Package Leaflet: Information for the User

Vildagliptina Stada 50mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What is Vildagliptina Stada and what it is used for

2.What you need to know before you start taking Vildagliptina Stada

3.How to take Vildagliptina Stada

4.Possible side effects

5.Storage of Vildagliptina Stada

6.Contents of the pack and additional information

The active ingredient ofVildagliptina Stada, vildagliptina, belongs to a group of medications called“oral antidiabetic drugs”.

Vildagliptinais used to treat adult patients with type2 diabetes when the diabetes cannot be controlled solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptina alone or in combination with other oral antidiabetic drugs you are already taking if these are not sufficiently effective in controlling diabetes.

Type2 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 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 Stada works

Vildagliptinastimulates the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medication has been shown to reduce blood sugar levels, which will help 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.

Do not take vildagliptin:

• if you are allergic to vildagliptin or to any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin if you:

• have type1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taking it with vildagliptin to avoid low blood sugar [hypoglycemia]).
• have moderate or severe kidney disease (you will need to take a lower dose of vildagliptin).
• are undergoing dialysis.
• have liver disease.
• have heart failure.
• 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 vildagliptin. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment withvildagliptin, 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 ofvildagliptinis not recommended in children and adolescents under 18years.

Other medications and Vildagliptin Stada

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 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 machinery

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

Vildagliptin Stada 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 23 mg of sodium (1mmol) 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.

Dose

The dose ofvildagliptinthat each person should take varies depending on their condition. Your doctor will indicate exactly the number ofvildagliptintablets that you should take. The maximum daily dose is 100mg.

The recommended dose ofvildagliptinis:

• 50mg once a day in the morning, if you are takingvildagliptinalong with another medication known as asulfonilurea.

• 100mg per day in two doses of 50mg in the morning and evening if you are takingvildagliptinalone, with another medication known asmetforminor aglitazona, with a combination ofmetformin and a sulfonilurea, or withinsulin (with or without metformin).

• 50mg per day in the morning if you havemoderate or severe kidney diseaseor if you are undergoingdialysis.

How to takeVildagliptin Stada

• Swallow the tablet whole with a little water.

Duration of treatment withVildagliptin Stada

Takevildagliptinevery day as your doctor indicates. You may have 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 moreVildagliptin Stadathan you should

If you have taken too many tablets ofvildagliptin, or if someone else has taken your medication,consult your doctor immediately.

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.

You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

If you forget to takeVildagliptin Stada

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 withVildagliptin Stada

Do not stop takingthis medicationunless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctororpharmacist.

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

Some symptoms require immediate medical attention

You should stop takingvildagliptinand seek medical attention immediately if you experience any of the following side effects:

• angioedema (rare: may affect up to 1 in 1,000people).Symptoms include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or urticaria
• liver disease (hepatitis) (rare).Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine
• pancreatitis (inflammation of the pancreas) (unknown frequency).Symptoms include intense and persistent abdominal pain (stomach area), which may radiate to 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 10people)

• shaking, headache, dizziness, nausea, low blood glucose

Rare (may affect up to 1 in 100people)

• fatigue

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

Frequent

• shaking, headache, dizziness, weakness, low blood glucose

Rare

• constipation

Very rare (may affect up to 1 in 10,000people)

• sore throat, nasal congestion

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

Frequent

• weight gain, swollen hands, ankles, or feet (edema)

Rare

• headache, weakness, low blood glucose

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

Frequent:

• dizziness

Rare

• headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood glucose

Very rare

• sore throat, nasal congestion, fever

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

Frequent

• dizziness, shaking, weakness, low blood glucose, 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, heartburn

Rare

• diarrhea, flatulence

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

Unknown frequency (cannot be estimated from available data)

• pruritic rash, pancreatitis, localized skin peeling or blisters, muscle pain
• liver disease (hepatitis): usually resolves when treatment is discontinued. Symptoms include yellow skin and eyes, nausea, loss of appetite, or dark-colored urine.
• abnormal liver function tests, usually reversible when treatment is suspended.

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 Medicinal Products for Human Use 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 pack and on the packaging after "CAD". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

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

Composition of Vildagliptina Stada 50 mg tablets EFG

• The active ingredient is vildagliptin. Each tablet contains 50mg of vildagliptin.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate (type A) (from potato) and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Vildagliptina Stada 50 mg tablets EFG are round, white to pale yellow tablets, flat, beveled edges and a diameter of 8.0 ± 0.2 mm.

Vildagliptina Stada 50 mg tablets EFG is available in carton boxes containing normal or single-dose blisters of14, 28, 30, 56, 60, 90, 105, 112 or 180tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Last review date of this leaflet:April 2021

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