Vildagliptin Kern Pharma 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin Kern Pharma 50 mg tablets EFG

vildagliptin

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, pharmacist or nurse.
• 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 could harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

List of contents in this leaflet:

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

1. What Vildagliptina Kern Pharma is and what it is used for

The active substance in 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 control blood sugar levels. Your doctor will prescribe this medicine 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 reduce 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 Vildagliptina Kern Pharma works

This medicine 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 recommended to you.

2. What you need to know before taking Vildagliptin Kern Pharma

Do not take Vildagliptin Kern Pharma:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptin Kern Pharma

• 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 this medicine to prevent low blood glucose levels [hypoglycaemia]).
• 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 must 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 this medicine. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Vildagliptin Kern Pharma, every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating increased liver enzymes (transaminases).

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Taking Vildagliptin Kern Pharma with other medicines

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 Kern Pharma 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 that affect 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 this medicine during pregnancy. It is unknown whether Vildagliptin Kern Pharma passes into breast milk. You must not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking Vildagliptin Kern Pharma, do not drive or operate tools or machinery.

Vildagliptin Kern Pharma contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

3. How to take Vildagliptin Kern Pharma

Follow exactly the instructions for using this medicine 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 required varies from person to person depending on their condition. Your doctor will tell you exactly how many tablets of Vildagliptin Kern Pharma you should take. The maximum daily dose is 100 mg.

The recommended dose of Vildagliptin Kern Pharma 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 divided doses of 50 mg in the morning and evening, if you are taking Vildagliptin Kern Pharma alone, with another medicine known as metformin or a glitazone, or with a combination of metformin and a sulfonylurea.

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

How to take Vildagliptin Kern Pharma

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin Kern Pharma

• Take this medicine 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 Kern Pharma than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, consult your doctor immediately. You may require medical attention. If you visit a doctor or go to the nearest hospital, take the pack with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Vildagliptin Kern Pharma

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 taking Vildagliptin Kern Pharma

Do not stop taking Vildagliptin Kern Pharma unless your doctor tells you to. If you have any doubts about the duration of treatment with Vildagliptin Kern Pharma, 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 Vildagliptina Kern Pharma 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 abdominal pain (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 vildagliptine 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 Vildagliptina Kern Pharma 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 Vildagliptina Kern Pharma 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 Vildagliptina Kern Pharma 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 Vildagliptina Kern Pharma, metformin and a sulfonylurea:

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

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

• Common: headache, chills, nausea (malaise), low blood glucose levels, stomach burning
• Uncommon: diarrhea, flatulence

Since 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 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 Kern Pharma

• Keep this medicine out of 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.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Kern Pharma

• The active substance is vildagliptin.
• Each tablet contains 50 mg of vildagliptin.
• The other components are lactose, microcrystalline cellulose, sodium carboxymethylstarch type A (from potato), and magnesium stearate.

Appearance of the product and contents of the pack

Vildagliptina Kern Pharma 50 mg tablets EFG are white, round tablets, approximately 9 x 4.06 mm ± 0.04 mm in size, with a score on one side and a "K" engraved on the other.

Vildagliptina Kern Pharma 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 and Manufacturer

Kern Pharma S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Spain: Vildagliptina Kern Pharma 50 mg tablets EFG

Portugal: Vildagliptina Pharmakern 50 mg tablets

Date of the most recent review of this leaflet: June 2022

Other sources of information

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/