Package Insert: Information for the User

Vildagliptina Kern Pharma 50mg Tablets EFG

vildagliptina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

The active ingredient of this medication, vildagliptin, belongs to a group of medications called «oral antidiabetics».

Vildagliptin is used to treat adult patients with type 2 diabetes when the diabetes cannot be controlled solely by diet and exercise. It helps to control blood sugar levels. Your doctor will prescribe this medication alone or in combination with other antidiabetic medications you are already taking if these are not sufficiently effective in controlling diabetes.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not function 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 the production of sugar by the liver and causes blood sugar levels to increase. Both substances are produced in the pancreas.

How Vildagliptina Kern Pharma works

This medication stimulates the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels. This medication has been shown to reduce blood sugar levels, which will help to prevent complications of your diabetes. Although you start taking this medication for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended to you.

Do not take Vildagliptina Kern Pharma:

• if you are allergic to vildagliptin or any of the other components of this medication (listed in section6). If you think you could be allergic to vildagliptin or any other component of Vildagliptina Kern Pharma, do not take this medication and consult your doctor.

Warnings and precautions

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

• if you have type1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken with this medication to avoid low blood sugar [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.
• ifyou have or have had pancreatitis.

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

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 medication. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Vildagliptina Kern Pharma, at three-month intervals 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 this medication is not recommended in children and adolescents under 18years.

Use of Vildagliptina Kern Pharma with other medications

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

Your doctor may change your Vildagliptina Kern Pharma dose if you are taking other medications such as:

• thiazides or other diuretics (also known as urine medications)
• corticosteroids (usually used to treat inflammation)
• thyroid medications
• certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use this medication during pregnancy. It is unknown whether Vildagliptina Kern Pharma passes into breast milk. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

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

Vildagliptina Kern Pharma contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

How much to take and when

The dose of vildagliptin that each person should take varies depending on their condition. Your doctor will indicate exactly the number of Vildagliptin Kern Pharma tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of Vildagliptin Kern Pharma is:

• 50 mg once a day in the morning, if you are taking vildagliptin together with another medication known as a sulfonylurea.

• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking Vildagliptin Kern Pharma alone, with another medication known as metformin or a glitazone, with a combination of metformin and a sulfonylurea.

• 50 mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Vildagliptin Kern Pharma

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin Kern Pharma

• Take this medication every day as your doctor indicates. You may need to follow this treatment for a long period of time.
• Your doctor will perform regular checks to ensure that 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 medication,consult your doctor immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vildagliptin Kern Pharma

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at your 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 the missed doses.

If you interrupt treatment with Vildagliptin Kern Pharma

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

You should stop taking Vildagliptina Kern Pharma 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 that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (unknown frequency): symptoms that include intense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptin and metformin:

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

Some patients experienced the following side effects while taking Vildagliptina Kern Pharma and a sulfonylurea:

• Frequent: tremor, headache, dizziness, weakness, decreased blood glucose
• Infrequent: 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 Kern Pharma and a glitazone:

• Frequent: weight gain, swollen hands, ankles, or feet (edema)
• Infrequent: headache, weakness, decreased blood glucose

Some patients experienced the following side effects while taking Vildagliptina Kern Pharma only:

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

Some patients have had the following side effects while taking Vildagliptina Kern Pharma, metformin, and a sulfonylurea:

• Frequent: dizziness, tremor, weakness, low blood glucose, excessive sweating

Some patients have had the following side effects while taking Vildagliptina Kern Pharma and insulin (with or without metformin):

• Frequent: headache, chills, nausea (discomfort), low blood glucose, stomach burning
• Infrequent: diarrhea, flatulence

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

• Unknown frequency (cannot be estimated from available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the blister and on the packaging after "CAD". The expiration date is the last day of the month indicated.
• This medication does not require special conditions for conservation.
• Medications should not be thrown into the drains or trash.Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vildagliptina Kern Pharma

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

Appearance of the product and contents of the packaging

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

Vildagliptina Kern Pharma 50 mg tablets are available in packaging containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multiple packaging formed by 3 packaging, each containing 112 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicine has been authorized in the member states of the European Economic Area with the following names:

Spain Vildagliptina Kern Pharma 50 mg tablets EFG

Portugal Vildagliptina Pharmakern 50 mg tablets

Date of the last review of this leaflet: June 2022

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/