Leaflet: information for the user

Vildagliptin pensa 50 mg tablets EFG

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 or pharmacist.

-This medicine has been prescribed for you only,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, or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Vildagliptin pensa is and what it is used for

2. What you need to know before you start taking Vildagliptin pensa

3. How to take Vildagliptin pensa

4. Possible side effects

5. Storage of Vildagliptin pensa

6. Contents of the pack and additional information

The active ingredient vildagliptin belongs to a group of medications called “oral antidiabetics”.

Vildagliptin is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely with diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medications 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 causes blood sugar levels to rise. Both substances are produced in the pancreas.

How vildagliptin works

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

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 Vildagliptina pensa

-if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you might be allergic to vildagliptin 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 starting to take Vildagliptina pensa

• 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 medicine known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin 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,
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop taking it due to liver disease, you should not take this medicine.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse 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.

Tests of liver function should be performed before starting treatment with this medicine, at three-month intervals during the first year, and periodically thereafter.This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years.

Other medicines and Vildagliptina pensa

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

Your doctor may change your vildagliptin dose if you are taking other medicines such as:

• thiazides or other diuretics (also called urine medicines),
• corticosteroids (usually used to treat inflammation),
• thyroid medicines,
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use vildagliptin during pregnancy. It is unknown whether vildagliptin passes into breast milk. You should 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.

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as blurred vision. This can be hazardous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

Vildagliptina pensa contains lactose and sodium

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

This medicine contains less than 23 mgof sodium (1 mmol) per tablet; this is essentially “sodium-free”.

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.

What amount should you 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 (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptin alone, with another medication called metformin or a glitazone, with a combination of metformin and a sulfonylurea.

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

How to take Vildagliptin pensa

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin pensa

• Take vildagliptin every 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 more Vildagliptin pensa than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medication, consult your doctor immediately , or call the Toxicology Information Service, phone 91 562 04 20 . 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 take Vildagliptin pensa

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 pensa

Do not stop taking vildagliptin unless your doctor tells you to. If you have doubts about the duration of treatment with vildagliptin, 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 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 swelling of the 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): tremors, 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: tremors, 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 glitazone:

• 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 only:

• 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, tremors, 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, heartburn.
• 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://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 storage conditions.

Do not use this medication 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 you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vildagliptina pensa

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components (excipients) are anhydrous lactose, sodium stearate fumarate, microcrystalline cellulose, and sodium croscarmellose.

Appearance of the product and content of the packaging

Vildagliptina pensa are round, biconvex tablets, white to off-white in color, approximately 8.0 mm in diameter.

They are presented in packaging containing 14, 28, or 56 tablets in aluminum / OPA-aluminum-PVC blisters.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

O

GALENICUM HEALTH, S.L.U.

Calle Sant Gabriel, 50

08950 Esplugues de Llobregat, Barcelona

Spain

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

Spain: Vildagliptina pensa 50 mg tablets EFG

Portugal: Vildagliptina toLife

Italy: Vildagliptin Pensa

Revision date of this leaflet: February 2022

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