Vildagliptin Viatris 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin Viatris 50 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Vildagliptin Viatris is and what it is used for
2. What you need to know before taking Vildagliptin Viatris
3. How to take Vildagliptin Viatris
4. Possible adverse effects
5. How to store Vildagliptin Viatris
6. Contents of the pack and other information

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

The active substance 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 control blood sugar levels. Your doctor will prescribe vildagliptin either alone or in combination with other antidiabetic medicines you are already taking, if these are not sufficiently effective in controlling diabetes.

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

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

How vildagliptin works

Vildagliptin stimulates the pancreas to 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 from your diabetes.

Even if you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise regimen recommended to you.

2. Before taking/using Vildagliptin Viatris

Do not take this medicine

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

Warnings and precautions

Talk to 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 condition called diabetic ketoacidosis,
• if you are taking an antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood glucose levels [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 a disease of the pancreas.

If you have previously taken vildagliptin but had to stop due to liver disease, you should not take this medicine.

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

You should have liver function tests performed before starting treatment with vildagliptin, every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medicines and Vildagliptin Viatris

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

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

• thiazides or other diuretics (also called water tablets),
• corticosteroids (generally used to treat inflammation),
• thyroid medications,
• certain medicines affecting the nervous system.

Pregnancy and breastfeeding

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

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

Driving and use of machines

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

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable for you to drive or operate machinery.

Vildagliptin Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take/use Vildagliptin Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin required varies from person to person depending on their condition. Your doctor will tell you exactly how many vildagliptin tablets you should take. The maximum daily dose is 100 mg.

The usual dose of vildagliptin is:

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

• 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 sulphonylurea, or with insulin.

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

How to take Vildagliptin Viatris

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin Viatris

• Take vildagliptin every day as long as your doctor tells you to. You may need to continue this treatment for a long period of time.
• Your doctor will carry out periodic checks to ensure that the treatment is having the desired effect.

If you take more Vildagliptin Viatris than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the packaging with you.

If you forget to take Vildagliptin Viatris

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

If you stop treatment with Vildagliptin Viatris

Do not stop taking vildagliptin unless your doctor tells you to. If you have any doubts about how long you should continue treatment with vildagliptin, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Some symptoms require immediate medical attention

You must stop taking vildagliptin and contact your doctor immediately if you experience any of the following adverse 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 indicate a reaction called “angioedema”,
• liver disease (hepatitis) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis),
• inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people): symptoms including severe and persistent pain in the abdomen (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients experienced the following adverse 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 and abdominal pain (abdominal pain), diarrhea, heartburn, nausea (feeling unwell), 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): inflammation of the pancreas.

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

• Frequency not known (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Viatris

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

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin Viatris

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other components are lactose (see section 2, "Before taking/using Vildagliptin Viatris"), microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate.

Appearance of the product and contents of the pack

Vildagliptin Viatris 50 mg tablets are white to off-white, round, flat tablets, marked with "VLD" on one side and plain on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization 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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 – Madrid
Spain

This medicinal product is authorized 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, comprimé
Finland: Vildagliptin Mylan
Italy: Vildagliptin Mylan
Norway: Vildagliptin Mylan
Portugal: Vildagliptina Mylan

Date of the most recent review of this leaflet: 07/2023

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