Package Insert: Information for the User

Vildagliptin Normon 50 mg Tablets EFG

Vildagliptin

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient of Vildagliptina Normon, 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 solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medicines you are already taking if these are not effective enough to control diabetes.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not work properly. It can also appear if 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 increases blood sugar levels. Both substances are produced in the pancreas.

How Vildagliptina Normon 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 diabetes complications. Although you start taking this medicine for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended.

Do not take Vildagliptina Normon

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

Warnings and precautions

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

• 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 a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood glucose [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 pancreatitis.

If you have previously taken vildagliptin but had to stop taking it 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 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 soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medications and Vildagliptina Normon

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

Your doctor may change your vildagliptin 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 vildagliptin during pregnancy. It is unknown whether vildagliptin passes into breast milk. Do not take vildagliptin if you are breastfeeding or plan to breastfeed.

Driving and operating machines

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

Vildagliptina Normon contains lactose

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

Follow exactly the administration instructions for this medication as 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 you should take varies depending on your condition. Your doctor will indicate exactly the number of vildagliptin tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin 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 alone, with another medication known as 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 or severe kidney disease or if you are undergoing dialysis.

How to Take Vildagliptin Normon

• Swallow the tablet whole with a little water.

Duration of Treatment with Vildagliptin Normon

• Take vildagliptin 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 Normon 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 call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Vildagliptin Normon

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 your 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 Normon

Do not stop taking vildagliptin unless your doctor tells you to. If you have any doubts about the duration of treatment or the use of this medication, ask your doctor, pharmacist, or nurse.

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 vildagliptin 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 levels.
• Infrequent (may affect up to 1 in 100 people): fatigue.

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

• Frequent: tremor, headache, dizziness, weakness, decreased blood glucose levels.
• Infrequent: constipation.
• Rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion.

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

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

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

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

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

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

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

• Frequent: headache, chills, nausea (discomfort), low blood glucose levels, 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 any special temperature for conservation.

Store in the original packaging to protect it from moisture.

Do not use Vildagliptina Normon if you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Vildagliptin Normon

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are lactose, microcrystalline cellulose, crospovidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Vildagliptin Normon 50 mg tablets EFGare round, white to slightly yellowish, flat, bisected, and marked with «V» on one face and anonymous on the other.

Aluminum - Polyamide/Aluminum/PVC blisters. Packaging of 28 and 56 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:August 2021

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86150/P_86150.html