VILDAGLIPTINA TARBIS 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the pack:

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

1. What is Vildagliptina Tarbis 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 they are not effective enough to control your diabetes.

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

Insulin is a substance that helps to reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes sugar production 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. What you need to know before you take Vildagliptina Tarbis

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 you start 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 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 or 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 occurs, 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 Tarbis

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.

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

Driving and using machines

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

Vildagliptina Tarbis contains lactose

Vildagliptina Tarbis contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Vildagliptina Tarbis contains sodium

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

3. How to take Vildagliptina Tarbis

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 recommended dose of vildagliptina is:

• 50 mg once daily 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 Tarbis

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Tarbis

• Take vildagliptina every day for as long as your doctor recommends. 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 Tarbis 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 Tarbis

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 forgotten doses.

If you stop taking Vildagliptina Tarbis

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) (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 vildagliptina 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 vildagliptina 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 vildagliptina and a glitazone:

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

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

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

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

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

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

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

Since the marketing of this product, 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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Tarbis

• 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 refers to the last day of that month.
• Blister: Store in the original package to protect from moisture.
• Bottle: Keep the bottle tightly closed to protect from moisture.
• Do not use Vildagliptina Tarbis if you notice that the packaging is damaged or shows signs of deterioration.

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 other information

Composition of Vildagliptina Tarbis

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

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

Appearance of the product and contents of the pack

Vildagliptina Tarbis 50 mg tablets EFG are white to off-white, round tablets 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 multipacks consisting of 3 packs, each containing 112 tablets, and in HDPE bottles containing 100 tablets.

Not all 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

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

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

Netherlands Vildagliptine Hetero 50 mg tablets

Germany Vildagliptin Hetero 50 mg tablets

Spain Vildagliptina Tarbis 50 mg tablets EFG

Date of last revision of this leaflet: June/2020

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