Vildagliptin Tarbis 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin Tarbis 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Vildagliptina Tarbis 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 of 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 that has been recommended to you.

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

Do not take this medicine

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If you think you might 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 taking 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 sugar 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 pancreatic disease.

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

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's advice on 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 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• thiazides or other diuretics (also called water tablets),
• corticosteroids (commonly 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 are planning 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 planning to breastfeed.

Driving and using machines

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

Vildagliptin Tarbis contains lactose

Vildagliptin Tarbis contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

Vildagliptin Tarbis contains sodium

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

3. How to take Vildagliptin Tarbis

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

How much to take and when

The dose of vildagliptin each person should take varies 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 recommended dose of vildagliptin is:

• 50 mg once daily in the morning, if you are taking vildagliptin together 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 are undergoing dialysis.

How to take Vildagliptin

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin

• 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 the treatment is having the desired effect.

If you take more Vildagliptin than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, consult your doctor immediately, or call the Toxicology Information Service at telephone number 91 562 04 20. You may require 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 Vildagliptin

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 forgotten doses.

If you stop treatment with Vildagliptin

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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) (rare): 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) (frequency not known): 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 and metformin:

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

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

• Common: tremor, headache, dizziness, weakness, decreased blood glucose.
• Uncommon: constipation.
• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion.

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

• Common: weight gain, swollen hands, ankles, or feet (edema).
• Uncommon: headache, weakness, decreased blood glucose.

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

• Common: dizziness.
• Uncommon: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, decreased blood glucose.
• Very rare: sore throat, nasal congestion, fever.

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

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

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

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

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

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

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Tarbis

• 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 packaging after "EXP". The expiry date refers to the last day of the month indicated.
• Blister: store in the original packaging to protect it from moisture.
• Bottle: keep the bottle tightly closed to protect it from moisture.
• Do not use Vildagliptin Tarbis if you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Tarbis

• The active substance is vildagliptine.

Each tablet contains 50 mg of vildagliptine.

• The other components are microcrystalline cellulose (E460), anhydrous lactose, sodium starch glycolate (type A) and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Vildagliptina Tarbis 50 mg tablets EFG are round, white to off-white tablets, marked with "V15" on one side and "H" on the other.

Vildagliptina Tarbis 50 mg tablets EFG 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, as well as in HDPE bottles containing 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Netherlands: Vildagliptine Hetero 50 mg tabletten
Germany: Vildagliptin Hetero 50 mg tabletten
Spain: Vildagliptina Tarbis 50 mg comprimidos EFG

Date of the most recent revision of the leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}