Package Leaflet: Information for the User

Vildagliptin cinfa 50 mg 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 give it 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 section 4.

The active ingredient of this medication is vildagliptin, which 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 by diet and exercise. It helps 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 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 increase. Both substances are produced in the pancreas.

How Vildagliptina cinfa works

This medication 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 cinfa

• 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 cinfa.

• 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 you take it 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 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 medicines and Vildagliptina cinfa

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 cinfa contains lactose

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

Vildagliptina cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg)per tablet; that is, 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 tablets that 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 along 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

• Swallow the tablet whole with a little water.

Duration of vildagliptin treatment

• 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 cinfa than you should

If you have taken too many tablets of vildagliptin, 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 cinfa

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 the treatment with Vildagliptin cinfa

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 seek medical attention 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) (unknown frequency): 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) (rare: may affect up to 1 in 1,000 people): symptoms that 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:

• Very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common: (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain and abdominal area (abdominal pain), diarrhea, heartburn, nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis (inflammation of the pancreas).

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

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface or hematomas.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 of 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 packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Do not store at a temperature above 30°C.

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. 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 Vildagliptin cinfa

• The active ingredient is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other components are: microcrystalline cellulose , anhydrous lactose , sodium carboxymethylcellulose (type A) (from potato) , low-substitution hydroxypropylcellulose , anhydrous colloidal silica , and stearate and sodium fumarate.

Appearance of the product and contents of the packaging

White, cylindrical, flat, beveled-edge tablets, marked with “L” on one face.

Vildagliptin cinfa 50 mg tablets EFG are available in packaging of 28 and 56 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)

Spain

Last review date of this leaflet: March 2024

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/

You can access detailed and updated information about this medicine 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/86023/P_86023.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86023/P_86023.html