration of treatment with vildagliptina, consult 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 vildagliptina 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) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may be indicative of liver disease (hepatitis).
• pancreatitis (rare: may affect up to 1 in 1,000 people): 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 vildagliptina:

• 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, tremors, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (edema), excessive sweating, vomiting, stomach pain and abdominal area (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 sugar levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis.

Since the marketing of this product, 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 rash or flat, red, round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Viatris

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 on the carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use vildagliptina if you notice that the package is damaged or shows signs of tampering.

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 Viatris

• The active substance is vildagliptina.

Each tablet contains 50 mg of vildagliptina.

• The other ingredients are lactose (see section 2, “Before taking Vildagliptina Viatris”), microcrystalline cellulose, pregelatinized maize starch and magnesium stearate.

Appearance of the product and pack contents

Vildagliptina Viatris 50 mg tablets are white to off-white, round, flat tablets with «VLD» on one side and flat on the other.

Vildagliptina Viatris 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks consisting of 3 packs, each containing 112 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Adipharm EAD

130 ‘Simeonovsko shosse’ Blvd.,

1700 Sofia,

Bulgaria

or

Combino Pharm (Malta) Ltd.

HF60, Hal Far Industrial Estate

BBG3000,

Malta

or

Genepharm S.A.

18th km Marathonos Avenue

15351 Pallini Attiki

Greece

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 – Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark Vildagliptin Mylan

Spain Vildagliptina Viatris 50 mg tablets EFG

France Vildagliptine Mylan 50 mg, tablet

Finland Vildagliptin Mylan

Italy Vildagliptin Mylan

Norway Vildagliptin Mylan

Portugal Vildagliptina Mylan

Date of last revision of this leaflet: 07/2023

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